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The National Institutes of Health (NIH) established the Human Research Protections Program (HRPP) to protect the rights and safeguard the welfare of human subjects who participate in the NIH Intramural Research Program (IRP). The NIH IRP HRPP is made of NIH officials, 27 NIH Institutes and Centers, 12 Institutional Review Boards (IRBs), and researchers and staff who conduct and support research involving human subjects.

The HRPP is divided into three arms: Governance, Regulatory Compliance, and Protocol Development.

  1. Governance Arm – The governance arm oversees the NIH HRPP and consists of the:
    • The Deputy Director Intramural Research (DDIR) – the NIH Institutional official responsible for the NIH HRPP and, through written authority from the Director, NIH, is the signatory for the Federal Wide Assurance, filed with Office of Human Research Protections (OHRP), and is responsible for oversight of human subjects research at the NIH.
    • The Deputy Director for Intramural Clinical Research (DDICR) – oversees the IRP clinical research program and is delegated responsibilities for overseeing the administration of the NIH HRPP. The DDICR chairs the Intramural Clinical Research Steering Committee (ICRSC).
    • Advisory Committees: serve in an advisory capacity to the Governance Arm of the HRPP and include the Medical Executive Committee (MEC); the Human Subjects Research Advisory Committee (HSRAC); the IRB Professional Administrators Committee (IPAC); the Intramural Clinical Research Steering Committee (ICRSC); and the Intramural Working Group (IWG). The Scientific Directors, Institute/Center Directors, and the Clinical Center Director also serve the Governance Arm of the HRPP in an advisory capacity.
  2. Regulatory Compliance Arm – The regulatory compliance arm carries out the day-to-day operation of the HRPP as well as reviewing research. The regulatory compliance arm consists of the:
    • NIH Office of Human Subjects Research Protections (OHSRP) – the OHSR reports directly to the DDIR (the governance arm). This office is responsible for assisting IRP researchers, research staff, IRBs and others understand and comply with the ethical guidelines, regulatory requirements and NIH policy and procedures for research involving human subjects.
    • The Director, OHSRP – reports to the DDIR and, through written delegated authority from the DDIR, the OHSRP Director coordinates and oversees the NIH HRPP day-to-day operations. The OHSRP Director is the designated Human Protections Administrator (HPA) for the NIH Federal Wide Assurance (FWA).
    • Institutional Review Boards (IRBs) – The NIH IRBs review and approve all research involving human subjects conducted in the IRP (unless the research is exempt from IRB review, pursuant to 45 CRF46.101 (b)) in accordance with the regulatory mandates to protect subjects’ rights and safeguard their welfare. The NIH IRP maintains 12 IRBs, in part because the NIH Institutes and Centers are administratively separate organizations with discrete missions and research portfolios. However, all IRBs report to the NIH and follow the requirements of NIH’s FWA, the HRPP Policies, the NIH Standard Operating Procedures for IRBs, and the Clinical Center Medical Administrative Series Policies (“MAS Policies”). Each IRB has a Chair and Administrative Staff. The 12 NIH IRBs are:
      • Addictions IRB
      • Combined Neurosciences Blue Panel
      • Combined Neurosciences Purple Panel
      • Combined Neurosciences White Panel
      • National Cancer Institute
      • National Cancer Institute Special Studies
      • National Institute of Allergy and Infectious Diseases
      • National Institute of Child Health and Human Development
      • National Institutes of Diabetes and Digestive and Kidney Diseases and National Institute of Arthritis & Musculoskeletal Diseases
      • National Institute of Environmental Health Sciences
      • National Human Genome Research Institute
      • National Heart, Lung and Blood Institute

The Clinical Center, National Institute of Nursing Research (NINR), National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the National Center for Complementary and Alternative Medicine (NCCAM) may rely on any NIH IRB listed above, depending on the nature of the protocol and the expertise needed for its review.

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