Informed Consent for Research Using Biospecimens, Genetic Information and Other Personal Data

Abstract

While human subjects research once consisted primarily of research on people, advances in biobanking, genetics and big data have transformed the research landscape. Personal data and biospecimens are increasingly at the centre of research, giving rise to difficult questions about whether and how to apply legal and ethical principles - such as informed consent - that were developed for research on people. The first part of this article explores questions about consent that arise in the context of authorising research on personal data and biospecimens, focusing on the legal and ethical basis of the consent requirement, the use of specific versus broad consent, and the significance of anonymisation. The second part of the article looks at issues of consent that arise beyond the individual’s decision to participate, focusing on the return of individualised research results, community consent, and the ownership of biospecimens. This article is intended to be an encyclopaedia entry. It is forthcoming in the eLS.