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

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

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

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

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

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.”

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.

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: http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical- research-policy/models-irb-review

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

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

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

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

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.

Resources OHRP Engagement Guidance: https://www.hhs.gov/ohrp/regulations- and-policy/guidance/guidance-on-engagement-of- institutions/index.html SmartIRB Reliance system: https://smartirb.org/reliance/ Participating Institutions: https://smartirb.org/participating-institutions/ SOPs and Guidance: https://smartirb.org/resources/ ESTR Step-by-Step Guide for Submitting and External IRB Request https://estrsupport.fss.harvard.edu/ExternalIRB