A year after President Barack Obama announced the Precision Medicine Initiative (PMI) in his State of the Union address, the National Institutes of Health (NIH) has established a central institutional review board (IRB) for the PMI Cohort Program.
The PMI is dedicated to developing treatments for cancer and other diseases and conditions that are specific to a patient’s genetics, environment, and lifestyle to improve survival rates and lower the risk of adverse effects. The goal of the Cohort Program is to enroll 1 million or more participants across the United States in a database of electronic health records (EHRs) and biospecimens in order to better research precision medicine to both treat and prevent diseases and chronic conditions. Subjects who consent to the study will also agree to be re-contacted throughout the life of the multi-year study as research progresses.
The NIH-established IRB will serve as the IRB of record for the study, and will work out reliance agreements with local IRBs across the country. Vanderbilt University will run the pilot program for enrolling the first subjects. NIH’s goal is to have 79,000 subjects enrolled by the end of this year, and to reach 1 million by the end of 2019.
Look for more coverage of the PMI Cohort Program in an upcoming issue of IRB Advisor.