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Human Rights Documentation

Human rights are fundamental to the United Nations. The Preamble of the UN Charter states:

We the peoples of the United Nations [are] determined... to reaffirm faith in fundamental human rights, in the dignity and worth of the human person, in the equal rights of men and women and of nations large and small.

One of the early acts of the General Assembly was to draft and adopt the Universal Declaration of Human Rights, resolution 217 A of 10 December 1948. 

More recent UN actions include the adoption of international human rights treaties, the creation of the position of United Nations High Commissioner for Human Rights in 1993 and the establishment of the Human Rights Council in 2006. There is on-going discussion  about how to reform the treaty-body system. 

During its 60th session, the General Assembly adopted the World Summit Outcome, resolution 60/1  of 16 September 2005, which called, inter alia, for strengthening of the UN's human rights mechanisms. Reform of the human rights mechanisms is ongoing and the documentation is changing to reflect the changes. This guide provides an overview of current practice, as well as guidance on the historical documentation. 

The UN Yearbook on Human Rights was published for the years 1946-1988. 

Available Translations

Arabic: وثائق الأمم المتحدة: حقوق الإنسان

Chinese: 联合国文件: 人权

English: UN Human Rights Documentation

French: Documents de l’ONU : Droits de l’homme

Spanish: Documentación de la ONU : Derechos Humanos

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• URL: https://research.un.org/en/docs/humanrights

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Human Rights

Human rights are norms that aspire to protect all people everywhere from severe political, legal, and social abuses. Examples of human rights are the right to freedom of religion, the right to a fair trial when charged with a crime, the right not to be tortured, and the right to education.

The philosophy of human rights addresses questions about the existence, content, nature, universality, justification, and legal status of human rights. The strong claims often made on behalf of human rights (for example, that they are universal, inalienable, or exist independently of legal enactment as justified moral norms) have frequently provoked skeptical doubts and countering philosophical defenses (on these critiques see Lacrois and Pranchere 2016, Mutua 2008, and Waldron 1988). Reflection on these doubts and the responses that can be made to them has become a sub-field of political and legal philosophy with a very substantial literature (see the Bibliography below).

This entry addresses the concept of human rights, the existence and grounds of human rights, the question of which rights are human rights, and relativism about human rights.

1. The General Idea of Human Rights

2.1 how can human rights exist, 2.2 normative justifications for human rights, 2.3 political conceptions of human rights, 3.1 civil and political rights, 3.2 social rights, 3.3 rights of women, minorities, and groups, 3.4 environmental rights, 4. universal human rights in a world of diverse beliefs and practices, bibliography: books and articles in the philosophy of human rights, recent collections, guides to international human rights law, other resources, related entries.

This section attempts to explain the general idea of human rights by identifying four defining features. The goal is to answer the question of what human rights are with a description of the core concept rather than a list of specific rights. Two people can have the same general idea of human rights even though they disagree about which rights belong on a list of such rights and even about whether universal moral rights exist. The four-part explanation below attempts to cover all kinds of human rights including both moral and legal human rights and both old and new human rights (e.g., both Lockean natural rights and contemporary human rights). The explanation anticipates, however, that particular kinds of human rights will have additional features. Starting with this general concept does not commit us to treating all kinds of human rights in a single unified theory (see Buchanan 2013 for an argument that we should not attempt to theorize together universal moral rights and international legal human rights).

(1) Human rights are rights . Lest we miss the obvious, human rights are rights (see Cruft 2012 and the entry on rights ). Most if not all human rights are claim rights that impose duties or responsibilities on their addressees or dutybearers. Rights focus on a freedom, protection, status, or benefit for the rightholders (Beitz 2009). The duties associated with human rights often require actions involving respect, protection, facilitation, and provision. Rights are usually mandatory in the sense of imposing duties on their addressees, but some legal human rights seem to do little more than declare high-priority goals and assign responsibility for their progressive realization. One can argue, of course, that goal-like rights are not real rights, but it may be better to recognize that they comprise a weak but useful notion of a right (See Beitz 2009 for a defense of the view that not all human rights are rights in a strong sense. And see Feinberg 1973 for the idea of “manifesto rights”). A human rights norm might exist as (a) a shared norm of actual human moralities, (b) a justified moral norm supported by strong reasons, (c) a legal right at the national level (where it might be referred to as a “civil” or “constitutional” right), or (d) a legal right within international law. A human rights advocate might wish to see human rights exist in all four ways (See Section 2.1 How Can Human Rights Exist?).

(2) Human rights are plural . If someone accepted that there are human rights but held that there is only one of them, this might make sense if she meant that there is one abstract underlying right that generates a list of specific rights (See Dworkin 2011 for a view of this sort). But if this person meant that there is just one specific right such as the right to peaceful assembly this would be a highly revisionary view. Human rights address a variety of specific problems such as guaranteeing fair trials, ending slavery, ensuring the availability of education, and preventing genocide. Some philosophers advocate very short lists of human rights but nevertheless accept plurality (see Cohen 2004, Ignatieff 2004).

(3) Human rights are universal . All living humans—or perhaps all living persons —have human rights. One does not have to be a particular kind of person or a member of some specific nation or religion to have human rights. Included in the idea of universality is some conception of independent existence . People have human rights independently of whether they are found in the practices, morality, or law of their country or culture. This idea of universality needs several qualifications, however. First, some rights, such as the right to vote, are held only by adult citizens or residents and apply only to voting in one’s own country. Second, the human right to freedom of movement may be taken away temporarily from a person who is convicted of committing a serious crime. And third, some human rights treaties focus on the rights of vulnerable groups such as minorities, women, indigenous peoples, and children.

(4) Human rights have high-priority . Maurice Cranston held that human rights are matters of “paramount importance” and their violation “a grave affront to justice” (Cranston 1967). If human rights did not have high priority they would not have the ability to compete with other powerful considerations such as national stability and security, individual and national self-determination, and national and global prosperity. High priority does not mean, however, that human rights are absolute. As James Griffin says, human rights should be understood as “resistant to trade-offs, but not too resistant” (Griffin 2008). Further, there seems to be priority variation within human rights. For example, when the right to life conflicts with the right to privacy, the latter will generally be outweighed.

Let’s now consider five other features or functions that might be added.

Should human rights be defined as inalienable? Inalienability does not mean that rights are absolute or can never be overridden by other considerations. Rather it means that its holder cannot lose it temporarily or permanently by bad conduct or by voluntarily giving it up. It is doubtful that all human rights are inalienable in this sense. One who endorses both human rights and imprisonment as punishment for serious crimes must hold that people’s rights to freedom of movement can be forfeited temporarily or permanently by just convictions of serious crimes. Perhaps it is sufficient to say that human rights are very hard to lose. (For a stronger view of inalienability, see Donnelly 2003, Meyers 1985).

Should human rights be defined as minimal rights? A number of philosophers have proposed the view that human rights are minimal in the sense of not being too numerous (a few dozen rights rather than hundreds or thousands), and not being too demanding (See Joshua Cohen 2004, Ignatieff 2005, and Rawls 1999). Their views suggest that human rights are—or should be—more concerned with avoiding the worst than with achieving the best. Henry Shue suggests that human rights concern the “lower limits on tolerable human conduct” rather than “great aspirations and exalted ideals” (Shue 1996). When human rights are modest standards they leave most legal and policy matters open to democratic decision-making at the national and local levels. This allows human rights to have high priority, to accommodate a great deal of cultural and institutional variation among countries, and to leave open a large space for democratic decision-making at the national level. Still, there is no contradiction in the idea of an extremely expansive list of human rights and hence minimalism is not a defining feature of human rights (for criticism of the view that human rights are minimal standards see Brems 2009 and Raz 2010). Minimalism is best seen as a normative prescription for what international human rights should be. Moderate forms of minimalism have considerable appeal, but not as part of the definition of human rights.

Should human rights be defined as always being or “mirroring” moral rights? Philosophers coming to human rights theory from moral philosophy sometimes assume that human rights must be, at bottom, moral rather than legal rights. There is no contradiction, however, in people saying that they believe in human rights, but only when they are legal rights at the national or international levels. As Louis Henkin observed, “Political forces have mooted the principal philosophical objections, bridging the chasm between natural and positive law by converting natural human rights into positive legal rights” (Henkin 1978). Theorists who insist that the only human rights are legal rights may find, however, that the interpretations they can give of universality, independent existence, and high priority are weak.

Should human rights be defined in terms of serving some sort of political function? Instead of seeing human rights as grounded in some sort of independently existing moral reality, a theorist might see them as the norms of a highly useful political practice that humans have constructed or evolved. Such a view would see the idea of human rights as playing various political roles at the national and international levels and as serving thereby to protect urgent human and national interests. These political roles might include providing standards for international evaluations of how governments treat their people and specifying when use of economic sanctions or military intervention is permissible (see Section 2.3 Political Conceptions of Human Rights below).

Political theorists would add to the four defining elements suggested above some set of political roles or functions. This kind of view may be plausible for the very salient international human rights that have emerged in international law and politics in the last fifty years. But human rights can exist and function in contexts not involving international scrutiny and intervention such as a world with only one state. Imagine, for example, that an asteroid strike had killed everyone in all countries except New Zealand, leaving it the only state in existence. Surely the idea of human rights as well as many dimensions of human rights practice could continue in New Zealand, even though there would be no international relations, law, or politics (for an argument of this sort see Tasioulas 2012). And if in the same scenario a few people were discovered to have survived in Iceland and were living without a government or state, New Zealanders would know that human rights governed how these people should be treated even though they were stateless. How deeply the idea of human rights must be rooted in international law and practice should not be settled by definitional fiat. We can allow, however, that the sorts of political functions that Rawls and Beitz describe are typically served by international human rights today.

2. The Existence and Grounds of Human Rights

A philosophical question about human rights that occurs to many people is how it is possible for such rights to exist. Several possible ways are explored in this section.

The most obvious way in which human rights come into existence is as norms of national and international law that are created by enactment, custom, and judicial decisions. At the international level, human rights norms exist because of treaties that have turned them into international law. For example, the human right not to be held in slavery or servitude in Article 4 of the European Convention for the Protection of Human Rights and Fundamental Freedoms (Council of Europe, 1950) and in Article 8 of the International Covenant on Civil and Political Rights (UN 1966) exists because these treaties establish it. At the national level, human rights norms exist because they have through legislative enactment, judicial decision, or custom become part of a country’s law. For example, the right against slavery exists in the United States because the 13th Amendment to the U.S. Constitution prohibits slavery and servitude. When rights are embedded in international law we speak of them as human rights; but when they are enacted in national law we more frequently describe them as civil or constitutional rights.

Enactment in national and international law is clearly one of the ways in which human rights exist. But many have suggested that this cannot be the only way. If human rights exist only because of enactment, their availability is contingent on domestic and international political developments. Many people have looked for a way to support the idea that human rights have roots that are deeper and less subject to human decisions than legal enactment. One version of this idea is that people are born with rights, that human rights are somehow innate or inherent in human beings (see Morsink 2009). One way that a normative status could be inherent in humans is by being God-given. The U.S. Declaration of Independence (1776) claims that people are “endowed by their Creator” with natural rights to life, liberty, and the pursuit of happiness. On this view, God, the supreme lawmaker, enacted some basic human rights.

Rights plausibly attributed to divine decree must be very general and abstract (life, liberty, etc.) so that they can apply to thousands of years of human history, not just to recent centuries. But contemporary human rights are specific and many of them presuppose contemporary institutions (e.g., the right to a fair trial and the right to education). Even if people are born with God-given natural rights, we need to explain how to get from those general and abstract rights to the specific rights found in contemporary declarations and treaties.

Attributing human rights to God’s commands may give them a secure status at the metaphysical level, but in a very diverse world it does not make them practically secure. Billions of people do not believe in the God of Christianity, Islam, and Judaism. If people do not believe in God, or in the sort of god that prescribes rights, and if you want to base human rights on theological beliefs you must persuade these people of a rights-supporting theological view. This is likely to be even harder than persuading them of human rights. Legal enactment at the national and international levels provides a far more secure status for practical purposes.

Human rights could also exist independently of legal enactment by being part of actual human moralities. All human groups seem to have moralities in the sense of imperative norms of interpersonal behavior backed by reasons and values. These moralities contain specific norms (for example, a prohibition of the intentional murder of an innocent person) and specific values (for example, valuing human life.) If almost all human groups have moralities containing norms prohibiting murder, these norms could partially constitute the human right to life.

The view that human rights are norms found in all human moralities is attractive but has serious difficulties. Although worldwide acceptance of human rights has been increasing rapidly in recent decades (see 4. Universal Human Rights in a World of Diverse Beliefs and Practices ), worldwide moral unanimity about human rights does not exist. Human rights declarations and treaties are intended to change existing norms, not just describe the existing moral consensus.

Yet another way of explaining the existence of human rights is to say that they exist most basically in true or justified ethical outlooks. On this account, to say that there is a human right against torture is mainly to assert that there are strong reasons for believing that it is always morally wrong to engage in torture and that protections should be provided against it. This approach would view the Universal Declaration as attempting to formulate a justified political morality for the whole planet. It was not merely trying to identify a preexisting moral consensus; it was rather trying to create a consensus that could be supported by very plausible moral and practical reasons. This approach requires commitment to the objectivity of such reasons. It holds that just as there are reliable ways of finding out how the physical world works, or what makes buildings sturdy and durable, there are ways of finding out what individuals may justifiably demand of each other and of governments. Even if unanimity about human rights is currently lacking, rational agreement is available to humans if they will commit themselves to open-minded and serious moral and political inquiry. If moral reasons exist independently of human construction, they can—when combined with true premises about current institutions, problems, and resources—generate moral norms different from those currently accepted or enacted. The Universal Declaration seems to proceed on exactly this assumption (see Morsink 2009). One problem with this view is that existence as good reasons seems a rather thin form of existence for human rights. But perhaps we can view this thinness as a practical rather than a theoretical problem, as something to be remedied by the formulation and enactment of legal norms. The best form of existence for human rights would combine robust legal existence with the sort of moral existence that comes from widespread acceptance based on strong moral and practical reasons.

Justifications for human rights should defend their main features including their character as rights, their universality, and their high priority. Such justifications should also be capable of providing starting points for justifying a plausible list of specific rights (on starting points and making the transition to specific rights see Nickel 2007; see also Section 3 Which Rights are Human Rights? below). Further, justifying international human rights is likely to require additional steps (Buchanan 2012). These requirements make the construction of a good justification for human rights a daunting task.

Approaches to justification include grounding human rights in prudential reasons, practical reasons, moral rights (Thomson 1990), human well-being (Sumner 1987, Talbott 2010), fundamental interests (Beitz 2015), human needs (Miller 2012), agency and autonomy (Gewirth 1996, Griffin 2008) dignity (Gilabert 2018, Kateb 2011, Tasioulas 2015), fairness (Nickel 2007), equality, and positive freedom (Gould 2004, Nussbaum 2000, Sen 2004). Justifications can be based on just one of these types of reasons or they can be eclectic and appeal to several (Tasioulas. 2015).

Grounding human rights in human agency and autonomy has had strong advocates in recent decades. For example, in Human Rights: Essays on Justification and Application (1982) Alan Gewirth offered an agency-based justification for human rights. He argued that denying the value of successful agency and action is not an option for a human being; having a life requires regarding the indispensable conditions of agency and action as necessary goods. Abstractly described, these conditions of successful agency are freedom and well-being. A prudent rational agent who must have freedom and well-being will assert a “prudential right claim” to them. Having demanded that others respect her freedom and well-being, consistency requires her to recognize and respect the freedom and well-being of other persons. Since all other agents are in exactly the same position as she is of needing freedom and well-being, consistency requires her to recognize and respect their claims to freedom and well-being. She “logically must accept” that other people as agents have equal rights to freedom and well-being. These two abstract rights work alone and together to generate equal specific human rights of familiar sorts (Gewirth 1978, 1982, 1996). Gewirth’s aspiration was to provide an argument for human rights that applies to all human agents and that is inescapable. From a few hard-to-dispute facts and a principle of consistency he thinks we can derive two generic human rights—and from them, a list of more determinate rights. Gewirth’s views have generated a large critical literature (see Beyleveld 1991, Boylan 1999).

A more recent attempt to base human rights on agency and autonomy is found in James Griffin’s book, On Human Rights (2008). Griffin does not share Gewirth’s goal of providing a logically inescapable argument for human rights, but his overall view shares key structural features with Gewirth’s. These include starting the justification with the unique value of human agency and autonomy (which Griffin calls “normative agency”), postulating some abstract rights (autonomy, freedom, and well-being), and making a place for a right to well-being within an agency-based approach.

In the current dispute between “moral” (or “orthodox”) and “political” conceptions of human rights, Griffin strongly sides with those who see human rights as fundamentally moral rights. Their defining role, in Griffin’s view, is protecting people’s ability to form and pursue conceptions of a worthwhile life—a capacity that Griffin variously refers to as “autonomy,” “normative agency,” and “personhood.” This ability to form, revise, and pursue conceptions of a worthwhile life is taken to be of paramount value, the exclusive source of human dignity, and thereby the basis of human rights (Griffin 2008). Griffin holds that people value this capacity “especially highly, often more highly than even their happiness.”

“Practicalities” also shape human rights in Griffin’s view. He describes practicalities as “a second ground” of human rights. They prescribe making the boundaries of rights clear by avoiding “too many complicated bends,” enlarging rights a little to give them safety margins, and consulting facts about human nature and the nature of society. Accordingly, the justifying generic function that Griffin assigns to human rights is protecting normative agency while taking account of practicalities.

Griffin claims that human rights suffer even more than other normative concepts from an “indeterminacy of sense” that makes them vulnerable to proliferation (Griffin 2008). He thinks that tying all human rights to the single value of normative agency while taking account of practicalities is the best way to remedy this malady. He criticizes the frequent invention of new human rights and the “ballooning of the content” of established rights. Still, Griffin is friendly towards most of the rights in the Universal Declaration of Human Rights. Beyond this, Griffin takes human rights to include many rights in interpersonal morality. For example, Griffin thinks that a child’s human right to education applies not just against governments but also against the child’s parents.

Griffin’s thesis that all human rights are grounded in normative agency is put forward not so much as a description but as a proposal, as the best way of giving human rights unity, coherence, and limits. Unfortunately, accepting and following this proposal is unlikely to yield effective barriers to proliferation or a sharp line between human rights and other moral norms. The main reason is one that Griffin himself recognizes: the “generative capacities” of normative agency are “quite great.” Providing adequate protections of the three components of normative agency (autonomy, freedom, and minimal well-being) will encounter a lot of threats to these values and hence will require lots of rights.

Views that explain human rights in terms of the practical political roles that they play have had prominent advocates in recent decades. These “political” conceptions of human rights explain what human rights are by describing the things that they do . Two philosophers who have developed political conceptions are discussed in this section, namely, John Rawls and Charles Beitz (for helpful discussions of political conceptions and their alternatives see the collections of essays in Etinson 2018 and Maliks and Schaffer 2017).

Advocates of political conceptions of human rights are often agnostic or skeptical about universal moral rights while rejecting wholesale moral skepticism and thinking possible the provision of sound normative justifications for the content, normativity, and roles of human rights (for challenges to purely political views see Gilabert 2011, Liao and Etinson 2012, Sangiovanni 2017, and Waldron 2018).

John Rawls introduced the idea of a political conception of human rights in his book, The Law of Peoples (Rawls 1999). The basic idea is that we can understand what human rights are and what their justification requires by identifying the main roles they play in some political sphere. In The Law of Peoples this sphere is international relations (and, secondarily, national politics). Rawls was attempting a normative reconstruction of international law and politics within today’s international system, and this helps explain Rawls’s focus on how human rights function within this system.

Rawls says that human rights are a special class of urgent rights . He seems to accept the definition of human rights given in Section 1 above. Besides saying that human rights are rights that are high priority or “urgent,” Rawls also accepts that they are plural and universal. But Rawls was working on a narrower project than Gewirth and Griffin. The international human rights he was concerned with are also defined by their roles in helping define in various ways the normative structure of the global system. They provide content to other normative concepts such as legitimacy, sovereignty, permissible intervention, and membership in good standing in the international community.

According to Rawls the justificatory process for human rights is analogous to the one for principles of justice at the national level that he described in A Theory of Justice (Rawls 1971). Instead of asking about the terms of cooperation that free and equal citizens would agree to under fair conditions, we ask about the terms of cooperation that free and equal peoples or countries would agree to under fair conditions. We imagine representatives of the world’s countries meeting to choose the normative principles that constitute the basic international structure. These representatives are imagined to see the countries they represent as free (rightfully independent) and equal (equally worthy of respect and fair treatment). These representatives are also imagined to be choosing rationally in light of the fundamental interests of their country, to be reasonable in seeking to find and respect fair terms of cooperation, and impartial because they are behind a “veil of ignorance”—they lack information about the country they represent such as its size, wealth, and power. Rawls holds that under these conditions these representatives will unanimously choose principles for the global order that include some basic human rights (for further explanation of the global original position see the entries on John Rawls and original position ).

Rawls advocated a limited list of human rights, one that leaves out many fundamental freedoms, rights of political participation, and equality rights. He did this for two reasons. One is that he wanted a list that is plausible for all reasonable countries, not just liberal democracies. The second reason is that he viewed serious violations of human rights as triggering permissible intervention by other countries, and only the most important rights can play this role.

Leaving out protections for equality and democracy is a high price to pay for assigning human rights the role of making international intervention permissible when they are seriously violated. We can accommodate Rawls’underlying idea without paying that price. To accept the idea that countries engaging in massive violations of the most important human rights are not to be tolerated we do not need to follow Rawls in equating international human rights with a heavily-pruned list. Instead we can work up a view—which is needed for other purposes anyway—of which human rights are the weightiest and then assign the intervention-permitting role to this subset.

Charles Beitz’s account of human rights in The Idea of Human Rights (Beitz 2009) shares many similarities with Rawls’s but is much more fully developed. Like Rawls, Beitz deals with human rights only as they have developed in contemporary international human rights practice. Beitz suggests that we can develop an understanding of human rights by attending to “the practical inferences that would be drawn by competent participants in the practice from what they regard as valid claims of human rights.” Observations of what competent participants say and do inform the account of what human rights are. The focus is not on what human rights are at some deep philosophical level; it is rather on how they work by guiding actions within a recently emerged and still evolving discursive practice. The norms of the practice guide the interpretation and application of human rights, the appropriateness of criticism in terms of human rights, adjudication in human rights courts, and—perhaps most importantly—responding to serious violations of human rights. Beitz says that human rights are “matters of international concern” and that they are “potential triggers of transnational protective and remedial action.”

Beitz does not agree with Rawls’s view that these roles require an abbreviated list of human rights. He accepts that the requirements of human rights are weaker than the requirements of social justice at the national level, but denies that human rights are minimal or highly modest in other respects.

Beitz rightly suggests that a reasonable person can accept and use the idea of human rights without accepting any particular view about their foundations. It is less clear that he is right in suggesting that good justifications of human rights should avoid as far as possible controversial assumptions about religion, metaphysics, ideology, and intrinsic value (see the entry public reason ). Beitz emphasizes the practical good that human rights do, not their grounds in some underlying moral reality. This helps make human rights attractive to people from around the world with their diverse religious and philosophical traditions. The broad justification for human rights and their normativity that Beitz offers is that they protect “urgent individual interests against predictable dangers (”standard threats“) to which they are vulnerable under typical circumstances of life in a modern world order composed of independent states.”

3. Which Rights are Human Rights?

This section discusses the question of which rights belong on lists of human rights. The Universal Declaration’s list, which has had great influence, consists of six families: (1) Security rights that protect people against murder, torture, and genocide; (2) Due process rights that protect people against arbitrary and excessively harsh punishments and require fair and public trials for those accused of crimes; (3) Liberty rights that protect people’s fundamental freedoms in areas such as belief, expression, association, and movement; (4) Political rights that protect people’s liberty to participate in politics by assembling, protesting, voting, and serving in public office; (5) Equality rights that guarantee equal citizenship, equality before the law, and freedom from discrimination; and (6) Social rights that require that governments ensure to all the availability of work, education, health services, and an adequate standard of living. A seventh category, minority and group rights, has been created by subsequent treaties. These rights protect women, racial and ethnic minorities, indigenous peoples, children, migrant workers, and the disabled.

Not every question of social justice or wise governance is a human rights issue. For example, a country could have too many lawyers or inadequate provision for graduate-level education without violating any human rights. Deciding which norms should be counted as human rights is a matter of considerable difficulty. And there is continuing pressure to expand lists of human rights to include new areas. Many political movements would like to see their main concerns categorized as matters of human rights, since this would publicize, promote, and legitimize their concerns at the international level. A possible result of this is “human rights inflation,” the devaluation of human rights caused by producing too much bad human rights currency (See Cranston 1973, Orend 2002, Wellman 1999, Griffin 2008).

One way to avoid rights inflation is to follow Cranston in insisting that human rights only deal with extremely important goods, protections, and freedoms. A supplementary approach is to impose several justificatory tests for specific human rights. For example, it could be required that a proposed human right not only protect some very important good but also respond to one or more common and serious threats to that good (Dershowitz 2004, Donnelly 2003, Shue 1996, Talbott 2005), impose burdens on the addressees that are justifiable and no larger than necessary, and be feasible in most of the world’s countries (on feasibility see Gilabert 2009 and Nickel 2007). This approach restrains rights inflation with several tests, not just one master test.

In deciding which specific rights are human rights it is possible to make either too little or too much of international documents such as the Universal Declaration and the European Convention. One makes too little of them by proceeding as if drawing up a list of important rights were a new question, never before addressed, and as if there were no practical wisdom to be found in the choices of rights that went into the historic documents. And one makes too much of them by presuming that those documents tell us everything we need to know about human rights. This approach involves a kind of fundamentalism: it holds that when a right is on the official lists of human rights that settles its status as a human right (“If it’s in the book that’s all I need to know.”) But the process of identifying human rights in the United Nations and elsewhere was a political process with plenty of imperfections. There is little reason to take international diplomats as the most authoritative guides to which human rights there are. Further, even if a treaty’s ratification by most countries can settle the question of whether a certain right is a human right within international law, such a treaty cannot settle its weight. The treaty may suggest that the right is supported by weighty considerations, but it cannot make this so. If an international treaty enacted a right to visit national parks without charge as a human right, the ratification of that treaty would make free access to national parks a human right within international law. But it would not be able to make us believe that the right to visit national parks without charge was sufficiently important to be a real human right (see Luban 2015).

The least controversial family of human rights is civil and political rights. These rights are familiar from historic bills of rights such as the French Declaration of the Rights of Man and the Citizen (1789) and the U.S. Bill of Rights (1791, with subsequent amendments). Contemporary sources include the first 21 Articles of the Universal Declaration , and treaties such as the European Convention , the International Covenant on Civil and Political Rights , the American Convention on Human Rights, and the African Charter on Human and People’s Rights . Some representative formulations follow:

Everyone has the right to freedom of thought and expression. This right includes freedom to seek, receive, and impart information and ideas of all kinds, regardless of frontiers, either orally, in writing, in print, in the form of art, or through any other medium of one’s choice. (American Convention on Human Rights, Article 13.1)

Everyone has the right to freedom of peaceful assembly and to freedom of association with others, including the right to form and to join trade unions for the protection of his interests (European Convention, Article 11).

Every citizen shall have the right to participate freely in the government of his country, either directly or through freely chosen representatives in accordance with the provisions of the law. 2. Every citizen shall have the right of equal access to the public service of his country. 3. Every individual shall have the right of access to public property and services in strict equality of all persons before the law (African Charter, Article 13).

Most civil and political rights are not absolute—they can in some cases be overridden by other considerations. For example, the right to freedom of movement can be restricted by public and private property rights, by restraining orders related to domestic violence, and by legal punishments. Further, after a disaster such as a hurricane or earthquake free movement is often appropriately suspended to keep out the curious, permit access of emergency vehicles and equipment, and prevent looting. The International Covenant on Civil and Political Rights permits rights to be suspended during times “of public emergency which threatens the life of the nation” (Article 4). But it excludes some rights from suspension including the right to life, the prohibition of torture, the prohibition of slavery, the prohibition of ex post facto criminal laws, and freedom of thought and religion.

The Universal Declaration included social (or “welfare”) rights that address matters such as education, food, health services, and employment. Their inclusion has been the source of much controversy (see Beetham 1995). The European Convention did not include them (although it was later amended to include the right to education). Instead they were put into a separate treaty, the European Social Charter . When the United Nations began the process of putting the rights of the Universal Declaration into international law, it followed the same pattern by treating economic and social standards in a treaty separate from the one dealing with civil and political rights. This treaty, the International Covenant on Economic, Social, and Cultural Rights (the “Social Covenant,” 1966), treated these standards as rights—albeit rights to be progressively realized.

The Social Covenant’s list of rights includes nondiscrimination and equality for women in economic and social life (Articles 2 and 3), freedom to work and opportunities to work (Article 4), fair pay and decent conditions of work (Article 7), the right to form trade unions and to strike (Article 8), social security (Article 9), special protections for mothers and children (Article 10), the right to adequate food, clothing, and housing (Article 11), the right to basic health services (Article 12), the right to education (Article 13), and the right to participate in cultural life and scientific progress (Article 15).

Article 2.1 of the Social Covenant sets out what each of the parties commits itself to do about this list, namely to “take steps, individually and through international assistance and co-operation…to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant.” In contrast, the Civil and Political Covenant commits its signatories to immediate compliance, to “respect and to ensure to all individuals within its territory the rights recognized in the present Covenant” (Article 2.1). The contrast between these two levels of commitment has led some people to suspect that economic and social rights are really just valuable goals. Why did the Social Covenant opt for progressive implementation and thereby treat its rights as being somewhat like goals? The main reason is that many of the world’s countries lacked the economic, institutional, and human resources to realize these standards fully or even largely. For many countries, noncompliance due to inability would have been certain if these standards had been treated as immediately binding.

Social rights have often been defended with linkage arguments that show the support they provide to adequate realization of civil and political rights. This approach was first developed philosophically by Henry Shue (Shue 1996; see also Nickel 2007 and 2016). Linkage arguments defend controversial rights by showing the indispensable or highly useful support they provide to uncontroversial rights. For example, if a government succeeds in eliminating hunger and providing education to everyone this promotes people’s abilities to know, use, and enjoy their liberties, due process rights, and rights of political participation. Lack of education is frequently a barrier to the realization of civil and political rights because uneducated people often do not know what rights they have and what they can do to use and defend them. Lack of education is also a common barrier to democratic participation. Education and a minimum income make it easier for people near the bottom economically to follow politics, participate in political campaigns, and to spend the time and money needed to go to the polls and vote.

Do social rights yield a sufficient commitment to equality? Objections to social rights as human rights have come from both the political right and the political left. A common objection from the left, including liberal egalitarians and socialists, is that social rights as enumerated in human rights documents and treaties provide too weak of a commitment to material equality (Moyn 2018; Gilabert 2015). Realizing social rights requires a state that ensures to everyone an adequate minimum of resources in some key areas but that does not necessarily have strong commitments to equality of opportunity, to strong redistributive taxation, and to ceilings on wealth (see the entries equality , equality of opportunity , distributive justice , and liberal feminism ).

The egalitarian objection cannot be that human rights documents and treaties showed no concern for people living in poverty and misery. That would be wildly false. One of the main purposes of including social rights in human rights documents and treaties was to promote serious efforts to combat poverty, lack of education, and unhealthy living conditions in countries all around the world (see also Langford 2013 on the UN Millennium Development Goals). The objection also cannot be that human rights facilitated the hollowing out of systems of welfare rights in many developed countries that occurred after 1980. Those cuts in welfare programs were often in violation of the requirements of adequately realizing social rights.

Perhaps it should be conceded that human rights documents and treaties have not said enough about positive measures to promote equal opportunity in education and work. A positive right to equal opportunity, like the one Rawls proposed, would require countries to take serious measures to reduce disparities between the opportunities effectively available to children of high-income and low-income parents (Rawls 1971).

A strongly egalitarian political program is best pursued partially within but mostly beyond the human rights framework. One reason for this is that the human rights movement will have better future prospects for acceptance and realization if it has widespread political support. That requires that the rights it endorses appeal to people with a variety of political views ranging from center-left to center-right. Support from the broad political center will not emerge and survive if the human rights platform is perceived as mostly a leftist program.

Do social rights protect sufficiently important human interests? Maurice Cranston opposed social rights by suggesting that social rights are mainly concerned with matters such as holidays with pay that are not matters of deep and universal human interests (Cranston 1967, 1973. Treatments of objections to social rights include Beetham 1995; Howard 1987; and Nickel 2007). It is far from the case, however, that most social rights pertain only to superficial interests. Consider two examples: the right to an adequate standard of living and the right to free public education. These rights require governments to try to remedy widespread and serious evils such as severe poverty, starvation and malnutrition, and ignorance. The importance of food and other basic material conditions of life is easy to show. These goods are essential to people’s ability to live, function, and flourish. Without adequate access to these goods, interests in life, health, and liberty are endangered and serious illness and death are probable. Lack of access to educational opportunities typically limits (both absolutely and comparatively) people’s abilities to participate fully and effectively in the political and economic life of their country.

Are social rights too burdensome? Another objection to social rights is that they are too burdensome on their dutybearers. It is very expensive to guarantee to everyone basic education and minimal material conditions of life. Frequently the claim that social rights are too burdensome uses other, less controversial human rights as a standard of comparison, and suggests that social rights are substantially more burdensome or expensive than liberty rights. Suppose that we use as a basis of comparison liberty rights such as freedom of communication, association, and movement. These rights require both respect and protection from governments. And people cannot be adequately protected in their enjoyment of liberties such as these unless they also have security and due process rights. The costs of liberty, as it were, include the costs of law and criminal justice. Once we see this, liberty rights start to look a lot more costly.

Further, we should not generally think of social rights as simply giving everyone a free supply of the goods they protect. Guarantees of things like food and housing will be intolerably expensive and will undermine productivity if everyone simply receives a free supply. A viable system of social rights will require most people to provide these goods for themselves and their families through work as long as they are given the necessary opportunities, education, and infrastructure. Government-implemented social rights provide guarantees of availability (or “secure access”), but governments should have to supply the requisite goods in only a small fraction of cases. Note that education is often an exception to this since many countries provide free public education irrespective of ability to pay.

Countries that do not accept and implement social rights still have to bear somehow the costs of providing for the needy since these countries—particularly if they recognize democratic rights of political participation—are unlikely to find it tolerable to allow sizeable parts of the population to starve and be homeless. If government does not supply food, clothing, and shelter to those unable to provide for themselves, then families, friends, and communities will have to shoulder this burden. It is only in the last hundred or so years that government-sponsored social rights have taken over a substantial part of the burden of providing for the needy. The taxes associated with social rights are partial replacements for other burdensome duties, namely the duties of families and communities to provide adequate care for the unemployed, sick, disabled, and aged. Deciding whether to implement social rights is not a matter of deciding whether to bear such burdens, but rather of deciding whether to continue with total reliance on a system of informal provision that distributes assistance in a very spotty way and whose costs fall very unevenly on families, friends, and communities.

Are social rights feasible worldwide? Another objection to social rights alleges that they are not feasible in many countries (on how to understand feasibility see Gilabert 2009). It is very expensive to provide guarantees of subsistence, measures to protect and restore people’s health, and education. Many governments will be unable to provide these guarantees while meeting other important responsibilities. Rights are not magical sources of supply (Holmes and Sunstein 1999).

As we saw earlier, the Social Covenant dealt with the issue of feasibility by calling for progressive implementation, that is, implementation as financial and other resources permit. Does this view of implementation turn social rights into high-priority goals? And if so, is that a bad thing?

Standards that outrun the abilities of many of their addressees are good candidates for treatment as goals. Viewing them as largely aspirational rather than as imposing immediate duties avoids problems of inability-based noncompliance. One may worry, however, that this is too much of a demotion for social rights because goals seem much weaker than rights. But goals can be formulated in ways that make them more like rights. They can be assigned addressees (the parties who are to pursue the goal), beneficiaries, scopes that define the objective to be pursued, and a high level of priority (see Langford 2013 and Nickel 2013; see also UN Human Rights and the 2030 Sustainable Development Goals ). Strong reasons for the importance of these goals can be provided. And supervisory bodies can monitor levels of progress and pressure low-performing addressees to attend to and work on their goals.

Treating very demanding rights as goals has several advantages. One is that proposed goals that greatly exceed our abilities are not so farcical as proposed duties that do so. Creating grand lists of social rights that many countries cannot presently realize seems farcical to many people. Perhaps this perceived lack of realism is reduced if we understand that these “rights” are really goals that countries should seriously promote. Goals coexist easily with low levels of ability to achieve them. Another advantage is that goals are flexible: addressees with different levels of ability can choose ways of pursuing the goals that suit their circumstances and means. Because of these attractions it may be worth exploring sophisticated ways to transform very demanding human rights into goals. The transformation may be full or partial. It is possible to create right-goal mixtures that contain some mandatory elements and that therefore seem more like real rights (see Brems 2009). A right-goal mixture might include some rights-like goals, some mandatory steps to be taken immediately, and duties to realize the rights-like goals as quickly as possible.

Equality of rights for historically disadvantaged or subordinated groups is a longstanding concern of the human rights movement. Human rights documents repeatedly emphasize that all people, including women and members of minority ethnic and religious groups, have equal human rights and should be able to enjoy them without discrimination. The right to freedom from discrimination figures prominently in the Universal Declaration and subsequent treaties. The Civil and Political Covenant, for example, commits participating states to respect and protect their people’s rights “without distinction of any kind, such as race, color, sex, language, political or other opinion, national or social origin, property, birth, or social status” (on minority and group rights see Kymlicka 1995, Nickel 2007).

A number of standard individual rights are especially important to ethnic and religious minorities, including rights to freedom of association, freedom of assembly, freedom of religion, and freedom from discrimination. Human rights documents also include rights that refer to minorities explicitly and give them special protections. For example, the Civil and Political Covenant in Article 27 says that persons belonging to ethnic, religious, or linguistic minorities “shall not be denied the right, in community with other members of their group, to enjoy their own culture, to profess and practice their own religion, or to use their own language.”

Feminists have often protested that standard lists of human rights do not sufficiently take into account the different risks faced by women and men. For example, issues like domestic violence, reproductive choice, and trafficking of women and girls for sex work did not have a prominent place in early human rights documents and treaties. Lists of human rights have had to be expanded “to include the degradation and violation of women” (Bunch 2006, 58; see also Lockwood 2006 and Okin 1998). Violations of women’s human rights often occur in the home at the hands of other family members, not in the street at the hands of the police. Most violence against women occurs in the “private” sphere. This has meant that governments cannot be seen as the only addressees of human rights and that the right to privacy of home and family needs qualifications to allow police to protect women within the home.

The issue of how formulations of human rights should respond to variations in the sorts of risks and dangers that different people face is difficult and arises not just in relation to gender but also in relation to age, profession, political affiliation, religion, and personal interests. Due process rights, for example, are much more useful to young people (and particularly young men) than they are to older people since the latter are far less likely to run afoul of the criminal law.

Since 1964 the United Nations has mainly dealt with the rights of women and minorities through specialized treaties such as the International Convention on the Elimination of All Forms of Racial Discrimination (1965); the Convention on the Elimination of All Forms of Discrimination Against Women (1979); the Convention on the Rights of the Child (1989), and the Convention on the Rights of Persons with Disabilities (2007). See also the Declaration on the Rights of Indigenous Peoples (2007). Specialized treaties allow international norms to address unique problems of particular groups such as assistance and care during pregnancy and childbearing in the case of women, custody issues in the case of children, and the loss of historic territories by indigenous peoples.

Minority groups are often targets of violence. Human rights norms call upon governments to refrain from such violence and to provide protections against it. This work is partly done by the right to life, which is a standard individual right. It is also done by the right against genocide which protects some groups from attempts to destroy or decimate them. The Genocide Convention was one of the first human rights treaties after World War II. The right against genocide is clearly a group right. It is held by both individuals and groups and provides protection to groups as groups. It is largely negative in the sense that it requires governments and other agencies to refrain from destroying groups; but it also requires that legal and other protections against genocide be created at the national level.

Can the right against genocide be a human right? More generally, can a group right fit the general idea of human rights proposed earlier? On that conception, human rights are rights of all persons . Perhaps it can, however, if we broaden our conception of who can hold human rights to include important groups that people form and cherish (see the entry on group rights ). This can be made more palatable, perhaps, by recognizing that the beneficiaries of the right against genocide are individual humans who enjoy greater security against attempts to destroy the group to which they belong (Kymlicka 1989).

In spite of the danger of rights inflation, there are doubtless norms that should be counted as human rights but are not generally recognized as such. After all, there are lots of areas in which people’s dignity and fundamental interests are threatened by the actions and omissions of individuals and governments. Consider environmental rights, which are often defined to include rights of animals or even of nature itself (see the entry on environmental ethics ). Conceived in this broad way environmental rights don’t have a good fit with the general idea of human rights because the rightholders are not humans or human groups.

Alternative formulations are possible, however. A basic environmental human right can be understood as requiring maintenance and restoration of an environment that is safe for human life and health. Many countries have environmental rights of this sort in their constitutional bills of rights (Hayward 2005). And the European Union’s Bill of Rights, the Charter of Fundamental Rights of the European Union , includes in Article 37 an environmental protection norm: “A high level of environmental protection and the improvement of the quality of the environment must be integrated into the policies of the Union and ensured in accordance with the principle of sustainable development.”

A human right to a safe environment or to environmental protection does not directly address issues such as the claims of animals or biodiversity, although it might do so indirectly using the idea of ecosystem services to humans (see Biodiversity and Human Rights . A justification for a human right to a safe environment should show that environmental problems pose serious threats to fundamental human interests, values, or norms; that governments may appropriately be burdened with the responsibility of protecting people against these threats; and that most governments actually have the ability to do this.

Climate change is currently a major environmental threat to many people’s lives and health, and hence it is unsurprising that human rights approaches to climate change have been developed and advocated in recent decades (see Bodansky 2011, Gardiner 2013, and UN Human Rights and Climate Change ). One approach, advocated by Steve Vanderheiden accepts the idea of a human right to an environment that is adequate for human life and health and derives from this broad right a more specific right to a stable climate (Vanderheiden 2008). Another approach, advocated by Simon Caney, does not require introducing a new environmental right. It suggests instead that serious action to reduce and mitigate climate change is required by already well-established human rights because severe climate change will violate many people’s rights to life, food, and health (Caney 2010). One could expand this approach by arguing that severe climate change should be reduced and mitigated because it will cause massive human migrations and other crises that will undermine the abilities of many governments to uphold human rights (for evaluation of these arguments see Bell 2013).

Two familiar philosophical worries about human rights are that they are based on moral beliefs that are culturally relative and that their creation and advocacy involves ethnocentrism. Human rights prescribe universal standards in areas such as security, law enforcement, equality, political participation, and education. The peoples and countries of planet Earth are, however, enormously varied in their practices, traditions, religions, and levels of economic and political development. Putting these two propositions together may be enough to justify the worry that universal human rights do not sufficiently accommodate the diversity of Earth’s peoples. A theoretical expression of this worry is “relativism,” the idea that ethical, political, and legal standards for a particular country or region are mostly shaped by the traditions, beliefs, and conditions of that country or region (see the entry on moral relativism ). The anthropologist William G. Sumner, writing in 1906, asserted that “the mores can make anything right and prevent condemnation of anything” (Sumner 1906).

Relativists sometimes accuse human rights advocates of ethnocentrism, arrogance, and cultural imperialism (Talbott 2005). Ethnocentrism is the assumption, usually unconscious, that “one’s own group is the center of everything” and that its beliefs, practices, and norms provide the standards by which other groups are “scaled and rated” (Sumner 1906; see also Etinson 2018 who argues that ethnocentrism is best understood as a kind of cultural bias rather than as a belief in cultural superiority). Ethnocentrism can lead to arrogance and intolerance in dealings with other countries, ethical systems, and religions. Finally, cultural imperialism occurs when the economically, technologically, and militarily strongest countries impose their beliefs, values, and institutions on the rest of the world. Relativists often combine these charges with a prescription, namely that tolerance of varied practices and traditions ought to be instilled and practiced through measures that include extended learning about other cultures.

The conflict between relativists and human rights advocates may be partially based on differences in their underlying philosophical beliefs, particularly in metaethics. Relativists are often subjectivists or noncognitivists and think of morality as entirely socially constructed and transmitted. In contrast, philosophically-inclined human rights advocates are more likely to adhere to or presuppose cognitivism, moral realism , and intuitionism .

During the drafting in 1947 of the Universal Declaration, the Executive Board of the American Anthropological Association warned of the danger that the Declaration would be “a statement of rights conceived only in terms of the values prevalent in Western Europe and America.” Perhaps the main concern of the AAA Board in the period right after World War II was to condemn the intolerant colonialist attitudes of the day and to advocate cultural and political self-determination. But the Board also made the stronger assertion that “standards and values are relative to the culture from which they derive” and thus “what is held to be a human right in one society may be regarded as anti-social by another people” ( American Anthropological Association Statement on Human Rights 1947 ).

This is not, of course, the stance of most anthropologists today. Currently the American Anthropological Association has a Committee on Human Rights whose objectives include promoting and protecting human rights and developing an anthropological perspective on human rights. While still emphasizing the importance of cultural differences, anthropologists now often support cultural survival and the protection of vulnerable cultures, non-discrimination, and the rights and land claims of indigenous peoples.

The idea that relativism and exposure to other cultures promote tolerance may be correct from a psychological perspective. People who are sensitive to differences in beliefs, practices, and traditions, and who are suspicious of the grounds for extending norms across borders, may be more inclined to be tolerant of other countries and peoples than those who believe in an objective universal morality. Still, philosophers have been generally critical of attempts to argue from relativism to a prescription of tolerance (Talbott 2005). If the culture and religion of one country has long fostered intolerant attitudes and practices, and if its citizens and officials act intolerantly towards people from other countries, they are simply following their own traditions and cultural norms. They are just doing what relativists think people mostly do. Accordingly, a relativist from a tolerant country will be hard-pressed to find a basis for criticizing the citizens and officials of the intolerant country. To do so the relativist will have to endorse a transcultural principle of tolerance and to advocate as an outsider cultural change in the direction of greater tolerance. Because of this, relativists who are deeply committed to tolerance may find themselves attracted to a qualified commitment to human rights.

East Asia is the region of the world that participates least in the international human rights system—even though some important East Asian countries such as Japan and South Korea do participate. In the 1990s Singapore’s Senior Minister Lee Kuan Yew and others argued that international human rights as found in United Nations declarations and treaties were insensitive to distinctive “Asian values” such as prizing families and community (in contrast to strong individualism); putting social harmony over personal freedom; respect for political leaders and institutions; and emphasizing responsibility, hard work, and thriftiness as means of social progress (on the Asian Values debate see Bauer and Bell 1999; Bell 2000; Sen 1997; and Twining 2009). Proponents of the Asian values idea did not wish to abolish all human rights; they rather wanted to deemphasize some families of human rights, particularly the fundamental freedoms and rights of democratic participation (and in some cases the rights of women). They also wanted Western governments and NGOs to stop criticizing them for human rights violations in these areas.

At the 1993 World Conference on Human Rights in Vienna, countries including Singapore, Malaysia, China, and Iran advocated accommodations within human rights practice for cultural and economic differences. Western representatives tended to view the position of these countries as excuses for repression and authoritarianism. The Conference responded by approving the Vienna Declaration . It included in Article 5 the assertion that countries should not pick and choose among human rights: “All human rights are universal, indivisible and interdependent and interrelated. The international community must treat human rights globally in a fair and equal manner, on the same footing, and with the same emphasis. While the significance of national and regional particularities and various historical, cultural and religious backgrounds must be borne in mind, it is the duty of States, regardless of their political, economic and cultural systems, to promote and protect all human rights and fundamental freedoms.”

Perhaps the debate about relativism and human rights has become obsolete. In recent decades widespread acceptance of human rights has occurred in most parts of the world. Three quarters of the world’s countries have ratified the major human rights treaties, and many countries in Africa, the Americas, and Europe participate in regional human rights regimes that have international courts (see Georgetown University Human Rights Law Research Guide in the Other Internet Resources below). Further, all of the world’s countries now use similar political institutions (law, courts, legislatures, executives, militaries, bureaucracies, police, prisons, taxation, and public schools) and these institutions carry with them characteristic problems and abuses (Donnelly 2003). Finally, globalization has diminished the differences among peoples. Today’s world is not the one that early anthropologists and missionaries found. National and cultural boundaries are breached not just by international trade but also by millions of travelers and migrants, electronic communications, international law covering many areas, and the efforts of international governmental and non-governmental organizations. International influences and organizations are everywhere and countries borrow freely and regularly from each other’s inventions and practices.

Worldwide polls on attitudes towards human rights are now available and they show broad support for human rights and international efforts to promote them. Empirical research can now replace or supplement theoretical speculations about how much disagreement on human rights exists worldwide. A December 2011 report by the Council on Foreign Relations surveyed recent international opinion polls on human rights that probe agreement and disagreement with propositions such as “People have the right to express any opinion,” “People of all faiths can practice their religion freely,” “Women should have the same rights as men,” “People of different races [should be] treated equally,” and governments “should be responsible for ensuring that [their] citizens can meet their basic need for food.” Big majorities of those polled in countries such as Argentina, Ukraine, Azerbaijan, Egypt, Iran, Kenya, Nigeria, China, India, and Indonesia gave affirmative answers. Further, large majorities (on average 70%) in all the countries polled supported UN efforts to promote the human rights set out in the Universal Declaration. Unfortunately, popular acceptance of human rights ideas has not, however, prevented a recent slide in many of these same countries towards authoritarianism.

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Applying a Human Rights Approach to Social Work Research and Evaluation pp 11–21 Cite as

Understanding and Applying a Human Rights Lens

• Tina Maschi 3  
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Part of the book series: SpringerBriefs in Rights-Based Approaches to Social Work ((SBHRSWP))

Chapter 2 of “ Applying a Human Rights Approach to Social Work Research and Evaluation: A ‘Rights’ Research Manifesto ,” presents the first theme-based strategy of a rights research approach, Understanding and Applying a Human Rights Lens . It reviews: (1) the values and principles of a human right framework (UN 2015 ), (2) relevant human rights instruments, such as the Universal Declaration of Human Rights , (3) familiarity with human rights implementation mechanisms, and (4) knowledge and application of the central constructs for research that advances human rights and the mission of social work. They are reviewed in that order, respectively. The chapter includes experiential exercises that assist rights research users to conceptualize and apply human rights with a diversity of research designs, populations, and settings.

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Maschi, T. (2016). Understanding and Applying a Human Rights Lens. In: Applying a Human Rights Approach to Social Work Research and Evaluation. SpringerBriefs in Rights-Based Approaches to Social Work. Springer, Cham. https://doi.org/10.1007/978-3-319-26036-5_2

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The Universal Declaration of Human Rights (UDHR) is a milestone document in the history of human rights. Drafted by representatives with different legal and cultural backgrounds from all regions of the world, the Declaration was proclaimed by the United Nations General Assembly in Paris on 10 December 1948 ( General Assembly resolution 217 A ) as a common standard of achievements for all peoples and all nations. It sets out, for the first time, fundamental human rights to be universally protected and it has been translated into over 500 languages . The UDHR is widely recognized as having inspired, and paved the way for, the adoption of more than seventy human rights treaties, applied today on a permanent basis at global and regional levels (all containing references to it in their preambles). 

Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world,

Whereas disregard and contempt for human rights have resulted in barbarous acts which have outraged the conscience of mankind, and the advent of a world in which human beings shall enjoy freedom of speech and belief and freedom from fear and want has been proclaimed as the highest aspiration of the common people,

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Whereas a common understanding of these rights and freedoms is of the greatest importance for the full realization of this pledge,

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Proclaims this Universal Declaration of Human Rights as a common standard of achievement for all peoples and all nations, to the end that every individual and every organ of society, keeping this Declaration constantly in mind, shall strive by teaching and education to promote respect for these rights and freedoms and by progressive measures, national and international, to secure their universal and effective recognition and observance, both among the peoples of Member States themselves and among the peoples of territories under their jurisdiction. 

All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.

Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. Furthermore, no distinction shall be made on the basis of the political, jurisdictional or international status of the country or territory to which a person belongs, whether it be independent, trust, non-self-governing or under any other limitation of sovereignty.

Everyone has the right to life, liberty and security of person.

No one shall be held in slavery or servitude; slavery and the slave trade shall be prohibited in all their forms.

No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.

Everyone has the right to recognition everywhere as a person before the law.

All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination.

Everyone has the right to an effective remedy by the competent national tribunals for acts violating the fundamental rights granted him by the constitution or by law.

No one shall be subjected to arbitrary arrest, detention or exile.

Everyone is entitled in full equality to a fair and public hearing by an independent and impartial tribunal, in the determination of his rights and obligations and of any criminal charge against him.

• Everyone charged with a penal offence has the right to be presumed innocent until proved guilty according to law in a public trial at which he has had all the guarantees necessary for his defence.
• No one shall be held guilty of any penal offence on account of any act or omission which did not constitute a penal offence, under national or international law, at the time when it was committed. Nor shall a heavier penalty be imposed than the one that was applicable at the time the penal offence was committed.

No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks.

• Everyone has the right to freedom of movement and residence within the borders of each state.
• Everyone has the right to leave any country, including his own, and to return to his country.
• Everyone has the right to seek and to enjoy in other countries asylum from persecution.
• This right may not be invoked in the case of prosecutions genuinely arising from non-political crimes or from acts contrary to the purposes and principles of the United Nations.
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• No one shall be arbitrarily deprived of his nationality nor denied the right to change his nationality.
• Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family. They are entitled to equal rights as to marriage, during marriage and at its dissolution.
• Marriage shall be entered into only with the free and full consent of the intending spouses.
• The family is the natural and fundamental group unit of society and is entitled to protection by society and the State.
• Everyone has the right to own property alone as well as in association with others.
• No one shall be arbitrarily deprived of his property.

Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance.

Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.

• Everyone has the right to freedom of peaceful assembly and association.
• No one may be compelled to belong to an association.
• Everyone has the right to take part in the government of his country, directly or through freely chosen representatives.
• Everyone has the right of equal access to public service in his country.
• The will of the people shall be the basis of the authority of government; this will shall be expressed in periodic and genuine elections which shall be by universal and equal suffrage and shall be held by secret vote or by equivalent free voting procedures.

Everyone, as a member of society, has the right to social security and is entitled to realization, through national effort and international co-operation and in accordance with the organization and resources of each State, of the economic, social and cultural rights indispensable for his dignity and the free development of his personality.

• Everyone has the right to work, to free choice of employment, to just and favourable conditions of work and to protection against unemployment.
• Everyone, without any discrimination, has the right to equal pay for equal work.
• Everyone who works has the right to just and favourable remuneration ensuring for himself and his family an existence worthy of human dignity, and supplemented, if necessary, by other means of social protection.
• Everyone has the right to form and to join trade unions for the protection of his interests.

Everyone has the right to rest and leisure, including reasonable limitation of working hours and periodic holidays with pay.

• Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.
• Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.
• Everyone has the right to education. Education shall be free, at least in the elementary and fundamental stages. Elementary education shall be compulsory. Technical and professional education shall be made generally available and higher education shall be equally accessible to all on the basis of merit.
• Education shall be directed to the full development of the human personality and to the strengthening of respect for human rights and fundamental freedoms. It shall promote understanding, tolerance and friendship among all nations, racial or religious groups, and shall further the activities of the United Nations for the maintenance of peace.
• Parents have a prior right to choose the kind of education that shall be given to their children.
• Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.
• Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.

Everyone is entitled to a social and international order in which the rights and freedoms set forth in this Declaration can be fully realized.

• Everyone has duties to the community in which alone the free and full development of his personality is possible.
• In the exercise of his rights and freedoms, everyone shall be subject only to such limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a democratic society.
• These rights and freedoms may in no case be exercised contrary to the purposes and principles of the United Nations.

Nothing in this Declaration may be interpreted as implying for any State, group or person any right to engage in any activity or to perform any act aimed at the destruction of any of the rights and freedoms set forth herein.

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Why Human Subjects Research Protection Is Important

Background: Institutional review boards (IRBs), duly constituted under the Office of Human Research Protection, have the federally mandated responsibility of reviewing research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in any study. The road leading to the current regulations and ethical considerations has been long and checkered.

Methods: This paper reviews the history of human subjects participating in research, including examples of egregious events, and the ethical analyses that precipitated the evolution of the mandated protections afforded participants in research under current federal regulations.

Results: Key documents—from the Nuremberg Code in 1947 to the Belmont Report in 1978 to Moral Science: Protecting Participants in Human Subjects Research in 2011—that have informed the ethics debate regarding human subjects protection in research activities are presented in light of their historic significance, highlighting the complexity of the issues surrounding protection of human subjects in research.

Conclusion: The examples from history and the scarcity of contemporary examples demonstrate that the regulations for the protection of humans participating in research have evolved in a way that minimizes the probability that subjects will be harmed when they choose to participate in research. The examples also reinforce the importance of individual responsibility. Failure of IRBs to provide appropriate review and oversight can lead to severe consequences, as can abrogation by the investigator to place the well-being of the subjects as the primary responsibility in any research protocol. Understanding how we arrived at the current approach and some of the failures that directed this course can support efforts to continually reevaluate and improve the safety of subjects who are willing to participate in research activities.

INTRODUCTION

Participation of human subjects in research presents a challenging ethical dilemma. A research subject may be asked to participate in a study of no benefit and no substantial risk or in a study with the potential for significant benefit but also significant risk. In placebo-controlled studies, subjects may be exposed to significant risk for no benefit to the individual. These variants are confounded by treatment protocols—most commonly encountered in oncology trials—that compare the effect of an investigational arm to the standard of care, further blurring the distinction between research and medical treatment.

Institutional review boards (IRBs) have the federally mandated responsibility to review research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in the study. The road leading to the current regulations and ethical considerations has been long and checkered. The system that has evolved minimizes the risks for unethical behavior and serious adverse events but is not infallible. Understanding how we have arrived at the current approach and analyzing some of the ethical lapses that directed this course support efforts to continually reevaluate the regulations in order to improve the safety of subjects who are willing to participate in research activities.

EVOLUTION OF HUMAN SUBJECTS PROTECTION

Our current approach to human subjects protection has evolved with efforts to understand questionable ethical behavior in research over the course of several hundred years. One might suggest that the jester conscripted to sample the king's food to ensure that it was safe to eat presaged the use of vulnerable populations as subjects for research, but the evolution of the management of smallpox is perhaps a more applicable early perspective on research in humans. Three centuries ago, reports of good outcomes following variolation—inhalation of the scabs from persons infected with smallpox—were circulating in Asia. In 1717, Lady Mary Wortley Montagu, the wife of the British ambassador to Turkey, became an advocate of variolation after learning about it in Constantinople. In 1721, after she returned to England, Lady Montagu and the Princess of Wales urged variolation of “several prisoners and abandoned children” by having smallpox scabs inserted under their skin. Several months later, the children and prisoners were deliberately exposed to smallpox. When none contracted the disease, the procedure was deemed safe, and members of the royal family were treated according to this new protocol. 1

Later that same century, Edward Jenner developed inoculation with a vaccine. Many of his contemporaries had noted that milkmaids who had contracted cowpox seemed immune to the much more lethal smallpox. In May 1796, Jenner isolated material from the cowpox lesions on the milkmaid Sarah Nelms and inoculated 8-year-old James Phipps who developed fever and malaise about 9 days after the inoculation. Some accounts report that Phipps was the son of Jenner's gardener. A few months later, Jenner deliberately inoculated Phipps with material from fresh smallpox lesions, and the child remained healthy. The adoption of this process was not immediate but slowly spread and is widely cited as the first scientific approach proving vaccination. 2

This early use of children and prisoners portends a long history of selecting what are now considered vulnerable populations to be the subjects of research. Participation was commonly without consent, with no knowledge of their participation, and with no explanation of the research. Information was withheld from those selected to participate in research activities perceived as dangerous to more acceptable members of society, and the therapies developed were generalized only if they were proven relatively safe and effective in what are now recognized as vulnerable populations.

Numerous instances of research experiments in subsequent years exposed vulnerable subjects to risk, including a pivotal research disaster in Germany just before World War II that led to regulations for human subjects participation in research projects.

The Reich Circular of 1931

As reported by Sir Graham Wilson in the book The Hazards of Immunization , “Between 10 December 1929 and 30 April 1930, 251 of 412 infants born in the old Hanseatic town of Lubeck received three doses of BCG [bacillus Calmette-Guerin] vaccine by the mouth during the first ten days of life. Of these 251, 72 died of tuberculosis, most of them in two to five months and all but one before the end of the first year. In addition, 135 suffered from clinical tuberculosis but eventually recovered; and 44 became tuberculin-positive but remained well.” 3

Bonah and Menut describe how Albert Calmette was able to establish the BCG vaccine as a nonexperimental “prophylactic treatment” against tuberculosis. 4 By definition, a medical experiment, as opposed to any other medical action, has definite ethical implications and consequences. Even though the BCG vaccine was in experimental stages, Calmette convinced a court that the vaccine was a “post-experimental, routine medical treatment.” By avoiding the definition of an experiment, Calmette did not have to inform the children's parents about the risks of the vaccine. As a result of this tragedy, Dr Julius Moses, a critic of unethical human experimentation who referred to “experimental mania,” drafted guidelines for human experimentation. After debate in parliament and the press, the guidelines were published and became official in 1931. The guidelines applied to everyone in Germany. 5 , 6

These rules for research in human subjects were issued as the Reich Circular of 1931 ( Figure 1 ). The document is quite informative for its contrast with later events in Germany and worth reviewing for correlation with ethical concepts now well accepted in ethical thinking. It is worth noting that these guidelines emphasize special responsibilities for utilization of “innovative therapy,” suggesting a similar level of responsibility for these procedures as for research.

The Reich Circular, 1931 6

World War II and the Nuremberg Code

Despite the ethical ideals espoused in the Reich Circular, the travesty of the Holocaust followed shortly afterward, leading to war criminal trials after the surrender of Germany ended World War II in Europe.

The Nuremberg trials that began in 1945 and concluded in 1947 were held in response to the atrocities Germany committed during the war. The so-called Doctors’ Trial represents a major turning point in human research protection. Twenty-three physicians were indicted, accused of crimes against humanity by conducting criminal scientific and medical experiments on concentration camp prisoners. Sixteen defendants were found guilty. 7

Several German doctors had argued that no international law or informal statement differentiated between legal and illegal human experimentation, despite the aforementioned Reich Circular. Two US doctors who worked with the prosecution during the trial, Andrew Ivy and Leo Alexander, objected to this argument. On April 17, 1947, Dr Alexander submitted a memorandum to the United States Counsel for War Crimes outlining 6 points defining legitimate medical research. The trial verdict reiterated almost all of these points in a section entitled Permissible Medical Experiments and expanded the original 6 points into 10. These 10 points became known as the Nuremberg Code ( Figure 2 ). 8

The Nuremberg Code, 1947 10

Similar atrocities were carried out on Chinese citizens in Japanese camps; of particular note are the biological warfare experiments at Unit 731 in the Pacific theater that were obscured by agreements made during the surrender of Japan and with the complicity of the United States. 9 The details of these atrocities remained classified until they were acknowledged by Congress in the Japanese Imperial Government Disclosure Act of 2000 (Pub L No. 106-567, Title VIII of the Intelligence Authorization Act of 2000) that called for declassification and release of records related to Japanese war crimes during World War II. 10

Declaration of Helsinki

The tenets of the Nuremberg Code, while guiding the future for human research protection, represent a military code of conduct with no standing in civil international or US law. By absolutely requiring the voluntary consent of the individual, the Nuremberg Code notably does not address the needs of children or other special populations unable to provide consent. The Nuremberg Code inspired the World Medical Association (WMA)—an international association currently comprised of 114 national medical associations, including the American Medical Association—to propose a similar code of conduct for participating members by publishing the Declaration of Helsinki in 1964. This document reiterates the provisions of the Nuremberg Code and expands the provisions to allow for the participation of children and other potentially compromised subjects in research. The Declaration of Helsinki serves as a guideline for ethical research and has been amended 7 times, most recently at the WMA General Assembly in October 2013, to reflect contemporary ethical issues as they have evolved since the initial statement in 1964. 11

Ethics Violations in the United States

Meanwhile, research continued in the United States with particular concerns attached to research involving vulnerable populations, exemplified by numerous studies involving institutionalized children and studies that breached ethically sound research practices. Henry Beecher, a well-recognized physician at Massachusetts General Hospital, surveyed the contemporary literature to identify ethical concerns and organized lectures around his observations. These lectures eventually culminated in a special article published in the New England Journal of Medicine in 1966. 12

In “Ethics and Clinical Research,” Beecher reported that he had reviewed 100 consecutive articles published in 1964 “in an excellent journal,” and after culling his list to address the editor's request, selected 12 articles that demonstrated serious ethical concerns. The purpose of Beecher's article was to demonstrate the widespread lapse in ethical issues in medical research and to encourage reform in the ethical approach to human subjects research that inspired Congress to reconsider legislative reforms for human subjects protection.

An article by Jean Heller that appeared in the Washington Star on July 25, 1972 placed an exclamation point in the history of human research ethics. 13 Heller reported on a long-term study sponsored by the US Public Health Service on the effect of syphilis if left untreated in poor rural African American subjects. Officially known as the “Tuskegee Study of Untreated Syphilis in the Negro Male,” the study enrolled 399 subjects with syphilis and 201 uninfected controls from the African American community surrounding Tuskegee, AL for “treatment of bad blood.” In exchange for taking part in the study, the men received free medical examinations, free meals, and burial insurance but were not given the benefit of providing informed consent. No treatment was provided; the research plan was to follow the subjects to establish a natural history for the disease if left untreated. Although originally projected to last 6 months, the study continued for 40 years. 14

Treatments available at the onset of the trial in 1932, even if provided, were not very effective and would have been heavy metals, involving at least 30 months of treatment, a 30% cure rate, and significant toxicity. By 1945, penicillin had been proven to be an effective therapy for syphilis with few side effects. Once penicillin was established as effective, the US Public Health Service set up centers for treatment but determined that the data from the Tuskegee experiments were too important to abandon and decided that the study should be continued with no treatment provided to the participants. Similar determinations were made in subsequent years, with the last review occurring as recently as 1969. 14

While medical research such as the Tuskegee study garnered most of the attention for ethical lapses, other areas of research involving human subjects also raised concerns. The Milgram experiments carried out in the early 1960s at Yale University are a lightning rod for discussion of ethical issues in human subjects research in social sciences. 15 Intrigued by the Nuremberg trials defendants’ argument that they were simply following orders, Stanley Milgram set out to determine if the German defendants were particularly obedient to authority figures compared to other members of society. Milgram recruited subjects for an experiment in learning via newspaper ads. The male research subjects were assigned to act as a teacher asking questions of a learner (a confederate of Milgram) who was attached to electrodes. The teachers were instructed to increase the severity of electrical shocks if the learner answered the questions incorrectly. Shocks were labeled from 15v to 450v, with 15v indicated as mild, 300v as severe, and 450v as XXX. Many of the teacher subjects eventually shocked the learner at 450v and exhibited increasing signs of distress as the shocks they delivered increased in perceived severity. 15 These experiments evoked significant concern among those in social sciences in regard to the questionable ethics of the deception used, as well as the potential for long-term psychological harm that might be incurred by unwitting participants.

Federal Policy for Protection of Human Subjects and the National Research Act

The public outcry over the Tuskegee study, other reports of ethical lapses in both medical and social research, and the alarm in the medical community raised by Dr Beecher's article in the New England Journal of Medicine led Congress to action. On May 30, 1974, the US Department of Health, Education, and Welfare (DHEW), responsible for oversight of the National Institutes of Health, replaced previous policies with comprehensive regulations governing the protection of human subjects (45 CFR §46). 16 One month later in July 1974, Congress passed the National Research Service Award Act of 1974 (Pub L No. 93-348). 17 Title II of the act, Protection of Human Subjects of Biomedical and Behavioral Research, created the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Along with being assigned several other tasks, the National Commission was directed to make recommendations to the DHEW secretary about the ethical principles that should underlie human subjects research. 18

The Belmont Report

The National Commission issued several reports in response to the directives. The most notable among a collection of important documents is the Belmont Report, named after the Smithsonian conference center where the group convened, that was issued in 1978. 19 This document, widely regarded as the landmark analysis of ethics in human subjects research, serves as the foundation for discussion of ethical concerns in research ethics involving human subjects, as well as the source of federal regulations for research established by the Office for Human Research Protections (OHRP).

The Belmont Report is divided into three sections. The first section briefly states the National Commission's recognition that even as the report was being written, the distinction between medical practice and research was blurred. The report defines medical practice as “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation for success. Research, on the other hand, is defined as “an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).” This section further expounds on the conflation between the use of the terms experimental and research. When used in reference to a procedure or treatment that significantly deviates from typical (ie, a treatment that is “new, different or untested”), the report notes that an “experimental” treatment is not necessarily research. Although they excluded “experimental” treatment from research and the applicable anticipated regulations, the National Commission strongly recommended that such treatments should eventually be incorporated into formal research protocols “to determine if they are safe and effective.” The first section of the Belmont Report concludes with the recognition that practice and research may go hand in hand: “the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.” 19 This language is reminiscent of the Reich Circular recommendation regarding “innovative therapy.”

The second section is the heart of the report and defines three principles that should guide the discourse surrounding any ethical concerns related to research in human subjects: respect for persons, beneficence, and justice. The principle of nonmaleficence, now commonly accepted as one of the four principles of biomedical ethics, was notably absent.

• Respect for persons : The principle of respect for persons requires that “individuals should be treated as autonomous agents,” and those with “diminished autonomy are entitled to protection.” These concepts inform “two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.” The National Commission defines the elements that would be necessary to qualify as an autonomous individual and explores circumstances that would define those who should be considered to be of diminished autonomy and thus deserving of protection.
• Beneficence : The principle of beneficence as defined by the National Commission encompasses the concept of do no harm included in the Hippocratic Oath and notes that the term is commonly thought “to cover acts of kindness or charity that go beyond strict obligation.” The National Commission proposes two general rules that inform beneficence as an obligation: “(1) do not harm and (2) maximize possible benefits and minimize possible harms.” The implications of these duties within the context of both individual investigators and society at large are examined.
• Justice : The principle of justice is posed as the following question: “Who ought to receive the benefits of research and bear its burdens?” This principle is broad in potential implications and can be summarized as evaluating the appropriate distribution of the risks and burdens of research among individuals, groups, or even situations in which inherent inequalities may need to be considered to reach an ethically informed decision. The National Commission proposes the following framework for beginning these discussions: “(1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.” The discussion of justice continues with the historic context for including the principle of justice and how lapses in justice (ie, the Tuskegee study) were the primary impetus for the formation of the National Commission.

The final section of the Belmont Report addresses the application of these principles and the implications of their requirements when considering three important elements of research involving human subjects: informed consent, assessment of risks and benefits, and selection of subjects for research.

Informed consent. The consent process has three components: information, comprehension, and voluntariness. Reaching agreement on an appropriate standard for evaluating the quality of information that should be provided to potential participants about a proposed research project is difficult and eventually ends with the suggestion that the standard of “the reasonable volunteer” might best fulfill the requirements of respect for persons, beneficence, and justice. A caveat is provided, citing the problem posed by research where “informing subjects of some pertinent aspect of the research is likely to impair the validity of the research,” a key area of ethical concern (lack of disclosure) raised by the Milgram study discussed previously. The National Commission proposes that such studies may only be appropriate if “(1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them,” further noting that “Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.” 19

Regarding the component of comprehension, the Belmont Report states, “The manner and context in which information is conveyed is as important as the information itself.” The level of comprehension is also important within the context of the individual's ability to understand the information, with emphasis that the obligation for ensuring subject understanding increases in importance relative to the level of risk posed by participation in the study. The National Commission suggests that some level of questioning the subject to ensure comprehension is appropriate and even suggests that written responses to questions may be appropriate if risks are exceptionally high. 19 If participation of subjects with compromised abilities is anticipated, researchers must be particularly diligent in evaluating the level of comprehension by the subject's proxy and ensure that the proxy is indeed capable of representing the best interests of the subject. The report even suggests that the proxy might need to be present or available during the research interventions to withdraw the subject from the study if the proxy perceives that withdrawal may be in the subject's best interest.

Voluntariness is a concept consistently emphasized in the Reich Circular, the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Although voluntariness may appear to be self-evident, it may be the most difficult concept to address. The Belmont Report emphasizes that the subject must be “free of coercion and undue influence.” Coercion is specifically defined as “an overt threat of harm” and in most circumstances is relatively easy to evaluate. However, arguments can be made about what defines “undue influence.” Discussions about appropriate levels of compensation for participation are common, particularly when studies involve financial or other considerations made to possibly financially compromised subjects. The Belmont Report specifically notes, “inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.” Other concerns related to undue influence involve social standing, employment, or other circumstances that may be difficult to assess but are worthy of consideration for individual subjects.

Assessment of risks and benefits. The National Commission notes that a favorable risk/benefit assessment is associated with the principle of beneficence. This definition is particularly appropriate in that the National Commission's interpretation of beneficence includes the duty of nonmaleficence. The Belmont Report examines the meaning of risk and benefit in the setting of potential types of harm that may be experienced by individual subjects, the families of the individual subjects, society at large, or special groups of subjects in society. Benefits are also discussed in relation to the individual and society at large. In summarizing the risks and benefits of research, the Belmont Report states

…assessment of the justifiability of research should reflect at least the following considerations:

Brutal or inhumane treatment of human subjects is never morally justified.

Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures.

When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject—or, in some rare cases, to the manifest voluntariness of the participation).

When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits.

Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process. 19

Selection of subjects for research. The third element, selection of subjects for research, finds its primary guidance in the principle of justice where the moral requirements demand that the procedures and outcomes for the selection of subjects are fair to the individual and within the social context. Participation in potentially beneficial research should be fairly distributed to all who wish to participate, and risky research should not be offered only to less desirable subjects. In the context of society, risks should be distributed after careful consideration of the burdens and the ability of individuals in identifiable groups to bear those burdens. As a generalization, adults should be considered before children, and participation by institutionalized individuals should invoke very careful consideration. Even with these safeguards, the National Commission believed that the selection of subjects may continue to reflect injustice arising from social, racial, sexual, and cultural biases institutionalized in society. Harking back to the ethical concerns that prompted the National Commission, the Belmont Report concludes with the following: “One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.” 19

Although not included in the body of the report, a footnote specifically addresses the difficulty in extrapolating these tenets to human subjects research in the social sciences: “Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies.” 19 An appropriate ethical approach for some areas of social and psychological studies remains elusive. Matthew Salganik, professor of sociology at Princeton University, discusses the issues surrounding the difficulty in applying the Belmont Report recommendations at his blog. 20

The Belmont Report was submitted to Congress on April 18, 1979.

Other Reports by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research

Although the Belmont Report is the centerpiece for the analysis of research in human subjects, the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research provided significant additional guidance for Congress to consider as the legislators moved forward to formulate regulations for the governance of human subjects in research. During the 4 years of the National Commission's appointment, other publications provided analysis of concerns related to specific questions (Table), and many of the recommendations were incorporated into the subsequent regulations for human subjects protection. 21

Table .

Human Subjects Protection in Research Reports From the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1974-1978 21

FOIA, Freedom of Information Act.

Principles of Biomedical Ethics

Another landmark publication from 1979 deserves attention for its sustained influence on the field of biomedical ethics and its deviation from the three ethical principles put forth by the Belmont Report. In Principles of Biomedical Ethics , Tom Beauchamp and James Childress argue for inclusion of nonmaleficence as an independent principle to formulate the now-familiar four principles that inform contemporary bioethical discourse. 22 As previously noted, nonmaleficence is considered a duty under the umbrella of the principle of beneficence in the Belmont Report. Beauchamp and Childress maintained that the tradition to do no harm central to the tenets of the Hippocratic Oath incorporates the concept of nonmaleficence at its core and is essential to any discussion of the ethics of medical practice. As such, they argued, this concept should be considered as separate from and not subsidiary to beneficence: “First, to confuse them is to obscure distinctions that we make in ordinary moral discourse. Second, ordinary moral discourse expresses the defensible conviction that we have certain duties not to injure others that are not only distinct from but also more stringent than our duties to benefit others.” 22 The authors make the distinction that the negative duty to cause no harm should be encompassed by nonmaleficence, and the positive but not so strongly established moral duty to benefit others should constitute the core of beneficence. The authors acknowledged that other eminent scholars disagreed with the separation of nonmaleficence and beneficence, but they constructed an argument that has been upheld by the historic inclusion of nonmaleficence in most bioethics discussions following their book's original publication (the book is now its seventh edition). The book has had a significant influence on the still-evolving field of bioethics contemporary to its publication and the Belmont Report. Both authors regularly served as staff members for the Kennedy Institute Intensive Bioethics Course, and Beauchamp served as staff philosopher for the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research that produced the Belmont Report. The authors acknowledged the influence of several other members of the commission and other colleagues who contributed significantly to their deliberations as their work progressed.

US Legislative Updates, 1981

DHEW officially became the Department of Health and Human Services (HHS) in 1980, and in response to the Belmont Report, the HHS and the US Food and Drug Administration (FDA) significantly revised their protection of human subjects regulations in 1981 (45 CFR §46 and 21 CFR §50). 16 , 18 , 23

These regulations specifically address concerns related to vulnerable populations in Subparts B, C, and D, incorporating the recommendations from the National Commission. The Research on the Fetus report 24 informed Subpart B (additional protections for pregnant women, human fetuses, and neonates), Subpart C (additional protections for prisoners) reflected the recommendations in Research Involving Prisoners , 25 and Subpart D (additional protections for children) was informed by the Research Involving Children report. 26

HUMAN SUBJECTS PROTECTION OVERSIGHT

Oversight in the united states.

To this point, this review has focused on some of the historic events and documents precipitating evaluation of the ethical requirements for human subjects research in the United States and a review of the regulations that evolved from that history. The question not yet addressed is how these regulations should be enforced. As with the discussion of research ethics, the approach to enforcement of regulations also lies within the National Research Service Award Act of 1974 (Pub L No. 93-348). 17 In addition to establishing the National Commission responsible for the Belmont Report, the National Research Act elected to perpetuate the regulatory mechanism for research extant within many departments of DHEW that evolved from the US Public Health Service requirements initiated by the Surgeon General in 1966. The background of this development is described in William Curran's article, “Government Regulation of the Use of Human Subjects in Medical Research: The Approach of Two Federal Agencies.” 27

This system for review of human subjects research within DHEW as described in The Institutional Guide to DHEW Policy on Protection of Human Subjects 28 became the model for institutional review boards (IRBs) that the National Research Act would require of grantees and contractees for review of research involving human subjects. The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research was specifically charged with reviewing the function of IRBs and making recommendations for integrating the role of the IRB into the regulatory process to provide oversight of the application of ethical principles and of the regulations. 18

On September 1, 1978, the National Commission completed the less spectacular but equally important report, Institutional Review Boards , 29 before submitting the Belmont Report on September 30 that same year. Institutional Review Boards outlines the National Commission's concept of the ideal environment for the application of the federal regulations.

In the introduction to the report, the National Commission provides this understated assessment of the role of the IRB: “This review of proposed research by IRBs is the primary mechanism for assuring that the rights of human subjects are protected.” 29 The document outlines the ideal responsibilities of the IRB in the oversight of research to ensure that human subjects receive appropriate protections and ethical treatment for their willingness to participate in research, sometimes at no benefit to themselves. The National Commission summarized their objective as follows:

In the recommendations that follow, the Commission expresses its judgment about the ways in which those elements [that must be considered in balancing society's interests in protecting the rights of the subjects and in developing knowledge that can benefit the subjects or society as a whole] ought to be brought to bear on research practices, so that a reasonable and ethical balance of society's interests may be attained.

The Commission's deliberations begin with the premise that investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others, who are independent of the research, must share this responsibility, because investigators are always in positions of potential conflict by virtue of their concern with the pursuit of knowledge as well as the welfare of the human subjects of their research.

The Commission believes that the rights of subjects should be protected by local review committees operating pursuant to federal regulations and located in institutions where research involving human subjects is conducted. 29

The document continues this proposal and is seemingly all-inclusive in its conception of the IRB. Highlights include a list of the requirements that must be met to approve research and details for reviewing and approving the consent process, including the essential elements to be included and the safeguards that should be in place to ensure that the process is respected. Specific recommendations also address the constitution of the IRB; how it should be funded; and legal protections for the board, the process, and its members.

Most of the recommendations from the Institutional Review Boards report were incorporated into the HHS regulations—HHS being the responsible federal agency—as part of the rules revision in 1981 in response to the Belmont Report and several other publications of the National Commission. Acting independently from HHS, the FDA also adopted IRBs as a regulatory mechanism, with regulations first issued in 1981 as part of the agency's response to provisions of the National Research Act. 18 , 30

One particularly relevant recommendation of the National Commission from Institutional Review Boards remained outstanding after the changes in 1981: “Recommendation (1) (A) Federal law should be enacted or amended to authorize the Secretary of Health, Education, and Welfare to promulgate regulations governing ethical review of all research involving human subjects that is subject to federal regulation.” 29

The report notes significant “variations arising out of differences in wording, imposition of additional requirements, introduction of minor changes, etc.” among the different agencies apart from DHEW involved in research involving human subjects and expresses concern that this variability places an unnecessary burden on the individual IRBs for interpreting and properly enforcing the regulations. The National Commission's recommendation was to establish “DHEW as the sole authority” for regulations, expressing the belief that such a rule “would reduce the burden on IRBs to interpret and apply the regulations to which they are subject. Moreover, uniformity would assure a minimum level of protection to human subjects of research, no matter which federal agency is supporting the research or which entity is conducting it.” 29 Having inherited the mantle of responsibility from the now-extinct DHEW and recognizing the reality of this assessment, the newly designated HHS explored implementation of this recommendation, particularly as it related to the function of IRBs. As with most changes affecting multiple branches of government, the process became complex. In December 1981, the President's Commission for the Study of Ethical Problems in Medicine and in Biomedical and Behavioral Research, a new commission appointed by Congress in 1978, entered the fray and recommended that all federal departments and agencies adopt the HHS regulations (45 CFR §46). In addition, an ad hoc Committee for the Protection of Human Subjects—composed of representatives and ex officio members from departments and agencies that conducted, supported, or regulated research involving human subjects—was appointed in May 1982 by the president's science advisor to respond to the recommendations of this new commission. After much consideration and negotiation, these efforts were finally addressed by adoption of the Federal Policy for the Protection of Human Subjects, known as the Common Rule, in 1991 and codified in the individual regulations by 15 federal departments and agencies. Each of these agencies includes in its chapter of the Code of Federal Regulations (CFR) section numbers and language that are identical to those of the HHS codification at 45 CFR §46, Subpart A for the regulation of human subjects participation in research. The HHS regulations also include Subparts B, C, and D as additional regulations pertaining to vulnerable subjects. 16 , 31

In addition to harmonizing the regulations across agencies of the federal government, the Common Rule requires institutions that receive funds for research involving human subjects from federal agencies that are signatories to the Common Rule to certify that the research has been reviewed and approved by an IRB that meets the specific requirements for composition, for functioning, and for the criteria followed to approve research. By mandate of the Common Rule, IRBs are empowered to approve, require modifications of, or disapprove research activities and are required to conduct continuing review of ongoing research at least annually.

The FDA concurs with the Common Rule but claims special privilege in not signing on to it. In the Federal Register of November 10, 1988 (53 FR 45678), the agency proposed to amend its regulations in 21 CFR §50 and §56 so that they conformed to the Federal Policy for the Protection of Human Subjects to the extent permitted but noted that the FDA is a regulatory agency that rarely supports or conducts research under its regulations. 32

International Oversight

With the adoption of the Common Rule, regulations for human subjects research conducted within the United States became well established, but research has never been confined by the borders of the United States. Even though a project funded by federal monetary support may have some leverage to require adherence to US regulations, significant numbers of human research subjects participate in studies well beyond the influence of the US regulations. The international norms for participation of human subjects in research evolved along a course that frequently cross-pollinated with the concepts culminating in the Common Rule. The Declaration of Helsinki was an early statement of basic tenets that should apply to all research involving human subjects, and it has continued to evolve, with updates reflecting new issues as they become relevant. While addressing the ethical concepts, the Declaration of Helsinki does not provide an organizational or regulatory framework for human subjects protection. Providing this framework on an international basis presented a challenge well beyond the challenge of harmonizing regulations across different federal agencies as was accomplished by the Common Rule. The difficulties encountered in implementing the Common Rule represent only a microcosm of the enormous task of harmonizing regulatory and organizational concepts across the borders of different cultures and political systems. However, this task was particularly relevant because of the evolution of research into an international enterprise with multicenter drug trials and the expansion of vaccine trials in children. Many of these studies are conducted by multinational contract research organizations that have access to populations of subjects with exposure to diseases that may not be widely encountered in the United States.

An argument can be made that the process for oversight of human subjects in research at the international level started in 1948 before the Declaration of Helsinki when the United Nations Educational, Scientific and Cultural Organization (UNESCO) joined with the World Health Organization (WHO) to establish a permanent Council for Coordination of International Medical Congresses, formally constituted in Brussels in 1949 as a nongovernmental organization with the purpose of facilitating “the exchange of views and scientific information in the medical sciences by securing continuity and coordination between international organizations of medical sciences, by making their work known, and by providing them with material aid where necessary.” 33 The scope of activities gradually expanded to include collaborative efforts among international medical activities in addition to the coordination of participating congresses. In 1992, the name of the council was changed to the Council for International Organizations of Medical Sciences (CIOMS), and its statutes were revised to reflect the expanded role. 33

The original council ventured into medical research by organizing a 1959 meeting in Vienna under the auspices of UNESCO and the WHO “to discuss the principles, organization and scope of ‘controlled clinical trials,’ which must be carried out if new methods or preparations used for the treatment of disease are to be accurately assessed clinically.” The executive secretary summarized the meeting: “The conference was in itself an experiment.” 34

Following this meeting, the council became much more involved in considerations regarding research and particularly the participation of human subjects in research trials, eventually publishing Proposed International Guidelines for Biomedical Research Involving Human Subjects in 1982. The purpose of the guidelines was “to indicate how the ethical principles that should guide the conduct of biomedical research involving human subjects, as set forth in the Declaration of Helsinki, could be applied, particularly in developing countries, given their socioeconomic circumstances, laws and regulations, and executive and administrative arrangements.” 35 This quote is from the background notes for International Ethical Guidelines for Biomedical Research Involving Human Subjects published in 1993 after discussion and reconsideration of the comments received in response to the proposed guidelines. 35

The publication of the guidelines in 1993, soon after the name change to CIOMS, represented a landmark for international research ethics. The steering committee included an international staff of 24 members and an even larger list of advisors and consultants. The committee was co-chaired by Robert Levine from Yale University, who was listed as a “Special Consultant” on the Belmont Report and authored the first four articles for discussion in the appendix to the Belmont Report, and John H. Bryant, an American physician with a distinguished career in international medical practice. In addition to the Declaration of Helsinki, the International Ethical Guidelines for Biomedical Research Involving Human Subjects was strongly influenced by the Belmont Report as demonstrated by the inclusion of the following text under the heading General Ethical Principles:

All research involving human subjects should be conducted in accordance with three basic ethical principles, namely respect for persons, beneficence and justice. It is generally agreed that these principles, which in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies. 35

The guidelines acknowledge the evolution of the principles following the publication of the Belmont Report with the statement, “Beneficence further proscribes the deliberate infliction of harm on persons; this aspect of beneficence is sometimes expressed as a separate principle, non-maleficence (do no harm).” 35

The table of contents of the 1993 International Ethical Guidelines for Biomedical Research Involving Human Subjects , provided in Figure 3 , outlines the subjects the steering committee felt to be the most pertinent issues for research conducted in an international setting. In addition to the obvious influence of the Declaration of Helsinki, this document reinterprets many of the issues presented in the Belmont Report, in reports from the presidential commissions, and in 45 CFR §46, Subparts A, B, C, and D to provide an adaptable set of guidelines suitable for application across a broad spectrum of cultural and political environments. The notable exception to the similarities with the US regulations is the inclusion of a guideline titled “Compensation of Research Subjects for Accidental Injury” that provides for the following: “Research subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependents are entitled to material compensation. The right to compensation may not be waived.” 35 To date, no uniform program for compensation of human subjects injured in research is addressed in the US regulations.

Table of Contents, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993 35

The International Ethical Guidelines for Biomedical Research Involving Human Subjects was updated in 2002, and CIOMS continues its efforts to revise the guidelines as dictated by changes in research requiring human subjects.

THE GUATEMALA SEXUALLY TRANSMITTED DISEASES STUDY

All the efforts described to this point promoted regulations and procedures based on an ethically sound approach to protecting human subjects who, by consent or proxy, will be participating in research. The ethics of the research environment seems to have improved as a result of these efforts both in the United States and internationally. Notable instances of particularly egregious studies have come to light since the publication of the Belmont Report, but most of these studies originated before that document was issued. One study in particular raised eyebrows for its similarity to the transgressions committed in the Tuskegee study and, after investigation, was found to have ties to the Tuskegee study.

In October 2010, the United States disclosed that the US Public Health Service sponsored studies of sexually transmitted diseases in Guatemala beginning in 1946. This exposé began with the discovery of documents among papers donated by Dr John Cutler to the library at the University of Pittsburgh. Before retiring, Cutler was on the faculty at the university's School of Public Health following a long career in the US Public Health Service where he had been one of the staff members involved with the Tuskegee study. Hoping to gain insight into the Tuskegee study, Dr Susan Reverby from Wellesley was reviewing Cutler's papers when she came across previously unknown information about experiments investigating sexually transmitted diseases in Guatemala that Cutler and his associates conducted. 36 An account in the American Journal of Public Health reports that “… more than 5000 uninformed and unconsenting Guatemalan people were intentionally infected with bacteria that cause sexually transmitted diseases” and many were never treated. 37

When the details of these experiments came to light, they precipitated an apology from President Barack Obama and specific directives to the Presidential Commission for the Study of Bioethical Issues, a commission appointed by Obama, to “convene a panel to conduct, beginning in January 2011, a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government. I also request that the Commission oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study” ( Figure 4 ). 38

Directive from President Barack Obama to investigate the Guatemalan studies, 2010 38

The Presidential Commission's first report, “ Ethically Impossible” STD Research in Guatemala from 1946 to 1948 , provides a detailed account of the history surrounding the Guatemala studies and all of the supporting evidence. In the preface, the Presidential Commission reports, “With dual responsibilities to give a full and fair accounting of events largely hidden from history for nearly 65 years and also provide an assessment of the current system, the Commission decided to publish two reports. This is the first report, a historical account and ethical assessment of the Guatemala experiments.” 38

The specific political circumstances in which the experiments were conceived and carried out is critical to gaining some understanding of how ethically questionable research, however ill-conceived, was carried out by people who most probably had good intentions. The significance of the deleterious effects of sexually transmitted diseases among troops in World War II and how those effects precipitated the experiments are difficult to understand in today's world of effective antibiotics. In the 1940s wartime environment, however, understanding all aspects of sexually transmitted diseases was perceived as a crucial aspect of the military's ability to field an effective fighting force for the war in Europe. The experiments must be viewed in this historic context to understand the powerful motivation behind the studies.

The “ Ethically Impossible ” report includes an excerpt from a 1943 letter from Dr Joseph Earle Moore, Chair of the Subcommittee on Venereal Diseases under the National Research Council, to A. N. Richards, Chair of the Medical Research Committee of the Office of Scientific Research and Development, in which Moore wrote that he expected “approximately 350,000 fresh infections with gonorrhea [in the Armed Forces], [which] will account for 7,000,000 lost man days per year, the equivalent of putting out of action for a full year the entire strength of two full armored divisions or of ten aircraft carriers.” 38 Moore estimated that the cost of treating the anticipated infections would be $34 million, equivalent to approximately $440 million today, adjusted for inflation.

Within this context, serious planning to meet the challenge of understanding and treating sexually transmitted diseases appears to have coalesced at the national level in 1942. Planning for these studies continued through the following year, with one of the principals suggesting “the possibility of using federal prisoners, Army prisoners, or conscientious objectors as an alternative” for research subjects. 38 In 1943, experiments began at the US Penitentiary in Terre Haute, IN, that continued for 2 years. The focus of the experiments was on efforts to infect prisoners with Neisseria gonorrhoeae to test various methods for prophylaxis and treatment. Isolates of bacteria were applied directly to the penises of subjects in an effort to reliably infect the “volunteers.” However, the failure to reliably infect subjects in this fashion clearly indicated that studies of prophylactic techniques would not be possible with this approach, leading to consideration of other options.

The studies were performed under the direction of Dr John F. Mahoney, then head of the US Public Health Service/Venereal Disease Research Laboratory (VDRL) set up within the US Marine Hospital in Staten Island, NY. Mahoney directed the Terra Haute prison studies from his Staten Island laboratory, while 28-year-old Dr Cutler ran the studies at the prison. Following the end of World War II in 1945, the military support for the studies was less enthusiastic, but the Public Health Service remained committed to supporting the research with plans to move the research to Guatemala. A 1947 article Mahoney published in the Journal of Venereal Disease Information provides some insight into why the studies were moved: “It has been considered impractical to work out, under postwar conditions in the United States, the solution of certain phases concerned with the prevention and treatment of syphilis. These problems are largely concerned with the development of an effective prophylactic agent for both gonorrhea and syphilis and the prolonged observation of patients treated with penicillin for early syphilis. Because of the relatively fixed character of the population and because of the highly cooperative attitude of the officials, both civil and military, an experimental laboratory in Guatemala City has been established….” 39

As fate would have it, a Guatemalan physician named Funes, who had served a fellowship at the VDRL and returned to Guatemala, was essential to the transition of the studies to his country. In August 1946, Cutler transitioned from Terra Haute to Guatemala at Funes's urging. Cutler staffed a clinic that provided the regular health inspections required for registered sex workers and suggested that the facility provide an environment of “normal exposure” through which sexually transmitted diseases could be more predictably transmitted. The studies in Guatemala evaluated possible prophylactic intervention “in cooperation with the Guatemalan Venereal Disease Control Department” that Funes directed and the local penitentiary “where exposure of volunteers to infected prostitutes would provide the testing opportunities.” 38 Enrolling prisoners, a contained and restricted population, after they had had sexual intercourse with commercial sex workers known to be infected with sexually transmitted diseases, promised to establish, according to Cutler, a “rapid and unequivocal answer as to the value of various prophylactic techniques” through the preferred technique of “normal exposure.” 38

After beginning with studies of “normal exposure” in prisoners, Cutler expanded the population of research subjects to include patients in a psychiatric hospital and again tried artificial means of infection, including scarification—mechanically damaging the skin and mucous membranes of the penis—to enhance the likelihood of infecting the subject. An even more aggressive study included at least 7 women in a psychiatric institution who were infected by the injection of syphilis specimens directly into the subarachnoid space surrounding the brain. Only 5 of them later received medical therapy. 38 In addition, studies to follow the serology of children in a large orphanage were undertaken to better understand the specificity of tests for sexually transmitted diseases, an additional goal of the Guatemalan studies.

Studies in which subjects were intentionally infected were completed in the later months of 1948, and Cutler left Guatemala in December 1948 to join a WHO Disease Demonstration Team in India. From April 1949 to July 1950, this team worked to establish a venereal disease control demonstration in various parts of India and teach advanced methods of control for sexually transmitted diseases. Meanwhile, the US Public Health Service hired Funes and another Guatemalan physician, Dr Salvado, to continue “the observation of certain of the patient groups” after Cutler left Guatemala. Funes's staff collected data on residents of the orphanage, inmates of the penitentiary, individuals from the psychiatric hospital, schoolchildren, and the members of “various Indian tribes in the vicinity of Guatemala” who had participated in the experiments. Funes was hired to “advise concerning the clinical examinations of treated patients, their re-treatment as may be required, the collection of blood specimens for serologic examinations at periodic intervals, the preparation and shipment of all blood specimens collected for serologic examination” to the United States, and “the submission of such reports as may be necessary for the completion of the study of this patient group.” 38 Based on the one report available in the Cutler Documents, Funes and his staff followed approximately 248 people from the mental institution, completing 243 blood draws and 170 lumbar punctures. Several of those subjects tested positive for syphilis during the follow-up experiments. The subjects from the psychiatric hospital were followed until at least 1953. The published work resulting from the Guatemala experiments also indicates that Funes continued to do serological testing on the children at the orphanage until at least 1949.

The experiments in Terra Haute were conducted and supported by many of the same people involved in the Guatemala experiments with the same goal of finding suitable prophylaxes for sexually transmitted diseases. However, throughout their discussion of the background leading to the experiments in the United States and the subsequent Guatemalan experiments, the Presidential Commission provides details of concerns voiced among those planning the studies. These details construct a compelling argument that all along the way there was an undercurrent of concern that the studies proposed were at the least controversial, most probably unethical, and in some instances arguably illegal. The Presidential Commission reached the conclusion that “Conducting the experiments in Guatemala provided an opportunity to work with reduced concern for some of the key obstacles associated with the Terre Haute experiments: fear of adverse legal consequences and bad publicity.” In a footnote to the report, the authors point out that “These concerns followed the researchers to Guatemala, however, as evidenced by some of their efforts to limit and restrict access to information about the work.” 38

The Presidential Commission summarized their findings as follows: “In the Commission's view, the Guatemala experiments involved unconscionable violations of ethics, even as judged against the researchers’ own understanding of the practices and requirements of medical ethics of the day.” The report concludes

Although some individuals are more blameworthy than others, the blame for this episode cannot be said to fall solely on the shoulders of one or two individuals. The unconscionable events that unfolded in Guatemala in the years 1946 to 1948 also represented an institutional failure of the sort that modern requirements of transparency and accountability are designed to prevent. In the final analysis, institutions are comprised of individuals who, however flawed, are expected to exercise sound judgment in the pursuit of their institutional mission. This is all the more true and important when those individuals hold privileged and powerful roles as professionals and public officials. One lesson of the Guatemala experiments, never to take ethics for granted, let alone confuse ethical principles with burdensome obstacles to be overcome or evaded, is a sobering one for our own and all subsequent generations. We should be ever vigilant to ensure that such reprehensible exploitation of our fellow human beings is never repeated. 38

The second charge from President Obama to the Presidential Commission was to provide a “thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.” The Presidential Commission addressed this directive in their report Moral Science: Protecting Participants in Human Subjects Research that was completed in December 2011. 40

Regarding whether the regulations would prevent abuses similar to the studies in Guatemala, the Commission noted, “Existing evidence suggests both that the rules governing federal research today adequately guard against abuses analogous to those perpetrated in Guatemala in the 1940s and that current regulations generally appear to protect people from avoidable harm or unethical treatment, insofar as is feasible given limited resources, no matter where U.S.-supported research occurs.” 40 The report summary continued as follows:

The current U.S. system provides substantial protections for the health, rights, and welfare of research subjects and, in general, serves to “protect people from harm or unethical treatment” when they volunteer to participate as subjects in scientific studies supported by the federal government. However, because of the currently limited ability of some governmental agencies to identify basic information about all of their human subjects research, the Commission cannot say that all federally funded research provides optimal protections against avoidable harms and unethical treatment. The Commission finds significant room for improvement in several areas where, for example, immediate changes can be made to increase accountability and thereby reduce the likelihood of harm or unethical treatment. 40

The report outlines the Presidential Commission's observations and recommendations based on a thorough review of federally funded research, including studies that may involve human subjects in other countries. One issue the Commission raised was the general lack of accessibility to data: “there is no ready source that comprehensively describes its [the federally funded human research enterprise] basic characteristics, such as level of funding, or number of studies, subjects, or geographic locations. Instead, what exists are isolated pockets of information and some descriptive summaries.” 40 This difficulty in acquiring information prompted the Presidential Commission's first recommendation to improve accountability through public access: “accountability can and should be refined through improving access to basic information about the scope and volume of human subjects research funded by the government.” The commission cites precedent for this recommendation from the Institute of Medicine–issued Responsible Research: A Systems Approach to Protecting Research Participants , with its recommendation to extend the oversight system to all research, regardless of funding source or research setting. 41

Treatment and compensation for research-related injuries were also identified as an issue of concern, a subject that has been scrutinized regularly in past discussions as human research protection has evolved. Obama's Commission noted that this issue still required attention at the time of their review, pointing out that most other developed countries require sponsors, investigators, or others engaged in research to provide treatment or reimbursement free of charge to the subject for research-related injury or illness. As discussed earlier, one of the deviations from the general agreement between CIOMS and US regulations is the recommendation for subject compensation in the CIOMS guidelines. The Presidential Commission “draws a bright line affirming the view of most bioethicists and others, including the majority of nations supporting human subjects research around the globe, that human subjects should not individually bear the costs of care required to treat harms resulting directly from that research.” 40 Recognizing that previous bioethics commissions and other advisory bodies had opined in favor of compensation or treatment for research-related injuries with relative silence by the government, the Commission advocated a response as to reasons for changing or maintaining the status quo. This issue remains open with no progress as this article is being written.

The Commission also asked that the OHRP examine, recognize, and define when protections delineated in foreign laws and regulations are accepted as equivalent to US regulations and exercise its longstanding authority to recognize these protections when available. Protections offered by international partners have been a source of confusion, as the federal regulations state that equivalent protections from international studies should be accommodated but do not provide guidance for how they should be defined. This directive has been reevaluated several times since its inception, including a specific request from the United Kingdom in 2007 to provide a determination of equivalence for human research protections afforded by UK regulations. As of the Commission's report in 2011, the OHRP had not formally recognized any country's protections as equivalent.

The Commission also noted that the FDA, while not signatory to the Common Rule, does adhere to the regulations at 45 CFR §46, Subpart A whenever possible and accepts data from foreign studies that comply with certain international standards for human subjects protection, such as studies that abide by good clinical practice, the Declaration of Helsinki, or certain host country regulations. This practice should provide a model to develop a system for recognizing equivalent protections as currently regulated by provisions in the Common Rule.

In its final recommendation, Promoting Current Federal Reform Efforts, the Presidential Commission called for broad reform of federal research rules and procedures beyond simply addressing equivalent protections.

The Commission supports the federal government's proposed reforms to:

a) Restructure research oversight to appropriately calibrate the level and intensity of the review activities with the level of risk to human subjects;

b) Eliminate continuing review for certain lower-risk studies and regularly update the list of research categories that may undergo expedited review;

c) Reduce unnecessary, duplicative, or redundant institutional review board review in multi-site studies. Regardless of the process used to review and approve studies, institutions should retain responsibility for ensuring that human subjects are protected at their location as protection of human subjects includes much more than institutional review board review. The use of a single institutional review board of record should be made the regulatory default unless institutions or investigators have sufficient justification to act otherwise;

d) Make available standardized consent form templates with clear language understandable to subjects;

e) Harmonize the Common Rule and existing regulations of the Food and Drug Administration, and require that all federal agencies conducting human subjects research adopt human subjects regulations that are consistent with the ethical requirements of the Common Rule; and

f) Work toward developing an interoperable or compatible data collection system for adverse event reporting across the federal government. 40

Most of these provisions were included in the revisions to the Common Rule that updated the original provisions from 1991 and were effective January 21, 2019, with the exception of staged implementation of single IRB review for multisite studies. Twenty federal agencies follow the Common Rule, with the notable exception of the FDA. So far, no official indication of the FDA's intent has been provided, although the expectation is that some effort will be made to harmonize the regulations—at least in a similar fashion as previous agreements.

OTHER HUMAN SUBJECTS PROTECTION FAILURES

This exposition of how we have arrived at the current rules and regulations for protecting human subjects who participate in research is lengthy but is at best an outline. Even this abbreviated history should elicit an appreciation of the complexity of the ethics surrounding protection of human subjects in research. A fair question is whether these provisions have significantly altered the landscape since Dr Beecher published his concerns in the New England Journal of Medicine in 1966. A cursory review turns up a few exceptions to the relative safety afforded by the current protections, with three that are particularly instructive.

Jesse Gelsinger

Jesse Gelsinger had just turned 18, the legal age for consent, when he volunteered in 1999 for a phase 1 gene therapy study designed for treatment of ornithine transcarbamylase (OTC) deficiency. Phase 1 studies are designed primarily to determine the appropriate dose of a drug. Gelsinger was born with a mild form of OTC that was well controlled by diet and drug therapy; he had minimal risk of serious complications from the disease as long as he followed his treatment protocol. He did not stand to benefit significantly from his participation in the phase 1 study but felt that he should volunteer because of the knowledge that might benefit others.

Gelsinger died 4 days after receiving an experimental therapy consisting of a gene attached to an adenovirus that would theoretically serve as a delivery system to insert the new gene into the DNA of his liver cells. The death was unexpected in a relatively healthy 18-year-old, and the outcome precipitated a long and contentious investigation into how the protections that should have prevented Gelsinger from participating in the study were circumvented or ignored. The investigation uncovered questions regarding (1) information that should have been included in the consent form, (2) the actual risk posed by the study based on complications from similar studies that were not disclosed in reports to regulatory bodies, (3) why Gelsinger was enrolled in the study in violation of the protocol's inclusion/exclusion criteria, (4) the potential risk/benefit analysis based on the mild nature of his disease that would argue against his participation, and (5) an undisclosed conflict of interest for the director of the gene studies program that may have clouded decisions at critical points during conduct of the study. 42 - 45

Examination of this study demonstrates that the protections afforded to subjects are well established but still depend on the assumption that the individuals responsible for every step of the evaluation and approval of studies and those who actually conduct the research all perform reliably in their roles.

Johns Hopkins Lead Abatement Study

Another notable case revolves around the issues of appropriate consent, appropriate risks for children (or any vulnerable population), and disclosure of results obtained in research studies. The Kennedy Krieger Institute (KKI), an affiliate of Johns Hopkins Children's Center, conducted a study evaluating the effectiveness of lead abatement programs in low-income housing in Baltimore, MD during the 1990s. The study recruited families to live in houses either untouched or treated with different abatement techniques to determine which processes were most effective in protecting children from the significant neurologic effects of elevated lead levels that were endemic among children living in low-income housing in Baltimore. The goal was “to find a relatively inexpensive and effective method for reducing—though not eliminating—the amount of lead in children's homes and thereby reducing the devastating effect of lead exposure on children's brains.” 46 A total of 108 families with young children were recruited to live in houses with lead levels ranging from none to levels just below the existing legal limit, and the children's serum lead levels were monitored. In two homes, the lead levels in the children crossed into toxic levels, but the families were not informed or advised to move out of the toxic environment. Eventually, a lawsuit was filed on behalf of the two children, and it raised significant ethical questions surrounding informed consent, appropriate risks, and disclosure of results that are reviewed at length in the article “With the Best Intentions: Lead Research and the Challenge to Public Health.” 46 The Maryland Court of Appeals opinion equated the multiyear lead study with the Tuskegee study in its egregious disregard for research ethics in a vulnerable population.

Ellen Roche

Ellen Roche was a healthy 24-year-old laboratory technician at the Johns Hopkins Asthma and Allergy Center. She volunteered to take part in a 2001 lung function physiology experiment in which normal pulmonary function in healthy volunteers would be manipulated by inhalation of hexamethonium, a compound that interferes with normal nervous system interaction with the lungs to mimic a mild asthma attack. Although it had been used in the 1950s to treat hypertension, hexamethonium fell into disuse as more effective drugs became available, and the FDA withdrew approval in 1972. Of note, hexamethonium was never approved as an inhaled medication. Roche was the fourth patient to receive hexamethonium in the trial. At least one previous subject had had mild persistent respiratory symptoms that the investigator dismissed as a cold. Roche became very ill, with significant pulmonary abnormalities presenting within 24 hours. The symptoms progressed to multisystem organ failure, and she died within a month. 47 , 48

The ensuing investigation turned up several concerns:

• The literature search relied on PubMed and one contemporary textbook of pulmonary medicine to explore the potential use of hexamethonium for the purpose proposed in the research plan. Neither source revealed any indication of concerns, although other databases and older textbooks warned of significant pulmonary complications associated with hexamethonium.
• No request was made to determine if the FDA required an investigational new drug application, even though the medication was no longer approved and had never been approved as an inhalational drug.
• The consent form referred to hexamethonium as a medication but failed to mention that FDA approval had been withdrawn.
• A few subjects included in previous studies used inhaled hexamethonium with no mention of problems in the subsequent publications, but two subjects did have significant difficulties that were not reported as the investigator did not consider them related to the drug.
• The hexamethonium used in the study was of chemical grade and was not prepared as a pharmaceutical agent. 47 , 48

This list is not complete and raises many concerns, but the focus of the investigation became the lack of adequate research to confirm that the compound used to induce asthma symptoms was safe. The responsibility for this failure primarily attached to the investigator, with additional concern focusing on a review process that failed to follow proper procedures for approval of the protocol. During the follow-up, several articles from the 1950s reporting that hexamethonium could cause fatal lung inflammation similar to the pulmonary complications leading to the demise of Ellen Roche were identified. PubMed's coverage of the literature starts in the mid-1960s. In addition, review of the FDA records related to the withdrawal of hexamethonium in 1972 cited the drug's “substantial potential toxicity” as one element leading to the decision. 48

The examples of ethical issues from history and the scarcity of contemporary examples demonstrate that regulations for the protection of humans participating in research have evolved in a way that minimizes the probability of harm to subjects choosing to participate in research. These examples also reinforce the importance of individual responsibility to faithfully execute the requirements of their assigned roles. Failure of IRBs to provide appropriate review and oversight can lead to severe consequences, as can abrogation by the investigator to place the well-being of the subjects as the primary responsibility in any research protocol. Furthermore, these examples support the argument that no amount of regulation or oversight can completely remove the variable of individual failures to adhere to the rules or accept the responsibility associated with their role in research that may precipitate serious unexpected consequences. The rules and expectations for those charged with the review, administration, and performance of research requiring human subjects can only minimize the probability that these instances will occur. The point at which the primary responsibility of protecting human subjects from preventable harm deviates to focus on some other aspect of the research that leads to harm is rarely predictable. Simplified to the world of Monty Python, “Nobody expects the Spanish Inquisition!”

ACKNOWLEDGMENTS

The author has no financial or proprietary interest in the subject matter of this article.

This article meets the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties Maintenance of Certification competencies for Patient Care, Medical Knowledge, and Systems-Based Practice.

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Human Rights Research and Ethics Review: Protecting Individuals or Protecting the State?

* E-mail: [email protected]

Affiliations Health and Human Rights Division, Human Rights Watch, New York, New York, United States of America, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America

Affiliations Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America, Center for Public Health and Human Rights, Johns Hopkins University, Baltimore, Maryland, United States of America

Affiliations Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America, Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, United States of America

• Joseph J. Amon, 
• Stefan D. Baral, 
• Chris Beyrer, 

Published: October 16, 2012

• https://doi.org/10.1371/journal.pmed.1001325
• Reader Comments

Citation: Amon JJ, Baral SD, Beyrer C, Kass N (2012) Human Rights Research and Ethics Review: Protecting Individuals or Protecting the State? PLoS Med 9(10): e1001325. https://doi.org/10.1371/journal.pmed.1001325

Copyright: © Amon et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: The authors received no specific funding for this article.

Competing interests: CB is a member of the PLOS Medicine Editorial Board. All other authors have declared that no competing interests exist.

Abbreviations: LMICs, low- and middle-income countries; MSM, men who have sex with men; REC, research ethics committee

Provenance: Not commissioned; externally peer reviewed.

Summary Points

• Recently there has been a dramatic expansion in research conducted in low- and middle-income countries, as well as research ethics committees (RECs) in these countries.
• RECs in low- and middle-income countries have little experience overseeing human rights research and may be subject to government control or influence that may favor the interests of the state over the interests of individual research participants.
• Many human rights investigators are trained in disciplines with ethical codes and professional norms, but do not typically engage RECs nor see human rights documentation as research, and they tend to view REC approval as counterproductive to the protection of research participants.
• Case studies of human rights research can provide important lessons on navigating conflicts of interest posed by some local (i.e., in country) RECs.
• Expanding the use of community engagement and developing strong ethical operating principles can help ensure that individuals and researchers are protected in human rights research and investigations.

Human rights violations play an important role as determinants of, or structural barriers to, health [1] – [6] . Research, investigation, and documentation focused on human rights have led to the development of rights-based interventions [7] , [8] and the promotion of human rights in the core strategies of international health organizations [9] , [10] .

At the same time, health and human rights investigations raise complex ethical and methodological challenges [11] . Key questions have emerged about the roles of ethical review and research ethics committees (RECs) when criminalized or marginalized populations are part of research or program efforts [12] , [13] . Human rights researchers may also follow ethical codes and professional norms such as those of journalists or lawyers, for example, but these do not typically engage RECs and may in fact define their work differently than biomedical or epidemiologic definitions of “research” [14] – [16] . Furthermore, members of local (i.e., in country) RECs may have conflicts of interest when state actors have a role in or supervision over RECs and can exert their influence to limit the scope of or impede investigations into human rights abuses.

In some circumstances, interests other than ensuring the sound protection of research participants may come to dominate the decisions that RECs make, including whether they agree to review the research and/or allow the research to be conducted at all. Researchers aware of these decision-making processes may “self censor” the focus of their research or choose to conduct research elsewhere. As increasing amounts of research are conducted on the impact of human rights on health, more attention is needed on the roles of RECs and researchers to ensure genuine protection of the individuals involved in human rights investigations.

Here we present examples of how human rights researchers can address complex ethical challenges by building the capacity of community-based organizations representing vulnerable populations and by adopting ethical operating principles. We illustrate our policy proposals using case studies of research involving men who have sex with men (MSM) in Africa, ethnic minorities in Myanmar, and individuals in compulsory drug treatment centers in Asia.

Human Participant Protections

The protection of participants in health-related research has evolved into a well-articulated international framework supported by normative documents, conventions, and, in growing numbers of jurisdictions, laws. Key among these are the World Medical Association's 1964 Declaration of Helsinki [17] , the US Department of Health and Human Services Belmont Report and regulations for the protection of research participants [18] , [19] , the Council for International Organizations of Medical Sciences international ethical guidelines [20] , and the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( http://www.ich.org/ ). All of these guidelines require prior review of research by an REC before research can be implemented. More recently, the World Health Organization published standards for such committees outlining key requirements for their structure, governance, and review standards [21] .

Over the last ten years, there has been extraordinary growth in the numbers of RECs in low- and middle-income countries (LMICs). As new committees in LMICs have emerged, many countries have adopted a structure whereby local committees, affiliated with specific research institutions or organizations, are supported by a national committee. The national committee is in charge of creating policies, providing oversight, and, in some cases, performing an additional, final review.

Unfortunately, the methodology and intent of human rights research has not been fully considered in existing standards and guidelines on the ethical conduct of research. Similarly, RECs have traditionally been orientated to biomedical and epidemiologic research and have rarely considered human rights research. While principles such as autonomy, beneficence, non-malevolence, and justice are common to ethical codes in diverse disciplines [14] – [16] , [18] , [22] , the definition of “research” and the requirement for REC review are not universal across different types of research.

Defining “Research”

The definition of research and the difference between health research (typically requiring ethics review) and monitoring, evaluation, or practice (typically exempt from review) are not straightforward [23] . For individuals engaged in rights research and RECs considering their jurisdiction over such research, the determination of whether a human rights investigation constitutes research can be contentious and may reflect differences in disciplinary training and professional norms.

Health and human rights investigations can often be considered “non-research” under the US Department of Health and Human Services and international definitions that define research as developing “generalizable knowledge” [19] , [20] . Documentation of particular human rights abuses, factors that contribute to particular cases of human rights abuse, or human rights protections in particular situations are not usually considered “generalizable.” While broader surveys determining the prevalence of abuses may be considered research, in some cases they may be considered monitoring, which, again, is commonly exempt from review. In addition, individuals who provide testimony or evidence of human rights abuses are not traditional research participants. Instead, these individuals have an important motivation for engagement in human rights investigations, that is, for seeing such investigations as perhaps their only means of achieving justice for themselves and their communities. Thus, their view of the balance of “risk” versus “benefit” may be substantially different from the view held by biomedical researchers or REC members.

Conducting Research on MSM and HIV in Africa

Recently identified HIV outbreaks among MSM in several African countries have revealed many neglected or hidden human rights abuses. These abuses include discrimination in access to HIV prevention and treatment, lack of access to justice, police abuse, arbitrary arrest and detention, and ill-treatment and torture. In nearly all African countries in which research has been conducted, HIV infection rates have been markedly higher among MSM than among other men of reproductive age [24] – [29] . These epidemics are occurring among largely hidden, stigmatized, and—in many countries—criminalized MSM communities, challenging research and service provision [30] .

In some countries, police have specifically targeted outreach workers providing information and condoms to MSM [31] , [32] , and health-care workers have been complicit in efforts to “prove” homosexuality with forced anal exams [33] – [35] . In Uganda, conducting research on MSM, including investigations of possible human rights abuses, has become difficult or impossible. Reasons for this difficulty include proposed legislation to make sodomy a capital offense and to criminalize the failure to report individuals suspected of engaging in homosexual behaviors, and targeted violence against individuals identified as MSM, including murder [36] , [37] .

Nevertheless, MSM health service providers and gay service and rights organizations and activists in many African countries have been enthusiastic partners in HIV-related programs, including research, even though governments have been reluctant to support research on MSM. In several cases, governments have actively opposed research that would lend credence to the reality that lesbian, gay, bisexual, and transgender persons exist in their countries, and to the fact that MSM are at elevated risk for HIV infection [37] , [38] .

At one site of a multi-country study being conducted by two of the authors of this article (S. D. B. and C. B.), the head of the only university-based REC informed the research team that, since homosexuality was criminalized in the country, no research protocols related to MSM would be accepted for review. The REC chair told the researchers that the role of the REC included the protection of social and cultural values of the country. While RECs may legitimately reference social and cultural values in considering what constitutes risk to individual human participants, the REC in this case defined its role well beyond protection of human welfare to instead reinforce a political position of the state.

In response, researchers engaged community-based organizations serving MSM in the country to gauge the level of support for the study, and trained community leaders on research ethics [39] . The study protocol was then reviewed by community leaders, who suggested protocol changes based on further community consultation. At the same time, the protocols were also reviewed by a REC in the US that was informed that the in-country REC had refused to review the protocol. After approval by the US REC, the researchers decided that the final decision to proceed should be made by the community-based organizations in country based upon their assessment of the risks and benefits of the research. Community members also participated in validating research findings, and members of the community presented the results to their peers and in domestic and international forums.

Investigating Health and Human Rights in Myanmar

In democratic societies where government legitimacy has broad acceptance, and where ministries of health are seen as working to advance the health and well-being of the population, researchers rarely question whether academic or state entities have the right to form and oversee RECs. In contrast, in repressive societies, and where an REC is seen as not representative of, or legitimately protecting the interests of, a particular vulnerable group (e.g., prisoners, women, or an ethnic or religious minority), RECs may be understood as agents of the state: prioritizing the protection of state interests over those of research participants.

In the case of Myanmar, decades of civil and ethnic conflict have left large areas of the country under contested political control. Several major ethnic nationalities, including the Karen, Kachin, Chin, Shan, Mon, and Wa, have been in open armed conflict with the ruling military-backed regime or have cease-fire agreements that allow them considerable autonomy. Most of these ethnic groups do not have formal relationships with the ruling government.

In working with ethnic populations in border zones since 1992, we (as well as collaborators from the University of California, Los Angeles, and other entities) have struggled with the question of who most legitimately represents these populations and specifically who should safeguard their rights and interests if researchers or investigators want to collect data. For individuals with no formal communication with the regime they are fighting, the concept that this regime could make decisions for their health and well-being is both absurd and offensive. However, popular support for the government in exile is strong among most of Myamnar's ethnic national organizations, and this exiled government has a well-established health and welfare committee. Consequently, we have helped to establish and build the capacity of an REC composed of Myanmar physicians and nurses in exile, community health workers, community members, and faith-based leaders. This group has now had several years of experience functioning as an REC and reviewing proposals, and their authority has been accepted by RECs at US institutions [40] – [42] .

Documenting Abuses in Compulsory Drug Treatment Centers

Between July 2007 and September 2011, Human Rights Watch conducted investigations of compulsory detention of drug users in China [43] , [44] , Cambodia [45] , Viet Nam [46] , and the Lao People's Democratic Republic [47] . In these countries, drug use is legal but drug users are subject to extrajudicial administrative detention for the purpose of compulsory treatment of drug dependency. The investigations conducted by Human Rights Watch included interviews with individuals recently detained in drug detention centers; key informant interviews with non-government organizations, funding entities, and, in some cases, government officials; review of relevant government laws and policies; and review of international donor policies and programs in drug detention centers. The investigators found that individuals in drug detention centers were routinely held without clinical determination of drug dependency or due process, and once detained were denied evidence-based drug treatment as well as other basic health services. Drug users were often forced to perform arduous physical exercise, military drills, or forced labor, and were subject to physical and sexual abuse.

While research on drug addiction, HIV virology, HIV prevalence, and HIV prevention has been routinely conducted inside detention centers with the approval of government-affiliated RECs and the authorization of the government-controlled detention centers, the specific ethical concerns of conducting research in institutions that violate due process protections have not been addressed. At a minimum, researchers should be expected to accurately characterize the research setting and status of participants. Yet, researchers have often ignored the conditions within and lack of judicial oversight of such centers, presenting them as legitimate treatment facilities [48] , [49] . Researchers rarely report on the availability of evidence-based drug dependency treatment [48] , [50] – [55] and have obscured the status of research participants (e.g., referring to detainees as “patients” [48] or vaguely alluding to their “complex legal needs” [55] ). Published papers also often omit mention of the challenges of conducting independent research [48] , [50] – [55] . One study acknowledged using detention center staff to witness consent [55] , potentially increasing the risk of coercion. Researchers who do not have full, independent, or ongoing access to detention centers may be unable to assess negative consequences for research participants, and detainees who do not have access to legal counsel or the right to free speech may be unable to file a complaint alleging abusive research.

In response to these challenges, we chose to conduct research with individuals in the community who had been recently released from detention centers. However, human rights monitoring by independent international organizations is not allowed in China, Viet Nam, or the Lao People's Democratic Republic, and we did not feel that local RECs would approve research related to torture and ill-treatment. Therefore, a decision was made to proceed without local REC approval in order to protect both research participants and researchers, who we feared could be targeted by the state for proposing research that is viewed as sensitive to state security or disruptive of government goals of “social harmony.” In place of local REC approval, and because we felt that there was no defined community of recently released drug users to formally consult with (and that community engagement in the context of ongoing persecution would not be safe regardless), researchers developed and followed specific ethical operating principles. In contrast to the typical approach of RECs, where review is limited to the research protocol, every step of the research, from the protocol review to implementation to dissemination of results to scientific, diplomatic, and media audiences included internal ethics review by technical and legal experts.

Mitigating Risks in Human Rights Investigations

To address the possible conflicts investigators may face in protecting participants in the course of health and human rights investigations, local RECs are needed that can be considered truly independent. In addition, two distinct and complementary strategies—community-based review and the development of strong ethical operating principles—can help protect investigators and participants in health-related human rights research.

In the context of governments that persecute specific populations, actively limit free speech, and routinely punish criticism of the state, RECs are unlikely to be independent. Under these circumstances, using local RECs to safeguard the rights and interests of research participants may be counterproductive, putting both investigators and participants at risk. In these settings, researchers may need to actively engage communities and follow clear ethical operating principles in place of local REC review.

Community-based review and participatory research have a long history and were developed to address community members' concerns about neglect by and communities' mistrust of researchers, health-care systems, and government [56] , [57] . Conducted correctly, community-based participatory research (including financial and technical support for community engagement and leadership) creates bridges between policy-makers, scientists, and communities; facilitates reciprocal learning; assists in the development of culturally appropriate measurement instruments and interventions; and establishes a level of trust that enhances both the quantity and the quality of data collected and programs delivered [39] , [57] – [61] . While there is a well-established body of literature on engagement of marginalized populations in high-income settings and on some vulnerable populations in LMICs [57] , [58] , the issues faced by criminalized and violently stigmatized populations have less often been addressed.

One challenge of community-based review is that in many settings the “community” is not homogenous, organized, or able to participate in extensive consultation and review of proposed research. Research with migrants, prisoners, drug users, and criminalized populations is often conducted without a representative advocacy group. In other settings, it may not be clear who legitimately speaks for marginalized populations. In all settings, community-based review can be time-consuming and resource intensive.

In conducting human rights research, particularly in settings where safety may be of particular concern, a critical first step is to have standing procedures on investigator and participant protection. All Human Rights Watch staff who conduct interviews, for example, undergo security training and training on participants' protection and data safety. Researchers can also receive specialized training on how to sensitively interview people in such a way as to minimize risk of re-traumatization, including training on interviewing victims of sexual violence, children, persons in extreme pain, prisoners, and the mentally disabled. All researchers must participate in a security meeting prior to a research mission that establishes chains of communication so that security emergencies can be identified and handled once the mission is in progress. Post-mission meetings are held if security concerns arise, and the security of participants stemming from contact with researchers is monitored. Prior to publication of any findings from research (in the form of reports, journal articles, press releases, opinion pieces, photography, or other media), legal review is required and provides further assessment of research participant protection.

For individuals who experience human rights abuses, the consequences of reporting that abuse are often uncertain. Yet even when the risk of retaliation is judged to be high, many individuals may be willing to take such a risk in order to press for justice, despite the fact that justice may take years or even decades to be served. Individuals who are a part of communities that are systematically discriminated against, stigmatized, or criminalized may experience high levels of ongoing harm, and see participation in a human rights investigation as one of few means of challenging those abuses or demanding redress.

In the decade to come, RECs in LMICs will likely acquire increasing jurisdiction, resources, and authority over local research. These changes will offer a promise of greater protection for research participants who in the past have faced abuses with little opportunity for redress. But RECs may have little experience in evaluating the inherent risks faced by individuals vulnerable to human rights abuses as well as the risks and benefits from participation in a human rights investigation. RECs, which primarily review pre-research protocols, may also be poorly suited to the review of dynamic investigations using open-ended research methodologies where the risk to participants is less a result of research processes (e.g., questionnaires) than from post-research products (e.g., reports, legal processes, and media coverage).

The use of RECs to limit health and human rights research for political, cultural, or other considerations is a misuse of the legitimate functions of RECs. Careful attention must be paid when local committees assert that their views represent local cultural norms, or that human rights are an illegitimate focus of research as they express foreign values. A critical distinction for researchers is understanding the difference between respecting cultural traditions that are “matters of etiquette, ritual, or religion,” with little or no relation to ethics, from those cultural traditions with ethical (or human rights) implications, such as female genital mutilation or infanticide [62] . Cultural practices or government policies that either deliberately or incidentally serve to suppress or threaten the rights of certain people cannot be respected. RECs, charged specifically with upholding the rights and protection of individuals, should not use culture or “values” as a means to deny human rights.

Increasing attention to human rights as a determinant of health will result in increasing requests to RECs to review research that investigates the role and complicity of state actors, government laws and policies, and social or cultural norms as they relate to health. Stronger, independent RECs trained in human rights may be better equipped to more adequately review this research. When RECs are unable to do so, or where research on human rights or criminalized or marginalized populations is expressly prohibited, researchers may need to rely upon alternative strategies, including engaging communities and following ethical operating principles, to ensure that research participants are protected and that research is ethically conducted. While such innovations do not eliminate all risks, and may be costly in terms of time and resources, the alternatives, which may include acceding to censorship or not conducting investigations at all, are unacceptable limits.

Author Contributions

Wrote the first draft of the manuscript: JJA. Contributed to the writing of the manuscript: JJA SDB CB NK. ICMJE criteria for authorship read and met: JJA SDB CB NK. Agree with manuscript results and conclusions: JJA SDB CB NK.

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Technological advancements affect the future of human rights.

The evolution of technology will have inevitably profound implications for the human rights framework.

From a practical perspective, technology can help move the human rights agenda forward. For instance, the use of satellite data can monitor the flow of displaced people; artificial intelligence can assist with image recognition to gather data on rights abuses; and the use of forensic technology can reconstruct crime scenes and hold perpetrators accountable.

Yet, for the multitude of areas in which emerging technologies advance the human rights agenda, technological developments have equal capacity to undermine efforts. From authoritarian states monitoring political dissidents by way of surveillance technologies, to the phenomenon of “deepfakes” destabilizing the democratic public sphere, ethical and policy-oriented implications must be taken into consideration with the development of technological innovations.  

Technological advancements also introduce new actors to the human rights framework. The movement has historically focused on the role of the state in ensuring rights and justice. Today, technological advancements and the rise of artificial intelligence and machine learning, in particular, necessitate interaction, collaboration, and coordination with leaders from business and technology in addition to government.

The Carr Center's Technology and Human Rights Program brings together the Technology and Human Rights Fellowship, with a new cohort selected each academic year to perform research on the challenges of technology to the human rights framework. Additionally, the program hosts the  Towards Life 3.0: Ethics and Technology in the 21st Century  webinar series, which draws upon a range of scholars, tech leaders, and public interest technologists to address the ethical aspects of the long-term impact of AI on society and human life.

A new sub-theme of the Technology and Human Rights Fellowship gives special focus to research on "Surveillance Democracy or Capitalism?," a cohort that connects fellows' projects to the research in Shoshana Zuboff's 2019 book,  The Age Surveillance Capitalism,  and Mathias Risse’s 2023 book,  Political Theory of the Digital Age . This portion of the Technology and Human Rights Fellowship is co-directed by Mathias Risse and Shoshana Zuboff. 

Our Technology and Human Rights Fellows

Alexandra Belias

Head of Product Policy & Partnerships DeepMind

Isabel Ebert

Senior Research Fellow at the Institute for Business Ethics University of St. Gallen

Mona Elswah

DPhil Candidate Oxford Internet Institute

Albert Fox Cahn

Founder and Executive Director Surveillance Technology Oversight Project

Nnenna Ifeanyi-Ajufo

Associate Professor of Law Buckinghamshire New University

Dragana Kaurin

Founder and Executive Director Localization Lab

Nitika Khaitan

Criminal Defense Lawyer LL.M. Candidate, Harvard Law School

Sebastian Lehuede

Postdoctoral Scholar University of Cambridge

Matthew MacDonald

Doctoral Candidate in Philosophy Harvard University

Ella McPherson

Associate Professor University of Cambridge

Lucas Meier

Junior Research Fellow University of Cambridge

Sebastian Smart

Regional Director Chilean National Human Rights Institution

Sharath Srinivasan

David and Elaine Potter Associate Professor University of Cambridge

Phumzile Van Damme

Former Member of Parliament South Africa

From Our Tech & Human Rights Fellows

The consequences of video game moderation.

Online video games are social networks, afflicted with the same speech moderation questions as other social media platforms. 

Rights, Systematicity, and Misinformation

The dangers of new technology, misinformation, and how they intersect with human rights.

Does AI Understand Arabic?

Mona Elswah zooms in on the AI-powered content moderation by Meta’s Facebook in relation to managing Arabic content. 

Provocations for Human Rights & Technology

Breaking from big tech, human rights advocates working with technology envision data, platforms and systems aligned with pluralism and solidarity.

Technology Dependence & Racial Inequality

The exacerbation of racial inequality through the design of technologies shows how the evolution of digital technologies impacts our human rights.

Automation Anxiety

Rapid advances in AI have created a global sense of urgency around the ways that automated systems are changing human lives, but not all of these changes are necessarily for the better. 

Can We Move Fast Without Breaking Things?

As technology becomes ever more prevalent, evidence of the undesirable consequences has become too difficult to ignore.

Not My A.I.

Feminist theories and practices are important tools to acknowledge the existence of the political structures behind the deployment of technologies.

Online Platforms & Mental Health

In recent years, there has been growing concern regarding the unintended mental health impact of online platforms and whether they might be driving a public health crisis.

Towards Life 3.0 Webinars

Ai as a catalyst for participatory governance.

Beth Noveck discusses the transformative potential of AI in reshaping governance and strengthening democratic processes. 

AI and Ethics in Science Fiction

Award-winning science fiction author Jo Walton discusses artificial intelligence in science fiction. 

Technology, Repression, & Geopolitics

Steve Feldstein of the Carnegie Endowment discusses the role of artificial intelligence is reshaping repression.

Generative AI and Deepfakes

Samuel Gregory of WITNESS discusses the dangers of generative AI and deepfakes for our human rights.

Seeing Through the Fog in Russia and Ukraine

Aric Toler of Bellingcat discusses the Russian invasion of Ukraine.

AI and the Future of Democracy

Mathias Risse discusses the potential impacts of artificial intelligence on the future of our democracy.

Related Content

The age of surveillance capitalism, making a movement, black witnessing, smartphones, and the new protest journalism.

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Definition of Human Subjects Research

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Decision Tool: Am I Doing Human Subjects Research?  

The questionnaire is a tool to assist you with determining whether your project involves non-exempt human subjects research, meets the criteria for exempt human subjects research, or does not involve human subjects research. 

Human Subjects Research Infographic

This resource summarizes the definition of human subjects research and provides examples of human subjects research projects. It also describes what you will need when you are preparing your NIH application and what is required if you are funded.

Exempt Human Subjects Research Infographic

This resource is a guide to simplify the understanding of the exemptions from the federal regulations for the protection of human subjects research. It summarizes Exemptions 1, 2, 3, 4, 5, 6, 7 and 8, providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and aspects one must consider when engaged in exempt or non-exempt human subjects research. 

Research Involving Private Information or Biospecimens Flowchart

Studies involving the use of human specimens or data may or may not be considered to be research involving human subjects, depending on the details of the materials to be used. Use this flowchart to help determine if studies involving private information or biospecimens may meet the definition of human subjects research.

Public Health Surveillance Exclusions

Learn about research activities which may qualify for a public health surveillance exclusion. Find useful information, key resources, and instructions for NIH applicants and offerors.

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Lesson 2: What is Human Subjects Research?

Please note: This lesson will take approximately 1 hour and 35 minutes to complete. Use the next and previous buttons to advance through the course. You will be able to print a completion certificate for your records at the end of this training. OHRP does not collect information about who accesses it.

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Purpose of this Lesson

This lesson will explain how the Common Rule regulations define “research” and “human subjects” and explain what it means to be exempt from the regulations. This lesson focuses on the Revised Common Rule (or 2018 Requirements) that became effective in 2018.

Lesson Overview

This lesson contains four parts:

Part 1: Background of Human Subjects Research

Part 2: is the activity research, part 3: does the research involve human subjects, part 4: is the human subjects research exempt.

You will answer quiz questions throughout each part to test your knowledge. A correct response is required to advance in the lesson.

Learning Objectives

After completing this lesson, you will be able to:

• Identify if a certain activity meets the regulatory definition of research.
• Identify if research involves human subjects based on the regulatory definition.
• Determine whether a particular project is non-exempt human subjects research under the Common Rule.

Go to Section: Introduction > The Concept of Non-exempt Human Subjects Research > Identifying Non-Exempt Human Subjects Research > Quiz Questions

Introduction

The Common Rule applies to human subjects research that is supported or conducted by a Common Rule agency. For research supported or conducted by the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) is the office with the authority to enforce the regulations. Many research institutions choose to apply the Common Rule to all of their human subjects research regardless of funding source.

This lesson focuses on the Revised Common Rule that became effective in 2018.

The Concept of Non-exempt Human Subjects Research

Even when funded by a Common Rule agency, not all research involving humans is required to follow the Common Rule. The Rule only applies to activities that qualify as human subjects research under the regulation and that do not qualify for an exemption. This is commonly referred to as non-exempt human subjects research.

Note that, in addition to the Common Rule (subpart A), non-exempt human subjects research funded by HHS must also comply with subparts B, C, & D of the regulations at 45 CFR 46. These subparts provide additional protections for certain special populations involved in research.

This lesson explains how the regulations define research and human subjects and explains what it means to be exempt from the regulations. Understanding these concepts is important to knowing when the regulations apply and when they do not.

Identifying Non-Exempt Human Subjects Research

To figure out whether a particular activity is non-exempt human subjects research under the Common Rule, ask the following three questions, in this order :

• Is the activity research according to the regulations?
• Does the research involve human subjects based on the definition in the regulations?
• Is the human subjects research exempt?

The determination of whether a research study is non-exempt human subjects research is usually made by an institution’s Human Research Protection Program (HRPP) or IRB office. In addition to applying the Common Rule’s basic protections for human subjects in research, the HRPP or IRB office also may ensure that the activity aligns with institutional policies, ethical guidelines, and other regulations and policies that might be relevant.

What is non-exempt human subjects research?

All research involving human volunteers in the United States is required to follow the Common Rule. True or false?

An investigator plans to do a research project involving human subjects that is not funded by the Federal government. Can she proceed with her proposed project without IRB review?

In an institution, who usually determines whether a research study is non-exempt human subjects? (Select all that apply)

In deciding whether a project is non-exempt human subjects research under the Common Rule, what is the first question you should ask?

Go to Section: Defining Research > Categories of Activities Deemed Not to Be Research > Quiz Questions > Determining When the Common Rule Requirements Apply

Defining Research

Let’s start with the first question: Is the activity research according to the regulations?

Not all work that we would colloquially call ‘research’ is considered to be research under the Common Rule. The Common Rule defines research as:

“a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

To decide if a certain activity meets the regulatory definition of research, consider:

• It would likely involve a hypothesis, research question, and a plan to systematically collect and analyze data.
• The systematic investigation adds information and contributes to generalizable knowledge in the field.
• For example, lots of information is published that comes from activities that do not meet the Common Rule’s definition of research. And sometimes results from research that meets the Common Rule definition never get published.

Categories of Activities Deemed Not to Be Research

The revised Common Rule also lists four specific types of activities that are deemed not to be research:

• Scholarly and journalistic activities that focus on information specifically about certain individuals.
• Certain public health surveillance activities.
• Certain activities solely for criminal justice or criminal investigative purposes.
• Certain operational activities in support of national security missions.

Review the regulatory descriptions of these four categories of activities deemed to be not research under §46.102(l).

Watch the video to learn more.

The Common Rule defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalize knowledge.” True or false?

What are the criteria for the regulatory definition of research? (Select all that apply)

Select all activities deemed not to be research under the Common Rule. (Select all that apply)

Determining When the Common Rule Regulatory Requirements Apply

So, when deciding if a specific activity comes under the Common Rule,

First, ask whether it meets the regulatory definition for research—and remember to consider the four categories of activities deemed not to be research.

If the answer is “No,” then the Common Rule does not apply and, as a result, the activity does not have to be reviewed and approved by an IRB before starting. However , investigators should always check with their institution’s HRPP or IRB office to see whether there are institutional policies to follow even if the regulations don’t apply.

If, however, the answer to the first question is “ Yes ” – the activity does meet the regulatory definition of research, THEN ask the second question: Does the research involve human subjects?

Go to Section: Defining Human Subject > Living Individuals > Identifying the Subject > Interaction and Intervention > Identifiable Private Information > Quiz Questions > Determining When the Common Rule Requirements Apply

Defining Human Subject

The revised Common Rule defines human subject as:

“a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

While there is a lot of detail in the definition of human subject, it generally boils down to this:

It is important to understand the key terms in this definition to determine when a research study involves human subjects according to the regulations.

Living Individuals

Human Subject: “ a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

First of all, notice that it specifies living individuals. Therefore, for the purpose of the Common Rule, research that only involves information or biospecimens from deceased persons would not be considered human subjects research.

Identifying the Subject

Human Subject: “a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

The phrase ‘about whom’ is important. A human subject is the person that the information is about, not necessarily the person providing the information. In the case of biospecimens, the human subject is the person from whom the specimen was taken.

For example:

Interaction and Intervention

• Interactions occur when investigators communicate or have interpersonal contact with research participants, for example verbally, in writing, or electronically, to obtain information about them for the research.
• Interventions , on the other hand, include both physical procedures by which investigators collect information or biospecimens and manipulations of the subjects or the subjects’ environment for the purpose of the research.
• Examples of interventions include assigning subjects to take a particular drug in a clinical trial, asking subjects to complete a certain task for research purposes, and changing the background noise level to study how subjects’ stress levels vary.

Identifiable Private Information

Human Subject: “a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens .”

Note, also, that the researchers may or may not have interacted or intervened with the subject at all – for example, they might use leftover blood samples from clinical tests; but if the blood sample is identifiable, then the person is considered to be a human subject.

A proposed research project involves studying tissue samples from cadavers being used in a local medical school to train students. Personal information about the deceased individuals will be used in the research. Is this human subjects research?

Question 10

A proposed research project involves asking participants to complete a task and answer questions on a computer. No identifiable information will be recorded about participants. Is this human subjects research?

Question 11

A proposed research project will use leftover blood samples from clinical tests to check for levels of a certain metabolite. Investigators will also review patients’ identifiable medical records to obtain other necessary health information. Is this human subjects research?

Question 12

Which of the following activities, when carried out for the purpose of research, would constitute research involving human subjects under the Common Rule? (Select all that apply)

Question 13

Research that only involves specimens from deceased persons would not be considered human subjects research. True or false?

Apply this definition of “human subjects” to your research to determine whether your research study constitutes human subjects research under the Common Rule. If the answer is “no,” then the Common Rule does not apply.

If, on the other hand, the answer to this second question is “yes,” and it is human subjects research, then you go on to the third question: Is it exempt?

Go to Section: Could the Human Subjects Research Be Exempt? > Exempt Human Subjects Research > Quiz Questions > Determining When the Common Rule Requirements Apply

Could the Human Subjects Research Be Exempt?

There are eight exemption categories listed in the revised Common Rule. If all of the activities in a human subjects research study meet the criteria for one or more of these exemption categories, the study is exempt from the Common Rule requirements for oversight. This means, for example, that the research does not need to undergo initial or continuing IRB review for approval as required by the regulations.

The Common Rule does not specify who can make determinations about exemptions. Most institutions require that investigators submit proposed research to the institution’s HRPP or IRB office for the determination about whether it meets the criteria for an exemption. Additionally, certain exemptions require a “limited IRB review” to determine that specific conditions are met for the exemption to apply.

Exempt Human Subjects Research

An entire human subjects research projects that has been determined to meet the conditions for one or more exemption categories in the Common Rule can generally proceed without having to comply with the regulatory requirements.

One thing to remember, however, is that if investigators make changes to the research at a later time, they should check with their institution’s HRPP or IRB office to make sure that the research still meets the exemption criteria. If the changes cause the research study to no longer meet the criteria for exemption, then the research is no longer exempt and must comply with the regulatory requirements and undergo IRB review . Investigators should work closely with their HRPP or IRB office to avoid surprises like this that could affect the progress of their research.

Click here to watch a video explaining the exemption categories.

Question 14

What does it mean for a research project to be exempt?

Question 15

The Common Rule specifies who should make determinations about exemptions. True or false?

Question 16

Where should a researcher go to inquire whether something qualifies as an exemption? (Select all that could apply)

Question 17

Once a research study is determined to be exempt, it will always be exempt regardless of any subsequent changes that might be made to it. True or false?

Human subjects research studies that do not qualify for an exemption are referred to as non-exempt human subjects research. Unless there is a Secretarial waiver, they must comply with the Common Rule regulatory requirements, including IRB review and approval, before the research can begin. For non-exempt cooperative research studies involving multiple institutions, the review would generally be done by a single IRB.

Go to Section: Wrap Up > Completion Certificate

This lesson explained the process of determining whether a research project meets the criteria for being non-exempt human subjects research under the Common Rule. Remember that if it doesn’t satisfy the regulatory definition of either research or human subject, or if all of the activities in the human subjects research meet the criteria for one or more of the exemptions, then the Common Rule regulatory requirements do not apply to the project, but investigators may still be subject to any institutional policies that are in place. Investigators should work with their institution’s Human Research Protection Program (HRPP) or IRB office to find answers and determine how to proceed.

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