Research on Human Biological Materials: What Consent Is Needed, and When

Abstract

Requirement for informed, express, and specific consent is one of the key principles of research ethics that evolved as a reaction to the atrocities of the Nazi medicine as well as a response to the unethical human experimentation revealed during the post World War II period. Such consent is thought to be the default position in clinical research and any softening of the requirement is usually perceived as an exception which requires justification. However, in some areas of human research the requirement is more and more often both weakened in practice and criticised by the members of the research community and ethicists. In this chapter we discuss circumstances under which research on human biological materials is in fact conducted without specific consent or re-consent of a donor. First, we explore the research use of materials that were collected for broadly-defined research purposes for which broad consent was initially secured. Second, we discuss the possibility to waive consent in research use of biological materials that were initially collected for non-research purposes without consent for research use. Third, we address three alternative regulatory regimes allowing turning residual biological materials into research collections during the collection procedure. These alternatives that justify the so-called research storage of biological materials collected for non-research purposes can be based on precautionary consent, presumed consent, and no consent.