Overview of External IRBs

When relying on an external or single IRB (sIRB) of record, it is the Principal Investigator’s responsibility to adhere to policies and procedures of the IRB of record.  In cases when there is an external or centralized IRB utilized, the IRB of Record policies prevail.  However, the Principal Investigator will also be required to continue to follow Stony Brook University’s institutional policies as well as state and local laws governing human subjects’ research.  

Section 17.17 of the Human Subjects Standard Operating Procedures Manual includes information specific to use of an external IRB.

Department of Health and Human Services (DHHS) / Office for Human Research Protections (OHRP)

Website:  http://www.hhs.gov/ohrp/

Regulations: 45 CFR 46.114 – The revised Common Rule’s Cooperative research Provision

Food and Drug Administration (FDA)

Website:  http://www.fda.gov/
Regulations:​ FDA: 21 CFR 56.114 - - Cooperative Research

National Institutes of Health (NIH)
Website: https://www.nih.gov/

In addition to the Common Rule, multi-site human subject research supported by the NIH is subject to the requirement of a single Institutional Review Board (sIRB): NIH sIRB Policy or Multi-Site Research

SBU Documents/Guidance

• SBU Reliance Policy 
• Reliance Request Form
• PI Responsibilities 
• Local Context Information

Common Terms

Authorization Agreement - a written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities. This agreement may also be referred to as a reliance agreement or cede review agreement.

Cede review - the act of transferring IRB review and oversight.

Reviewing IRB - the IRB of record performing review on behalf of one or more institutions, also referred to as the single IRB and/or central IRB.

Relying Institution - the entity that agrees to rely upon the reviewing IRB.

Multi-Site Study - A multi-site study uses the same protocol to conduct non-exempt human research at more than one site.  

sIRB: -An sIRB (Single Institutional Review Board) is the selected IRB of record that conducts the ethical review for participating sites of the multi-site study.

External IRB/sIRB vs Local Review Responsibilities:

The image below depicts the different responsibilities of the external/sIRB compared to the local institution. 

 

Grant Application Information requirements for sIRB:

Required by NIH for Multi-Site Grant Applications
The NIH Single IRB Policy requires the following new information in grant applications for multi-site research submitted on and after January 25, 2018:

Human Subjects section

A Single IRB Plan should include the following elements:

• Name of the sIRB of record
• Indicate that: (1) All sites, including any added after award, agree to rely on the sIRB; (2) Sites will sign a reliance agreement that will include a communication plan; (3) Indicate who will maintain records of the reliance agreements

See details in Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.

Budget and Budget Justification

Any IRB fees that will be charged as direct costs, and any personnel costs directly related to managing the IRB arrangements. See the PHS G.300 – R&R Budget Form for information about where in the budget form to put this information.

Accordion Item Title	Accordion Item Content
What is a Reliance Agreement?	A reliance agreement (also called an IRB Authorization Agreement) is a document signed by two or more institutions engaged in human subjects research that permits an institutional IRB to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site. The agreement is a tool to avoid duplicate initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site protocol.
If I plan to use another IRB for oversight of my study, do I need permission from the SBU IRB? If so, what do I submit?	Yes. The Office of Research Compliance (ORC) has created Reliance Request Form to be submitted and reviewed to determine if SBU IRB can rely on another institution. You must submit your request before making any commitment that SBU IRB will rely on an external IRB. Once you have received confirmation of our willingness to enter into a reliance arrangement, you will be asked to submit an abbreviated application via myResearch IRB.
When we rely on an outside IRB do we use the consent template from the SBU website or the template provided by the Reviewing IRB?	The reviewing IRB will approve a template Informed consent form with certain sections that can be edited and/or completed with local information. Frequently, the reviewing IRB will collect a local context form to assist in determining what local language should be included. Once the local information has been included and approved, this is the consent version that should be used here at SBU. SBU generally requires that informed consent templates include the following local context: ·       SBU Logo ·       Local HIPAA and Privacy language ·       Local information on payment ·       Subject injury language either required by contract or local requirements ·       Any state law required language relevant to the study
Reportable Events: I am a PI for a protocol that uses an external IRB for review. If an unanticipated problem has occurred with one of my subjects, do I report it to SBU IRB or the external IRB?	BOTH. Investigators approved through an external IRB review must report local unanticipated problems, deviations, complaints, and any noncompliance to the ORC via myResearch in addition to reporting to the external IRB. Copies of the report submitted to the external IRB are generally acceptable, but additional information may be requested on an as needed basis.
Can SBU IRB act as the IRB of record?	This decision is made on a case by case basis. All requests for SBU IRB to act as the IRB of record must be submitted using the Reliance Request Form.

Use of external IRBs is permitted for the following types of studies:

• The study is industry initiated/sponsored and using an External IRB that SBU has a fully executed Master Service Agreement. (Advarra or WIRB).
• The study is a federally sponsored, multicenter or collaborative trial that requires the use of an sIRB.
• SBU is a participant in the National Cancer Institute’s Central Institutional Review Board (CIRB) Initiative. SBU investigators who wish to enroll patients onto CIRB-approved protocols are encouraged to utilize this service.

All other requests for the use of an external IRB are considered on a case-by-case basis. All requests should be submitted to Lu-Ann.Kozlowski@stonybrook.edu using the Reliance Request Form.

Once a reliance request has been approved or if utilizing one of the pre-approved external IRBs, a local submission through myResearch IRB is required for administrative acknowledgment.

Initial Submissions

• Instructions for creating a NEW study with an external IRB of record in myResearch:

Initial Submission Required Documentation and Process

Continuing Review Submissions

• Instructions for creating a Continuing Review submission with an external IRB of record in myResearch:

Continuing Review Submission Required Documentation and Process