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

2. What is IRBchoice?
IRBshare 2.0
IRBshare+

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

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

10. 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

11. 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

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

13. 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)

14. 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)

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

16. 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 s