New report on ethics and law governing personal data in research

Link to positive response to the report at "Etikbloggen" (in Swedish)

The purpose of the report “Registerforskning – etiken bakom juridiken” is to elucidate the ethical line of thought behind the laws relevant for register-based research in Sweden. The report investigates how different interests are balanced against each other in the preparatory works relevant for applicable legislations. It focuses on laws concerning the relationship between individuals and society, such as the Personal Data Act, the Ethics Review Act, and the Biobanks Act. A central aspect of register-based research concerns balancing individual integrity and autonomy versus the positive effects that the research can result in for the individual and for the public (e.g. increased knowledge and social justice). The main ethical values and principles that are discussed are integrity, autonomy, beneficence, non-malfeasance, public trust and justice.

The report concludes that a clear definition of personal integrity is absent in the legislation, which makes the balancing of interests somewhat difficult to interpret. More specifically, there is a need to clarify what is meant by protecting integrity when performing register-based research: Is it primarily a matter of maintaining confidentiality, or one of protecting the right of individuals to decide whether or not their data and samples can be used? Furthermore, the report demonstrates that register-based research  is considered differently compared to other societal activities using personal information, such as quality control within healthcare and journalism (for which informed consent or ethical vetting is not required). Yet it is not obvious that register-based research is neither less important nor more dangerous.

The report was produced within the project SIMSAM-INFRA and constitutes part of the background material for the ongoing governmental commission aiming at improving the prerequisites for register-based research.

Link to the report “Registerforskning – etiken bakom juridiken” (in Swedish).