IRB Open House Implementation of Single IRB Review

IRB Open House: Implementation of Single IRB Review May 19, 2017 1

Topics • Drivers for Centralized IRB Review – Regulatory changes – Trial Innovation Network • How JHM IRB will address the Single IRB requirements – Key Decisions – When JHM is serving as the IRB of Record – When JHM is Relying on an External IRB 2

NIH Policy Use of a Single IRB for Multi-site Research June 21, 2016: NIH published a new final policy that requires single IRB review for multi-site NIH-funded research – Original implementation deadline: May 25, 2017 – Extended to: September 25, 2017 What types of studies does this policy apply to? – U. S. NIH-funded multi-site studies that involve non-exempt research – It does not apply to sites outside of the U. S. How will it work? – Study teams must include their plan for single IRB review at the time of application (including communication plans, identification of the IRB of record, and confirmation from all sites that they will comply with the NIH policy on s. IRB review) – If awarded, NIH approval of the proposal for single IRB use will appear as a term and condition in the Notice of Award or Contract Award letter FAQs: http: //osp. od. nih. gov/sites/default/files/s. IRB_Extramural_FAQs. pdf Scenarios for Costs: https: //grants. nih. gov/grants/guide/notice-files/NOT-OD-16 -109. html

Common Rule Final rule: Published January 19, 2017 – Effective Date: January 19, 2018 [For most provisions] v Common Rule extends Single IRB review requirement to all “cooperative research” [Research involving one or more institutions] v Implementation date: January 20, 2020 v Allows for enforcement action against external IRBs [previously issues of noncompliance were addressed with the organization that relied] Commentary about the Final Rule suggests that the FDA may revise its applicable regulations for human subjects protections to align with Common Rule changes [including provisions for single IRB review] 4

Trial Innovation Network • • Initiative launched by NCATS to leverage the resources of the CTSAs and help accelerate clinical trials Three Trial Innovation Centers [TICs] each with their own central IRB [CIRB]: – University of Utah – Duke University/Vanderbilt University – Johns Hopkins University School of Medicine/Tufts University Recruitment Innovation Center [RIC]: Vanderbilt University Trial Assignment through the Network v v CIRB Development of SOPs Develop systems to support the activities of the CIRB Develop plans to monitor the IRB approval process and develop metrics to evaluate CIRB success Work with other TICs to develop innovative strategies for operationalizing CIRB review. Activity of the TICs will be support by a platform hosted by Vanderbilt

SMART IRB Reliance Agreement • In anticipation of the release of the NIH policy, the National Center for Advancing Translational Sciences [NCATS] funded a multi-institutional collaborative initiative to develop a national IRB reliance agreement [SMART IRB] – As of September 2016, this agreement is now available: https: //smartirb. org/ – FWA-holding Institutions sign on to use the agreement through a joinder process. – Once you are a signatory to SMART, you may use SMART as your reliance agreement for any specific study that also involves institutions that are SMART signatories – Johns Hopkins Medicine IRB signed on in October 2016 Key Facts: • • Eliminates the need for study-specific reliance agreement negotiations Institutions may have “addendums” to cover items not specified in the agreement such as indemnification – The JHM IRB will have an addendum All TIC studies will use the SMART IRB reliance agreement as their base Where possible and appropriate JHM will use the SMART agreement to cover other CIRB activities 203 signatories 64 CTSA Hubs

Progress to Date: Key Decisions • 3 IRBs; 3 electronic systems – Where JHU single IRB services are needed, only JHM IRB will serve as the single IRB. • Investigators may not indicate [in a grant application] that JHU is willing to rely on an external IRB or JHM IRB is willing to serve as the IRB of Record without first securing a letter of support from the appropriate IRB. 7

Progress to Date: Key Decisions • For all NIH-funded research and where possible for non. NIH funded research, the SMART IRB Reliance Agreement will be used as the basis for Reliance. • Where the SMART IRB Reliance Agreement cannot be used, standardized templates have been developed for cross-institutional use that cover varied scenarios [other academic site, community practice, company. etc. ] 8

Progress to Date: Key Decisions for JHU (technical) • Studies where JHU is involved will be entered into our e. IRB 2 system – Questions and workflow remain specific to JHU – Will need to build integration to Huron IRB Exchange and adapt e. IRB 2 • Studies where JHU is not involved AND JHU is the SIRB will be entered into our new SIRB system – Federated Authentication to enable non-JH affiliates to access system using their own credentials – Stay on upgrade path - limit customizations – Familiar questions and workflow – Supported integration with Huron IRB Exchange 9

Where Are We Now? When JHU Will Serve as the Single IRB Developed • Reliance Request Survey • Template text for grant applications • Template letters of support • Site-specific information sheet • Internal workflows for IRB staff processing reliance requests • External workflows for investigators • FWA information sheet • Addendum for SMART IRB agreement In Progress • New e-SIRB system accessible to external users [Sep 2017] • Fee structure/budget calculator • Educational tools for relying organizations • Monitoring strategy • Tools to facilitate CIRB review [e. g. consent builder tool] 10

Where Are We Now? When JHU Will Rely on an External IRB Developed • Reliance Request Survey • Template letters of support • Document outlining required consent language when relying • Internal workflows for IRB staff processing reliance requests • External workflows for investigators • Dedicated team of expedited local context reviewers with referral to convened IRB, when necessary • PI assurance document In Progress • Refined local application for reliance requests in e. IRB 2 • Outreach to each HRPP component to assess impact and ensure a compliant approach • Enhanced monitoring strategy 11

Questions/Discussion Contact Information: Janelle Maddox-Regis IRB Reliance Manager Johns Hopkins University School of Medicine jmaddox 3@jhmi. edu