Single IRB Review FAQS

What is single IRB review?

Single IRB review means that a single IRB of record (aka Reviewing IRB) conducts the ethical review for sites participating in a multi-site study. To use a single IRB, institutions must enter into formal arrangements called reliance agreements to document which institution will serve as the Reviewing IRB and which will cede IRB review to that institution.

How could single IRB review affect my federal funding proposal?

Single IRB review requirements can affect:

  • The types of documents and assurances that need to be included in your funding application – you may need letters of support from a UW IRB and other participating institutions in support of single IRB review.
  • Study budgets – additional personnel and services may be required in support of the multi-site research and costs for the Reviewing IRB may need to be included.
  • Sign offs needed before a funding proposal can be forwarded – a UW IRB must agree to the proposed Reviewing IRB cited in any funding application and provide documentation of that support.

What should I do if I am required to use a single IRB for my funding proposal?

Health sciences researchers should contact the Health Sciences IRBs office as soon as possible. The Health Sciences IRBs office can advise you regarding:

  • information to include in your grant
  • the appropriate IRB to oversee the research
  • budgeting for IRB review
  • putting together a communication plan, which is required by the NIH policy
  • other implications of the single IRB review policy for the study team, such as additional roles and responsibilities the study team may incur as a result of using a single IRB.

The Health Sciences IRBs office also can reach out to the IRBs at other institutions involved in the funding proposal to discuss single IRB arrangements and provide, when appropriate, a letter of support related to single IRB review for the funding proposal.

How do I request a single IRB review (aka reliance arrangement) for my study?

Health sciences researchers should contact the Health Sciences IRBs office (i.e., the office of the IRB that would oversee the study if it were reviewed at the UW) as soon as you become aware of the potential need to identify a single IRB to oversee your research study. The Health Sciences IRB office will be able to guide you regarding whether your study is eligible for a reliance arrangement, which IRB might be the appropriate one to oversee the study, and what steps will be required should the funding be secured. In addition, the Health Sciences IRB office can provide a letter of support as well as language you can include in your funding proposal regarding single IRB review.

Can I use an independent (aka commercial IRB), such as Western IRB, as the single IRB for my study?

An independent IRB may be an appropriate approach for single IRB review. Email the Health Sciences IRBs Office Reliance Team (irbreliance@wisc.edu) to determine if the UW has a contract in place with the independent IRB. If no contract is in place, the time to negotiate and finalize such a contract could delay any award. If an independent IRB is used, the study team will need to work with the independent IRB to develop a proposed budget for IRB review. If sufficient funds are not budgeted to pay for the review by an independent IRB, the researcher’s department would be responsible for covering those costs.

How can the SMART IRB Agreement help me with the single IRB review requirement?

In September 2016, the UW joined a master IRB authorization agreement, called the SMART IRB Agreement, which easily allows the institution to document reliance arrangements with other institutions that also have joined the SMART IRB agreement. Using the SMART IRB agreement eliminates the need to negotiate IRB authorization agreements, also called reliance agreements, on a study-by-study basis. Some NIH grants strongly encourage applicants to use the SMART IRB agreement.

How do I know which institutions have signed onto the SMART IRB Agreement?

Institutions that have joined SMART IRB are listed here. If you do not see an institution you wish to collaborate with listed on this website, contact the Health Sciences IRBs Office, which may be able to work with the site to have it join SMART IRB.



Keywords:sIRB, multisite, multi-site   Doc ID:79969
Owner:Faye L.Group:Health Sciences IRBs
Created:2018-02-07 18:00 CDTUpdated:2018-02-07 18:00 CDT
Sites:Health Sciences IRBs
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