IRB practices and policies regarding the secondary research use of biospecimens.

Aaron J Goldenberg,Steven Joffe,Erin Rothwell,Nicole Deming,Jeffrey R Botkin,Suzanne M Rivera,Thomas H Murray,Rebecca Anderson,Karen J Maschke,Beth F Rosenthal

doi:10.1186/s12910-015-0020-1

Abstract

BackgroundAs 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.MethodsThis paper reports on data from a survey of IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens. Specifically, IRB ADs were asked about consent for future use of biospecimens, assignment of risk for studies using biobanked specimens, and sharing of biospecimens/data.ResultsOur data indicate that IRBs take varying approaches to protocol review, risk assessment, and data sharing, especially when specimens are not anonymized.ConclusionUnclear or divergent policies regarding biospecimen research among IRBs may constitute a barrier to advancing genetic studies and to inter-institutional collaboration, given different institutional requirements for human subjects protections.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-015-0020-1) contains supplementary material, which is available to authorized users.

Highlights

As sharing and secondary research use of biospecimens increases, institutional review boards (IRBs) and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking
For Clinical and Translation Science Awards (CTSAs) consisting of multiple institutions represented by numerous IRBs, we surveyed the Administrative Directors (ADs) of the IRB at the institution within that CTSA which received the most National Institutes of Health (NIH) funding (according to the NIH Research Portfolio Online Reporting Tool (RePORT) [11]
Most (57%) of the IRBs represented by the ADs reviewed more than 100 new protocols involving genetic research each year

Summary

Introduction

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. Questions about how to apply human subjects protections to biobanking-related research have challenged institutional review boards (IRBs) [1,2,3,4] These include: what consent approaches are appropriate for collecting, storing, and using research participants’ biospecimens and their associated data; whether and how language in original consent forms should be considered when conducting secondary studies using stored biospecimens; what level of risk (no more than minimal or greater than minimal) should be assigned to studies using stored biospecimens; and what requirements should be imposed for sharing biospecimens with internal and external researchers [4,5,6,7]?

Methods

Results

Discussion

Conclusion