April 20, 2015
On April 20, 2015, the NIH published a Notice seeking the public’s input to inform the development of a strategic vision for building a national participant group (called a cohort) of 1 million or more American volunteers to take part in research (see NOT-OD-15-096). As part of the President’s proposed Precision Medicine Initiative, data collected from the cohort will serve as a research resource for developing and validating new approaches for tailoring diagnostic, prevention, and treatment strategies based on individual differences and incorporate them into clinical practice to improve health. Cohort participants will be asked to provide biological specimens, as well as behavioral and environmental data, all linked to their electronic health records (EHRs). The goal is to set the foundation for a new way of doing research that fosters open, responsible data sharing with the highest regard to patient privacy, and that puts engaged participants at the center. Qualified researchers from many organizations will, with appropriate protections of participant confidentiality, have access to the cohort’s de-identified data for research analysis.
NIH requests public input on the characteristics, purpose and overall aspects in the development and implementation of the national research cohort, as well as information about existing and potentially new research entities that might be combined to form the cohort. Responses to this RFI are entirely voluntary, and responders are encouraged to address any of the categories listed in the RFI. Responses will be compiled and may be shared publicly. All responses must be submitted online by May 7, 2015.