December 16, 2015
The National Institutes of Health has published a Request for Information (RFI) to gather input on best practices for administering physical evaluations and collecting biological samples (called biospecimens) for direct volunteers of the Precision Medicine Initiative (PMI) Cohort Program. Physical evaluations will involve measuring vital signs, height, weight, and possibly other physical measurements. Additionally, the PMI Cohort Program plans to collect blood, urine, and possibly other biospecimens.
In addition to strategic approaches to creating an infrastructure for these collections, the RFI calls for information on distributing standardized biospecimen collection kits to healthcare workers who will be conducting the baseline health examinations on direct volunteers; handling and processing samples in a manner consistent with Clinical Laboratory Improvement Amendments (CLIA)(link is external) before the data is analyzed and assuring biospecimen quality and integrity after collection; developing a standardized procedure that would ensure quality control of the biospecimens as they are handled, shipped, archived and analyzed; and providing cost estimations for these services.
The deadline for response is January 15, 2016.