Overview: IRBshare  IRBchoice Todd Rice, MD, MSc Associate Professor | VU HRPP Medical Director Vanderbilt University Medical Center December 11, 2015

What is IRBchoice? IRBshare 2.0 IRBshare+

What’s the same?! Single IRB review of multisite studies + maintain study oversight (“shared review”) One-time master reliance agreement A national network of collaborators Transparent IRB approvals to support best practices, shared expertise, and increased consistency

What’s new?! Single IRB review of multisite studies + transfer study oversight (“ceded review”) Flexible reliance preferences on a study-by-study basis Institutional profiles to identify collaborators + establish reliance terms One platform to document and track all reliance relationships Study-specific instructions for research teams to help maintain compliance

WHY? Multiple types of reliance are used | One size doesn’t fit all! Match studies with the appropriate type of reliance based on The institution The study The investigator involved Need a method for tracking different reliance agreements NHLBI-funded R01 to expand IRBshare + better understand the use of reliance to inform policy

Eligibility Any US based institution (public, private; hospital, academic medical center, clinic ) with a Federalwide Assurance with the Department of Health and Human Services. AAHRPP accreditation is not required Institutions do not have to have an IRB to join IRB required to be the Lead of any study IRB required to use the Shared Review Process

Institutional Profiles Your HRPP FWA, accreditation, expertise and specialties Your Local Context State laws + local policies Your Reliance Preferences Shared Review Ceded Review Willingness to serve as the Lead IRB Preference for handling HIPAA determinations and reporting and auditing responsibilities when serving as the Lead IRB

Institutional Profiles Your submission preferences when serving as the RELYING IRB Initial submission Documentation for ancillary reviews Adverse event reporting Required ongoing approval documentation, if any

Customized Action Plan when Ceding Review Lead IRB Review 45 CFR 46.111 Adverse events Conflict of interest Local context Reports to OHRP / FDA HIPAA determinations Audits Radiation Safety Biosafety Billing/ Qualify Clinical Trial Local Review

Customized Action Plan PROCESS Lead IRB states preference Relying IRB can accept or request change Lead IRB makes final decision Negotiable Pieces of Reliance Options Will you make HIPAA determinations? Yes | No Preference for providing IRB meeting minutes/summaries (redacted) Upon request | Routinely Preferred method for filing the following with OHRP/FDA (listed as separate questions on Institutional Profile): unanticipated problems reports serious or continuing noncompliance suspension/termination for cause reports File report on behalf of Relying Institution Work jointly with the Relying Institution on the report Allow Relying IRB to independently file report after review and comment Allow relying sites to review and comment on 1. unanticipated problem reports or 2. serious or continuing noncompliance? Y  how many days? N Timeline for filing suspension/termination for cause reports Allow institution to provide comment File immediately Preferred method for conducting the following at Relying Sites: Routine audits For-cause audits The local site would conduct the audit My IRB Work with the local site to share audit responsibilities. Hire an independent entity to conduct the audit

Investigator Responsibilities and Instructions Sheet What: General Investigator Responsibilities when conducting human research Responsibilities to the Lead IRB Shared—none Ceded—any responsibilities that the IRB of Record wants to make the investigator aware of related to submission of ongoing communications to the IRB of record Responsibilities to the Local Site Any responsibilities that the local IRB wants to make the investigator aware of related to submission and reporting to the local institution How: Automatically generated by the system! Insert instructions into your institutional profile when Relying Lead IRB indicates instructions for the specific study

System Changes: Better Usability Getting started tab More instructions re: next steps Separate tabs for Lead IRB and Relying IRB tabs + documents

System Changes: Data Collection Indicate model offered by the Lead site Indicate model selected by Relying site (based on what’s offered by Lead) Indicate why model selected (Lead + Relying sites)

Multiple Ways to Initiate Use Same Process: IRB uploads approval study Contact another IRB *New Process*: Investigator registers study on IRBchoice website (no login required)

Timeline + Logistics Agreement released Transition Period ends January 15, 2016, full shift to IRBchoice.org New website and resources available: https://www.irbchoice.org/p/

Contact Emily for more information + watch for emails Coming in 2016 An extra day! It’s leap year! Monday, February 29! 30-minute individual site check-ins with Emily + Jenni Beadles Establishing volunteer member/liaison workgroups Guidance Workgroup For IRBs using a single IRB via IRBchoice (communication, best practices, tips, shared resources) For investigators using IRBchoice System features Future directions Improving usability Expanding the network (how to reach new institutions) How to reach new institutions Contact Emily for more information + watch for emails