Policy 101 Organizational Structure of the OHSRP OFFICE

Policy 101 - Organizational Structure of the OHSRP OFFICE OF POLICY AND ACCREDITATION

Policy 101 Implementation Release date: 9/14/2020 Effective date: 9/21/2020

Purpose: ◦ Describes the organizational structure of the OHSRP and the function of its offices. Policy 101 – Organizational Structure of the OHSRP Scope: § NIH Institutional Official (IO) § NIH IRB Executive Chair § The staff of the OHSRP and its offices: ◦ The Office of IRB Operations (IRBO) ◦ The office of Compliance and Training (o. C&T) • The office of Policy and Accreditation (o. P&A)

Policy 101 - key points The organizational structure of the NIH Human Research Protection Program (HRPP) underwent major structural changes between 2017 and 2019, based on recommendations of the Advisory Committee to the DDIR. This included consolidation of the NIH IRBs and IRB operations under OHSRP. Policy 101 describes the new structure of the OHSRP and its offices under this new organization. Policy 101 also describes the role and responsibilities of the NIH IRB Executive Chair, which is a new role at the NIH. Policy 101 describes the role and responsibilities of the NIH Institutional Official (IO).

Policy 101 – Functions of OHSRP promotes the rights, safety and welfare of human subjects and promotes the NIH Intramural Research Program’s mandate by: • Reviewing exempt and non-exempt human subjects research activities of the NIH Intramural Research Program (IRP); • Developing NIH HRPP policies and IRB procedures; • Maintaining accreditation of the NIH HRPP • Conducting educational activities for NIH investigators and the NIH IRB; and • Conducting QA/QI of the NIH IRB

Policy 101 – Role of the Institutional Official (IO) The role of the NIH IO is to: • Be the highest organizational official responsible for the NIH HRPP • Serve as the signatory for the NIH IRP’s Federalwide Assurance, ensuring compliance with 45 CFR 46 • Set the tone for an institutional culture of respect for human research subjects by ensuring the standing of the IRB within the institution • Ensure the HRPP, under the auspices of OHSRP, functions effectively • Ensure that the NIH IRP provides sufficient resources and support necessary to ensure the safe and effective conduct of research involving human subjects

Policy 101 – Role of the OHSRP Director The Director of OHSRP works closely with the IO to ensure that resources are adequate to maintain the proper functioning of the NIH HRPP and the functional offices of OHSRP. In addition, the OHSRP Director is delegated by the DDIR to: • Provide coordination and oversight over the day-to-day operations of the HRPP and OHSRP • Serve as the Human Protections Administrator for the NIH FWA • Sign certain agreements (e. g. reliance agreements)

Policy 101 – Role of the NIH IRB Executive Chair The NIH IRB Executive Chair is responsible for overseeing the NIH IRB including: • The NIH IRB Chairs • Educating IRB Members and IRBO staff • Selecting IRB Members and Chairs • Evaluation of IRB members and Chairs • Evaluating the composition of the IRB • Providing consultation to IRB members and IRBO staff on approvability of research and IRB or exempt determinations • Delegating authority to expedited reviewers to approve research

Policy 101 – The Office of IRB Operations (IRBO) The IRBO is responsible for: • Managing and supporting the efficient and effective regulatory oversight of the NIH IRB. • Interfacing with other divisions of the NIH IRP that are responsible for the review and approval of research (e. g. , Ancillary Reviews). • Preparing the minutes of the NIH IRB • Providing pre-review of IRB submission • Providing guidance to research teams regarding IRB submissions and stipulations • When delegated as IRB members, making expedited or exempt determinations

Policy 101 – The office of Compliance and Training The OHSRP office responsible for: • Review and management of reportable events that occur during the conduct of IRP human subjects research activities. • Providing education and training related to human subjects protections policies and procedures • Conducting noncompliance investigations • Conducting Quality Assurance/Quality Improvement reviews of NIH IRB activities

Policy 101 – The office of Policy and Accreditation The OHSRP office responsible for: • Writing Human Research Protection Program (HRPP) policies • Managing accreditation activities for the NIH HRPP

Resources Policy 101 and associated change table and guidance is posted on the IRBO website Questions? Contact IRB@od. nih. gov