• IRB: ETHICS & HUMAN RESEARCH

Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders

The use of biospecimens from biobanks raises a unique set of issues for researchers and institutional review boards (IRBs) that can complicate human subjects protections and may hinder the development of policies to promote and govern the use of biospecimens for health-related research. In this article, we present qualitative results of interviews with key leaders at a number of IRBs at institutions in the Clinical Translational Science Awards consortium about their policies and procedures for biospecimen use and data sharing, how they were developed, and how they are revised. It is important to understand attitudes and perspectives of these key IRB leaders to develop ethically sound and practical policies and practices. The results indicate that more detailed guidance at the federal level on specific issues (e.g., expectations regarding review of original consent forms) may be needed to assist IRBs as they attempt to address issues raised by biobanking and to develop more consistent policies, guidance, and practices across institutions.

Rothwell E, Maschke KJ, Botkin JR, Goldenberg A, Murray TH, Rivera SM. Biobanking research and human subjects protections: Perspectives of IRB leaders. IRB: Ethics & Human Subject Research 2015;37(2):8-13.