Single IRB

Use of a Single Institutional Review Board is now required for non-exempt projects funded by the U.S. National Institutes of Health or projects funded by a U.S. Federal department or agency that has adopted the Revised Common Rule when certain criteria are met.

The Revised Common Rule Single IRB requirement is in addition to the U.S. NIH grant policy requirement for Single IRB review. If a study is conducted or supported by NIH, both the NIH Single IRB Policy for Multi-site Research and the Revised Common Rule Single IRB requirement for cooperative research would apply. A Single IRB must be used if it was required under either the NIH Single IRB Policy for Multi-site Research or the Revised Common Rule Single IRB requirement.

While this page provides information about when a Single IRB is required, institutions may voluntarily enter into reliance arrangements for non-exempt human research projects. For more information about reliance processes, please visit our Reliance Process webpage.

We highly recommend that you contact the HRPP early, as the decision of which IRB should serve as IRB of record may require discussions between the institution’s IRBs.

• NIH Single IRB Requirements

  The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a Single Institutional Review Board (Single IRB).

  We highly recommend that you contact the HRPP early, as the decision of which IRB should serve as IRB of record may require discussions between the institution’s IRBs.

  Effective Date

  This policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018.  Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application.  For contracts, the policy applies to all solicitations issued on or after January 25, 2018.

  Applicability

  • NIH-funded
  • Non-exempt human subject research
  • Multi-site where each site will conduct the same protocol
  • Domestic sites
  • Supported through grants, cooperative agreements, contracts, or NIH intramural Research Program
  • Does not apply to foreign sites

  Exceptions

  The NIH will determine whether to grant an exception following an assessment of the need. Exceptions to the NIH policy will be made where review by the proposed Single IRB would be prohibited by a Federal, Tribal, or State law, regulation, or policy.  Requests for exceptions that are not based on a legal, regulatory, or policy requirement will be considered if there is a compelling justification for the exception.

  Expectations for Applications / Proposals

  Applicant / Offerors will be expected to include a plan for use of a Single IRB in the applications / proposals they submit to NIH. NIH’s acceptance of submitted plan will be incorporated as a term and condition in Notice of Award or in Contract Award.

  Single IRB Plan

   The PHS Human Subjects and Clinical Trials Information Form Application Guide provides instructions on what needs to be included in the Single IRB plan. NIH submission guidelines state that the Single IRB plan should include the following elements

  • Describe how you will comply with the NIH Policy on the Use of Single IRB for Multi-Site Research.
  • Provide the name of the IRB that will serve as the Single IRB of record.
  • Indicate that all identified participating sites have agreed to rely on the proposed Single IRB and that any sites added after award will rely on the Single IRB.
  • Briefly describe how communication between sites and the Single IRB will be handled.
  • Indicate that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the Single IRB and participating sites.
  • Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.
  • Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.
  • Note: If your human subjects study meets the agency definition of "Delayed Onset," include information regarding how the study will comply with the NIH Single Institutional Review Board (Single IRB) policy prior to initiating any multi-site study in the delayed onset study justification.

  The NIH submission guidelines provide the following exceptions which would need to be addressed in the Single IRB plan.

  • For Studies with Legal-, Regulatory-, or Policy-based Claims for Exception as described by the Single IRB Policy: Indicate that review by an Single IRB will not be possible for all or some sites (specify which sites) because local IRB review is required by an existing Federal/State/Tribal law or policy. Include a specific citation to the relevant law, policy, or regulation.
  • For sites requesting an exception based on compelling justification: Indicate which site(s) is requesting an exception to the use of the Single IRB and provide compelling justification based on ethical or human subjects protection issues or other well-justified reasons. NIH will determine whether to grant an exception following an assessment of the need. Note: 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 any 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).

  For research in which most or all of the collaborating institutions will utilize the SMART IRB Agreement, a template description of the SMART IRB for federal grant applications is available.

  Communication Plan

  NIH instructions state that researchers do NOT include the communication plan(s) documents in the NIH application. A sample communication plan for institutions using the SMART IRB is available.

  Delayed Onset

  If your human subjects study meets the NIH definition of "Delayed Onset," include information regarding how the study will comply with the NIH Single Institutional Review Board policy prior to initiating any multi-site study in the delayed onset study justification.

• Revised Common Rule Single IRB Requirements

  Projects seeking funding from a Federal department or agency that has adopted the Revised Common Rule for the protection of human subjects in research are now required to identify and use a Single Institutional Review Board when certain criteria are met. Any institution located in the United States that is engaged in cooperative non-exempt research must rely upon approval by a Single IRB for that portion of the research that is conducted in the United States, with limited exceptions.

  At MSU, this requirement only applies to projects funded or supported by a Federal department or agency that has adopted the Revised Common Rule for the protection of human subjects.

  Effective Date

  Unless an exception applies, for non-exempt cooperative research projects subject to the Revised Common Rule (2018 Requirements) and that are conducted or supported by a Federal department or agency, IRB review and approval by a Single IRB review is required.

  With respect to HHS- conducted or supported research, the U.S. Office for Human Research Protections (OHRP) has determined that the following research is excepted from the Single IRB mandate:

  • Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB approved the research before January 20, 2020, or
  • Cooperative research conducted or supported by NIH if either:
    • the NIH Single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
    • NIH excepted the research from its Single IRB policy before January 20, 2020.

  Please contact the MSU HRPP if you have questions about whether the Single IRB Requirement applies to your study.

  Applicability

  • Funded or supported by a Federal department or agency that has adopted the Revised Common Rule
  • Non-exempt cooperative human subject research
  • Institutions located in the United States
  • Single IRB required for the portion of the research that is conducted in the United States

  Exceptions

  The following research is excepted from the requirement for Single IRB review:

  • 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 or agency supporting or conducting the research determines and documents that the use of a Single IRB is not appropriate for the particular context.

  If a study appears to require a Single IRB, documentation from a representative of the Federal department or agency supporting or conducting the research would typically need to be provided to the MSU HRPP to confirm the exception from the Single IRB requirement.  

  Selection of the Single IRB

  The reviewing Single IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. See the MSU Requirements for Single IRB selection below for the MSU HRPP process.

  The MSU HRPP must agree upon the selection of the Single IRB prior to submission of the grant proposal. Please contact the MSU HRPP as early as possible for the Single IRB selection.

  Expectations for Applications / Proposals

  The Federal department or agency that is conducting or supporting the research will determine what needs to be included in the application or proposal.

  For NIH funded research, please see the NIH Single IRB Requirements section for NIH requirements.

MSU Requirements

When a proposal may involve a Single IRB, the MSU Principal Investigator contacts the MSU HRPP to identify the Single IRB. When an MSU IRB will be identified as the Single IRB, the MSU HRPP must agree upon the selection of MSU as the Single IRB prior to submission of the grant. When MSU will be involved as a participating site, the MSU HRPP must still be contacted regarding the reliance upon another institution as the Single IRB.

When MSU is the primary awardee, selection of the Single IRB will be dependent upon factors such as:

• Complexity of the proposed study
• Expertise
• Number and types of sites (academic, hospital, other)
• Location of research
• Risk level
• Resources

In some instances, use of an independent (commercial) IRB as the Single IRB may be required.

MSU Requirements for Single IRB Selection

When a proposal may involve a Single IRB, follow the steps below. We highly recommend that you begin this process early, as the decision of which IRB should serve as IRB of record may require discussions between the institution’s IRBs. Please note that this process occurs prior to submission of the grant proposal.

1. The MSU Principal Investigator (PI) completes the “HRP-562 - Template – Use of a Single IRB” available on the Templates The MSU PI may contact Kim Hess, IRB Administrator and Reliance Coordinator, at ORRS.irbreliance@msu.edu if there are questions about identification of the Single IRB.
2. The MSU PI submits a New Study submission in the Click™ Research Compliance System that includes the “HRP-562 - Template – Use of a Single IRB.” At the time of the Single IRB submission, the MSU PI does not need to complete any other templates.
3. The MSU HRPP reviews the selection of the Single IRB.
4. When an MSU IRB will be identified as the Single IRB, the MSU HRPP must agree upon the selection of MSU as the Single IRB.
5. When MSU will be involved as a participating site, the MSU HRPP must still agree to the reliance upon another institution as the Single IRB.
6. The MSU HRPP will request an acknowledgement letter between MSU and each site to document that all sites have agreed to rely upon the proposed Single IRB. The executed acknowledgment letter(s) will be provided to the MSU PI as it may be needed by Sponsored Programs for the grant submission. Alternate arrangements may be made based on the other institution’s requirements. A reliance agreement does not need to be executed at the proposal stage; this would be needed at Just-In-Time.
7. When instructed by the MSU HRPP, the MSU PI will withdraw the submission in Click and submit either a complete IRB study or an external IRB request upon notice of potential funding.

Costs

When MSU serves as the Single IRB, researchers cannot include direct costs to support the administrative tasks of supporting a Single IRB in the budget.

When an independent (commercial) IRB or when another institution’s IRB serves as the Single IRB, the Federal department or agency supporting the research’s requirements related to costs apply.

For NIH, Independent IRBs, which are not affiliated with a research institution, are neither included under another institution’s F&A rate agreement nor do they have Federally-negotiated indirect cost rate agreements of their own. Therefore, the fees charged by independent IRBs may be charged as a direct cost when they are serving as the Single IRB. Please refer to http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html for further guidance on Single IRB cost allocation.

Resources

• HRPP Manual Section, 2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health)
• HRPP Manual Section, 2-2-G, Revised Common Rule Single IRB Requirement
• NIH website, Single IRB Policy for Multi-Site Research
• MSU Reliance FAQs

Questions?

If you have any questions about the Single IRB requirement or reliance, please contact ORRS.irbreliance@msu.edu.