48 CFR 370.301
370.301 Policy.
United States · 48 CFR — Federal Acquisition Regulations System · Status: effective
Cite this
- Citation
- 48 CFR 370.301, 370.301 Policy, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/245295
- Permanent ID
ys:prov:245295@1- SHA-256
207350279ad807f7ad7a01d286073efc5d3add24191f880457a3fbf5233bfee4
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Full text
It is the Department of Health and Human Services (HHS) policy that the contracting officer shall not award a contract involving human subjects until the prospective contractor provides assurance that the activity will undergo initial and continuing review by an appropriate Institutional Review Board (IRB) in accordance with HHS regulations at 45 CFR 46.103. The contracting officer shall require a Federal-wide assurance (FWA), approved by the HHS Office for Human Research Protections (OHRP), of each contractor, subcontractor, or institution engaged in human subjects research in performance of a contract. OHRP administers the assurance covering all HHS-supported or HHS-conducted activities involving human subjects.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.