WMA Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects.

Foundation: World Medical Association.
source : World Medical Association.
language original: English.
Copyright of the original English: No.
English translation: WMA.
Previous versions: Detailed in the document.
Copyright of the Spanish translation: No.
Checked on 24 July 2018.

Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975:

29th World Medical Assembly, Tokyo, Japan, October 1975
35th World Medical Assembly, Venice, Italy, October 1983
41st World Medical Assembly, Hong Kong, Hong Kong, September 1989
48th General Assembly, Somerset West, South Africa, October 1996
52nd General Assembly, Edinburgh, Scotland, October 2000
grade of Clarification, added by the WMA General Assembly, Washington 2002
grade of Clarification, added by the WMA General Assembly, Tokyo 2004
59th General Assembly, Seoul, Korea, October 2008
64th General Assembly, Fortaleza, Brazil, October 2013

Introduction

1. The World Medical Association (WMA) has promulgated the Declaration of Helsinki as proposal of ethical principles for medical research involving human subjects, including research on identifiable human material and information.

The Declaration should be considered as a whole and one paragraph should be applied with consideration of all other relevant paragraphs.

2. In accordance with the WMA's mandate, the Declaration is intended primarily for physicians. The WMA urges others involved in medical research involving human subjects to adopt these principles.

General principles

3. The Declaration of Geneva of the World Medical Association binds the physician to the formula "the health of my patient first and foremost", and the International Code of Medical Ethics states that: "A physician shall consider the best interests of the patient when providing medical care".

4. The physician's duty is to promote and to safeguard the health, welfare and rights of patients, including those involved in medical research. The physician's knowledge and conscience must be subordinate to the fulfilment of this duty.

5. Progress in medicine is based on research, which ultimately must include human studies.

6. The primary purpose of medical research in human subjects is to understand the causes, course and effects of diseases and to improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be continuously evaluated through research to ensure their safety, efficacy, effectiveness, accessibility and quality.

7. Medical research is subject to ethical standards that serve to promote and ensure respect for all human beings and to protect their health and individual rights.

8. Although the primary goal of medical research is to generate new knowledge, this goal should never take precedence over the rights and interests of the research subject.

9. In medical research, it is the duty of physicians to protect the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with a physician or other health care professional and never with the research participants, even if they have given their consent.

10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries, as well as existing international norms and standards. No national or international ethical, legal or regulatory requirement should be permitted to diminish or eliminate any of the protections for research subjects set forth in this Declaration.

11. Medical research should be conducted in a manner that minimises potential harm to the environment.

12. Medical research involving human subjects should be conducted only by persons with appropriate scientific and ethical education, training and qualifications. Research on healthy patients or volunteers requires the supervision of a physician or other appropriately qualified and competent health care professional.

13. Groups that are under-represented in medical research must have appropriate access to participation in research.

14. A physician who combines medical research with medical care should involve his or her patients in research only to the extent that there is justified potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the study will not adversely affect the health of the patients taking part in the research.

15. Appropriate compensation and treatment should be ensured for individuals who are harmed during their participation in research.

Risks, Costs and Benefits

16. In the practice of medicine and medical research, most interventions involve some risks and costs.

Medical research involving human subjects should only be conducted when the importance of the research goal outweighs the risk and costs to the research subject.

17. All medical research involving human subjects must be preceded by a careful comparison of the risks and costs to the individuals and groups participating in the research compared with the foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures should be implemented to minimise risks. Risks should be continuously monitored, assessed and documented by researcher.

18. Physicians should not engage in research studies involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks involved outweigh the expected benefits or if there is conclusive evidence of definitive results, physicians should evaluate whether to immediately continue, modify or discontinue the study.

Vulnerable groups and individuals

19. Some groups and individuals subject to the research are particularly vulnerable and may be more likely to suffer abuse or additional harm.

All vulnerable groups and individuals must receive specific protection.

20. Medical research on a vulnerable group is only justified if the research responds to the health needs or priorities of this group and the research cannot be conducted on a non-vulnerable group . In addition, this group will be able to benefit from the knowledge, practices or interventions resulting from the research.

requirements scientific and research protocols

21. Medical research involving human subjects must conform to generally accepted scientific principles and must be supported by a thorough knowledge of the scientific literature, other relevant sources of information, as well as by properly conducted laboratory and animal experiments, where appropriate. Care should also be taken to ensure the welfare of animals used in experiments.

22. The project and method of any human study should be clearly described and justified in a research protocol .

The protocol should always refer to relevant ethical considerations and should indicate how the principles set out in this Statement have been considered. The protocol should include information on funding, sponsors, institutional affiliations, potential conflicts of interest and incentives for study subjects, and information on provisions for treating or compensating subjects who have suffered harm as a result of their participation in the research.

In clinical trials, the protocol should also describe the appropriate arrangements for stipulations after essay.

Research Ethics Committees

23. The research protocol should be submitted for consideration, comment, committee and approval to the relevant research ethics committee prior to the start of the study. This committee should be transparent in its operation, should be independent of researcher, sponsor or any other subject of undue influence, and should be appropriately qualified. The committee should consider the laws and regulations in force in the country where the research is being conducted, as well as current international standards, but these should not be allowed to diminish or eliminate any of the protections for research subjects set out in this Declaration.

The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially on any serious adverse events. No amendments should be made to the protocol without the consideration and approval of the committee. After the study is completed, investigators should submit a final report to the committee with a summary of the study results and conclusions.

Privacy and confidentiality

24. Every precaution should be taken to safeguard the privacy of the research participant and the confidentiality of their personal information. class .

Informed consent

25. The participation of persons capable of giving informed consent in medical research must be voluntary. While it may be appropriate to consult with family members or community leaders, no person capable of giving informed consent should be included in a study unless he or she freely consents.

26. In medical research involving human subjects capable of giving informed consent, each potential participant must receive adequate information about the objectives, methods, sources of funding, potential conflicts of interest, institutional affiliations of researcher, anticipated benefits, foreseeable risks and discomforts of the experiment, post-study stipulations and any other relevant aspects of the research. The potential participant should be informed of the right to participate or not to participate in the research and to withdraw consent at any time without risk of reprisal. Special attention should be given to the specific information needs of each potential participant, as well as to the methods used to submit the information.

After ensuring that the individual has understood the information, the physician or other appropriately qualified person must then seek, preferably in writing, the individual's voluntary informed consent. If consent cannot be given in writing, the process for achieving it should be formally documented and witnessed.

All persons participating in medical research should have the option of being informed about the overall results of the study.

27. In seeking informed consent for participation in research, physicians should take special care when the potential participant is related to them by a dependent relationship or if they consent under duress. In such a situation, informed consent should be given at order by an appropriately qualified person who has nothing to do with that relationship.

28. When the potential participant is incapable of giving informed consent, the physician must seek the informed consent of the legally authorised representative. Such persons should not be included in research that is not likely to be of benefit to them, unless the research has as its goal promote purpose the health of group represented by the potential participant and such research cannot be conducted on persons capable of giving informed consent and the research involves only minimal risk and minimal cost.

29. If a potential research participant who is considered incapable of giving informed consent is able to give assent to participate or not to participate in research, the physician should request this, in addition to the consent of the legally authorised representative. The potential participant's dissent must be respected.

30. Research on individuals who are physically or mentally incapable of giving consent, e.g., unconscious patients, may be conducted only if the physical/mental condition that prevents informed consent is a necessary characteristic of the group research subject. In these circumstances, the physician should seek informed consent from the legally authorised representative. If the legally authorised representative is not available and if the research cannot be delayed, the study may be conducted without informed consent, provided that the specific reasons for including individuals with a condition that prevents them from giving informed consent have been stipulated in the research protocol and the study has been approved by a research ethics committee C . Consent to remain in the research should be obtained as soon as possible from the individual or a legal representative.

31. The physician must fully inform the patient of the research-related aspects of care. A patient's refusal to participate in an investigation or decision to withdraw should never adversely affect the patient-physician relationship.

32. For medical research involving identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, the physician must seek informed consent for collection, storage and re-use. There may be exceptional situations in which it will be impossible or impracticable to obtain consent for such research. In this situation, the research may only be conducted after consideration and approval by a research ethics committee.

Use of placebo

33. The potential benefits, risks, costs and effectiveness of any new intervention should be assessed by comparison with the best proven interventions, except in the following circumstances:

Where there is no proven intervention, the use of a placebo, or no intervention at all, is acceptable; or

where, for scientifically sound and convincing methodological reasons, the use of any intervention less effective than the best proven intervention, the use of a placebo or no intervention is necessary to determine the efficacy and safety of an intervention.

Patients who receive any intervention that is less effective than the best proven intervention, placebo or no intervention, will not be at additional risk of serious or irreversible harm as a consequence of not receiving the best proven intervention.

Extreme care must be taken to avoid overuse of this option.

Stipulations post essay

34. Prior to the clinical essay , sponsors, researchers and host country governments should provide post essay access to all participants who still need an intervention that has been identified as beneficial at essay. This information should also be provided to participants during the informed consent process.

Registration and publication of research and dissemination of results

35. All research studies involving human subjects should be registered at database available to the public before the first subject is accepted.

36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with respect to the publication and dissemination of the results of their research. Researchers have a duty to make the results of their human subjects research publicly available and are responsible for the integrity and accuracy of their reports. All parties must accept the ethical standards of submission of information. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Publication should cite source funding, institutional affiliations and conflicts of interest. Research reports that do not adhere to the principles outlined in this Declaration should not be accepted for publication.

Unproven interventions in clinical practice

37. When proven interventions are not available in the care of a patient or other known interventions have result been ineffective, a physician, after seeking expert committee consent from the patient or a legally authorised representative, may be permitted to use unproven interventions if, in the physician's judgement, this gives some hope of saving life, restoring health or alleviating suffering. Such interventions should be further investigated in order to assess their safety and efficacy. In all cases, such new information should be recorded and, where appropriate, made publicly available.

(*) Paragraphs 26, 27, 28 and 29 have been editorially revised by the WMA Secretariat on 5 May 2015.