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

2. 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

3. 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 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 letter
FAQs:
Scenarios for Costs:

4. 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, 2020
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]

5. 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
CIRB Development
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

6. 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:
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

7. 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.

8. 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.]

9. Progress to Date: Key Decisions for JHU (technical)
Studies where JHU is involved will be entered into our eIRB2 system
Questions and workflow remain specific to JHU
Will need to build integration to Huron IRB Exchange and adapt eIRB2
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

10. 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]

11. 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 eIRB2
Outreach to each HRPP component to assess impact and ensure a compliant approach
Enhanced monitoring strategy

12. Questions/Discussion
Contact Information:
Janelle Maddox-Regis
IRB Reliance Manager
Johns Hopkins University School of Medicine