Research ethics in the wake of World War II
Medical research ethics was forced into the spotlight following the 1947 Doctors’ Trial in Nuremberg, which uncovered extensive medical experimentation on prisoners in concentration camps during World War II. The experiments were considered unquestionably ethically indefensible, based on their nature and the fact that they were conducted under direct or indirect duress.
One of the consequences of the trial was the Nuremberg Code, an appendix to the judgment, which was a set of research ethics principles for human experimentation (6, 7). A key component of the Code was informed consent. It stated that human experimentation must not be conducted on people who cannot or will not grant voluntary informed consent – regardless of the reason.
In 1964, the World Medical Association adopted the Declaration of Helsinki, which specifically provides ethics principles for medical research. It is generally accepted that the Nuremberg Code provided a foundation for the work on the Declaration (8). However, the Declaration differed substantially from the Nuremberg Code; it was written by doctors who planned to regulate their own activities, not an independent legal body, and the doctors had a different view of research ethics than the Nuremberg judges.
The Declaration consisted of general ethical guidelines for research, divided into clinical therapeutic research and non-therapeutic research. Informed consent was also a key component of the Declaration of Helsinki. The latter allowed consent to be obtained from the research subjects’ parents or guardians for clinical therapeutic research if the subjects were unable to grant consent themselves, unlike the Nuremberg Code. In other words, it was possible to circumvent the principle of informed consent if the research subject was deemed mentally or physically not competent, and the experiment was expected to be of great benefit. For non-therapeutic research, however, the subjects were required to have the mental, physical and legal ability to make their own independent decision (9).
The World Medical Association adopted the Declaration of Helsinki unanimously in 1964, following a decade of discussions and several revisions (8).
There were reports of unethical research in both the USA and the United Kingdom in the years following the Declaration of Helsinki. Renowned US doctor and researcher Henry Beecher published an article in the New England Journal of Medicine in 1966 (10), and British doctor Maurice Pappworth published his book the next year (11). They both mentioned concurrent cases of unethical research.
Beecher stated that «Nearly everyone agrees that ethics violations do occur. The practical question is, how often?». Both authors commented that only a few of the research articles discussed the extent to which informed consent had been obtained. Beecher examined the concept of «informed consent», and believed that it was difficult to obtain it in practice, but nonetheless asserted that it should always be sought, for sociological, ethical and legal reasons: «There is no choice in the matter» (10, p. 1355). Pappworth also argued in favour of research ethics committees at hospitals.
Both of these texts provided the foundation for a broader discussion among the authors’ colleagues. Many people took a defensive stance and claimed that the two authors were wrong, that such incidents did not occur, and that this critique should not take place in the public arena (12). The medical profession preferred not to air its dirty laundry in public.
Despite this, research ethics was gradually institutionalised in several Western countries during this period. In the USA, ethical peer review was introduced in the early 1950s. From 1966, all research projects involving experiments on human subjects were required to be presented to a research ethics committee (13, 14). In order to receive funding from the U.S. Public Health Service, research projects had to undergo an external assessment of the researcher’s ethical judgement before the projects could begin. The intention of the assessment was to review the rights of research subjects and the methods used to obtain informed consent. The assessment would weigh the risks and possible benefits associated with the project (13).
As several British research communities also received funding from the U.S. Public Health Service, this requirement, in conjunction with the discussion initiated by Pappworth, played an important role in the establishment of permanent research ethics committees in the United Kingdom in 1972 (13). Sweden had had institutional research ethics committees since 1966 (5).
In Norway, it became necessary to establish ad hoc committees whenever this was required by commissioners of research or for publication in international journals (15). Despite the scientific debate and the institutionalisation of research ethics in other countries, Norway did not appear to be in a hurry to establish permanent committees. A further two factors played a critical role here in Norway: a recommendation in the revised Declaration of Helsinki to establish research ethics committees in all countries, and external pressure in the form of the so-called Gro case.