Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices.
Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.
White
Mary Terrell
MT
Department of Community Health, Wright State University School of Medicine, P.O. Box 927, Dayton, OH 45401-0927, USA. mary.t.white@wright.edu
Gamm
Jennifer
J
D035843:Biomedical Research; D001800:Blood Specimen Collection; D032962:Consent Forms / Q000592:standards; D003625:Data Collection; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000592:standards*; D005069:Evaluation Studies as Topic; D036281:Genetic Research; D019983:Guideline Adherence; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D014019:Tissue Donors