Does the current consent process minimize the risks of genetics research?

Abstract

Completion of the human genome project is expected to lead to an increase in the number of individuals who participate in genetics research. The current informed consent process-developed prior to widespread genetics research-may not be sufficient to minimize the research risks that these individuals face. The current consent process focuses on informing individuals of the risks of research participation prior to their research enrollment. However, the risks of genetics research often are influenced by what subjects disclose to others after their research participation has ended. To assess whether the current consent process helps subjects remember the risks of future disclosures and, thereby, minimize the risks of genetics research, we interviewed 130 individuals who had previously participated in genetics research. Nineteen percent recalled that their samples would undergo genetic testing; 16% recalled that samples might be used for future research; 15% recalled that release of research records could affect their insurance status. These data suggest that current consent practices may not minimize the risks of genetics research. To address this concern, Institutional Review Boards and investigators should consider implementing supplemental mechanisms to help subjects remember when forgetting aspects of their research participation could place them at increased risk.