IRB Harmonization 2016 Review IRB harmonization can be defined as activities aimed at reducing regulatory and administration burdens through the implementation of various policies and procedures of integrated IRB review among institutions that frequently conduct multi-institutional studies, including community engaged research schools of medicine 3 three colleges of pharmacy 6 graduate programs 1 school of veterinary medicine. RTRN institutions are located primarily in urban centers in Alabama, California, Florida, Georgia, Hawaii, Louisiana, Mississippi, New York, Tennessee, Texas, the Commonwealth of Puerto Rico, and the District of Columbia. The RTRN and its Data and Technology Coordinating Center in Jackson, Mississippi, provides tools and support for joint projects with basic, clinical, and translational emphasis upon major diseases that disproportionately affect minority and underserved populations. The network also offers education and training, assistance with research design and implementation, data management, and competitive pilot funding An IRB Harmonization Working Group was established in December 2009 to identify strategies to address the complexity of multiple IRB review across the RTRN consortium. June 2, 2016 – 3PM EST

IRB Harmonization Primary Call Topics Summary Ensure awareness of the IRB Harmonization agreement and process Update the IRB Director’s Contact List Determine whether the IRB Harmonization SOP needs to be updated Notice of renewal date

Harmonization Agreement Benefits Reduce variability Reduce delays and duplication of effort Allow national-level discussion of difficult ethical issues First phase involved obtain ing a Memorandum of Understanding (MOU) among all 18 institutions as the appropriate tool for fostering inter-institutional IRB reliance. Hammatt ZE, et al. J Health Care Poor Underserved 2011; 22(4Suppl): 8-15

IRB Harmonization Initiative 2015 - All 18 RCMI institutions signed the IRB Authorization Agreement 2015 - Dr. Stephen Sodeke (Chair, Ethics and Regulatory Subcommittee) and Dr. Charlotte Owens (Associate Director, RCC Implementation) disseminated documents to IRB directors RTRN Standard Operating Procedure (SOP) Reliance Document Guidance to the Investigators The IRB AA expires June 30, 2017

Initial Report IRB harmonization for national networks dedicated to reducing health disparities in diverse underserved populations 2. An effort that engaged community partners

IRB Harmonization Document • Type of IRB review (full reciprocity, facilitated, deferral, single study, single investigator, consortium, etc.) • Type of studies to be reviewed (full-board and expedited) • Decision tree regarding designation of reviewing/relying IRB • Definitions of reviewing/relying IRB and PI responsibilities • Exclusions Phase One nvolved the following steps: • revision of Federalwide Assurance to reflect each institution’s potential reliance upon other institutions’ IRB review; • development of a Ceded Review form to enable RTRN investigators to initiate the process of ceded review electronically via the RTRN website; • maintaining a portal on the RTRN website for IRB notification and administration; • aligning policies and procedures to promote consistent implementation; and • establishing a central repository for tracking IRB reliance and RTRN collaboration through the Data and Technology Coordinating Center. Uniform consent form

Decision Tree - SOP

IRB Reliance Form Human Subject Research – The definition of human subject research is set forth in 45CFR §46.102(f) and 21CFR §50.3(g), §103(e), §312.3(b) and §812.3(p). Institutional Official – The Institutional Official (IO) is the Signatory Official on the Federal Wide Assurance (FWA) filed with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) to assure compliance with regulations governing protection of human subjects. Lead Principal Investigator (PI) – In this SOP, the Lead PI is the investigator who is responsible for submitting all applicable IRB documents and reports to the Reviewing IRB. Relying Principal Investigator (PI) – In this SOP, the Relying PI is the investigator who is collaborating with investigators from other RTRN institutions and is requesting that their institution’s IRB rely on the review and approval of the Reviewing IRB. Reviewing IRB (IRB of Record) – Reviewing IRB has oversight of research conducted at all collaborating sites Relying IRB – IRB has ceded review to another IRB for joint studies. Full reliance – The model in which the Reviewing IRB will take full responsibility for the review and oversight of the research conducted at all collaborating institutions. The Reviewing IRB will be the IRB of Record and the Relying IRB agrees to accept all terms of the Reviewing IRB. No reliance – Circumstances in which the IRB may not want to rely on another IRB for review due to institutional policies or other reasons. A single review can still be conducted amongst the remaining IRBs.

RTRN Data Sharing Policy June 16, 2015