From Duke: Informed consent for biobanking

Genet Med. 2014 Aug 21. doi: 10.1038/gim.2014.102. [Epub ahead of print]

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

Beskow LM1, Dombeck CB2, Thompson CP2, Watson-Ormond JK2, Weinfurt KP3.

Author information

• 11] Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA [2] Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
• 2Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
• 31] Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA [2] Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina, USA.

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, ethicsand 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.