Single IRB Guidance for UW Research Administrators

Page Updated: December 13th, 2018

The purpose of this guidance is to assist Research Administrators at UW-Madison with the implementation of federal Single Institutional Review Board (SIRB) requirements to ensure proposals continue to be submitted on time and accurately.

Overview of Single IRB

The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all participating sites.

The NIH Policy is effective January 25th, 2018. The full NIH policy can be accessed here. The UW-Madison policy that has been implemented to ensure compliance with the NIG policy can be accessed here.

Applicability

The NIH policy applies to NIH funded studies in which the sites are all using the same protocol. These will typically be clinical trials, but can include observational studies. This information was obtained from the NIH policy statement and the NIH FAQs on the Single IRB Policy for Multi-Site Research. See these resources for significant additional details not provided here.

The NIH policy applies to all studies that are:

  • Funded through grants, cooperative agreements, or contracts submitted to NIH on or after January 25th, 2018*, and
  • Involve non-exempt, human subjects research, and
  • Involve multiple sites, all of which are conducting the same protocol.

This policy does not apply to studies that are:

  • Funded to foreign awardees, or
  • Conducted at foreign sites (though domestic sites of the same study must be reviewed by a sIRB), or
  • Funded through career development, research training or fellowship awards, or
  • Collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.

All competing NIH grant applications (new, renewal, revision, or re-submission) for multi-site studies as defined above and with NIH receipt dates on or after January 25th, 2018 must include a plan describing the use of a sIRB for the study. See the next section for details.

What do I need to do before the proposal is submitted?

1. Determine who will serve as the sIRB for the study.
  1. Contact the appropriate UW-Madison IRB Office to help you identify the appropriate IRB that can serve as the sIRB for this study. This may include a UW-Madison IRB, an independent IRB (e.g., Western IRB, Quorum IRB, Schulman IRB), or another institution's IRB.
  2. In many situations, the lead PI, in collaboration with the IRB office at the lead PI's institution, will select the sIRB. The selected IRB must be willing to serve as the sIRB, and all of the participating sites must agree to rely on the sIRB. The selected IRB's willingness to serve in this role must be confirmed before naming that IRB in the funding application. Finally, NIH must concur with the selection. If the lead PI is from UW-Madison, UW-Madison will likely serve as the sIRB, unless the study involves a large number of sites.
  3. If you need assistance in making this determination, please contact the appropriate UW-Madison IRB Office.
    1. Health Sciences IRBs Office Reliance Team
      irbreliance@wisc.edu or 608-263-0022
    2. Education & Social Behavioral Sciences IRB Office
      608-263-2320
2. Develop the necessary documentation to meet proposal requirements.

If a UW-Madison IRB will not serve as the sIRB

You must obtain a letter from the proposed sIRB and provide the letter to the NIH (if UW-Madison will be the prime awardee). This must be included in the grant proposal.

If UW-Madison will act as sIRB

NIH will expect the following new information in grant applications for multi-site research on and after January 25th, 2018:

  1. A plan describing the use of an sIRB. The plan should identify the IRB that will serve as the sIRB and should address any requests for exceptions from the policy. This information should be in the human subjects section of the grant proposal.
    1. Specific requirements: see 'details' in Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.
    2. Location in the Grant Application: a new Human Subjects and Clinical Trial Information form called FORMS-E must be included in grant application packages and contracts for all human subjects and/or clinical trial research applications, beginning on January 25th, 2018. The sIRB plan is uploaded as an attachment to Question 3.2 of the new FORMS-E. Note: The UW-Madison IRBs strongly encourage the use of the SMART IRB Agreement as the IRB Authorization Agreement (IAA) to cover the sIRB arrangement. SMART IRB Agreement is a national master IAA and should be described in this section as well.
    3. Delayed-onset human subjects studies: those for which there is no well-defined, detailed plan for human subject involvement at the time of submission. If the delayed-onset research is likely to involve multiple sites, the delayed onset justification attachment must: 1) include information about how the study will comply with the sIRB policy, and 2) state that a sIRB plan will be provided prior to initiating the study.
  2. Budget and Budget Justification. The UW-Madison IRB staff can assist you in obtaining fee information as part of the process of identifying the most appropriate sIRB for your study.
    1. See the PHS G.300 - R&R Budget Form for information about where in the budget form to put this information.
    2. Note: Currently, UW-Madison has agreed to waive most sIRB fees, if UW-Madison will serve as the sIRB, to collect data to develop a fee structure in the future. Under special circumstances, however, some studies may nonetheless need to budget for sIRB fees, such as those that may be especially complex in terms of number of sites or regulatory issues.
    While not required by the NIH, the following items are recommended by the NIH and by the UW IRB based on past experience.
  3. A description of the resources you will need to manage IRB communications. Studies that are especially complex in terms of number of sites or regulatory issues may require additional staffing resources to manage the complex communications and document management associated with the use of an sIRB and with IRB-related coordination across sites. It is recommended that a staff member on the research team at the lead site serve in this capacity for the study. A brief description of what these duties may entail: "The IRB Liaison lead study team will include a reliance point of contact who will coordinate regulatory communications. This individual work directly with the overall PI, the lead study team, Reviewing IRB and relying institutions to serve as the primary point of contact to facilitate the provision of relevant information regarding participating sites to the Reviewing IRB and ensure the dissemination of IRB determinations and IRB-approved documents, facilitate submissions to the Reviewing IRB (including site-specific requirements in consent documents, identification of any variability in study implementation across sites that must be communicated to the Reviewing IRB, collection of information from participating sites to include in continuing review reports to the Reviewing IRB, site-specific amendments, personnel updates as required by the Reviewing IRB, reportable events).
  4. Letters of support from the appropriate UW-Madison IRB office. This letter is not the same as the formal IRB reliance agreements that may need to be established after the grant is awarded. Please contact the HS IRBs Reliance Team at irbreliance@wisc.edu or the Ed/SBS IRB (casey.pellien@wisc.edu) to obtain a letter of support for serving as the single IRB.
3. Upload the necessary requirements to the WISPER record and route the record through normal proposal submission channels.
  • In the UW-Madison proposal, RSP will look for the elements describe above:
    • A plan describing the use of a sIRb
    • Budget & Budget Justification
    • Letters of support
    • A description of the resources to manage sIRB communications

What needs to happen when the study will be funded or is funded?

UW-Madison anticipates that most studies funded under the sIRB policy will begin to receive notices of award in mid to late 2018.

RSP cannot release funding for a study without IRB approval. It is strongly advised that the following steps are initiated as soon as you receive communication directly from the sponsor, such as the Grants Management Specialist or Program Officer, that study funding is anticipated.

1. Confirm who will serve as the sIRB for the study

The entity serving as the sIRB should have been identified when the proposal was initially developed. If not, the NIH Institute or Center (IC) will ask us to identify the sIRB to be used and submit the required information as outlined above. The NIH IC will work with us to create an acceptable time frame for establishing the sIRB and obtaining IRB approval. Contact the appropriate UW-Madison IRB office for assistance in identifying the reviewing IRB and reaching out to institutions that will be asked to cede review to that IRB.

Note: RSP cannot release funding for a study without IRB approval. Failing to determine the sIRB at the initial proposal stage may result in significant delays in award set-up.

2. Facilitate the establishment of reliance agreements between the sIRB and sites

Each participating site will need to establish a reliance agreement, also known as an IRB authorization agreement, with the sIRB. The reliance agreement documents the arrangement and also establishes expectations about communication, reporting, and procedures. UW-Madison, and more than 350 other institutions, have already signed a master reliance agreement called the SMART IRB Agreement. The SMART IRB agreement eliminates the need to establish a study-specific reliance agreement. Studies and institutions making use of this this existing agreement will have a streamlined startup process.

3. Work with the identified Reviewing IRB to determine the appropriate submission process

In general, most sIRB review for multi-site studies will involve two steps:

  1. Submitting the study-wide protocol and consent materials for review by the sIRB.
  2. Submitting site-specific information such as investigator qualifications, site specific recruitment and consent information, and other local context information (e.g., state laws about the age of majority) for review by the sIRB.

Study teams will need to identify who will be responsible for submitting the study-wide protocol versus the site-specific application to the Reviewing IRB. If the UW-Madison serves as the Reviewing IRB, the Lead Study Team would be responsible for submitting the study-wide and site specific IRB applications. UW-Madison study teams should consider whether additional resources (e.g., regulatory support) may be needed as part of the funding application.

More info can be found here: https://kb.wisc.edu/hsirbs/21707

4. Upload the necessary documentation to the WISPER record for award set-up
  1. RSP will review the record, along with the award notice, prior to set-up to ensure all requirements are met before the funding is released.
  2. If the IRB approval is not in place, then the NIH IC may issue an award with terms and conditions that restrict all human subjects' activities. If this is the case, RSP will review, in conjunction with the appropriate UW IRB to determine if releasing the funding is acceptable.

sIRB Scenarios and Required Documentation

UW-Madison is prime and serving as sIRB
Proposal Sponsor-requested JIT Award Acceptance and Set Up Post-Award
  • Plan
  • Budget for secondary activities, if applicable

Optional: Exception request

  • Signed Reliance Agreements
  • IRB approval

OR

  • Plan to establish single IRB and obtain IRB approval
  • Award without restrictions on human subjects research

OR

  • Award with restrictions on human subjects research
  • Continuing IRB approval

OR

  • Signed Reliance Agreements
  • IRB approval
  • Amended award indicating that restrictions have been lifted
UW-Madison is prime and using independent IRB
Proposal Sponsor-requested JIT Award Acceptance and Set Up Post-Award
  • Plan
  • Budget

Optional: Exception request

  • Signed Reliance Agreements
  • IRB approval

OR

  • Plan to establish single IRB and obtain IRB approval
  • Award without restrictions on human subjects research

OR

  • Award with restrictions on human subjects research
  • Continuing IRB approval

OR

  • Signed Reliance Agreements
  • IRB approval
  • Amended award indicating that restrictions have been lifted
UW-Madison is prime and using required sIRB at another institution
Proposal Sponsor-requested JIT Award Acceptance and Set Up Post-Award
  • Plan
  • Budget

Optional: Exception request

  • Signed Reliance Agreements
  • IRB approval

OR

  • Plan to establish single IRB and obtain IRB approval
  • Award without restrictions on human subjects research

OR

  • Award with restrictions on human subjects research
  • Continuing IRB approval

OR

  • Signed Reliance Agreements
  • IRB approval
  • Amended award indicating that restrictions have been lifted
UW-Madison is participating site and serving as sIRB
Proposal Sponsor-requested JIT Award Acceptance and Set Up Post-Award
  • Agreement to follow plan and serve as sIRB
  • Signed Reliance Agreements
  • IRB approval

OR

  • Plan to establish single IRB and obtain IRB approval
  • Subaward without restrictions on human subjects research

OR

  • Subaward with restrictions on human subjects research
  • Continuing IRB approval

OR

  • Signed Reliance Agreements
  • IRB approval
  • Amended subaward indicating that restrictions have been lifted
UW-Madison is participating site and relying on independent IRB
Proposal Sponsor-requested JIT Award Acceptance and Set Up Post-Award
  • Agreement to rely on sIRB
  • Budget
  • Signed Reliance Agreement
  • IRB approval

OR

  • Plan to establish single IRB and obtain IRB approval
  • Subaward without restrictions

OR

  • Subaward with restrictions on human subjects activities
  • Continuing IRB approval

OR

  • Signed Reliance Agreement
  • IRB approval
  • Amended subaward indicating that restrictions have been lifted
UW-Madison is participating site and relying on required sIRB at another institution
Proposal Sponsor-requested JIT Award Acceptance and Set Up Post-Award
  • Agreement to rely on sIRB
  • Budget
  • Signed Reliance Agreement
  • IRB approval

OR

  • Plan to establish single IRB and obtain IRB approval
  • Subaward without restrictions

OR

  • Subaward with restrictions on human subjects activities
  • Continuing IRB approval

OR

  • Signed Reliance Agreement
  • IRB approval
  • Amended subaward indicating that restrictions have been lifted

Frequently Asked Questions

The UW Health Sciences IRB has developed a series of FAQs to address any addition questions you may have. These FAQs can be found here: (Still in development)