ABSTRACT

The World Medical Association (WMA) had adopted the Helsinki Declaration in 1964, laying down a requirement for ethics review of biomedical research involving humans. Another, perhaps even more important, reason for the development of research ethics committees (RECs) in Sweden was the decision made in 1966 by the US National Institutes of Health (NIH) that ethics review would be a mandatory prerequisite for financing. Quite a number of Swedish researchers were funded by the NIH, and thus had strong incentives for adapting to this new requirement. The first Swedish RECs were established by individual faculties of medicine; a nationwide system was then developed in cooperation with the Swedish Medical Research Council and the Ethics Delegation of the Swedish Society of Medicine. In Sweden, DNA samples and other human biological material have not been considered to be covered by general data protection rights such as these are laid down in the Personal Data Act.