FDAnews Device Daily Bulletin

Investigators and IRBs are advised to include language in consent forms for clinical trials that involve genetic testing to inform patients about privacy protections under the Genetic Information Nondiscrimination Act. The act, which takes effect between May 22, 2009, and May 21, 2010, prohibits discrimination in health coverage and employment based on an individual’s genetic information, according to an HHS Office for Human Research Protections guidance.
Clinical Trials Advisor