NOI - External Institutional Review Board (IRB) Services for Multi-Site Studies

The National Heart, Lung, and Blood Institute (NHLBI) is seeking to award a sole source contract for External Institutional Review Board (IRB) services to support ongoing multi-site clinical research studies. The selected contractor will provide IRB services on an as-needed basis, including initial and continuing review of study protocols, review of informed consent forms, and review of reportable events. The contract will be for a period of one year, from June 1, 2026, to May 31, 2027. The contractor must have the ability to serve as the IRB of record for ongoing multi-site FDA-regulated clinical studies and maintain continuity of IRB oversight for active protocols without disruption. • Initial and continuing review of multi-site study protocols • Review of investigators and sub-investigators • Review of informed consent forms (ICFs), including site-specific language • Review of recruitment materials and subject-facing documents • Review of protocol amendments and modifications • Review of reportable events requiring full board review • Site closeout activities • Administrative reviews and changes • Emergency use reviews, as required