Reliance
Overview
It is common for investigators from two or more institutions to partner to conduct human subjects research or be involved in multi-site research studies. To conserve resources and enhance and streamline the Institutional Review Board (IRB) review process when such collaborations occur, regulations allow institutions to “enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort” (45 CFR 46.114). In other words, regulations allow research partners to agree to rely on a single IRB for review and approval of their non-Exempt study. If a non-Rutgers-owned IRB is chosen as the reviewing IRB, it is called an External IRB, as it is external to our organization. Here are a couple of different types of external IRB models:
Central IRB
A reviewing IRB provides the ethical review for all sites participating in more than one multi-site study. The relying sites are usually in a network, consortium or particular program, such as the Children’s Oncology Group and National Cancer Institute Central IRB (NCI/CIRB).
Single Independent or Commercial IRB
The IRB is independent, established for commercial purposes, developing products and services to support the research industry. Pharmaceutical companies conducting multi-site studies usually rely on ‘Single Independent (Commercial) IRBs’ to coordinate IRB review services (e.g. WCG IRB).
Single IRB, or sIRB
A reviewing IRB, selected on a study-by-study basis by partner institutions, provides the ethical review for all relying sites participating in that multi-site study (2 or more sites). Rutgers IRB may choose to rely on another IRB or it may be chosen as the reviewing IRB, or IRB-of-Record, on which partners will rely for review. Learn more on NIH.gov
For each model, the Rutgers IRB enters into a reliance agreement with the Reviewing IRB. A reliance agreement is a formal, written document that provides a mechanism for institutions partnering in research to rely on one IRB to be responsible for multi-site IRB review. Funded and unfunded multi-site studies may enter into reliance agreements.
Definition
A reliance agreement (aka IRB Authorization Agreement (IAA)) is a formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions may use different descriptive terms, e.g., reliance agreement, cooperative agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federal-wide Assurance (FWA). MOUs are generally used when covering an entire research program; reliance agreements are generally used to cover a designated protocol or protocols.
The type of agreement may be based on the nature of established financial, legal, or collaborative relationships between the entities. The HHS Office for Human Research Protections (OHRP) sample template uses the term “authorization agreement”; the Food and Drug Administration (FDA) uses the term “agreement.” The agreement should clearly identify the IRB of record for a protocol or program and the delineation of responsibilities.
Types of Reliance Agreements
IRB Authorization Agreement (IAA)
An IAA is an agreement between Rutgers University 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) receiving funds from HHS must have an FWA. This agreement type is used to establish the IRB-of-Record (whether that's Rutgers University or the other institution). The IAA is signed by the Institutional Officials or designee at each institution.
Individual Investigator Agreement (IIA)
An IIA is an agreement between Rutgers University and an individual collaborator who is unaffiliated with Rutgers University and is not covered under an institution with an FWA. It allows research which requires coverage under a FWA to be conducted, if the individual collaborator agrees to conduct their human subject research under the direction and supervision of a Rutgers Principal Investigator and coverage under Rutgers’ FWA. This form would be used in place of an IRB Authorization Agreement (IAA) for eligible individual collaborators.
Common situations requiring the use of this agreement include when a researcher leaves Rutgers University but wishes to continue their research (and they did not move to new institute with a FWA) or a researcher who is part of a medical clinic/institution which does not have an FWA but will be conducting human subject research as part of a Rutgers study.
Common types of investigators using this form include former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partner, etc.
Master Reliance Agreements (MRA)
MRAs can be utilized when multiple studies are ceding 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 and are negotiated on a case by case basis.
Collaborative Institutional Agreement (CIA)
A CIA is an agreement between Rutgers University (RU) and an institution/organization that does not have an FWA. This agreement is only applicable to research that is non-federally funded involving non-profit community organizations in the local tristate area. This agreement outlines the responsibilities of RU and the community organization for the protection of human subjects. The CIA is signed by a representative who has the authority to make commitments on behalf of the organization and by the RU Institutional Official. For further information regarding this agreement, please contact the IRB Reliance Team at IRBrelianceteam@research.rutgers.edu.
Collaborating with External Institutions
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Rutgers is the IRB of Record |
Rutgers is relying on another IRB for IRB Approval |
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Collaborating with PI from another organization |
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SMART IRB
Streamlined, Multi-site, Accelerated Resources for Trials (SMART IRB)
Contrary to what the title implies, the Streamlined, Multi-Site, Accelerated Resources for Trials, or SMART IRB, is NOT an IRB, but rather an online system to facilitate reliance agreements, which are arrangements between institutions allowing the IRB of one or more institutions to rely on the IRB of another institution for the review of human subjects research in which they jointly seek to be engaged.
The SMART IRB Portal provides resources — forms, templates, agreements and sample Standard Operating Procedures — that investigators can freely use to coordinate, harmonize and streamline IRB review of dual or multi-site studies they propose to conduct in the United States, only.
Development of the SMART IRB platform was funded and supported by NIH to further its new policy mandating all multi-site clinical studies it funds to use a single IRB (sIRB) effective 9/25/17. Notwithstanding the original funder of the resource, use of the platform is available to investigators at member institutions, regardless of funding source.
Rutgers is a member of SMART IRB and our researchers are welcome to review the resources found at its website to begin thinking through the framework for reliance it offers.
Existing Master Reliance Agreements
Rutgers has existing Master Reliance Agreements with the following:
- Advarra IRB
- National Cancer Institute Central Institutional Review Board (NCI/CIRB)
- Biomedical Research Alliance of New York (BRANY)
- WCG IRB, which constitutes the following central IRBs:
- WIRB (Western IRB)
- Copernicus Group
- New England IRB
- Aspire IRB
- Midlands IRB
Overview
As per the Single IRB Policy (Single IRB for Multi-Site or Cooperative Research) and Revised Common Rule Cooperative Research Provision (eCFR :: 45 CFR Part 46 (2018-07-19) -- Protection of Human Subjects), studies being conducted at more than one U.S. site involving non-exempt human subjects research may need to have a single IRB.
For Rutgers University to serve as the IRB of Record, refer to the Single IRB submission Guidance which will provide instructions on completing the eIRB application.
Single IRB Submission Guidance
Rutgers Principal Investigators are highly encouraged to contact the Rutgers Institutional Review Board (IRB) to discuss the options available for IRB review to process a multi-site or collaborative study where Rutgers will serve as the IRB of Record. The IRB contact information is available within the Pre-Consultation Assistance tab.
In order for Rutgers IRB to serve as the IRB of Record for an external institution(s), a Single IRB (sIRB) eIRB application must be submitted for IRB review.
Pre-Consultation
It is highly recommended that a Rutgers University Principal Investigator contact the Rutgers IRB Reliance Team at least 5-6 weeks prior to the grant application's due date to discuss options for IRB review of a multi-site or collaborative study in which Rutgers will serve as the lead or participating site and how to properly include IRB fees in the proposal budget.
Contact the IRB Reliance Team to request a pre-consultation meeting.
Standard Operating Procedures
Procedure HRP-893 establishes the process when Rutgers University IRB serves as the IRB of Record for an External IRB. In addition, the Human Research Protection Program Toolkit contains documents required to establish a reliance agreement when an External IRB is relying on Rutgers University to serve as the IRB of Record.
You can review the SOP and documents in the HRPP Toolkit under External IRBs.
Single IRB Fees
There are IRB fees associated with externally funded Single IRB submissions. Please refer to the Single IRB Fees (Funded Studies) tab in the link provided for further details.
Overview
As per the Single IRB Policy (Single IRB for Multi-Site or Cooperative Research) and Revised Common Rule Cooperative Research Provision (eCFR :: 45 CFR Part 46 (2018-07-19) -- Protection of Human Subjects), studies being conducted at more than one U.S. site involving non-exempt human subjects research may need to have a single IRB.
For Rutgers to cede review to an external IRB serving as the IRB of Record, a designated Rutgers Principal Investigator is required to submit an Administrative Review application for IRB review and execution of a reliance agreement.
Administrative Review Guidance
Rutgers Principal Investigators are highly encouraged to contact the Rutgers Institutional Review Board (IRB) to discuss the options available for IRB review to process a multi-site or collaborative study where Rutgers will cede review to an external IRB. The IRB contact information is available within the Pre-Consultation Assistance tab.
In order for Rutgers IRB to cede review to an external IRB, an Administrative Review eIRB application must be submitted for IRB review.
Progress Reports
For submissions approved as “Administrative Review”, the investigators will submit a “Progress report” instead of “Continuing Review” request along with the renewed IRB approval from the IRB of record. When the eIRB continuation reminder is received, please sign into your eIRB initial workspace and create a Continuing Report. For renewal, please select “Progress Report” in section 1.0 Study Status as the type of report. The eIRB system will populate an abbreviated continuation application that requires information regarding the status of your research.
If you have any questions, please contact us: irbrelianceteam@research.rutgers.edu.
Flowchart
This flowchart is designed to help Rutgers University Principal Investigator(s) select the appropriate eIRB submission type when Rutgers University has ceded review of their research study to an external IRB acting as the Reviewing IRB.
Standard Operating Procedures
Procedure HRP-892 establishes the process when the Rutgers University IRB agrees to rely on an External IRB for review (i.e. cede review). You can review this SOP in the HRPP Toolkit under External IRBs.
Administrative Review IRB Fees
There is a one-time Administrative Review fee for externally funded submissions. Please refer to the Single IRB Fees (Funded Studies) tab in the link provided for further details.
Overview
Commercial IRBs are independent pay-for-service IRBs that provide regulatory and ethical review services for academic and non-academic institutions to conduct reviews of research involving human subjects. Rutgers University has established agreements with Advarra IRB, National Cancer Institute Central Institutional Review Board (NCI/CIRB), Biomedical Research Alliance of New York (BRANY) and WCG IRB. Each commercial IRB has their own submission requirements which are detailed on their websites.
WCG IRB
Overview
WCG IRB is an independent commercial IRB located in Olympia, WA. It is utilized to review, approve and monitor all industry-sponsored human subjects research. WCG IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Contact the IRB Reliance Team for all WCG IRB related inquires regardless of your assigned IRB.
Accordion Content
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All of the following requirements must apply:
- Study is industry-sponsored - The industry sponsor has written the protocol, is funding the research, and will monitor the conduct of the study
- The research will be conducted at a Rutgers performance site (site is owned and operated by Rutgers)
- The investigator(s) is/are Rutgers employees
- The investigator(s) is/are in good standing with the Rutgers IRB (e.g., no compliance issues, no expired studies, etc.)
- All study personnel involved in human subjects research have completed all educational requirements required by the Rutgers IRB
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Under the following circumstances, protocols may not be reviewed by WCG IRB and instead must be reviewed by a Rutgers IRB:
- Research will be conducted at a non-Rutgers performance site (such as a CINJ-affiliated site, VA affiliates, etc.)
- Research will have or could be perceived as having significant local impact on the University’s host communities, requiring special sensitivity to the University’s host communities’ attitudes and culture, and/or sufficient knowledge of the local research context
- Research will be conducted by investigators who have current compliance issues or are otherwise not in good standing with a Rutgers IRB
- Research requiring Institutional Biosafety oversight, such as research involving Infectious agents, recombinant DNA/human gene transfer, or Biologically-derived toxins
- Single Patient Expanded Access
- Establishing a Single Study Authorization Agreement (i.e., reliance agreement) with WCG IRB. This is when an affiliate (i.e., faculty member) of Rutgers University chooses to collaborate in human subject research with a non-Rutgers site utilizing WCG IRB as their IRB of Record. Please email the IRB Reliance Team to set up a pre-consultation meeting.
- Retrospective Chart Review
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All new, initial applications must be submitted electronically via eIRB. Make sure that you select WCG IRB as your IRB of record (campus).
WCG IRB will accept applications submitted directly from investigators only after local institutional clearance has been obtained.
WCG IRB Submission Instructions
Submission Process
- PI creates application in eIRB and selects "Commercial IRB" when asked to select the PI's campus.
- Rutgers IRB will receive your submission and conduct a local IRB review
- Submissions ready for WCG IRB initial review will be issued a local institutional clearance memo from Rutgers IRB.
- Upon receipt of the Rutgers institutional clearance memo, the investigator will submit their application directly to WCG IRB and upload the local institutional clearance memo as part of the WCG submission.
- Upon receipt of the WCG IRB approval, the PI must submit all the WCG IRB approved documents to Rutgers IRB via the eIRB initial study workspace.
- WCG IRB will arrange for monitoring ongoing research, as its policies and procedures require.
***WCG IRB will contact the investigator directly about any issues that may arise during the review process, and about those matters relevant to the conduct of the study once approved.
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Researchers submitting to WCG IRB, whether initial applications, continuing review applications and/or modifications of human subjects research must indicate the name and address of the sponsor or the investigator in the “Billing Information” section of the WCG IRB submission form, in accordance with the Clinical Trial Agreement or study contract. This information will make clear to WCG IRB who will be responsible for paying the WCG IRB fees and whom WCG IRB should bill.
If the CTA or study contract indicates that the sponsor will only reimburse the investigator for WCG IRB reviews, instead of the sponsor paying WCG IRB directly, the researcher must establish a purchase order payable to WCG IRB. The investigator must provide the number and mailing address to Rutgers-Accounts Payable in the “Billing Information” section of the WCG IRB submission form. This ensures that WCG IRB invoices will be paid as required by Rutgers accounting policy. The Rutgers Institutional Review Board does not pay WCG IRB fees. In addition to the WCG IRB invoice, a one-time HSPP administrative submission service fee of $750 is charged for initial applications. If the sponsor will only reimburse the investigator for WCG IRB-related expenses, the researcher must identify who will receive the invoice in the “Billing Information” section of the Rutgers Application for Review by WCG IRB. The invoice will be forwarded to the individual responsible for processing payment through a Banner Index number.
In addition to the WCG IRB invoice will be a one-time Administrative Submission Service Fee of $750 for initial applications. Sponsors will be billed separately by Rutgers IRB. Rutgers researchers submitting WCG IRB initial review application of human subjects research will indicate the contact information for billing the HSPP service fee in the “Billing Information” section of the Rutgers Application for Review by WCG IRB.
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The WCG IRB contract provides that, where additional knowledge of the community is required, representatives of Rutgers community may participate in WCG IRB reviews by teleconferencing.
WCG IRB Submissions
The WCG IRB Submission flowchart is designed to help Rutgers University Principal Investigator(s) when to submit to eIRB and/or WCG IRB (formerly WIRB) based on the application type.
Continuing Review
WCG IRB will provide the investigator with a continuation notice before the expiration of the study. All continuation requests must be sent directly to WCG IRB by the investigator using a WCG IRB Continuing Review Report Form (CRRF).
Modification/Amendments
All changes to the study must be submitted directly to WCG IRB by the investigator using a Research/Subject Recruitment Submission Form. The Rutgers IRB must also be notified via an eIRB Modification Request Form, if you are making changes to any of the following: Principal Investigator, Study Personnel, Performance Site(s), Change in Investigator.
Adverse Events & Unanticipated Problems
In the event of an adverse event or unanticipated problem involving risk to subjects or others, the investigator must submit a Promptly Reportable Information Form directly to the WCG IRB. If the occurrence is serious (deaths or life-threatening events) and occurred at a Rutgers performance site, a copy of the WCG IRB report form must be sent to the Rutgers Institutional Review Board within twenty-four (24) hours of discovery.
WCG IRB Fees
There is a one-time administrative submission service fee of $750 for initial applications. Sponsors will be billed separately by the Rutgers IRB (for all campuses).
Advarra
Overview
Advarra IRB is an independent commercial IRB located in Columbia, MD. It is utilized to review, approve and monitor all industry-sponsored human subjects research. Advarra IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Accordion Content
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All of the following requirements must apply:
- Study is industry-sponsored, that is, the industry sponsor has written the protocol, is funding the research, and will monitor the conduct of the study.
- The research will be conducted at a Rutgers and/or RWJBH performance site. (Site is owned and operated by Rutgers or RWJBH).
- The Principal investigator(s) is (are) Rutgers employees.
- The investigator(s) is (are) in good standing with the Rutgers IRB (e.g., no compliance issues, no expired studies where the PI is on restricted investigator status, etc.).
- All study personnel involved in human subjects research have completed all educational requirements required by the Rutgers IRB.
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Under the following circumstances, protocols may not be reviewed by Advarra IRB and instead must be reviewed by a Rutgers IRB when:
- The research will be conducted at a non-Rutgers performance site (such as a CINJ-affiliated site, VA affiliates, etc.).
- The research will have or could be perceived as having significant local impact on the University’s host communities, requiring special sensitivity to the University’s host communities’ attitudes and culture, and/or sufficient knowledge of the local research context.
- The research will be conducted by investigators who have current compliance issues or are otherwise not in good standing with a Rutgers IRB.
- Research requiring Institutional Biosafety oversight, such as research involving the following:
- Infectious agents
- Recombinant DNA/human gene transfer
- Biologically-derived toxins
- Single Patient Expanded Access
- Expanded Access (Compassionate Use)
- Retrospective Chart Review
Exceptions
- Single Patient Expanded Access
- Investigator-Initiated Research
In rare circumstances, justification must be provided to the Reliance Team via irbrelianceteam@research.rutgers.edu.
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All new, initial applications must be submitted electronically via eIRB. Make sure that you select Advarra IRB as your submission type.
Advarra IRB will not accept applications submitted directly from investigators without the Rutgers local institutional clearance memo.
Submission Process
- PI completes application in eIRB and selects "Commercial IRB" as the submission type.
- Rutgers IRB will receive your submission and conduct a local IRB review
- Submissions ready for Advarra IRB review will be sent a local institutional clearance memo from Rutgers IRB.
- Upon receipt of the Rutgers institutional clearance memo, the investigator will submit their application directly to Advarra IRB and upload the local institutional clearance memo as part of the Advarra submission.
- Upon receipt of the Advarra IRB approval, the PI must submit all the Advarra IRB approved documents to Rutgers IRB via the eIRB initial study workspace.
- Advarra IRB will arrange for monitoring ongoing research, as its policies and procedures require.
Advarra IRB will contact the investigator directly about any issues that may arise during the review process, and about those matters relevant to the conduct of the study once approved.
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The Advarra IRB contract provides that, where additional knowledge of the community is required, representatives of Rutgers community may participate in Advarra IRB reviews by teleconferencing.
Advarra IRB Submission Platform
Advarra IRB Study Submissions
This chart is designed to help Rutgers University Principal Investigator(s) with the order of submission between eIRB and Advarra IRB based on the application type.
Advarra IRB Submission Flowchart
Continuing Review
Advarra IRB will provide the investigator with a continuation notice before the expiration of the study. All continuation requests must be sent directly to Advarra IRB by the investigator.
Upon receipt of the Advarra Continuing Review (CR) IRB approval, the PI must submit a Progress Report to Rutgers IRB for local review and upload the CR Advarra IRB approval.
Modification/Amendments
All changes to the study must be submitted directly to Advarra IRB by the investigator.
The Rutgers IRB must also be notified via an eIRB Modification Request Form, if you are making changes to any of the following: Principal Investigator, Study Personnel, Performance Site(s), Change in Investigator and addition of Surrogate Consent.
Adverse Events & Unanticipated Problems
In the event of an adverse event or unanticipated problem involving risk to subjects or others, the investigator must report it directly to Advarra IRB.
If the occurrence is serious (deaths or life-threatening events) and occurred at a Rutgers performance site, a copy of the Advarra IRB report form must be sent to the Rutgers Institutional Review Board within twenty-four (24) hours of discovery.
Advarra IRB Fees
BRANY
Overview
BRANY IRB is an independent commercial IRB located in Lake Success, NY. It is utilized to review, approve and monitor all industry-sponsored human subjects research. BRANY IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Accordion Content
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All of the following requirements must apply:
- Study is industry-sponsored, that is, the industry sponsor has written the protocol, is funding the research, and will monitor the conduct of the study.
- The research will be conducted at a Rutgers and/or RWJBH performance site. (Site is owned and operated by Rutgers or RWJBH).
- The Principal investigator(s) is (are) Rutgers employees.
- The investigator(s) is (are) in good standing with the Rutgers IRB (e.g., no compliance issues, no expired studies where the PI is on restricted investigator status, etc.).
- All study personnel involved in human subjects research have completed all educational requirements required by the Rutgers IRB.
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Under the following circumstances, protocols may not be reviewed by BRANY IRB and instead must be reviewed by a Rutgers IRB when:
- The research will be conducted at a non-Rutgers performance site (such as a CINJ-affiliated site, VA affiliates, etc.).
- The research will have or could be perceived as having significant local impact on the University’s host communities, requiring special sensitivity to the University’s host communities’ attitudes and culture, and/or sufficient knowledge of the local research context.
- The research will be conducted by investigators who have current compliance issues or are otherwise not in good standing with a Rutgers IRB.
- Research requiring Institutional Biosafety oversight, such as research involving the following:
- Infectious agents
- Recombinant DNA/human gene transfer
- Biologically-derived toxins
- Single Patient Expanded Access
- Expanded Access (Compassionate Use)
- Retrospective Chart Review
Exceptions
- Single Patient Expanded Access
- Investigator-Initiated Research
In rare circumstances, justification must be provided to the Reliance Team via irbrelianceteam@research.rutgers.edu.
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All new, initial applications must be submitted electronically via eIRB. Make sure that you select Commercial IRB as your submission type.
Submission Process
- PI completes application in eIRB and selects "Commercial IRB" as the submission type.
- Rutgers IRB will receive the submission and conduct a local IRB review
- Upon receipt of the BRANY IRB approval, the PI must submit all the BRANY IRB approved documents to Rutgers IRB via the eIRB initial study workspace.
- BRANY IRB will arrange for monitoring ongoing research, as its policies and procedures require.
BRANY IRB will contact the investigator directly about any issues that may arise during the review process, and about those matters relevant to the conduct of the study once approved.
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The BRANY IRB contract provides that, where additional knowledge of the community is required, representatives of Rutgers community may participate in BRANY IRB reviews by teleconferencing.
BRANY IRB Submission Platform
BRANY IRB Study Submissions
This chart is designed to help Rutgers University Principal Investigator(s) with the order of submission between eIRB+ and BRANY IRB based on the application type.
BRANY IRB Submission Flowchart
Continuing Review
BRANY IRB will provide the investigator with a continuation notice before the expiration of the study. All continuation requests must be sent directly to BRANY IRB by the investigator.
Upon receipt of the BRANY Continuing Review (CR) IRB approval, the PI must submit a Progress Report to Rutgers IRB for local review and upload the CR BRANY IRB approval.
Modification/Amendments
All changes to the study must be submitted directly to BRANY IRB by the investigator.
The Rutgers IRB must also be notified via an eIRB Modification Request Form, if you are making changes to any of the following: Principal Investigator, Study Personnel, Performance Site(s), Change in Investigator and addition of Surrogate Consent.
Adverse Events & Unanticipated Problems
In the event of an adverse event or unanticipated problem involving risk to subjects or others, the investigator must report it directly to BRANY IRB.
If the occurrence is serious (deaths or life-threatening events) and occurred at a Rutgers performance site, a copy of the BRANY IRB report form must be sent to the Rutgers Institutional Review Board within twenty-four (24) hours of discovery.
BRANY IRB Fees
HRPP Reliance Team
Please Email: irbrelianceteam@research.rutgers.edu
Rutgers Reliance Team
Human Research Protection Program (HRPP)
335 George Street
Liberty Plaza, Suite 3100
New Brunswick, NJ 08901
Phone: (732) 235-9806
Malica T. Dock
Claribel Narvaez
Brenda Griffin
