Keith Norris, M.D., Executive VP, Research and Health Affairs Charles Drew University

1. CTSA-NICHD Workshop on Comparing Institutional Review Board (IRB) Models for Multisite Pediatric StudiesApril 23, 2009 Keith Norris, M.D., Executive VP, Research and Health Affairs Charles Drew University

2. Our Reciprocal IRB Agreement Cedars-Sinai Medical Center Charles Drew University of Medicine and Science Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center University of California, Los Angeles Adapted from UCSF

3. Considerations for Reciprocal IRB Agreements • Agree on types of Research Covered • Comply with Office for Human Research Protections’ (OHRP) guidance Terms of the Federalwide Assurance (FWA), March 20, 2002. • Institutional Officials need to agree that the Human Research Protection Programs (HRPP) at his or her institution may accept and/or rely on the review and approval by the HRPP at any institution named in the MOU

4. Lead or Reviewing IRB • Shall be at either the institutional location where subject contact, recruitment, and/or interactions/interventions, shall entirely or substantially take place; or • The institutional location that is the prime recipient of the research award; or • Both the Reviewing and the Relying IRBs agree on a case-by-case basis.

5. Duties and Responsibilities of the Relying Principal Investigator • The PI will submit IRB Application including a completed Notice of Intent to Rely on Another IRB. • Ensure that necessary and required coordination of any research activities occurs between institutions. • Follow IRB standards and guidelines of the reviewing IRB post-approval reporting: • amendments, continuing review reports, adverse events, other safety information, protocol violations or incidents, etc.

6. Initial and continuing reviews, amendments, authority to suspend or terminate the research. • Send a copy of the IRB Approval Letter to the Relying IRB(s). • Any institution’s HRPP may refuse, on a case-by-case basis, to be relied upon as the IRB of record for research involving the other institutions. • The Reviewing HRPP will keep complete records of studies that are subject to the MOU. Duties and Responsibilities of the Reviewing IRB

7. Duties and Responsibilities of the Relying HRPP • Issue an Acknowledgement Letter to the PI • Monitor compliance with the approved of research being conducted at the relying institution. • Advise the reviewing HRPP of any incidents of noncompliance or unanticipated problems of which it becomes aware. • May refuse, on a case-by-case basis, to rely on the review by another HRPP. • Keep records of studies that are subject to this MOU.

8. Duties and Responsibilities of Both the Reviewing and the Relying HRPP(s) • Maintain quality local institutional review committees • Provide protocol and grant comparison • Reporting unanticipated problems, serious and/or continuing noncompliance • Agree to cooperate on all issues

9. Maintain MOU on File • Include each other institution in its FWA on file with OHRP • Indemnification of each other • Insurance: agree to name the other Parties as additional named insureds. • Termination Clause • -agree in any event of termination under this section, cooperate to ensure minimal adverse impact to human subject research and protection of human research subjects. Duties and Responsibilities of Both the Reviewing and the Relying HRPP(s)