Prior to World War II, countries tended to make and keep their own laws and codes; as such, there were no overall guiding principles at a global level that gave worldwide accountability. Many of the codes were ones that an individual person had to make a conscious decision to abide by. This self-regulation, and its‘ failure during World War II and beyond, has lead to the development of codes which have accountability at a state or national level. The development of these codes shows how they have endeavoured to maintain an equal power differential between the researcher who is looking for scientific value, and the participant who is contributing to the greater good. Particularly in interventional studies, this regulation was needed. While it is important to explore the duty of care a researcher has to a research participant, these constructs are much more evident in clinical trial practice and the medicinal context. These constructs provide the basis for the movement from an individualistic moral position to a more legalistic tradition. This thesis aims to show why these constructs, while valid, may not always be appropriate for monitoring type studies. The purpose of the next section is to trace the development of codes from an individualistic moral position (as seen previously) to a more legalistic position, and to highlight the bias towards trial and clinical medicine.
Post-Nuremburg, there are subtle but obvious changes over time with regards to how research is perceived and investigated. Susser [205] looked at how Epidemiology as a research
construct has changed since the Second World War, with the advent of professional committees and codes of practice. This is seen in other types of research with voluntary codes of practice. However, the change from self-regulation to regulation by committee was inevitable after the Nuremburg trials. This can be traced through various events in the legislation, and to where the patient now has ultimate control over their participation in a research situation. While the participant may be acting autonomously by their participation in a research project, prior to their participation, the design and implementation of the study has been carried out by researchers to obtain the best possible results from their participation. Willams et al [206] notes that the potential for biased results is increasing as participation rates decrease. They propose utilising various persuasive communications to increase what
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they term altruistic behaviours to increase participation rates [206]. While this may enable researchers to gain some control with regards to reducing bias and potential confounders in a study, Fry [207] notes that benevolent intentions may not always have positive outcomes. It is the potential for non-positive outcomes that has made potential participants a part of the planning process.
This control by the participant in regards to their participation can be seen in the changes in studies from Tuskegee through the Belmont report (which was the start of corporatization of the research experience) through to activism in areas such as HIV and breast cancer. This activism takes the form of advocating for the rights of the group to be considered when designing studies which aim to benefit them [208, 209].
The Nuremburg trials have been taken to be a metaphorical line in the sand with respect to the development of overall principles to guide the researcher. Prior to this, self-regulation of doctors and researchers was an accepted part of the research process. While the Nuremburg judges recognized the importance of the underlying Hippocratic Oath and the maxim of ―First do no Harm‖, they also recognized that greater protection of human subjects was necessary [25]. While the Nuremburg code has not been adopted as is by any country or as a statement of ethics by any major medical association, its influence is seen in the development of codes by bodies such as the World Medical Association [25, 210]. Figure 7 shows the evolution of national and international statements in ethical thinking post World War II.
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Figure 7: The Development of Ethical Codes Relevant to Medical Practice and Related Health/Medical Experimentation Post World War II
•Nuremburg Trials and Code •Declaration of Geneva
•World Medical Association Code of Medical Ethics 1945-1950
•Wilson Memo
•World Medical Association Principles for Those in Research and Experimentation
•AMA Code of Medical Ethics Revision 1950-1959
•Declaration of Helsinki first published
•Beecher's investigation in previously carried out unethical research •First ethics committee in the UK
•Pappworth's "Human Guinea Pigs" expose 1960-1969
•Belmont Report
•American Congress passes the National Research Act 1970-1979
•American Medical Association Ethics Code Revision 1980-1989
•Council for International Organizations of Medical Sciences (CIOMS) Guidelines for Ethical Review of Epidemiological Studies (Switzerland)
•Revision of the World Medical Association International Code of Medical Ethics 1990-1999
•Most Recent Revision of the Declaration of Helsinki (Finland) •American Medical Association Revision of Code of Medical Ethics
•Central Office of Research Ethics Committees (COREC) established in the UK - superceeded by National Ethics Research Service (NERS)
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