title: IRB practices and policies regarding the secondary research use of biospecimens.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. aaron.goldenberg@case.edu.
authors.forename: Aaron J
authors.initials: AJ
authors.lastname: Goldenberg
authors.affiliation: The Hastings Center and the Centre for Biomedical Ethics, Garrison, New York, USA. maschkek@thehastingscenter.org.
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Maschke
authors.affiliation: Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA. Joffes@upen.edu.
authors.forename: Steven
authors.initials: S
authors.lastname: Joffe
authors.affiliation: Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. jeffrey.botkin@hsc.utah.edu.
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Botkin
authors.affiliation: Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. Erin.Rothwell@nurs.utah.edu.
authors.forename: Erin
authors.initials: E
authors.lastname: Rothwell
authors.affiliation: 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.
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Murray
authors.affiliation: Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA. Rebecca.Anderson@hsc.utah.edu.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Anderson
authors.affiliation: Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. nmd11@case.edu.
authors.forename: Nicole
authors.initials: N
authors.lastname: Deming
authors.affiliation: Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. bsf3@case.edu.
authors.forename: Beth F
authors.initials: BF
authors.lastname: Rosenthal
authors.affiliation: Department of Bioethics, TA212 School of Medicine, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, 44106, USA. smr140@case.edu.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Rivera
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics*; D003219:Confidentiality; D003299:Cooperative Behavior; D028744:Ethics Committees, Research; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D057766:Policy; D012108:Research Personnel; D011795:Surveys and Questionnaires; D014019:Tissue Donors