IRB practices and policies regarding the secondary research use of biospecimens

BMC Medical Ethics

Suzanne M Rivera⁴  Beth F Rosenthal⁴  Nicole Deming⁴  Rebecca Anderson³  Thomas H Murray¹  Erin Rothwell³  Jeffrey R Botkin³  Steven Joffe²  Karen J Maschke⁵  Aaron J Goldenberg⁴ 

[1] Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore;Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA;Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA;Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland 44106, OH, USA;The Hastings Center and the Centre for Biomedical Ethics, Garrison, New York, USA

关键词: Genetic research;    Data sharing;    Biospecimens;    Biobanks;    Policy;    IRBs;   

Others  :  1207606
DOI  :  10.1186/s12910-015-0020-1

 received in 2014-08-15, accepted in 2015-04-23,  发布年份 2015

【 摘 要 】

Background

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.

Methods

This 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.

Results

Our data indicate that IRBs take varying approaches to protocol review, risk assessment, and data sharing, especially when specimens are not anonymized.

Conclusion

Unclear 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.

【 授权许可】

   
2015 Goldenberg et al.; licensee BioMed Central.

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