www.wma.net
Open in
urlscan Pro
138.68.145.198
Public Scan
Submitted URL: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-huma...
Effective URL: https://www.wma.net/policies-post/wma-declaration-of-helsinki/
Submission: On December 05 via api from US — Scanned from GB
Effective URL: https://www.wma.net/policies-post/wma-declaration-of-helsinki/
Submission: On December 05 via api from US — Scanned from GB
Form analysis 1 forms found in the DOM
https://www.wma.net
<form class="navbar-form" role="search" action="https://www.wma.net">
<div class="input-group">
<input type="hidden" name="search_type" value="general">
<input name="s" type="text" class="form-control" placeholder="Search..." maxlength="50">
<span class="input-group-btn">
<button type="submit" class="btn btn-default">
<span class="fa fa-search fa">
<span class="sr-only">Search</span>
</span>
</button>
</span>
</div>
</form>Text Content
Search
* en
* es
* fr
* Join Us
Connect with us:
*
*
*
*
* What We Do
--------------------------------------------------------------------------------
Medical Ethics
--------------------------------------------------------------------------------
* Declaration of Geneva
* Declaration of Helsinki
* Declaration of Tokyo
* Declaration of Taipei
Human Rights
--------------------------------------------------------------------------------
* Right to Health
* Physicians in Distress
* Torture Prevention
* Women and Health
* LGBT
Public Health
--------------------------------------------------------------------------------
* Non-Communicable Diseases
* Communicable Diseases
* Climate Change
* Chemicals
* Green Health
* Social Determinants
Health Systems
--------------------------------------------------------------------------------
Caring Physicians of the World Initiative
--------------------------------------------------------------------------------
Campaigns
--------------------------------------------------------------------------------
* Influenza
* Health Care in Danger
* African Forum Project
Events
--------------------------------------------------------------------------------
Educational Resources
--------------------------------------------------------------------------------
* WCEA CME Courses
* Medical Ethics Manual
* Medical Ethics Course
* CPW Leadership Course
* Multidrug-Resistant Tuberculosis Course
* Tuberculosis Refresher Course
* Prison Medicine
* Antimicrobial Resistance Course
* Training and Resources in Research Ethics Evaluation
* Health Care in Danger
* Tobacco
* My Green Doctor
* Anti-counterfeit
* Workplace Wellness
* Social Determinants of Health Course
Activity Reports
--------------------------------------------------------------------------------
WMA Strategic Plan
--------------------------------------------------------------------------------
* Policy
--------------------------------------------------------------------------------
Current Policies
--------------------------------------------------------------------------------
Council Resolutions
--------------------------------------------------------------------------------
Archived Policies
--------------------------------------------------------------------------------
Archived Council Resolutions
--------------------------------------------------------------------------------
* Publications
--------------------------------------------------------------------------------
World Medical Journal
--------------------------------------------------------------------------------
Medical Ethics Manual
--------------------------------------------------------------------------------
WMA Annual Reports
--------------------------------------------------------------------------------
Background Documents
--------------------------------------------------------------------------------
Toolkits
--------------------------------------------------------------------------------
WMA DoH 1964-2014
--------------------------------------------------------------------------------
Speaking Books
--------------------------------------------------------------------------------
* News & Press
--------------------------------------------------------------------------------
Press Contact
--------------------------------------------------------------------------------
Press Releases
--------------------------------------------------------------------------------
Media Mentions
--------------------------------------------------------------------------------
Speeches, Talks, Interviews
--------------------------------------------------------------------------------
Interventions, WHO Governance
--------------------------------------------------------------------------------
Public Statements, Open Letters
--------------------------------------------------------------------------------
Blogs
--------------------------------------------------------------------------------
* Who We Are
--------------------------------------------------------------------------------
About us
--------------------------------------------------------------------------------
Members
--------------------------------------------------------------------------------
Structure
--------------------------------------------------------------------------------
Leaders
--------------------------------------------------------------------------------
Official Advisors (2023-2024)
--------------------------------------------------------------------------------
Secretariat
--------------------------------------------------------------------------------
History
--------------------------------------------------------------------------------
* General Assemblies
* Past Leaders
* Honoured Guests
* Officials
Alliance and Partners
--------------------------------------------------------------------------------
* Official Relationship
* Partners
* Junior Doctors
--------------------------------------------------------------------------------
About Us
--------------------------------------------------------------------------------
Membership
--------------------------------------------------------------------------------
Publications
--------------------------------------------------------------------------------
News(letters)
--------------------------------------------------------------------------------
Meetings
--------------------------------------------------------------------------------
Links
--------------------------------------------------------------------------------
Contact Us
--------------------------------------------------------------------------------
* Members’ Area
--------------------------------------------------------------------------------
Sign Up
--------------------------------------------------------------------------------
Working Documents
--------------------------------------------------------------------------------
Standing Documents
--------------------------------------------------------------------------------
* Terms of Reference
Guides and Forms
--------------------------------------------------------------------------------
Services & Events
--------------------------------------------------------------------------------
* Workgroup Information
* Event-related Information
* WMA Calendar
* Invitations to External Meetings
Policy / Current Policies / WMA Declaration of Helsinki - Ethical Principles for
Medical Research Involving Human Participants
*
*
WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING
HUMAN PARTICIPANTS
--------------------------------------------------------------------------------
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
and amended by the:
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of
Clarification added)
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification
added)
59th WMA General Assembly, Seoul, Republic of Korea, October 2008
64th WMA General Assembly, Fortaleza, Brazil, October 2013
and by the 75th WMA General Assembly, Helsinki, Finland, October 2024
PREAMBLE
1. The World Medical Association (WMA) has developed the Declaration of
Helsinki as a statement of ethical principles for medical research involving
human participants, including research using identifiable human material or
data.
The Declaration is intended to be read as a whole, and each of its constituent
paragraphs should be applied with consideration of all other relevant
paragraphs.
2. While the Declaration is adopted by physicians, the WMA holds that these
principles should be upheld by all individuals, teams, and organizations
involved in medical research, as these principles are fundamental to respect
for and protection of all research participants, including both patients and
healthy volunteers.
GENERAL PRINCIPLES
3. The WMA Declaration of Geneva binds the physician with the words, “The
health and well-being of my patient will be my first consideration,” and the
WMA International Code of Medical Ethics declares “The physician must commit
to the primacy of patient health and well-being and must offer care in the
patient’s best interest.”
4. It is the duty of the physician to promote and safeguard the health,
well-being and rights of patients, including those who are involved in
medical research. The physician’s knowledge and conscience are dedicated to
the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include
participants.
Even well-proven interventions should be evaluated continually through research
for their safety, effectiveness, efficiency, accessibility, and quality.
6. Medical research involving human participants is subject to ethical
standards that promote and ensure respect for all participants and protect
their health and rights.
Since medical research takes place in the context of various structural
inequities, researchers should carefully consider how the benefits, risks, and
burdens are distributed.
Meaningful engagement with potential and enrolled participants and their
communities should occur before, during, and following medical research.
Researchers should enable potential and enrolled participants and their
communities to share their priorities and values; to participate in research
design, implementation, and other relevant activities; and to engage in
understanding and disseminating results.
7. The primary purpose of medical research involving human participants is to
generate knowledge to understand the causes, development and effects of
diseases; improve preventive, diagnostic and therapeutic interventions; and
ultimately to advance individual and public health.
These purposes can never take precedence over the rights and interests of
individual research participants.
8. While new knowledge and interventions may be urgently needed during public
health emergencies, it remains essential to uphold the ethical principles in
this Declaration during such emergencies.
9. It is the duty of physicians who are involved in medical research to protect
the life, health, dignity, integrity, autonomy, privacy, and confidentiality
of personal information of research participants. The responsibility for the
protection of research participants must always rest with physicians or
other researchers and never with the research participants, even though they
have given consent.
10. Physicians and other researchers must consider the ethical, legal and
regulatory norms and standards for research involving human participants in
the country or countries in which the research originated and where it is
to be performed, as well as applicable international norms and standards.
No national or international ethical, legal or regulatory requirement
should reduce or eliminate any of the protections for research participants
set forth in this Declaration.
11. Medical research should be designed and conducted in a manner that avoids
or minimizes harm to the environment and strives for environmental
sustainability.
12. Medical research involving human participants must be conducted only by
individuals with the appropriate ethics and scientific education, training
and qualifications. Such research requires the supervision of a competent
and appropriately qualified physician or other researcher.
Scientific integrity is essential in the conduct of medical research involving
human participants. Involved individuals, teams, and organizations must never
engage in research misconduct.
13. Groups that are underrepresented in medical research should be provided
appropriate access to participation in research.
14. Physicians who combine medical research with medical care should involve
their patients in research only to the extent that this is justified by its
potential preventive, diagnostic or therapeutic value and if the physician
has good reason to believe that participation in the research will not
adversely affect the health of the patients who serve as research
participants.
15. Appropriate compensation and treatment for participants who are harmed as a
result of participating in research must be ensured.
RISKS, BURDENS, AND BENEFITS
16. In medical practice and in medical research, most interventions involve
risks and burdens.
Medical research involving human participants may only be conducted if the
importance of the objective outweighs the risks and burdens to the research
participants.
17. All medical research involving human participants must be preceded by
careful assessment of predictable risks and burdens to the individuals and
groups involved in the research in comparison with foreseeable benefits to
them and to other individuals or groups affected by the condition under
investigation.
Measures to minimize the risks and burdens must be implemented. The risks and
burdens must be continuously monitored, assessed, and documented by the
researcher.
18. Physicians and other researchers may not engage in research involving human
participants unless they are confident that the risks and burdens have been
adequately assessed and can be satisfactorily managed.
When the risks and burdens are found to outweigh the potential benefits or when
there is conclusive proof of definitive outcomes, physicians and other
researchers must assess whether to continue, modify or immediately stop the
research.
INDIVIDUAL, GROUP, AND COMMUNITY VULNERABILITY
19. Some individuals, groups, and communities are in a situation of more
vulnerability as research participants due to factors that may be fixed or
contextual and dynamic, and thus are at greater risk of being wronged or
incurring harm. When such individuals, groups, and communities have
distinctive health needs, their exclusion from medical research can
potentially perpetuate or exacerbate their disparities. Therefore, the
harms of exclusion must be considered and weighed against the harms of
inclusion. In order to be fairly and responsibly included in research, they
should receive specifically considered support and protections.
20. Medical research with individuals, groups, or communities in situations of
particular vulnerability is only justified if it is responsive to their
health needs and priorities and the individual, group, or community stands
to benefit from the resulting knowledge, practices, or interventions.
Researchers should only include those in situations of particular
vulnerability when the research cannot be carried out in a less vulnerable
group or community, or when excluding them would perpetuate or exacerbate
their disparities.
SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS
21. Medical research involving human participants must have a scientifically
sound and rigorous design and execution that are likely to produce
reliable, valid, and valuable knowledge and avoid research waste. The
research must conform to generally accepted scientific principles, be based
on a thorough knowledge of the scientific literature, other relevant
sources of information, and adequate laboratory and, as appropriate, animal
experimentation.
The welfare of animals used for research must be respected.
22. The design and performance of all medical research involving human
participants must be clearly described and justified in a research
protocol.
The protocol should contain a statement of the ethical considerations involved
and should indicate how the principles in this Declaration have been addressed.
The protocol should include information regarding aims, methods, anticipated
benefits and potential risks and burdens, qualifications of the researcher,
sources of funding, any potential conflicts of interest, provisions to protect
privacy and confidentiality, incentives for participants, provisions for
treating and/or compensating participants who are harmed as a consequence of
participation, and any other relevant aspects of the research.
In clinical trials, the protocol must also describe any post-trial provisions.
RESEARCH ETHICS COMMITTEES
23. The protocol must be submitted for consideration, comment, guidance, and
approval to the concerned research ethics committee before the research
begins. This committee must be transparent in its functioning and must have
the independence and authority to resist undue influence from the
researcher, the sponsor, or others. The committee must have sufficient
resources to fulfill its duties, and its members and staff must
collectively have adequate education, training, qualifications, and
diversity to effectively evaluate each type of research it reviews.
The committee must have sufficient familiarity with local circumstances and
context, and include at least one member of the general public. It must take
into consideration the ethical, legal, and regulatory norms and standards of the
country or countries in which the research is to be performed as well as
applicable international norms and standards, but these must not be allowed to
reduce or eliminate any of the protections for research participants set forth
in this Declaration.
When collaborative research is performed internationally, the research protocol
must be approved by research ethics committees in both the sponsoring and host
countries.
The committee must have the right to monitor, recommend changes to, withdraw
approval for, and suspend ongoing research. Where monitoring is required, the
researcher must provide information to the committee and/or competent data and
safety monitoring entity, especially about any serious adverse events. No
amendment to the protocol may be made without consideration and approval by the
committee. After the end of the research, the researchers must submit a final
report to the committee containing a summary of the findings and conclusions.
PRIVACY AND CONFIDENTIALITY
24. Every precaution must be taken to protect the privacy of research
participants and the confidentiality of their personal information.
FREE AND INFORMED CONSENT
25. Free and informed consent is an essential component of respect for
individual autonomy. Participation by individuals capable of giving
informed consent in medical research must be voluntary. Although it may be
appropriate to consult family members or community representatives,
individuals capable of giving informed consent may not be enrolled in
research unless they freely agree.
26. In medical research involving human participants capable of giving informed
consent, each potential participant must be adequately informed in plain
language of the aims, methods, anticipated benefits and potential risks and
burdens, qualifications of the researcher, sources of funding, any
potential conflicts of interest, provisions to protect privacy and
confidentiality, incentives for participants, provisions for treating
and/or compensating participants who are harmed as a consequence of
participation, and any other relevant aspects of the research.
The potential participant must be informed of the right to refuse to participate
in the research or to withdraw consent to participate at any time without
reprisal. Special attention should be given to the specific information and
communication needs of individual potential participants as well as to the
methods used to deliver the information.
After ensuring that the potential participant has understood the information,
the physician or another qualified individual must then seek the potential
participant’s freely given informed consent, formally documented on paper or
electronically. If the consent cannot be expressed on paper or electronically,
the non-written consent must be formally witnessed and documented.
All medical research participants should be given the option of being informed
about the general outcome and results of the research.
27. When seeking informed consent for participation in research the physician
or other researcher must be particularly cautious if the potential
participant is in a dependent relationship with them or may consent under
duress. In such situations, the informed consent must be sought by an
appropriately qualified individual who is independent of this relationship.
28. In medical research involving human participants incapable of giving free
and informed consent, the physician or other qualified individual must seek
informed consent from the legally authorized representative, considering
preferences and values expressed by the potential participant.
Those persons incapable of giving free and informed consent are in situations of
particular vulnerability and are entitled to the corresponding safeguards. In
addition to receiving the protections for the particularly vulnerable, those
incapable of giving consent must only be included if the research is likely to
either personally benefit them or if it entails only minimal risk and minimal
burden.
29. When a potential research participant who is incapable of giving free and
informed consent is able to give assent to decisions about participation in
research, the physician or other qualified individual must seek that assent
in addition to the consent of the legally authorized representative,
considering any preferences and values expressed by the potential
participant. The potential participant’s dissent should be respected.
30. Research involving participants who are physically or mentally incapable of
giving consent (for example, unconscious patients) may be done only if the
physical or mental condition that prevents giving informed consent is a
necessary characteristic of the research group. In such circumstances the
physician or other qualified individual must seek informed consent from the
legally authorized representative. If no such representative is available
and if the research cannot be delayed, the research may proceed without
informed consent provided that the specific reasons for involving
participants with a condition that renders them unable to give informed
consent have been stated in the research protocol and the research has been
approved by a research ethics committee.
Free and informed consent to remain in the research must be obtained as soon as
possible from a legally authorized representative or, if they regain capacity to
give consent, from the participant.
31. The physician or other researcher must fully inform potential participants
which aspects of their care are related to the research. The refusal of a
patient to participate in research or the patient’s decision to withdraw
from research must never adversely affect the patient-physician
relationship or provision of the standard of care.
32. Physicians or other qualified individuals must obtain free and informed
consent from research participants for the collection, processing, storage,
and foreseeable secondary use of biological material and identifiable or
re-identifiable data. Any collection and storage of data or biological
material from research participants for multiple and indefinite uses should
be consistent with requirements set forth in the WMA Declaration of Taipei,
including the rights of individuals and the principles of governance. A
research ethics committee must approve the establishment and monitor
ongoing use of such databases and biobanks.
Where consent is impossible or impracticable to obtain, secondary research on
stored data or biological material may be done only after consideration and
approval of a research ethics committee.
USE OF PLACEBO
33. The benefits, risks, burdens, and effectiveness of a new intervention must
be tested against those of the best proven intervention(s), except in the
following circumstances:
* If no proven intervention exists, the use of placebo, or no intervention, is
acceptable; or
* If for compelling and scientifically sound methodological reasons the use of
any intervention other than the best proven one(s), the use of placebo, or no
intervention is necessary to determine the efficacy or safety of an
intervention; and the participants who receive any intervention other than
the best proven one(s), placebo, or no intervention will not be subject to
additional risks of serious or irreversible harm as a result of not receiving
the best proven intervention.
Extreme care must be taken to avoid abuse of this option.
POST-TRIAL PROVISIONS
34. In advance of a clinical trial, post-trial provisions must be arranged by
sponsors and researchers to be provided by themselves, healthcare systems,
or governments for all participants who still need an intervention
identified as beneficial and reasonably safe in the trial. Exceptions to
this requirement must be approved by a research ethics committee. Specific
information about post-trial provisions must be disclosed to participants
as part of informed consent.
RESEARCH REGISTRATION, PUBLICATION, AND DISSEMINATION OF RESULTS
35. Medical research involving human participants must be registered in a
publicly accessible database before recruitment of the first participant.
36. Researchers, authors, sponsors, editors, and publishers all have ethical
obligations with regard to the publication and dissemination of the results
of research. Researchers have a duty to make publicly available the results
of their research on human participants and are accountable for the
timeliness, completeness, and accuracy of their reports. All parties should
adhere to accepted guidelines for ethical reporting. Negative and
inconclusive as well as positive results must be published or otherwise
made publicly available. Sources of funding, institutional affiliations,
and conflicts of interest must be declared in the publication. Reports of
research not in accordance with the principles of this Declaration should
not be accepted for publication.
UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE
37. When an unproven intervention is utilized in an attempt to restore health or
alleviate suffering for an individual patient because approved options are
inadequate or ineffective and enrollment in a clinical trial is not possible, it
should subsequently be made the object of research designed to evaluate safety
and efficacy. Physicians participating in such interventions must first seek
expert advice, weigh possible risks, burdens, and benefits, and obtain informed
consent. They must also record and share data when appropriate and avoid
compromising clinical trials. These interventions must never be undertaken to
circumvent the protections for research participants set forth in this
Declaration.
Disclaimer: ©2024 World Medical Association. All Rights Reserved. All
intellectual property rights in the Declaration of Helsinki are vested in the
World Medical Association. The WMA has granted JAMA exclusive rights to publish
the English-language version of the Declaration through December 31, 2024.
22nd October 2024
POLICY TYPES
Declaration
ARCHIVED VERSIONS
* » DoH-Jun1964
* » DoH-Oct1975
* » DoH-Oct1983
* » DoH-Sept1989
* » DoH-Oct1996
* » DoH-Oct2000
* » DoH-Oct2004
* » DoH-Oct2008
* » DoH-Oct2013
TAGS
Clinical Study, Ethics, Ethics Committee, Helsinki, Human Participants, Human
Subjects, Medical Research, Patient Autonomy, Placebo, Post-Trial Access (to
Care), Principle, Publication, Register, Research, Review Committee, Risk
Assessment, Subject Protection, Vulnerable Populations
RELATED WMA POLICIES
WMA DECLARATION OF GENEVA
Adopted by the 2nd General Assembly of the World Medical Associa...
Read more
WMA INTERNATIONAL CODE OF MEDICAL ETHICS
Adopted by the 3rd General Assembly of the World Medical Associa...
Read more
--------------------------------------------------------------------------------
Back to policies
Back to Top
--------------------------------------------------------------------------------
© 2024 World Medical Association
All Rights reserved.
Contact Us
Sitemap
Imprint
Disclaimer
Privacy policy
Cookie policy
Cookie Policy
This website uses cookies to ensure you get the best experience on our website.
Decline Allow Cookies