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

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

Co

SUBMITTER: Beskow LM 

PROVIDER: S-EPMC4336635 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature