Commercial / External IRBs and Single IRB

Relying on a Non-Rutgers IRB for approval.

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
  • 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.

About Reliance Agreements

  • 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.

  •  

    When Rutgers Is the IRB of Record

    When Rutgers Is Relying On Another IRB For IRB Approval

    Collaborating with Another PI From Another Organization

    1. Confirm if Rutgers University is willing to be the IRB of Record by contacting the Rutgers IRB Administrator. 
    2. Use the Rutgers IRB Reliance Agreement Template.
    3. Submit your study in eIRB for Rutgers IRB Review.
    1. Confirm if Rutgers University is willing to rely on the Non-Rutgers IRB by contacting Rutgers IRB Reliance Administrator.
    2. Use a IRB Reliance Agreement Template provided by the Non-Rutgers IRB.
    3. Submit your study in eIRB for Rutgers IRB Review.

     

     

    When Rutgers Is the IRB of Record

    When Rutgers Is Relying On Another IRB For IRB Approval

       

    Utilizing SMART IRB

     

    ***SMART IRB Does Not Provide IRB Approval.

    1. Confirm if the Non-Rutgers Institution is a member of SMART IRB (required).
    2. Both IRBs will adhere to the SMART IRB Master Reliance Agreement (MRA) (already setup and agreed upon).
    3. Submit your reliance request study using the SMART IRB website.
    4. Rutgers IRB will complete a Pre-Check in the SMART IRB System confirming IRB of Record.
    5. Submit your study for IRB approval in the Rutgers eIRB system using the regular approval process.
    6. Attach RU IRB Approval in SMART IRB.
    7. When SMART IRB Reliance Approval is received, you may commence with study activities.
    1. Confirm if the Non-Rutgers Institution is a member of SMART IRB (required).
    2. Both IRBs will adhere to the SMART IRB Master Reliance Agreement (MRA) (already setup and agreed upon).
    3. Submit your study using the SMART IRB website.
    4. Rutgers IRB will complete a Pre-Check in the SMART IRB System confirming IRB of Record.
    5. Submit your study for IRB approval in the Rutgers eIRB system requesting "Administrative Review".
    6. Attach IRB Approval in SMART IRB.
    7. When SMART IRB Reliance Approval is received, you may commence with study activities.

    ***Rutgers University is a member of SMART IRB and has joined the SMART IRB Master Reliance Agreement (MRA).

    • 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 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): 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.
    • Smart IRB (Master Reliance Agreements (MRA)):  an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. SMART IRB is not an IRB; rather, it's a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB's Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Investigators and their study teams, together with institutional and HRPP/IRB offices, use the SMART IRB platform to initiate single IRB review of a study. SMART IRB may be used by two or more institutions. Rutgers University is a member of SMART IRB.
    • Existing Master Reliance Agreements
      • ​​​​​​Advarra IRB
      • National Cancer Institute Central Institutional Review Board (NCI/CIRB)
      • Biomedical Research Alliance of New York (BRANY)
      • WCG IRB constitutes the following central IRBs: WIRB (Western IRB) Copernicus Group, New England IRB, Aspire IRB, and  Midlands IRB
  • It is highly recommended that a Rutgers Principal Investigator 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 either be the lead or participating site.

    Please contact the IRB requesting a pre-consultation meeting.

  • 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.

    Learn more about Single IRB Submissions

    Single IRB Fees

  • 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.

    How to submit an Administrative Review Submission.

    IRB Fees

    Status Report Date 6.1.22

  • Learn more about the IRB Submission Process.

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. Rutgers Human Subjects Protection Program is currently crafting policies to harmonize with SMART IRB to best serve the needs of our research community and will post guidance documents soon. Until that time, contact Rutgers HSPP Unit with questions about the SMART IRB Portal.

SMART IRB Learning Center

Contact Rutgers IRB Reliance Administrator

WCG IRB (formerly Western IRB)

Independent Commercial IRB

  • 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).

  • 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 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
  • Under the following circumstances, protocols may not be reviewed by WCG 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
    • 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
  • 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 not accept applications submitted directly from investigators.

    Submission Process

    1. PI complete application in eIRB and selects "Western IRB" when asked to select the PI's campus.
    2. Rutgers IRB will receive your submission and conduct a review.
    3. Submissions ready for WCG IRB review will be sent to WCG IRB by the Rutgers IRB.
    4. Upon receipt by WCG IRB, WCG IRB will issue a tracking number via email, directly to the investigator, by which the investigator can track their application. 
    5. WCG IRB will also notify the investigator directly via email of the approval or disapproval of the study after the WCG IRB meeting.
    6. 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.

    1. WCG IRB Fees
    2. One-Time Administrative Submission Service Fee of $750 for initial applications. Sponsors will be billed separately by the Rutgers IRB (For all Campuses).
  • 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.

  • 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.

  • 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.

  • Contact the IRB for all WCG IRB related inquires regardless of your assigned IRB.