1. Ceding Review: Using the new SmartIRB Online Reliance System
Scott Meyers, CIP
QA/QI Specialist

2. What is a Reliance Agreement?
Cede review Reciprocal agreement Reliance agreement Cooperative agreement IRB authorization agreement (IAA) Single IRB (sIRB)

3. What is a Reliance Agreement?
Formal, (written) document between multiple institutions
Master reliance agreement
Mechanism for an institution engaged in research to delegate institutional review board (IRB) review/oversight to an IRB of another institution.
When multiple institutions are engaged in the same
non-exempt, human subjects research

4. When is a Reliance Agreement Used?
When human subjects research is conducted at multiple sites
Reducing administrative burden and duplicative efforts
NIH single IRB requirement
When an institution is engaged in human subjects research through funding or an investigator’s role in the study
When an engaged institution does not have its own IRB
When a study involves special populations (e.g. prisoners), or when a trial requires specialized IRB expertise
*Reliance agreements apply not only to new protocols, but can also be used to add a new site or new staff to an existing protocol

5. NIH single IRB Policy
6/21/2016 – NIH issued its Final Policy on the Use of a Single IRB for Multi-Site Research:
“…establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single IRB to conduct ethical review required by the DHHS regulations…”
Why? Streamline IRB review process; remove redundancies; allow research to proceed efficiently; reduce unnecessary admin. burden

6. Excludes: career development, research training or fellowship awards
Applicability
NIH funded (e.g., grant, cooperative agt., contract, or NIH intramural Research Program)
Excludes: career development, research training or fellowship awards
Involves multiple sites (“participating sites”)
Domestic
Implementing “same” protocol
Exclusions b/c these focus on providing training/career development opportunities
Applies to sites regardless of whether they are subawards/primary awardee or separate awards made to sites
multisite = 2 or more sites domestic sites
Same research protocol = address same research question, involve the same methodologies, evaluate the same outcomes. Additionally, sites that are accruing research participants for studies that are identical except for variations due to local research context would be considered to be conducting the “same research protocol.”

7. Requires compelling justification
Exceptions to Policy
Review prohibited by a federal, tribal, or state law, regulation, or policy
Requires compelling justification
NIH expected to outline process for requests
Policy does not prohibit participating sites from duplicating review (NIH funds may not cover related costs)
Exceptions automatic for (1) research involving Tribal Nation, but should be noted in grant application/proposal/contract; (2) foreign sites.

8. NIH Mandate Effective Date
Updated in the Federal Register on 12/16/2016
Extended effective date
Competing grant applications (new, renewal, revision, or resubmission) with receipt dates of 1/25/2018 or later;
Ongoing, non-competing awards not expected to comply until grantee submits a competing renewal application
Guidance from NIH now available:
research-policy/models-irb-review

9. Serving as The Reviewing IRB
Aka Institution/IRB of Record, sIRB, etc.
No specific criteria, but appropriate when
HMS/HSDM/HSPH engaged in non-exempt human research
E.g., HMS/HSDM/HSPH in direct receipt of HHS funding; Harvard LMA School agents involved in interventions/interactions with participants, obtain informed consent, and/or access identifiable data
Domestic institutions only

10. HLMA IRB Requirements to rely on another IRB:
Designated IRB must hold a valid FWA AND one of the following:
The IRB has been designated as the single IRB (“sIRB”) as per the NIH Policy.
Institution is a joinder of the SmartIRB Online Reliance System
Institution is AAHRPP accredited
The Harvard Investigator(s) is a collaborator and human research primarily conducted at another organization (Harvard investigators are not interacting/intervening with participants)
Harvard LMA School engaged solely because it’s receiving federal funds

11. ESTR submission for ceded studies
ESTR record is necessary when Harvard is ceding IRB review
In ESTR select “Create New Study”, as normal
On the first page of the SmartForm (Basic Information Page) select “Yes” for number 7 to indicate that an external IRB will be responsible for the review of the study
Complete the SmartForm
You will be asked to upload either Harvard’s Cede Review Form (downloadable from ESTR) or a PDF of the SmartIRB application, if applicable

12. Harvard Catalyst Decommissioning
Schedule:
July 31, 2017 – Last day that NEW cede requests can be CREATED
August 15, 2017 – Last day that Investigators/Study Staff can SUBMIT a request
September 29, 2017 – Last day for institutions to ISSUE reliance determinations
No access as of September 30, 2017

13. SmartIRB Online Reliance system
Features:
279 participating Institutions as of 9/14/2017—constantly growing
Transparent – All parties have access to view status
Piecemeal workflow – PI’s home institution makes first determination of appropriateness of request
Ability to amend existing reliance agreements
Similar reliance application to the Harvard Catalyst application
**Note – Investigators/Study Staff must first request access to the system in order to create a login.

14. Resources
OHRP Engagement Guidance: and-policy/guidance/guidance-on-engagement-of- institutions/index.html SmartIRB Reliance system: Participating Institutions: SOPs and Guidance: ESTR Step-by-Step Guide for Submitting and External IRB Request