# WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI

**Ethical Principles for Medical Research Involving Human Subjects**

World Medical Association

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 2002 (Note of Clarification on paragraph 29 added)  
55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added)  
59th WMA General Assembly, Seoul, October 2008  

## INTRODUCTION

1)  The World Medical Association (WMA) has developed the Declaration of Helsinki as a
    statement of ethical principles for medical research involving human subjects, including
    research on identifiable human material and data.
    The Declaration is intended to be read as a whole and each of its constituent paragraphs
    should not be applied without consideration of all other relevant paragraphs.

2)  Although the Declaration is addressed primarily to physicians, the WMA encourages
    other participants in medical research involving human subjects to adopt these
    principles.

3)  It is the duty of the physician to promote and safeguard the health of patients, including
    those who are involved in medical research. The physician's knowledge and conscience
    are dedicated to the fulfilment of this duty.

4)  The Declaration of Geneva of the WMA binds the physician with the words, “The
    health of my patient will be my first consideration,” and the International Code of
    Medical Ethics declares that, “A physician shall act in the patient's best interest when
    providing medical care.”

5)  Medical progress is based on research that ultimately must include studies involving
    human subjects. Populations that are underrepresented in medical research should be
    provided appropriate access to participation in research.

6)  In medical research involving human subjects, the well-being of the individual research
    subject must take precedence over all other interests.

7)  The primary purpose of medical research involving human subjects is to understand the
    causes, development and effects of diseases and improve preventive, diagnostic and
    therapeutic interventions (methods, procedures and treatments). Even the best current
    interventions must be evaluated continually through research for their safety,
    effectiveness, efficiency, accessibility and quality.

8)  In medical practice and in medical research, most interventions involve risks and
    burdens.

9)   Medical research is subject to ethical standards that promote respect for all human
     subjects and protect their health and rights. Some research populations are particularly
     vulnerable and need special protection. These include those who cannot give or refuse
     consent for themselves and those who may be vulnerable to coercion or undue
     influence.
 
10)  Physicians should consider the ethical, legal and regulatory norms and standards for
     research involving human subjects in their own countries 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
     subjects set forth in this Declaration.

## PRINCIPLES FOR ALL MEDICAL RESEARCH

11) It is the duty of physicians who participate in medical research to protect the life, health,
     dignity, integrity, right to self-determination, privacy, and confidentiality of personal
     information of research subjects.
 
12)  Medical research involving human subjects 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.
 
13)  Appropriate caution must be exercised in the conduct of medical research that may
     harm the environment.
 
14)  The design and performance of each research study involving human subjects must be
     clearly described 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
     funding, sponsors, institutional affiliations, other potential conflicts of interest,
     incentives for subjects and provisions for treating and/or compensating subjects who are
     harmed as a consequence of participation in the research study. The protocol should
     describe arrangements for post-study access by study subjects to interventions identified
     as beneficial in the study or access to other appropriate care or benefits.
 
15)  The research protocol must be submitted for consideration, comment, guidance and
     approval to a research ethics committee before the study begins. This committee must
     be independent of the researcher, the sponsor and any other undue influence. It must
     take into consideration the laws and regulations 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
     subjects set forth in this Declaration. The committee must have the right to monitor
     ongoing studies. The researcher must provide monitoring information to the committee,
     especially information about any serious adverse events. No change to the protocol may
     be made without consideration and approval by the committee.
 
16)  Medical research involving human subjects must be conducted only by individuals with
     the appropriate scientific training and qualifications. Research on patients or healthy
    volunteers requires the supervision of a competent and appropriately qualified physician
    or other health care professional. The responsibility for the protection of research
    subjects must always rest with the physician or other health care professional and never
    the research subjects, even though they have given consent.

17) Medical research involving a disadvantaged or vulnerable population or community is
    only justified if the research is responsive to the health needs and priorities of this
    population or community and if there is a reasonable likelihood that this population or
    community stands to benefit from the results of the research.

18) Every medical research study involving human subjects must be preceded by careful
    assessment of predictable risks and burdens to the individuals and communities
    involved in the research in comparison with foreseeable benefits to them and to other
    individuals or communities affected by the condition under investigation.

19) Every clinical trial must be registered in a publicly accessible database before
    recruitment of the first subject.

20) Physicians may not participate in a research study involving human subjects unless they
    are confident that the risks involved have been adequately assessed and can be
    satisfactorily managed. Physicians must immediately stop a study when the risks are
    found to outweigh the potential benefits or when there is conclusive proof of positive
    and beneficial results.

21) Medical research involving human subjects may only be conducted if the importance of
    the objective outweighs the inherent risks and burdens to the research subjects.

22) Participation by competent individuals as subjects in medical research must be
    voluntary. Although it may be appropriate to consult family members or community
    leaders, no competent individual may be enrolled in a research study unless he or she
    freely agrees.

23) Every precaution must be taken to protect the privacy of research subjects and the
    confidentiality of their personal information and to minimize the impact of the study on
    their physical, mental and social integrity.

24) In medical research involving competent human subjects, each potential subject must be
    adequately informed of the aims, methods, sources of funding, any possible conflicts of
    interest, institutional affiliations of the researcher, the anticipated benefits and potential
    risks of the study and the discomfort it may entail, and any other relevant aspects of the
    study. The potential subject must be informed of the right to refuse to participate in the
    study or to withdraw consent to participate at any time without reprisal. Special
    attention should be given to the specific information needs of individual potential
    subjects as well as to the methods used to deliver the information. After ensuring that
    the potential subject has understood the information, the physician or another
    appropriately qualified individual must then seek the potential subject’s freely-given
    informed consent, preferably in writing. If the consent cannot be expressed in writing,
    the non-written consent must be formally documented and witnessed.

25) For medical research using identifiable human material or data, physicians must
    normally seek consent for the collection, analysis, storage and/or reuse. There may be
    situations where consent would be impossible or impractical to obtain for such research
    or would pose a threat to the validity of the research. In such situations the research may
    be done only after consideration and approval of a research ethics committee.

26) When seeking informed consent for participation in a research study the physician
    should be particularly cautious if the potential subject is in a dependent relationship
    with the physician or may consent under duress. In such situations the informed consent
    should be sought by an appropriately qualified individual who is completely
    independent of this relationship.

27) For a potential research subject who is incompetent, the physician must seek informed
    consent from the legally authorized representative. These individuals must not be
    included in a research study that has no likelihood of benefit for them unless it is
    intended to promote the health of the population represented by the potential subject,
    the research cannot instead be performed with competent persons, and the research
    entails only minimal risk and minimal burden.

28) When a potential research subject who is deemed incompetent is able to give assent to
    decisions about participation in research, the physician must seek that assent in addition
    to the consent of the legally authorized representative. The potential subject’s dissent
    should be respected.

29) Research involving subjects 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 population. In such circumstances the physician should seek informed consent
    from the legally authorized representative. If no such representative is available and if
    the research cannot be delayed, the study may proceed without informed consent
    provided that the specific reasons for involving subjects with a condition that renders
    them unable to give informed consent have been stated in the research protocol and the
    study has been approved by a research ethics committee. Consent to remain in the
    research should be obtained as soon as possible from the subject or a legally authorized
    representative.

30) Authors, editors and publishers all have ethical obligations with regard to the
    publication of the results of research. Authors have a duty to make publicly available
    the results of their research on human subjects and are accountable for the completeness
    and accuracy of their reports. They should adhere to accepted guidelines for ethical
    reporting. Negative and inconclusive as well as positive results should be published or
    otherwise made publicly available. Sources of funding, institutional affiliations and
    conflicts of interest should be declared in the publication. Reports of research not in
    accordance with the principles of this Declaration should not be accepted for
    publication.

## ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE

31) The physician may combine medical research with medical care only to the extent that
    the research is justified by its potential preventive, diagnostic or therapeutic value and if
    the physician has good reason to believe that participation in the research study will not
    adversely affect the health of the patients who serve as research subjects.

32) The benefits, risks, burdens and effectiveness of a new intervention must be tested
    against those of the best current proven intervention, except in the following
    circumstances:

* The use of placebo, or no treatment, is acceptable in studies where no current
        proven intervention exists; or
* Where for compelling and scientifically sound methodological reasons the use of
        placebo is necessary to determine the efficacy or safety of an intervention and the
        patients who receive placebo or no treatment will not be subject to any risk of
        serious or irreversible harm. Extreme care must be taken to avoid abuse of this
        option.

33) At the conclusion of the study, patients entered into the study are entitled to be
    informed about the outcome of the study and to share any benefits that result from it, for
    example, access to interventions identified as beneficial in the study or to other
    appropriate care or benefits.

34) The physician must fully inform the patient which aspects of the care are related to the
    research. The refusal of a patient to participate in a study or the patient’s decision to
    withdraw from the study must never interfere with the patient-physician relationship.

35) In the treatment of a patient, where proven interventions do not exist or have been
    ineffective, the physician, after seeking expert advice, with informed consent from the
    patient or a legally authorized representative, may use an unproven intervention if in the
    physician's judgement it offers hope of saving life, re-establishing health or alleviating
    suffering. Where possible, this intervention should be made the object of research,
    designed to evaluate its safety and efficacy. In all cases, new information should be
    recorded and, where appropriate, made publicly available.

## SOURCE

http://www.wma.net/en/30publications/10policies/b3/17c.pdf