Three experimental consent templates were developed by a review of the informed consent literature and were refined with input from an interdisciplinary panel of experts at BCM and focus group research conducted by two of the authors (AM, AG).11 The experimental consent templates were adapted for each genomic study. All of the consent documents contained specific information about the respective genomic study, including purpose, risks, benefits, compensation, and access to health records. Data sharing was explained in each consent document (see Supplemental Digital Content 1, which contains excerpted text from each consent type on data sharing). Participants were told that personally identifying information (e.g., their name) would never be released. Risks of data sharing were described as small potential breaches in privacy if DNA were traced back to the individual. Participants were cautioned that these risks could increase in the future. It was noted that a researcher’s obligation to protect privacy and confidentiality in restricted databases offers participants an extra layer of protection. Benefits of data sharing were characterized as aiding in the advancement of medical research by speeding up research and allowing other investigators to utilize the data to answer future research questions.
