Informed Consent for Research on Stored Blood and Tissue Samples: A Survey of Institutional Review Board Practices

Abstract

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.

Informed Consent and Subject Motivation to Participate in a Large, Population-Based Genomics Study: The Marshfield Clinic Personalized Medicine Research Project

“…The Office for Human Research Protections in the US Department of Health and Human Services released guidance for research involving coded private information and biological specimens [10]. High variability between IRBs in regard to review of genetic studies has been demonstrated [11, 12] and draft templates have been proposed to facilitate standardization of written informed consent documents for genetic research and DNA banking [13, 14]. …”

One-time general consent for research on biological samples

“…This profusion of guidance has led to divergent practices,1 2 with one study finding that institutional review boards in the United States recommend “various consent options, all of which are different.”3 Such variation may undermine the scientific value of patients' contributed samples and greatly increase the costs of such research. Assessing whether people's views support one of the recommended options for consent could provide a solution to these problems.…”

Ethical Considerations in Psychiatric Genetics

“…86−89 Institutional review boards may therefore lack consistent methods for evaluating informed consent forms, confidentiality protections, and other protocol elements. 96 Another set of ethical issues concerns whether and how new applications should be introduced clinically. It will require considerable research funding and many years to gather detailed information about the psychosocial and medical outcomes of genetic counseling and testing for specific psychiatric disorders.…”