Latest News
Declaration of Helsinki updated
The World Medical Association has recently announced its 2008 revision of the Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. The text is the result of the sixth comprehensive review of the Declaration, which was adopted by the WMA General Assembly in Helsinki, Finland in June 1964 and amended in 1975 (Tokyo), 1983 (Venice), 1989 (Hong Kong), 1996 (South Africa) and 2000 (Edinburgh). Notes of clarification to two specific paragraphs were added in 2002 and 2004.
The majority of the changes to the Declaration are incremental rather than radical, reflecting current perspectives and language pertaining to medical research. For example, the duty of the physician set out in paragraph 3 of the Introduction is to promote and safeguard the health of ‘patients, including those involved in medical research’, rather than the health of ‘the people’, and physicians no longer ‘obtain’ but rather ‘seek’ consent.
More substantively, provisions for the formulation of the research protocol have been subtly streamlined. In particular, paragraph 15 now incorporates the Note of Clarification on paragraph 30 (Tokyo 2004) regarding access of participants to benefits resulting from the research. As a result, arrangements for post-study access by study subjects to interventions identified during the study as being beneficial, or access to other appropriate care or benefits, must be described in the protocol.
Another point previously in issue was the extent to which a research ethics committee should be required to conform to the national laws and regulations of countries in which the proposed research was to take place. The need for such ‘conformity ’ is now gone, but the REC must ‘take into consideration’ laws and regulations, with the addition of ‘applicable international norms and standards’, so long as these do not reduce or eliminate any of the protections for research subjects set out in the Declaration.
The protection of research participants is arguably enhanced by the fact that ‘confidentiality of personal information’ and ‘integrity’ of such subjects, previously matters for precaution, are now embodied in the duty of physicians involved in research under paragraph 10, along with the protection of life, health, privacy and dignity. More controversially, doctors also have a new duty to protect to the ‘right to self-determination’ of their subjects, reflecting the increased level of recognition in the Declaration of the needs of communities.
The 2008 Declaration also requires a greater level of consideration of the effect of research on populations and communities than did previous texts. Paragraph 17 makes express the need for justification of research involving a disadvantaged or vulnerable population or community; it must be responsive to the community’s health needs and priorities, or the population must stand to benefit from the results of the research. Communities are again expressly mentioned in paragraph 18, in regard to the need for an assessment of risks and benefits of the research – for individuals or communities - that must precede every medical research study involving human subjects.
The requirements of informed consent are a main focus of Part B (The Principles for All Medical Research), without significant changes to the previous draft, other than an express recognition of the information needs of individuals and sensitivity to potential subjects who may be in a dependent relationship with the physician or may consent under duress. The only addition to the Declaration, a matter on which the PHG Foundation commented, is contained in paragraph 25. It admits that in some situations, in which identifiable human material or data is being used, a need to obtain consent might be impractical or jeopardise the research results; in these cases the research may be permitted once ethics committee approval is obtained.
Finally, the PHG Foundation made a further contribution to the circumstances in which a placebo or no treatment might be permitted. Whereas a new intervention would normally need to be tested against the ‘best current proven intervention’, the new text articulates two express situations in which a placebo might be acceptable: where there is no current proven intervention, or where there are compelling and scientifically sound methodological reasons for the use of a placebo, and the subjects are not at risk of serious or irreversible harm. This provision incorporates the prior Note of Clarification on paragraph 29 of the Declaration (Washington 2002) without conflating the two sets of circumstances into one paragraph, as set out in the proposal (from which we dissented) in the consultation document.