Rethinking the ethics of human biomedical non-interventional research

Abstract

Although there seems to be a consensus that research on personal data and/or biological material differs from other types of research, there is no agreement on how these differences should be regulated. Earlier solutions have been criticized as representing biobank exceptionalism, which is not justified or leads to a slippery slope. The present work discusses whether the distinction between interventional and non-interventional types of human biomedical research could be a criterion based on which the difference is justifiable, and whether it could form the basis for different solutions in regulatory frameworks. Current regulatory approaches and the dissimilarity of risks are elaborated. Based on David Wendler's normative criteria about the active role of investigators, it is shown that it is relevant to make the distinction between interventional and non-interventional research.