Ceded Review

[Narkis Eatman]

Giventhe increase in the number of sponsors who now require the use of a single institutional review board (IRB) review, many institutions are now challenged with serving as a single IRB for multisite research or relying on another IRB to review its research. The purpose of this document is to provide points to consider relating to the arrangement that is entered into where an institution cedes IRB review of research conducted at that institution to another IRB. The other IRB could be one at a similar institution (hospital, academic medical center, for-profit or non-profit institution) or an independent institutional review board that reviews, but does not conduct, research. The issues raised in this document are not intended to serve as a decision tool, but rather as a set of points to consider in making the decision whether to serve as a reviewing IRB or a relying institution. IRB administrators, institutional officials and investigators may find the information in this document a helpful resource in establishing and/or implementing this arrangement. As in any relationship, cooperation, collaboration and communication are critical to the success of the arrangement.

The premise of any of these reliance arrangements is that the reviewing institutional review boards will be subject to Federalwide Assurances and will follow the regulatory criteria for IRB review of research. Responsibilities of the relying institution will be based on the agreement and may vary from site to site. Both the reviewing IRBs and relying institutions have the responsibility of keeping track of the different obligations and responsibilities set forth in each IRB authorization agreement.

This document was developed with a focus on multi-site research conducted within the United States. However, many of the considerations for institutions and IRBs engaged in multisite research in the United States are applicable in the international context.

Before you can participate in a study being conducted through an outside IRB of Record, the BMC/BU Medical Campus IRB must first review your INSPIR cede application to (1) verify that you meet all the institutional requirements (such as CITI training); (2) verify that all applicable institutional and departmental electronic sign-offs have been obtained (such as by the Department Chair, Pharmacy, GCRU, etc.); and (3) decide whether it will agree to cede review to the outside IRB of record based on your research activities. If the BMC/BU Medical Campus IRB agrees to cede review, then this will be documented in a reliance agreement with the outside IRB of Record (either by a SMART IRB reliance agreement, or a traditional reliance agreement).

For general guidance on reliance agreements, SMART IRB, and different types of External Investigators, see the October 2019 CR TIMES Feature Article, SMART IRB and You. For a detailed reference list of all available HRPP resources related to ceding review, please click here.

Following are instructions for different types of research studies in which Principal Investigators may wish to cede review to an outside IRB of Record rather than the local BMC/BU Medical Campus IRB. Identify the type of research study from the list below, then prepare the INSPIR cede application, following any special variations to the cede application for your type of study.

These are basic instructions for participating in a study being conducted by an outside institution or IRB of Record; however, note the special instructions to the application below for multi-center industry-sponsored studies involving an investigational drug (IND) or investigational device (IDE); or NIH federally-funded studies requiring a Single IRB; or studies initiated by special consortium groups with a central institutional review board. For questions, send an email to med...@bu.edu.

Ceded research means the research is deferred to an external IRB (institutional review board) for oversight. Many research studies require single IRB review. Ceding oversight allows review by one IRB.

Ceded research requires specific standard operating procedures (SOPs) and forms. The guidance and forms below will help you determine whether your study will use an external IRB. They will also assist you in providing the external IRB with the information it needs to make a decision about your research proposal.

Investigators engaged in multi-site research can request a cede, or reliance, agreement when multiple Institutional Review Boards (IRB) are required. The term cede review refers to a reliance in which two or more institutions agree one institution will be designated as the Reviewing Institution/IRB for the study while the other institution(s) serve as the Relying Institution/IRB. The reviewing IRB would serve as the IRB of Record for the study.

The Reliance Request Process in the Online Reliance System must occur in addition to your submission for review by COUHES. The specific steps and requirements will depend on the reviewing IRB, but this is a general overview.

The USC IRB will agree to rely on an external IRB for IRB review for non-exempt multi-site research. Relying on an external IRB is also called ceding IRB review. Ceding review is the act of transferring IRB review and oversight from the USC IRB to an external IRB. The external IRB becomes the IRB of record (sIRB) that will review research on behalf of one or more institutions.

The submission of the ceded study application will allow the USC IRB to conduct a local context review to confirm that the researchers are qualified to conduct the study at USC and that the study meets all institutional, local, and state requirements. The USC IRB will also determine whether other ancillary reviews are required at USC before the study is conducted (i.e., Clinical Trials Office, Department of Contracts & Grants, Biosafety Committee, Radiation Safety Committee, Conflict of Interest Review Committee, etc.).

NOTE: If LA General Medical Center is a participating site and a letter of indemnification is requested from the reviewing IRB, they should remove the indemnification provision since the Los Angeles County Department of Health Services will not sign the letter.

Participants may not be enrolled into the study until the USC Clinical Trials Office (CTO) or Department of Contracts & Grants (DCG) has provided final cost, payment, and/or injury language for the USC consent form. The USC consent form must be revised to be consistent with the final language, if needed, and reviewed by the USC IRB. The revised USC consent form must then be submitted to the sIRB of record for approval.

NOTE: The investigator cannot conduct study activities until the reliance agreement is fully executed, USC IRB has issued an acknowledgement letter for the ceded study application, and the contract is fully executed.

You must report adverse events, unanticipated problems, protocol deviations, participant complaints, and other reportable events to the Overall PI/Lead Study Team or sIRB according to the sIRB Standard Operating Procedure for reporting.

If any participant complaints, noncompliance, or unanticipated problems occur at USC, you must also report them to the USC IRB. Submit the reportable event in iStar as soon as possible, but no later than 10 working days after you become aware of the event.

NOTE: Failure to report an event may result in the suspension of the study, and reporting to the required agencies, including funding agency, regulatory agencies (i.e., FDA, OHRP), etc.

Single IRB (sIRB) review occurs when research is being conducted at multiple universities/institutions but only a single IRB reviews and approves the research for multiple sites. sIRB review will only be required for new NIH-funded multisite studies submitted to NIH after January 25th, 2018. However, some sponsors/studies may require sIRB review or researchers may request sIRB for other multisite studies. Be advised that sIRB review does not eliminate many of the local administrative requirements for ensuring research compliance.

Ohio State conducts non-exempt human subjects research in cooperation with external institutions and investigators. These collaborations must be documented through reliance agreements. In certain situations, Ohio State may serve as the IRB of record for the collaborating site and/or external investigator, or Ohio State may rely on an external IRB.

An external individual investigator is someone who is not an employee or agent of Ohio State, who is conducting research activities on behalf of Ohio State on an IRB-approved research study, and who is not acting as an employee of any other institution with respect to their involvement in the research being conducted by Ohio State. For researchers meeting this criteria, Ohio State requires the individual to sign an Individual Investigator Agreement (IIA).

Ohio State is a participating institution in SMART IRB, a platform designed to ease common challenges and burdens associated with initiating multi-site research. SMART IRB allows institutions to minimize duplicative IRB reviews while maintaining appropriate oversight and navigating the National Institutes of Health (NIH) Policy on the Use of Single Institutional Review Board for Multi-Site Research and the 2018 Common Rule Cooperative Research Single IRB Mandate.

A ceded review request is an administrative review performed by the Office of Responsible Research Practices (ORRP) when an Ohio State principal investigator (PI) requests that an external IRB review their human subjects study. If Ohio State relies on an external IRB to review and approve research occurring at Ohio State, a reliance agreement is required. ORRP staff will facilitate this agreement once a submission requesting ceded review is received in Buck-IRB.

An investigator working with multiple institutions, each having their own IRB, may decide to have one IRB serve as the IRB of record for some or all participating sites. This practice is commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight. The Northwestern IRB is generally willing to cede oversight (rely) to a qualified IRB or serve as the IRB of Record for external sites.

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