The Declaration of Helsinki and public health

Abstract

Determining the optimal relationship between public health and individual health is a major ethical challenge for health systems and providers. In theory, there should be no conflict between the two – the public consists of individuals and public health can be considered as the sum of the health of all those individuals. However, the situation is not quite that simple. Conflicts do exist – over issues including funding, treatment, duties, rights and preferences. The focus of this paper is the conflict between individual and public health in the ethics of research on humans. I will use the World Medical Association (WMA)’s Declaration of Helsinki (DoH) to demonstrate that, while concern for the individual has predominated over the needs of public health since World War Two, in recent years there has been some movement towards redressing this imbalance. The DoH was first adopted at the 1964 WMA General Assembly in Helsinki. Its purpose was to provide guidance to physicians engaged in clinical research and its main focus was the responsibilities of researchers for the protection of research subjects. The advancement of medical science and the promotion of public health, although recognized as important objectives of medical research, were clearly subordinate to the well-being of individual research subjects. The reasons for this emphasis on protection of research subjects are not difficult to discern. The DoH, like its well-known predecessor, the Nuremberg Code, was intended to prevent mistreatment of research subjects such as had been practised by Nazi physicians. In the absence of external constraints like legal frameworks and research ethics committees, it placed the responsibility to protect research subjects on medical researchers, who at that time were mostly physicians. It drew heavily on traditional medical ethics, as summarized in documents such as the WMA Declaration of Geneva which requires of the physician that: “The health of my patient will be my first consideration.”1 In relation to the Nuremberg Code, however, the 1964 DoH represented a subtle shift in the balance between the responsibilities of the researcher to individual research participants and “to further scientific knowledge and to help suffering humanity”, i.e. for public health. This shift is most evident in the requirement to obtain the informed consent of participants. This requirement was absolute in the Nuremberg Code but was softened in the DoH to allow research on children, especially for vaccines, and on incompetent or ‘captive’ populations, such as prisoners and military personnel.2 Still, the 1964 DoH was composed mainly of restrictions on medical research designed to safeguard the interests of individual participants. The first revision of the DoH was adopted in 1975. In the wake of revelations that serious abuses of research ethics were relatively commonplace, the WMA made explicit what had only been implicit in the 1964 version that “In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject” (paragraph III. 4, 1975 version). As important as the needs of public health may be, they must not override the rights of individuals who take part in medical research. Since it appeared that some researchers could not be trusted to protect research participants, new requirements were added to the DoH, including advance review of projects by an independent committee and adherence to the principles of the DoH as a condition for publication of the results of the research. Minor amendments to the DoH were adopted in 1983, 1989 and 1996.3 These did not alter the predominance of the individual research subject’s interests over those of society. In contrast, the version that was adopted at the 2000 WMA General Assembly represented a major revision and expansion of the document. Although the emphasis on the primacy of the individual was retained, the following amendments indicate an increased awareness of the needs of public health: The 2000 version did away with the distinction between ‘therapeutic’ and ‘non-therapeutic’ research that had been a hallmark of the DoH since 1964. This distinction was based on the premise that much medical research is therapeutic, i.e. is intended to benefit the research subject: “The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient” (paragraph II. 6, 1996 version). In contrast, the purpose of research in the 2000 version is the advancement of knowledge for the benefit of future patients; double-blinded clinical trials clearly demonstrate this purpose and its limitations for the health needs of research subjects. The 2000 version introduced an entirely new concept – the responsibility of researchers and sponsors to provide benefits to populations: “Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research” (paragraph 19). Although the nature and extent of these benefits is not specified, the amendment clearly adds a significant public-health component to research ethics. In May 2007 the WMA Council authorized a new review of the DoH.4 A call for suggested amendments was distributed widely during 2007; the responses were collated and presented to the WMA Medical Ethics Committee in October 2007. Following that meeting a set of draft amendments was prepared by a working group and distributed for comment. A revised draft was considered by the Medical Ethics Committee in May 2008 and another consultation took place during the summer. The working group’s final recommendations will be considered at the 2008 WMA General Assembly. Although it will be up to the General Assembly to decide what, if any, changes will be made to the DoH, the working group’s draft amendments suggest a continuation of the trend, noted in the 2000 version, towards a greater concern for public-health, as follows: Specific mention is made of epidemiological research, which by its nature aims at the improvement of public health and health systems rather than the health of individual research subjects. Another suggested amendment calls for appropriate access to participation in research for populations that have previously been underrepresented, such as children and pregnant women. The statement on risks and burdens is expanded to include their application to the communities as well as to the individuals involved in the research. However, the statement that “considerations related to the well-being of the human subject should take precedence over the interests of science and society” is essentially unchanged.