Etik som rättsligt verktyg? Etikprövning av forskning som rättslig skyddsåtgärd för enskilda

Publicerad i Nordisk socialrättslig tidskrift nr 31–32.2022, april 2022 s. 39–70


Ethical review has in recent decades played an increasingly prominent role in the research community. In addition to the main function of the ethics review – to assess the benefits and risks of a planned research project – a further function has become increasingly important, namely ethical review as a tool for legal protection. International, European and Swedish fundamental rights documents entail a right to privacy (both physical and personal integrity) and the right to data protection. There are two internationally recognized safeguards to implement these rights in the field of scientific research: the requirement for informed consent and ethical review. The article analyzes the legal structure for ethical review in Swedish law, taking its departure in a matter decided by the Ethics Review Authority and the Board of Appeal for Ethics Review in 2020, where a research project was considered to fall outside the scope of the Ethics Review Act, after a narrow interpretation of relevant legal concepts. Based on an analysis of the phenomenon of juridification, the question is asked whether the Swedish ethics review is designed to provide adequate access to ethical review for research, while at the same time providing effective legal protection for research participants. The conclusion drawn is that the ethical review ought to be handled as an ethical tool, rather than a legal one. Focus ought to be placed on the ethical balancing of the benefits of a planned research project against the welfare of the research participants in the individual case, rather than a review of legal particularities.