1. Describe the National Institutes of Health (NIH) Office of Human Subjects Research Protections (OHSRP) support of the NIH Institutional Review Board (IRB).  

1. This policy applies to OHSRP, which includes the OHSRP Office of IRB Operations (IRBO) and OHSRP staff. 

OHSRP has developed a comprehensive glossary of definitions that describe the terms listed below.  The glossary can be found at the following link:  NIH IRP HRPP Policy Glossary.

Note: There may be more than one definition per term, so please review terms carefully to make sure they match the terms listed below. Qualified terms are indicated with a parenthetical qualification. When reviewing a definition, be sure that you are reviewing the appropriate definition that links to this policy. To further assist the reader, each term in the glossary cites the relevant policy number(s) indicating where the term is utilized.   

1. NIH Investigator

1. Requirements for support of IRB operations
   1. All review of exempt and non-exempt human subjects research by IRBO and/or the NIH IRB must be conducted in accordance with federal regulations and policies. (See Policy 3014-205 Requirements for IRB Submissions.) Accordingly, IRBO will:
      1. Promote the protection of the rights, safety and welfare of subjects participating in research activities at the NIH by advising and providing guidance to NIH investigators and the NIH IRB based on federal regulations and policies.
      2. Provide administrative support to the NIH IRB and serve as the primary liaison between the IRB and NIH investigators (e.g., send reminders to investigators and notify investigators about IRB determinations.) (See e.g., Policy 3014-204 Levels of IRB Review and Criteria for IRB Approval of Research.)
      3. Promote the efficiency of the NIH IRB and its effective review of research by conducting pre-review of IRB submissions to verify that they meet regulatory and policy requirements and are complete before assigning them to the IRB agenda. (See Policy 3014-205 Requirements for IRB Submissions and Policy 3014-106 Ancillary Reviews.)
      4. Comply with HRPP training requirements as specified in Policy 3014-103 Education Program.
      5. Manage IRB meetings (e.g. establish meeting schedules, set submission deadlines, provide meeting space when necessary, communications, and take minutes).
      6. Support IRB members (e.g., by creating and sending meeting agendas, scheduling IRB members and consultants as applicable, and tracking attendance and quorum at IRB meetings).
      7. Manage Informed Consent Documents for use by investigators.
      8. Manage IRB records (e.g., IRB meeting minutes, IRB meeting agendas, IRB submissions and agreements), consistent with the requirements of Policy 3014-206 Maintenance of Records.
      9. Maintain the IRB roster and composition, consistent with the requirements in Policy 3014-201 IRB Membership and Composition.
      10. Provide information and reports, upon request and as appropriate, to:
          1. Other NIH offices (e.g., to the NIH Office of Protocol Services and NIH or IC leadership); and
          2. Relying institutions, as consistent with the terms of the reliance agreement.
      11. Track IRB membership conflict of interests consistent with the requirements in Policy 3014-202 Board Member Financial Conflict of Interest.
      12. Support and participate in accreditation activities as directed.

NIH Policy

Policy 3014-103 Education Program 

Policy 3014-106 Ancillary Reviews 

Policy 3014-201 IRB Membership and Composition 

Policy 3014-202 Board Member Financial Conflicts of Interest 

Policy 3014-204 Levels of IRB Review and Criteria for IRB Approval of Research 

Policy 3014-205 Requirements for IRB Submissions 

Policy 3014-206 Maintenance of Records