medical research ethics doh

Declaration of Helsinki

Medical Research Involving Human Subjects

The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013. The current (2013) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes. The WMA would like to thank all those who submitted comments and suggestions for the most recent revision of the DoH.

In 2014, the WMA produced a celebratory publication to mark the 50th anniversary of the adoption of the Declaration of Helsinki. “The World Medical Association Declaration of Helsinki: 1964-2014 50 Years of Evolution of Medical Research Ethics” can be ordered online here .

Since 2016, the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks  has complemented the Declaration of Helsinki.

At the WMA Council meeting in April 2022, a workgroup was established to begin another revision of this important document. The American Medical Association (AMA) is leading this process.

The revision process is designed to be collaborative, transparent, and inclusive. The workgroup’s efforts are informed by regional and topical meetings spread over two years, where issues are discussed by local and international experts and engaged audiences with diverse opinions.  Resulting edits to the principles proposed by the workgroup are ultimately circulated worldwide for public comment periods for feedback.

The regional expert meetings are the following:

• Asian region in Tel Aviv, Israel, on 9-11 December
• Latin American region in Sao Paulo, Brazil on 24-25 February 2023 .
• Copenhagen, Denmark on 21-22 September 2023
• Tokyo Japan, from 30 November to 1 December 2023
• Vatican from 18 to 19 January 2024
• Johannesburg, South Africa, from 18 to 19 February 2024
• Munich, Germany, from 14 to 15 May 2024

In order to maximize input by all stakeholders and the public, we are providing two separate public comment periods. A phase 1 public comment period is being held in February 2024 to address issues from the first few regional meetings, and a phase 2 comment period will follow in the spring when additional topics have been addressed.

Consideration for Adoption: General Assembly Meeting Helsinki, Finland

The workgroup intends to recommend a final updated draft of the Declaration of Helsinki to the Medical Ethics Committee of the World Medical Association, and the document is intended to be considered by the Council and the General Assembly in Helsinki, Finland in October 2024.

*Translations in languages other than the WMA official languages (English/Spanish/French) are available below:

• Finnish translated by the Finnish Medical Association
• German  translated by the German Medical Association
• Japanese translated by the Japan Medical Association
• Portuguese version
• Czech translated by the Czech Medical Association
• Hungarian  translated by the Center for Ethics and Law in Biomedicine, Hungary

*Previous archived versions below are for research and information purpose only, use the updated version as reference.

• Declaration of Helsinki – Version 1964
• Declaration of Helsinki – Version 1975
• Declaration of Helsinki – Version 1983
• Declaration of Helsinki – Version 1989
• Declaration of Helsinki – Version 1996
• Declaration of Helsinki – Version 2000
• Declaration of Helsinki – Version 2004
• Declaration of Helsinki – Version 2008

WMA Policy Resources

• Declaration of Helsinki 
• PDF Version 
• Declaration of Taipei 

Related Readings

• WMA Council Report 2020-2021

DoH Conference Vatican 18 to 19 January 2024

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RESEARCH AND INNOVATION CENTER

Abu Dhabi Healthcare Sector has the potential to deliver high quality Medical Research and Innovation

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Department of Health has strategized key priorities that underpin the goal of improving the well-being of Abu Dhabi residents through prevention and access to integrated, innovative, high-quality and cost-effective healthcare. Genomic medicine is a ground-breaking genomics initiative that involves using genomic information about an individual to understand genetics bases, provide accurate diagnosis and treatment and implement precision medicine. A healthier Abu Dhabi community will not be achieved expediently unless innovation and research are at the core of its daily business.

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This applies to all entities who are interested in conducting a human subject research in Abu Dhabi such as:

• Healthcare facilities
• Academic institutes
• Contract Research Organizations (CRO’s)
• Government/Private institutes

Facilities should form a local Research Ethics Committee in order to submit their application to us

Follow the below requirements

Once approved, research authorization will be granted

Facility name will appear on the list of facilities approved to carry out human subject research

Requirements

• Application for Authorization to Conduct Human Subjects Research
• Research Ethics Committee (REC) members list - Including CVs and DOH health license if applicable
• Research Ethics Training Course For all ethics committee members
• DOH Undertaking letter - Signed by all REC members

Download Available Forms and Documents

Form#1 - Application for Authorization to Conduct Human Subjects Research

Form#2 - REC Details

REC Undertaking Letter

Directly upload the forms or for any inquiries, email us at [email protected]

Maximum file size is 8 MB

Organizations and researchers who are interested in conducting human subject research in the below streams, are welcomed to apply directly to DOH Medical Research Team

• Clinical Trials
• Multi-centers
• Processing of medical data outside UAE,
• Pharmaceutical/companies sponsored research, and Academic sponsored research.
• Others (COVID, etc)

Research proposals for the above streams will be evaluated by DOH ADHRTC (Abu Dhabi Research and Technology Committee)

Click here to download application form

Send your application form and all the required documents (Detailed proposal- Research team CVs and GCPs- Data collection Sheet- Questionnaire/Survey- Consent Form) to Medical Research team at [email protected]

ADHRTC Committee will review the application

Final outcome letter will be shared

Browse the Research Registry

Please check below:

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For any inquiries, email : [email protected]

The Showcase of Medical Research Publications from Abu Dhabi is a collection of valuable medical research which appeared in peer-reviewed journals from healthcare community within Abu Dhabi’s healthcare sector. The Showcase includes scientific literature on a wide range of medical topics.

Find out more about the medical research publications from Abu DHabi

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Health technology assessment (HTA) refers to the systematic evaluation of properties, effects, and/or impacts of health technology.

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Browse the Technology Registry

Form#1 - New Health Technology New therapeutic practices Submission Form

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Fill the forms and email us at [email protected]

For disapproval decisions: HTA applicants appealing submission to [email protected] (Within 30 days of receiving disapproval decision) to start the same journey.

Shape the future of healthcare through innovation. HealthTech Hub offers a comprehensive support network for the testing, implementation and commercialization of health technologies.

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Through this service, as drug agents and healthcare providers (hospitals), you can apply to code drugs, including conventional and general sale products. These codes are essential for drug product reimbursement by insurance and applicants can apply to amend coded drug details.

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Conditions The applicant must hand in the sample in person.

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Through this service you can access the unified electronic platform approved at the country level for prescribing and dispensing of narcotic, controlled and semi controlled medicines. The federal law obligates all healthcare facilities and providers to use the system for prescribing and dispensing narcotic, controlled and semi-controlled medicines. Also, all licensed healthcare facilities and pharmacies must provide Emirates ID card reader to all their physicians and pharmacists who are dealing with narcotic and controlled medicines. Register the health facility on the Electronic Platform for Controlled Medicines, or log-in the platform if the facility is registered, as mentioned in the links below.

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Through this service, concerned stakeholders including hospitals, pharmacies and drug suppliers are required to report all anticipated and /or actual drug shortages to DOH immediately in order to avert and mitigate the problem. Process:

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DoH will work closely with the drug suppliers, manufacturers & health care facilities to identify root causes of the reported shortages and fill any gaps in the supply chain to ensure ease of access and availability of necessary medicines to all residents of Abu Dhabi.

Through this service, healthcare professionals can report any suspected Adverse Reaction (AR), Medication Error (ME) and Adverse Event Following Immunization (AEFI) experienced from any of the drug product within the stipulated timeframe as defined in DoH policies, even if reporters are not certain that the particular medicinal product was the cause. Unintended adverse effects, drug abuse, overdose, interaction (including drug-drug and drug-food interactions) and unusual lack of therapeutic efficacy are all considered to be reportable suspected Adverse Reactions (AR).

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Through this service Healthcare facilities are required to submit their antidote stock report on monthly basis . The service allows the hospital user to report the stock of antidote by the 5th of each month. Process:

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The International Code of Medical Ethics of the World Medical Association

• 1 German Medical Association, Berlin, Germany
• 2 Chair, World Medical Association (WMA) International Code of Medical Ethics Workgroup, member of the WMA Medical Ethics Committee, and member of the WMA Council
• Special Communication World Medical Association Declaration of Helsinki World Medical Association JAMA
• Viewpoint The Revised Declaration of Geneva: The Modern-Day Physician’s Pledge Ramin Walter Parsa-Parsi, MD, MPH JAMA

One of the central missions of the World Medical Association (WMA) in its role as the global organization of physicians is to ensure the highest possible standard of ethical practice of the medical profession. Since its establishment in 1947 in the aftermath of one of the most egregious breaches of medical ethical principles, the WMA has adopted a comprehensive range of declarations, resolutions, and statements aimed at providing ethical and other guidance to the global medical profession.

At the heart of the WMA’s body of policies are 3 core documents: the Declaration of Geneva: The Physician’s Pledge (DoG), 1 the Declaration of Helsinki (DoH), 2 and the International Code of Medical Ethics (ICoME).

The inaugural DoG, which was initially adopted by the second General Assembly of the WMA in 1948 and most recently revised in 2017, concisely lays out the basic ethical principles for the medical profession in the form of a physician’s pledge. Although the DoG has undergone regular revisions over the years, the basic principles have remained consistent. 3

To address the specific ethical challenges of medical research involving human research participants, the WMA drafted and adopted the DoH in 1964. The DoH was last revised in 2013 and will undergo another revision starting in 2022. While geared primarily toward the medical profession, the DoH has proven to be a practical tool for nonphysician researchers as well. 4

The third and perhaps least well-known—at least to this point—core document of the WMA is the ICoME, which was adopted in 1949 following the DoG. The ICoME outlines the ethical principles and professional duties of the medical profession, including the physician’s responsibilities toward patients and society, as well as toward other physicians, students, and other health professionals and personnel.

As with all of the WMA policies, these 3 documents are reviewed and revised regularly to ensure their continued relevance.

In 2018, the Council of the WMA installed an international workgroup to review the ICoME, which had last been revised in 2006. The workgroup comprised WMA constituent members and observers from 19 countries representing all the WMA’s geographic regions. (The WMA’s global membership is categorized according to the following 7 geographic regions: Africa, Asia, Europe, Latin America, North America, the Pacific, and Eastern Mediterranean.) Each member of the workgroup was encouraged to consult with local ethics committees and experts, and to review the existing ethical guidelines and professional codes in their respective countries and determine which ethical principles might be outdated or missing from the most recently revised ICoME.

The representative nature of the workgroup led to extensive discussions not only about the content of the revised ICoME, but also about the linguistic subtleties of the document and how certain concepts and terminology might be understood or interpreted differently from region to region. The workgroup invested great effort to ensure that the ICoME could be applicable to different cultures and political systems by carefully and transparently assessing proposals and comments from the different world regions.

Following a substantial revision of the existing Code, a revised ICoME was unanimously adopted by the WMA General Assembly in October 2022 in Berlin, Germany ( Box ).

WMA International Code of Medical Ethics

Adopted by the 3rd General Assembly of the World Medical Association, London, England, October 1949 and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968 and the 35th World Medical Assembly, Venice, Italy, October 1983 and the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006 and the 73rd WMA General Assembly, Berlin, Germany, October 2022

The World Medical Association (WMA) has developed the International Code of Medical Ethics as a canon of ethical principles for the members of the medical profession worldwide. In concordance with the WMA Declaration of Geneva: The Physician’s Pledge and the WMA’s entire body of policies, it defines and elucidates the professional duties of physicians towards their patients, other physicians and health professionals, themselves, and society as a whole.

The physician must be aware of applicable national ethical, legal, and regulatory norms and standards, as well as relevant international norms and standards.

Such norms and standards must not reduce the physician’s commitment to the ethical principles set forth in this Code.

The International Code of Medical Ethics should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. Consistent with the mandate of the WMA, the Code is addressed to physicians. The WMA encourages others who are involved in healthcare to adopt these ethical principles.

General Principles

1. The primary duty of the physician is to promote the health and well-being of individual patients by providing competent, timely, and compassionate care in accordance with good medical practice and professionalism.

The physician also has a responsibility to contribute to the health and well-being of the populations the physician serves and society as a whole, including future generations.

The physician must provide care with the utmost respect for human life and dignity, and for the autonomy and rights of the patient.

2. The physician must practise medicine fairly and justly and provide care based on the patient’s health needs without bias or engaging in discriminatory conduct on the basis of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, culture, sexual orientation, social standing, or any other factor.

3. The physician must strive to use health care resources in a way that optimally benefits the patient, in keeping with fair, just, and prudent stewardship of the shared resources with which the physician is entrusted.

4. The physician must practise with conscience, honesty, integrity, and accountability, while always exercising independent professional judgement and maintaining the highest standards of professional conduct.

5. Physicians must not allow their individual professional judgement to be influenced by the possibility of benefit to themselves or their institution. The physician must recognise and avoid real or potential conflicts of interest. Where such conflicts are unavoidable, they must be declared in advance and properly managed.

6. Physicians must take responsibility for their individual medical decisions and must not alter their sound professional medical judgements on the basis of instructions contrary to medical considerations.

7. When medically appropriate, the physician must collaborate with other physicians and health professionals who are involved in the care of the patient or who are qualified to assess or recommend care options. This communication must respect patient confidentiality and be confined to necessary information.

8. When providing professional certification, the physician must only certify what the physician has personally verified.

9. The physician should provide help in medical emergencies, while considering the physician’s own safety and competence, and the availability of other viable options for care.

10. The physician must never participate in or facilitate acts of torture or other cruel, inhuman or degrading practices and punishments.

11. The physician must engage in continuous learning throughout professional life in order to maintain and develop professional knowledge and skills.

12. The physician should strive to practise medicine in ways that are environmentally sustainable with a view to minimising environmental health risks to current and future generations.

Duties to the Patient

13. In providing medical care, the physician must respect the dignity, autonomy, and rights of the patient.

The physician must respect the patient’s right to freely accept or refuse care in keeping with the patient’s values and preferences.

14. The physician must commit to the primacy of patient health and well-being and must offer care in the patient’s best interests. In doing so, the physician must strive to prevent or minimise harm for the patient and seek a positive balance between the intended benefit to the patient and any potential harm.

15. The physician must respect the patient’s right to be informed in every phase of the care process. The physician must obtain the patient’s voluntary informed consent prior to any medical care provided, ensuring that the patient receives and understands the information needed to make an independent, informed decision about the proposed care. The physician must respect the patient’s decision to withhold or withdraw consent at any time and for any reason.

16. When a patient has substantially limited, underdeveloped, impaired, or fluctuating decision-making capacity, the physician must involve the patient as much as possible in medical decisions. In addition, the physician must work with the patient’s trusted representative, if available, to make decisions in keeping with the patient’s preferences, when those are known or can reasonably be inferred. When the patient’s preferences cannot be determined, the physician must make decisions in the patient’s best interests. All decisions must be made in keeping with the principles set forth in this Code.

17. In emergencies, where the patient is not able to participate in decision making and no representative is readily available, the physician may initiate an intervention without prior informed consent in the best interests of the patient and with respect for the patient’s preferences, where known.

18. If the patient regains decision-making capacity, the physician must obtain informed consent for further intervention.

19. The physician should be considerate of and communicate with others, where available, who are close to the patient, in keeping with the patient’s preferences and best interests and with due regard for patient confidentiality.

20. If any aspect of caring for the patient is beyond the capacity of a physician, the physician must consult with or refer the patient to another appropriately qualified physician or health professional who has the necessary capacity.

21. The physician must ensure accurate and timely medical documentation.

22. The physician must respect the patient’s privacy and confidentiality, even after the patient has died. A physician may disclose confidential information if the patient provides voluntary informed consent or, in exceptional cases, when disclosure is necessary to safeguard a significant and overriding ethical obligation to which all other possible solutions have been exhausted, even when the patient does not or cannot consent to it.

This disclosure must be limited to the minimal necessary information, recipients, and duration.

23. If a physician is acting on behalf of or reporting to any third parties with respect to the care of a patient, the physician must inform the patient accordingly at the outset and, where appropriate, during the course of any interactions. The physician must disclose to the patient the nature and extent of those commitments and must obtain consent for the interaction.

24. The physician must refrain from intrusive or otherwise inappropriate advertising and marketing and ensure that all information used by the physician in advertising and marketing is factual and not misleading.

25. The physician must not allow commercial, financial, or other conflicting interests to affect the physician’s professional judgement.

26. When providing medical care remotely, the physician must ensure that this form of communication is medically justifiable and that the necessary medical care is provided. The physician must also inform the patient about the benefits and limitations of receiving medical care remotely, obtain the patient’s consent, and ensure that patient confidentiality is upheld. Wherever medically appropriate, the physician must aim to provide care to the patient through direct, personal contact.

27. The physician must maintain appropriate professional boundaries. The physician must never engage in abusive, exploitative, or other inappropriate relationships or behaviour with a patient and must not engage in a sexual relationship with a current patient.

28. In order to provide care of the highest standards, physicians must attend to their own health, well-being, and abilities. This includes seeking appropriate care to ensure that they are able to practise safely.

29. This Code represents the physician’s ethical duties. However, on some issues there are profound moral dilemmas concerning which physicians and patients may hold deeply considered but conflicting conscientious beliefs.

The physician has an ethical obligation to minimise disruption to patient care. Physician conscientious objection to provision of any lawful medical interventions may only be exercised if the individual patient is not harmed or discriminated against and if the patient’s health is not endangered.

The physician must immediately and respectfully inform the patient of this objection and of the patient’s right to consult another qualified physician and provide sufficient information to enable the patient to initiate such a consultation in a timely manner.

Duties to Other Physicians, Health Professionals, Students, and Other Personnel

30. The physician must engage with other physicians, health professionals and other personnel in a respectful and collaborative manner without bias, harassment or discriminatory conduct. The physician must also ensure that ethical principles are upheld when working in teams.

31. The physician should respect colleagues’ patient-physician relationships and not intervene unless requested by either party or needed to protect the patient from harm. This should not prevent the physician from recommending alternative courses of action considered to be in the patient’s best interests.

32. The physician should report to the appropriate authorities conditions or circumstances which impede the physician or other health professionals from providing care of the highest standards or from upholding the principles of this Code. This includes any form of abuse or violence against physicians and other health personnel, inappropriate working conditions, or other circumstances that produce excessive and sustained levels of stress.

33. The physician must accord due respect to teachers and students.

Duties to Society

34. The physician must support fair and equitable provision of health care. This includes addressing inequities in health and care, the determinants of those inequities, as well as violations of the rights of both patients and health professionals.

35. Physicians play an important role in matters relating to health, health education and health literacy. In fulfilling this responsibility, physicians must be prudent in discussing new discoveries, technologies, or treatments in non-professional, public settings, including social media, and should ensure that their own statements are scientifically accurate and understandable.

Physicians must indicate if their own opinions are contrary to evidence-based scientific information.

36. The physician must support sound medical scientific research in keeping with the WMA Declaration of Helsinki and the WMA Declaration of Taipei.

37. The physician should avoid acting in such a way as to weaken public trust in the medical profession. To maintain that trust, individual physicians must hold themselves and fellow physicians to the highest standards of professional conduct and be prepared to report behaviour that conflicts with the principles of this Code to the appropriate authorities.

38. The physician should share medical knowledge and expertise for the benefit of patients and the advancement of health care, as well as public and global health.

Duties as a Member of the Medical Profession

39. The physician should follow, protect, and promote the ethical principles of this Code. The physician should help prevent national or international ethical, legal, organisational, or regulatory requirements that undermine any of the duties set forth in this Code.

40. The physician should support fellow physicians in upholding the responsibilities set out in this Code and take measures to protect them from undue influence, abuse, exploitation, violence, or oppression.

©2022 World Medical Association. All Rights Reserved. All intellectual property rights in the International Code of Medical Ethics are vested in the World Medical Association.

However, before the revision process was concluded, it was complemented by a series of regional and international conferences, including in Sao Paulo, Brazil; Kuwait City, Kuwait; Bangkok, Thailand; Abuja, Nigeria; and Washington, DC. To gather further opinions and insights from the broader medical ethics community, the WMA presented interim drafts of the revised ICoME in special sessions at several international bioethics conferences. In addition, a highly successful online public consultation was held, resulting in hundreds of comments received from experts throughout the world. During this public consultation and the initial international meetings, it quickly became apparent that a newly added paragraph dealing with physician conscientious objection would be the most contentious issue and would therefore require the most consideration.

Conscientious objection in medicine refers to a physician’s refusal to carry out a certain medical procedure on moral or religious grounds. 5 The potential tension between the physician’s right to exercise a conscientious objection and the patient’s wish to access legally permitted procedures (including but not limited to abortion or physician-assisted suicide) led to many debates about the obligations of a physician who exercises such a right.

To delve into the nuances of these debates, the WMA hosted a dedicated international conference on this topic in Jakarta, Indonesia, in July 2022. Experts presented a range of arguments both for and against a physician’s right to refuse to perform certain interventions on the basis of conscience. Consensus was quickly reached about the right of physicians, in principle, to exercise a conscientious objection. But the ICoME is a document detailing the duties of physicians, and therefore the ultimate objective of the conference was to address the obligations, if any, a physician has toward a patient in the case of such an objection. At issue was the question of whether a physician is obliged to provide a patient with appropriate information for pursuing the requested intervention or even to refer the patient to a colleague who does not share this objection. Weighing all these arguments, the workgroup ultimately agreed on a compromise wording that also achieved consensus in the WMA General Assembly (see item 29).

The Code was also expanded to incorporate the concepts of patient autonomy, physician well-being, and equity and justice in health care. In addition, the workgroup determined that the principles of patient confidentiality and informed consent required further elaboration. Also, references to contemporary issues such as remote treatment, environmental sustainability, and advertising and social media have been addressed.

Throughout the revision process, the ICoME was also reviewed for compatibility with the DoG and DoH to avoid any contradictions or inconsistencies. Without diminishing the interrelationships between the DoG and the ICoME, the workgroup sought to lend the ICoME the renewed standing and attention needed to fulfill its purpose as a foundation of ethical principles defining the professional duties of physicians.

In pursuit of this objective, the workgroup drafted a revised ICoME that covers the vital ethical principles and duties of physicians, but without citing specific details, descriptions, or examples. This new and comprehensive Code is bolstered by the WMA’s policy apparatus, which addresses many of the issues therein in greater detail.

The workgroup restructured the ICoME by adding a new preamble, followed by a section of general principles. The remaining ethical duties are categorized as “duties to the patient,” “duties to other physicians, health professionals, students, and other personnel,” and “duties to society.” The final section entitled “duties as a member of the medical profession” highlights the obligation to follow, protect, and promote the ethical principles of the ICoME and to support other physicians in upholding them. Throughout the document, new, more modern and gender-inclusive language has been introduced.

As stated in the preamble, each of the paragraphs of the ICoME should be applied with consideration of all other relevant paragraphs and the Code must always be read as a whole.

WMA declarations, resolutions, and statements that are ethical in nature must achieve a three-quarter majority to pass the General Assembly. The successful unanimous adoption of the revised ICoME despite this rather high threshold can be attributed to a comprehensive and inclusive revision process that was carried out with respect not only for the ethical foundation upon which the WMA was established, but also for the WMA members, ethics experts, and other stakeholders who contributed to the process.

Physicians are facing unprecedented challenges brought on and exacerbated by changing clinical, political, legal, and market forces. At the same time, the medical profession is becoming more dynamic and interconnected on a global scale, making it increasingly crucial to reaffirm the fundamental and universal principles of medical ethics as reflected in the ICoME. Through their advocacy work, the WMA and its members hope to raise awareness of this document and, in so doing, provide a common ethical language for the medical profession and strengthen professional identity.

Corresponding Author: Ramin Walter Parsa-Parsi, MD, MPH, German Medical Association, Herbert-Lewin-Platz 1, Berlin 10623, Germany ( [email protected] ).

Published Online: October 13, 2022. doi:10.1001/jama.2022.19697

Conflict of Interest Disclosures: Dr Parsa-Parsi has reported receiving nonfinancial support from the World Medical Association (WMA) in the form of coverage of travel expenses related to WMA or International Code of Medical Ethics meetings.

Additional Contributions: I thank the International Code of Medical Ethics workgroup members, advisors, and observers for their commitment and valuable contributions throughout the revision process. I also thank Siobhan O'Leary for her editorial support.

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Parsa-Parsi RW. The International Code of Medical Ethics of the World Medical Association. JAMA. 2022;328(20):2018–2021. doi:10.1001/jama.2022.19697

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• Indian J Orthop
• v.51(1); Jan-Feb 2017

Ethics of medical research and publication

Ish kumar dhammi.

Department of Orthopaedics, UCMS and Guru Teg Bahadur Hospital, New Delhi, India

Rehan Ul Haq

The Indian Journal of Orthopaedics (IJO), an official journal of the Indian Orthopaedic Association (IOA) is one of the very few journals from the country (across all specialties) which is indexed with Science Citation Index (SCI) - expanded and therefore has to maintain a high publication standards. The journal strives to publish as many articles from the IOA members as possible. However, it has been observed that in spite of the huge amount of good quality clinical work being done in the country, the number of manuscripts from Indian authors is few. Moreover, many a times, in spite of the quality of the content being very good, publication has to be declined because of poor presentation or design. In order to help authors to improve the quality of their manuscripts and understand the review process better, the editorial team has decided to come out with a series of editorials. The previous two editorials in this series, one on indexing and other on plagiarism, 1 , 2 were well received by the readers. This editorial focuses on the ethics of medical publication.

The moment a research is conceived, especially if it involves human participants, ethical issues come into play. The World Medical Association (WMA) developed a set of ethical principles regarding human experimentation for the medical community called the Declaration of Helsinki (DoH). 3 It is widely regarded as the key document on human research ethics. This document contains 32 points. According to this document, “the primary purpose of medical research is to improve prophylactic, diagnostic, and therapeutic procedures and the understanding of the etiology and pathogenesis of disease.” 3 It further states that “even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility, and quality.” 3 Most research involves a team effort, and some junior members of the team who may be playing a substantial or lead role may not be aware of the ethical issues involved in human research though all researchers are equally abide by ethical principles. It is the duty of the senior researchers to discuss everyone involved in the project, make them aware about the ethical issues that need to be addressed.

Authors must know that irrespective of where or how a research is done, patients confidentiality, right to anonymity, and privacy is of paramount importance. 3 During the whole course of the conduct of the research till its final submission for possible publication, the authors must ensure that any information which reveals patient identity such as name and hospital number is avoided. A common mistake that should be avoided is submitting clinical photographs which reveal the patient identity. IJO, like many other journals, wants that only the images of affected areas must be provided to preserve patient anonymity. The patients’ face must be completely removed rather than just the eyes being blurred. If it is necessary to show patient's face then proper consent from patient is taken.

Authors must also understand that patients consent, given for medical management or surgery by the caregiver, should not be assumed to be blanket consent. A separate informed consent must always be taken if the researchers plan to use patient data for research purposes. Moreover, approval from an Institutional Review Board, Ethics Committee, Departmental Board of Study, or an equivalent authority of competence is mandatory for any human research. 3 A statement about the same in the material and method section must be made. Omission of the same may be a ground for technical or outright rejection of the manuscript. Sometimes, the editorial team may want to see a copy of the approval, and authors must keep it handy. It is also the morale duty of the researchers to ensure that the patients are not harmed. If at any time during the study, the authors feel that the patients interests are being harmed they must stop the study.

During the conduct of the study, fabrication (presenting unsubstantiated facts or data) and falsification (changing or selecting certain data to achieve desired results) should be strictly avoided. 4 If there is any missing datum, which usually is the case in most studies, no effort must be made to hide it. It should be reported with appropriate reason. It is also a good idea to involve a statistician early in your study so that design of the study and statistical tools can be fine-tuned. Doing an underpowered study and then misusing statistics to defend your results is also a type of ethical misconduct.

Based on the type of research, one is conducting, there are a number of broad consensus statements such as Consolidated Standards of Reporting Trials (CONSORT statement) for randomized controlled trials; Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA statement) and Strengthening the Reporting of OBservational studies in Epidemiology (STROBE statement) for observational studies, which researchers must use as templates not only to increase their chances of publication but also avoiding any ethical misconduct. 5 , 6 , 7 The Enhancing the QUAlity and Transparency of health Research (EQUATOR network) (website: http://www.equator-network.org ) is a very good network which provides a comprehensive collection of reporting guidelines that can be used based on the design of the study. It is a good idea that all research team members make themselves familiar with these statements at the time of start of the study so that they have a clear plan in their mind. All clinical trials done in India should be registered with the Clinical Trials Registry of India (CTRI) (website: http://ctri.nic.in ) set up by the Indian Council of Medical Research, and authors should provide the CTRI number along with the manuscript.

Once the study is complete and ready for submission, the first ethical issue that comes up is on authorship: Who should be listed as authors and in what order? The International Committee of Medical Journal Editors consensus statement is a useful guide and must always be followed. 8 Only those researchers who are involved in the conception and design, acquisition of data or analysis and interpretation of data, and drafting the article or revising it critically, must be listed as authors. 8 General supervision of the research group is not sufficient for authorship. 8 As a rule and good practice, the order of authorship should be based on the relative contribution of each author. Both honorary and ghost (not naming an author who has made a significant contribution) authorship should not be done. 9 , 10 Names of other researchers who have helped but who do not qualify to be authors may be declared in the acknowledgment section.

Plagiarism of any form, intentional or unintentional, must be strictly avoided. 2 If any of the authors has a doubt that some part of the manuscript may be plagiarized, they must run it through a plagiarism detecting software ( www.ithentical.com , www.turnitin.com , www.plagiarism.org , etc.) to avoid embarrassment later. 11 The authors must also ensure that they do not submit their manuscript to more than one journal at any given time. This is extremely important from the copyright point of view and may sometimes lead to serious consequences, to the extent of the article be retracted and disciplinary proceedings being initiated against the authors according to the Committee on Publication Ethics guidelines (website; http://publicationethics.org ). Junior researchers in their enthusiasm to get their work published may want to retort to this method, but the senior members must actively discourage them from doing it.

All authors must explicitly disclose all their personal or institutional conflicts of interest and source of funding for the research being submitted for possible publication. 12 This not only helps the editors but also the readers to interpret the results of the study more judiciously. Authors must always ensure that the conclusions they present should always be based on the results from their study and should not be influenced by the monetary or other benefits they may have gained as a result of conducting the study.

Most reputed journals including the IJO have a robust system of peer review. Peer review ensures that only the highest quality research is published, and errors and oversights corrected. 13 Following the review process, most authors would be asked to do a major or minor revision of their work. As an ethical rule authors must take the reviewers comments positively and must answer the concerns raised systematically and within the stipulated time frame. This helps the journal to meet their submission to decision time guidelines. Sometimes, queries might be raised by the editorial team even after a manuscript has been accepted and authors must again respond to them quickly. Once a manuscript is published, queries may be raised by the readers formally in the form of letter to editors of informal communication. Again it is the authors’ moral duty to respond to these questions. All records and data pertaining to the study must be maintained for a sufficient period of time so that they can be produced anytime for scrutiny if desired by readers, other researchers, agencies, or editorial teams.

The animals in experimental studies are used for research. They should be used if strict ethical ‘animal use guidelines’ are followed. They are used if there is clear benefit, with animal experiments to the environment, animals or humans. The optimal standards of animal health and care should be followed. 15 The “best practice in research involving animals will embody the principles of the 3Rs (replacement, reduction and refinement) and a paper must also demonstrate that the study has adhered to these. Further details of theses principles can be found on the National Centre for the Replacement, Refinement and Reduction of Animals in Research website ( http://www.nc3rs.org.uk/the-3rs ). 16 Animals should not be used if there are alternative approaches available.

The WMA Declaration of Geneva binds the physician with the words, “the health of my patient will be my first consideration.” 14 Further, the DoH states that “In medical research on human participants, considerations related to the well-being of the human participant should take precedence over the interests of science and society.” 3 If all members of a research team follow these words in letter and spirit, a number of ethical issues which crop up during the conduct and publication of medical research, especially involving human participants, would be taken care of automatically.

To summarize both authors and publishers have ethical obligations. “Reports of experimentation not in accordance with principles laid down by ‘Declaration of Helsinki’, should not be accepted for publication. 13

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