As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.

In July, the Department of Health and Human Services and the Office of Science and Technology Policy published an advance notice of proposed rulemaking proposing sweeping changes to the rules governing oversight of research on human subjects—changes aimed at “better protect[ing] human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.”1 The process is likely to amend not only the core regulation on human-subjects research , but also regulations governing vulnerable subjects, (...) IRB registration requirements, research regulations of the Food and Drug Administration, and the “privacy rule” of the .. (shrink)