학술논문
IRB practices and policies regarding the secondary research use of biospecimens.
Document Type
Academic Journal
Author
Goldenberg AJ; Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. aaron.goldenberg@case.edu.; Maschke KJ; The Hastings Center and the Centre for Biomedical Ethics, Garrison, New York, USA. maschkek@thehastingscenter.org.; Joffe S; Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA. Joffes@upen.edu.; Botkin JR; Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. jeffrey.botkin@hsc.utah.edu.; Rothwell E; Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. Erin.Rothwell@nurs.utah.edu.; Murray TH; The Hastings Center and the Centre for Biomedical Ethics, Garrison, New York, USA. thmurray46@gmail.com.; Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. thmurray46@gmail.com.; Anderson R; Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. Rebecca.Anderson@hsc.utah.edu.; Deming N; Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. nmd11@case.edu.; Rosenthal BF; Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. bsf3@case.edu.; Rivera SM; Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. smr140@case.edu.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 101088680 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6939 (Electronic) Linking ISSN: 14726939 NLM ISO Abbreviation: BMC Med Ethics Subsets: MEDLINE
Subject
Language
English
Abstract
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.
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.