May 19 2017 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 ID: 633807
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IRB Open House:Implementation of Single IRB Review
May 19, 2017Slide2
TopicsDrivers for Centralized IRB ReviewRegulatory changes Trial Innovation NetworkHow JHM IRB will address the Single IRB requirements Key DecisionsWhen JHM is serving as the IRB of RecordWhen JHM is Relying on an External IRB2Slide3
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 researchOriginal implementation deadline: May 25, 2017Extended to: September 25, 2017What 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 sIRB 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 letterFAQs: http://osp.od.nih.gov/sites/default/files/sIRB_Extramural_FAQs.pdf
Scenarios for Costs: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html Slide4
Common Rule Final rule: Published January 19, 2017 Effective Date: January 19, 2018 [For most provisions]Common Rule extends Single IRB review requirement to all “cooperative research” [Research involving one or more institutions]Implementation date: January 20, 2020Allows 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]4Slide5
Trial Innovation NetworkInitiative 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 UtahDuke University/Vanderbilt University Johns Hopkins University School of Medicine/Tufts University Recruitment Innovation Center [RIC]: Vanderbilt University Trial Assignment through the NetworkCIRB Development Development of SOPsDevelop systems to support the activities of the CIRBDevelop plans to monitor the IRB approval process and develop metrics to evaluate CIRB successWork with other TICs to develop innovative strategies for operationalizing
CIRB review. Activity of the TICs will be support by a platform hosted by VanderbiltSlide6
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 signatoriesJohns Hopkins Medicine IRB signed on in October 2016Key Facts:Eliminates the need for study-specific reliance agreement negotiationsInstitutions 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
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Progress to Date: Key Decisions3 IRBs; 3 electronic systemsWhere 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.7Slide8
Progress to Date: Key DecisionsFor 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.]8Slide9
Progress to Date: Key Decisions for JHU (technical) Studies where JHU is involved will be entered into our eIRB2 systemQuestions and workflow remain specific to JHUWill need to build integration to Huron IRB Exchange and adapt eIRB2Studies where JHU is not involved AND JHU is the SIRB will be entered into our new SIRB systemFederated Authentication to enable non-JH affiliates to access system using their own credentialsStay on upgrade path - limit customizationsFamiliar questions and workflowSupported integration with Huron IRB Exchange9Slide10
Where Are We Now? When JHU Will Serve as the Single IRB DevelopedReliance Request SurveyTemplate text for grant applicationsTemplate letters of supportSite-specific information sheet Internal workflows for IRB staff processing reliance requests External workflows for investigators FWA information sheet Addendum for SMART IRB agreementIn Progress
New e-SIRB system accessible to external users [Sep 2017]Fee structure/budget calculator Educational tools for relying organizationsMonitoring strategy Tools to facilitate CIRB review [e.g. consent builder tool]10Slide11
Where Are We Now? When JHU Will Rely on an External IRB DevelopedReliance Request SurveyTemplate letters of supportDocument outlining required consent language when relyingInternal workflows for IRB staff processing reliance requests External workflows for investigators Dedicated team of expedited local context reviewers with referral to convened IRB, when necessaryPI assurance document In ProgressRefined local application for reliance requests in eIRB2Outreach to each HRPP component to assess impact and ensure a compliant approach
Enhanced monitoring strategy11Slide12
Questions/DiscussionContact Information:Janelle Maddox-RegisIRB Reliance ManagerJohns Hopkins University School of Medicinejmaddox3@jhmi.edu