Informed consent for biobanking: consensus-based guidelines for adequate comprehension

Laura M Beskow, Carrie B Dombeck, Cole P Thompson, J Kemp Watson-Ormond, Kevin P Weinfurt, Laura M Beskow, Carrie B Dombeck, Cole P Thompson, J Kemp Watson-Ormond, Kevin P Weinfurt

Abstract

Purpose: Federal regulations and best practice guidelines identify categories of information that should be communicated to prospective biobank participants during the informed consent process. However, uncertainty remains about which of this information participants must understand to provide valid consent.

Methods: We conducted a Delphi process to define "adequate comprehension" in the context of biobanking consent. The process involved an iterative series of three online surveys of a diverse panel of 51 experts, including genome scientists, biobank managers, ethics and policy experts, and community and participant representatives. We sought consensus (>70% agreement) concerning what specific details participants should know about 16 biobank consent topics.

Results: Consensus was achieved for 15 of the 16 consent topics. The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act.

Conclusion: Our Delphi process was successful in identifying a concise set of key points that prospective participants must grasp to provide valid consent for biobanking. Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes, as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension.Genet Med 17 3, 226-233.

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