Single IRB Review FAQS
Version: March 2019
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 a letter of support from the proposed IRB of record 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.
- 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.
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 (email@example.com) 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. What do I need to do when UW is only a participating site?
The Reliance Team can also advise study teams selected as a site, or are considering acting as a site, for a federally funded multi-site protocol, regarding:
- budgeting for IRB review (reviewing IRBs may charge relying sites)
- protocol considerations for relying sites
- consent preparation
- submission of Request to Cede to an External IRB in ARROW
- reliance agreement
To request assistance with any of these items, please email the Reliance Team at firstname.lastname@example.org with as much of the following information as possible:
- study summary, draft protocol, or approved protocol
- draft or approved template consent
- any timelines or deadlines
- funding source
- proposed IRB of record
When working with a community partner (e.g., an individual or group employed or volunteering at a community organization and/or that is self-employed, in private practice), first determine whether IRB oversight is required for those community partners depending on whether they are engaged in human subjects research, as defined by federal guidance. A community partner may be engaged in research if they are involved in research activities such as data collection, recruiting participants, consenting participants, or analyzing identifiable data. A community partner may not be engaged in research if, for example, it is simply serving as a location for study activities or providing recruitment flyers to potential participants. Determining whether an external site or individual is engaged in human subjects research can be difficult, especially for community-engaged research. Study teams are encouraged to consult with the HS IRBs’ Reliance Team for assistance in making this determination when preparing an IRB application.
If a community partner is engaged in human subjects research, then all personnel involved in the research must have their study activities covered by an IRB. NOTE: If the study likely qualifies for exemption, IRB requirements are more flexible and study teams are encouraged to consult with the Reliance Team before submitting an application. Typically, UW-Madison will provide IRB oversight in these situations and study teams should plan to include an IRB of record request in their application, if the study likely does not qualify for exemption. If the HS IRBs will serve as IRB of record for a community partner, community partner personnel must complete human subjects training and be listed on the IRB protocol application. In addition, a formal agreement between UW-Madison and the community partner may be required pursuant to federal regulations.
Regardless of engagement status, a letter of cooperation for external sites may be required from the community partner site.
See Also: Training Options for External Personnel