Single IRB

• The single IRB mandate is a set of federal policies that require federally-funded research that involve multiple institutions to use one IRB to accomplish IRB review and approval for all of the institutions conducting the study/trial. The Single IRB Model allows multiple institutions that conduct the same protocol to cede to a single IRB for review.
• The single IRB mandate can be found in the following policies: NIH Single IRB Policy and Common Rule Cooperative Research Requirement.
• Effective January 25, 2018: All competing federally-funded grant applications (new, renewal, revision or re-submission) for multi-site studies with NIH receipt dates on or after January 25, 2018 must include a plan describing the use of a sIRB for the study.
• The single IRB applies to domestic sites of federally-funded studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported by grants, cooperative agreements contracts or the NIH Intramural Research Program. It does not apply to Foreign Sites, career development (K), research training (T) or fellowship awards (F) and current awards. Exceptions: VA sites; international sites; sites involving tribal nations.
• Exceptions: Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or Research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.

Baystate Health investigators who plan to submit initial, resubmission, or renewal applications for federal funding opportunities that involve human research performed at more than one site, or who plan to be a sub-contracted site on a proposal submitted by an investigator outside of Baystate Health, must undergo single IRB consultation. Regardless of whether you are in the grant proposal phase of initial submission, a single IRB consultation is required.

The consultation process is developed to engage with the research community during proposal time to ensure relevant information in alignment with single IRB requirements are included in the final submission. Single IRB Consultation is required when either requesting the Baystate Health IRB serve as the IRB of Record or cede IRB review to an external IRB.

It is recommended that you contact the Baystate Health IRB at least 5 weeks prior to the grant application due date to discuss options for IRB review of a multi-site or collaborative study where Baystate Health will be the lead or a participating site. To initiate the process please contact the IRB Reliance Analyst to request the consultation form. The Baystate Health IRB will evaluate on a case-by-case basis whether we are suited to serve as the single IRB for the proposed multi-site or collaborative project.

The main evaluation criteria for ceding review are:

• Is the project federally-funded?
• Is the reviewing IRB AAHRPP accredited?

The main evaluation criteria for Baystate serving as the IRB of record are:

• The risk level of the proposed research
• The number of participating sites
• The location of the participating sites
• The number of years the study will require IRB review.
• Other considerations such as (involvement of an IND or IDE, vulnerable populations, biosafety, COI…etc.)

During the review of the information provided, the Baystate Health IRB Office will provide one of the following:

• Direct communication that Baystate will (or will not) agree to cede review.
• Direct communication that single IRB requirement does (or does not) apply.
• Direct communication on our willingness to serve as the IRB of Record

The NIH Single IRB Policy requires single IRB plan information in grant applications for multi-site research submitted on and after January 25, 2018. For general information see Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and for specific details see Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.

For budgeting of single IRB fees, see Section F “Other Direct Costs” of the PHS G.300 – R&R Budget Form. For information on charging direct and indirect costs for single IRB activities, see the Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-Site Research. Per NIH guidance, if you intend to request an exception to the single IRB policy based on compelling justification, do not account for this exception in your proposed budget. The proposed budget must reflect all necessary single IRB costs without an exception (i.e. applicants should not assume that an exception will be granted when considering what single IRB costs to include in the budget).

Data Management and Sharing Policy (2023)- NIH Jan 2023 DMS Policy.

In January of 2023 the NIH approved the new, updated version of the Data Management and Sharing Policy, which broadens requirements for the storage and sharing of data, and what this will mean for researchers in writing grant proposals, institutions for storing and sharing data, and for the IRB in what to include in the informed consent form and process.

For more information, and for NIH resources on this topic, please visit the NIH link above.

• Baystate Health IRB is willing serve as the IRB of Record for external sites when federally mandated, required by sponsors, or on a case-by-case basis. Serving as the IRB of Record for another site or institution is established by reliance agreements. A reliance agreement is an agreement between two or more institutions that allows an institution’s IRB to rely on another institution’s IRB for review of human subjects’ research.
• It is the responsibility of the principal investigators and study teams to propose which site or institution will be the IRB of Record. You must ask for a consult with the sIRB Reliance Analyst (irbsingleprojects@baystatehealth.org) before submitting to the Baystate IRB.
• In order to for Baystate Health IRB to serve as the IRB of record for an external site a new study submission, or modification to an existing study, must be submitted in IRBNet. The submission must include any corresponding protocol details about external site activities and a draft reliance agreement for our review. We kindly ask that reliance agreements be provided for our review before external signatures are acquired.
• All reliance agreements must be completed in IREX, once the sIRB Reliance Analyst gives the go-ahead.
• Refer to the Single IRB (Baystate as IRB of Record) Manual for further guidance and instructions.

• Baystate Health is willing to rely on an external IRB when federally mandated, or on a case-by-case basis. Relying on another site or institution’s IRB is established by reliance agreements. A reliance agreement is an agreement between two or more institutions that allows an institution’s IRB to rely on another institution’s IRB for review of human subjects’ research. Currently, Baystate uses IREx and SMARTIRB, and other master agreements, to resolve reliance agreements. See below for further information.
• Schedule a consult with the sIRB Reliance Analyst (irbsingleprojects@baystatehealth.org) before submitting to the Baystate IRB.
• Submissions can be made through IRBNet via an initial submission .
• Refer to the External IRB Ceding Manual for further guidance and instructions

An IRB Authorization Agreement (IAA) is an agreement between Baystate Health and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, medical centers, NGOs, community organization, survey research organization) that receives funds from HHS must have an FWA.  Entities use this agreement type to establish which institution will serve as the IRB-of-Record. Each institution’s Institutional Official or designee signs the IAA.

• Individual investigator
• Baystate Principal Investigator (PI)
• Baystate Institutional Official or designee

A Master Reliance Agreement (MRA) is utilized when multiple studies cede review to a specific external IRB.  Master Agreements may be reciprocal in that signatory institutions can act as the site providing IRB review and oversight or the site relying.  Master Reliance Agreements may be for a single protocol or a number of protocols that are negotiated on a case by case basis.

• The IRB Reliance Exchange (IREx) is a web-based platform, supported by the Duke/Vanderbilt Trial Innovation Center (TIC), to facilitate Single IRB documentation, communication, and the exchange of information. Baystate Health is a participating institution of IREx and this method can be utilized to complete many study related processes for studies with other IREx participating institutions.
• IRBs, coordinating centers, and study teams use IREx for following features:
• Document and track reliance arrangements between FWA-holders and component sites
• Execute reliance agreements under the terms of the SMART IRB master reliance agreement
• Track participating site progress towards initial IRB approval
• Streamline and centralize the capture of participating sites’ local considerations on a study-by-study basis
• Centrally manage participating site approval documents from initial approval through study close
• Facilitate communications to participating sites when actions are required
• Automate notifications to participating sites of new approvals and upcoming continuing reviews

• Using IREx as the Lead Study Team/Coordinating Center
• Using IREx as the Participating Site Study Team
• IREx Workflows

The Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB), is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. SMART IRB is not an IRB, but a master reliance agreement which has over 580 participating institutions.  The SMART IRB master reliance agreement replaces the need to have an individual Institutional Authorization Agreement (IAA). 

Baystate Health is a participating institution of SMART IRB and this method can be utilized to complete the reliance process for a study being conducted with another SMART IRB participating institution. Please review the list of Participating Institutions to see if your collaborator is a member of SMART IRB. Additional resources are available on the SMART IRB Learning Center webpage.

• A drafted SMART IRB Letter of Acknowledgement OR inclusion of the SMART IRB Online Reliance Platform project ID (choose one).
• If the request is for Baystate Health to serve as the IRB of Record for an External IRB/Site, the protocol should include the "Multi-Site and Collaborative Research" section and explicitly state which sites will utilize SMART IRB for the reliance process
• If the request is for Baystate Health to cede review to an External IRB Request, the IRBNet application should reflect the name of the requested IRB of Record and that SMART IRB will be utilized for the reliance process.
• Any questions regarding the feasibility of the Baystate Health IRB serving as the IRB of Record for a multi-site study or ceding review to an External IRB, should be directed to the IRB Reliance Analyst

• The SMART IRB Letter of Acknowledgement (LOA) allows research teams to utilize a paper or electronic document to execute reliance agreements under the terms of the SMART IRB master reliance agreement. This document follows a similar process as other types of reliance agreements. Each site will need to sign a separate LOA with the proposed IRB of Record.
• Each institution that participates in SMART IRB typically has their own preferred template. Whichever site is the proposed IRB of Record will often request their template be used. Baystate Health kindly request signature lines be added to any LOA template for our consideration.
• SMART IRB Letter of Acknowledgment (LOA) --> search for Letter of Acknowledgement, Template

• Request Access: https://reliance.smartirb.org/users/sign_up
• Sign In: https://reliance.smartirb.org/users/sign_in

• Basic information about the research (title of study and a brief description)
• Name of Principal Investigator
• List the engaged sites which are requesting to cede review to the IRB of Record
• Identify activities and study team personnel at each site

• Reliance decisions in SMART IRB apply only to the determination of reliance and do not reflect IRB approval for the research project itself.  Approval for each collaborating institution must be obtained from the overall IRB of Record prior to beginning research with that site or its collaborators.
• If the reliance request was initiated after the reviewing IRB approved the study, the addition of sites and/or collaborators will need to be specifically review and approved, which is usually accomplished via a modification to the existing study.

What Documentation Is Needed When Submitting The Reliance Agreement Request?
This would depend on the type of submission and request (cede/rely) needed for the study. In order to process a request for Baystate IRB to serve as the IRB of record, we would need to ensure that the site is engaged in research and the protocol accurately reflects the role of each site involved. The external site would also need to have a Federal Wide Assurance (FWA) in place prior to executing the agreement. For studies requesting the Baystate IRB cede review to an external IRB, we would need to review the protocol, consent template, and any other relevant study documentation. In addition, the research staff member preparing the submission in IRBNet should be trained on the requirements for submitting an external IRB study.

• Informed consent
• Interaction or intervention with participants as part of the research
• Obtain or analyze personally-identifiable subject data
• Funding
• For more information regarding how to determine if a site is engaged, see our HRP-311 WORKSHEET Engagement Determination and OHRP Guidance on Engagement of Institutions in Human Subjects Research.

What Are The Main Elements The IRB Looks At When Reviewing A New Request?
Upon receiving a new request to cede/rely the main elements of review the Baystate IRB is looking at are: the qualifications of the investigator; the external IRB; the research procedures; the study population; and where the research is taking place. We are also reviewing the language included in the institutional authorization agreement. It is best to utilize the internal Baystate institutional authorization agreement templates as the language has been approved by all necessary institutional parties. When submitting a request to utilize an external institutional authorization agreement template, there may be additional institutional reviews needed prior to moving forward, which could result in additional time for processing.

How Long Is The Review Process?
The Baystate IRB understands that all research is important, and we want to facilitate the process for all investigators.  We also need to ensure the parameters outlined in the agreements are feasible for all involved parties.  We are paying very close attention to assure the terms we agree upon uphold the core principles of our Human Research Protection Program (HRPP) and also honor our commitments to our clinical partners.  In doing this it may add additional time for processing of new agreements. At this time the approximate timeline for processing of a Reliance Agreement is from 4-6 weeks, depending on the type of agreement.

• B01: Definitions
• B03.3 Manual: Baystate Ceding to Another IRB of Record Manual
• B03.3 Form: Consult Intake Form When Baystate is Ceding to Another IRB
• B03.3-AB Policy: Establishing Authorization Agreement (External IRB)
• B03.3 Reliance Studies: Vulnerable Populations Supplements R1-R4 (External IRB)
• B03.3 Worksheet: Communications and Responsibilities Worksheet (External IRB)
• B03.3 Worksheet: IRB Staff and Study Team Completeness Worksheet (External IRB)
• B03.4 Manual: Baystate as the IRB of Record Manual
• B03.4 Checklist: Elements of Consent Checklist (Baystate as IRB of Record)
• B03.4 Form: Consult Intake Form When Baystate is the IRB of Record
• B03.4-B Form: Basic Site Information Form (Baystate as IRB of Record)
• B03.4 Policy: Baystate Health Serving as the IRB of Record
• B03.4-A Policy: Establishing Authorization Agreements (Baystate as IRB of Record)
• B03.4 Worksheet: IRB Staff/Study Team Completeness Worksheet (Baystate as IRB of Record)
• B03.4-C Worksheet - Communications and Responsibilities (Baystate as IRB of Record)