The Role of IRBs in Research Involving Commercial Biobanks

Abstract

In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile a vast collection of biological materials, reanalyze extrant samples, collect new ones, and link the samples to medical records. The significant issue of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers.

Keywords: Institutional Review Boards, IRB, IRBs, Biobanks, medical records, consent, privacy, confidentiality, biological specimens, research

JEL Classification: K31, K32