Factors to Consider

Depending on the nature of your study, number of sites, and other factors, UW-Madison may not be your best option. This is not because the UW-Madison IRB does not want to support our researchers. Rather, we want to ensure the success for your study by helping identify the IRB which will meet the needs of your study. This assistance typically occurs through consultation with RELIANT.

Among the factors we will review with you:

• Number of study sites engaged in human research
• Timeframe for getting all study sites approved
  • If your study will have a narrow window in which to have all study sites approved, we will discuss with you how best to ensure your deadline is met
• Type of study sites
• Location of study sites and type of study interventions
  • If your study sites will be outside Wisconsin, additional considerations will apply in assessing your best reviewing IRB option, including whether:
    • Any state laws apply to your study and how IRB review must be conducted
    • Study interventions may require specific knowledge of local context to provide appropriate IRB review
    • Study sites have their own IRB/HRPP and, if not, what experience that site has with conducting human research, including qualified study personnel
• Budget considerations
  • While a commercial IRB may be the best option for your study, budgetary constraints may impact whether this is viable for your study.
    • Keep in mind that NIH will pay for sIRB review costs

For more information, see Appendix B- Single IRB Review Requirements.

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Engagement Determination

IRB oversight is required for UW-Madison or any other sites when they are determined to be engaged in human research per federal guidance and HRP-311-WORKSHEET-Engagement Determination. Assessing whether your study activities and/or those of any collaborators or external sites constitute engagement in human research can be challenging. We encourage you to contact RELIANT (irbreliance@wisc.edu) for assistance in determining whether UW-Madison and/or any external sites are engaged in human research before considering any sIRB arrangements.

Please keep in mind that interpretations of engagement guidance can vary across institutions. While RELIANT can assist you in making preliminary engagement determinations for sites or individuals not associated with an IRB, sites with an IRB will need to consult with their own IRB to determine whether they are engaged in human research.

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Multi-Site International Research

UW-Madison will often not be able to serve as IRB of record for sites or personnel in countries outside the US. Instead, review and approval by a review board or ethics committee in the country in which the research will be conducted should be obtained (a list of international standards on human subject protections can be found on the OHRP website ). In the event a review board and/or ethics committee is not available to review your study and/or does not review the type of research you plan to conduct, please contact RELIANT (irbreliance@wisc.edu) for assistance.

Additional information about international research can be found in HRP 103-Investigator Manual and HRP 336-WORKSHEET-International Research

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Community-Based Research Requirements

When working with a community partner (e.g., an individual or group employed or volunteering at a community organization and/or self-employed), the first step is to determine whether IRB oversight is required for these partners. IRB oversight is required if they are engaged in human research, as defined by federal guidance (see HRP 311-WORKSHEET-Engagement Determination for details). Whether a community partner is engaged in human research determines whether IRB oversight is even required.

A community partner may be engaged in research, for example, if they are:

• Collecting data (e.g., administering surveys)
• Administering study interventions (e.g., conducting focus groups)
• Consenting participants and/or
• Analyzing identifiable data

A community partner may not be engaged in research if, for example, they are:

• Serving as a location for study activities conducted only by UW-Madison personnel
• Providing recruitment flyers to potential participants
• Referring potential participants to the UW-Madison study team

If a community partner is engaged in human research AND the study is non-exempt, then all personnel involved in the research must have their study activities covered by an IRB. Typically, UW-Madison will provide IRB oversight in these situations. When preparing your application, you will need to include an IRB of record request for these individuals. Note that these external personnel must complete human research training and be listed on the IRB application. See other sections for information on how to list them and what human research training options are available.

A formal agreement between UW-Madison and the external individual is required pursuant to federal regulations. One of the following agreements will be used to document that UW-Madison is providing

IRB oversight for the external individual:

• For federally funded studies, an individual investigator agreement (IIA) is required. This agreement requires signatures from both the external individual and UW-Madison’s institutional official.
• For non-federally funded studies, a collaborating investigator summary (CIS) is required. This agreement does not require any signatures and is simply provided to the external individual.

In both cases, RELIANT will assist you in putting these agreements in place. NOTE: If the study likely qualifies for exemption, neither type of agreement is required.

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When UW-Madison Will Review for External Sites

Decisions about whether the institution can serve as the reviewing IRB are made in accordance with HRP 833-WORKSHEET-Considerations for Serving as sIRB as well as Appendices A: Q&A When UW Will Cede or Serve and B: Single IRB Review Requirements of this manual. The UW also may consider serving as the reviewing IRB in exceptional cases described in Appendix D: Unusual Circumstances, Serving and Ceding.

When proposing the UW serve as the reviewing IRB, study teams MUST consult with RELIANT prior to submitting grant or other funding applications. The UW cannot guarantee it will serve as the reviewing IRB without prior consultation. If the UW is not able to serve as the reviewing IRB, RELIANT will assist you in identifying another IRB that can serve as the single IRB.

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When UW-Madison Will Review for External Individuals

External individuals may need IRB oversight if they are engaged in human research for a non-exempt study and not affiliated with an entity with an IRB. In such cases, UW-Madison may agree to serve as their reviewing IRB. Decisions about whether the institution can serve as the reviewing IRB for external individuals who are not affiliated with an entity with an IRB/HRPP are made on a case-by-case basis per federal regulations and institutional guidance.

In some cases, though, UW-Madison IRBs will not serve as the reviewing IRB for external individuals when:

• UW-Madison, UWHC, or Madison VA faculty, staff, or students are not involved in the research;
• The IRB does not have sufficient knowledge of the local context (as required by federal guidelines) to assume IRB oversight for personnel that are requesting UW-Madison serve as IRB of record including personnel:
  • Located in states other than Wisconsin or international locations, particularly if external personnel will be performing study activities for which specific state law apply.
• The study qualifies for exemption.

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UW-Madison Serving as HIPAA Privacy Board

The institution’s IRB also serves as UW-Madison’s HIPAA Privacy Board. A HIPAA Privacy Board reviews requests for a waiver or an alteration of authorization for uses and disclosures of PHI. When serving as the reviewing IRB for external sites, the institution will typically agree to serve as Privacy Board for those sites, as applicable.

Even when the institution agrees to serve as Privacy Board for relying sites, those sites are responsible for adhering to their own institution’s HIPAA policies, including HIPAA security requirements. In addition, Privacy Boards only review requests for waivers and alterations of authorization. Review of authorization forms or language (if not included in a combined consent and authorization form) is the responsibility of the external site. This review will be completed by the relying site during the cede review process. (For information on how RELIANT works with relying sites, see the “Reliance Agreement Process” section.)

Please note that while UW-Madison considers pre-screening of medical records to determine eligibility to be preparatory to research and therefore not requiring a waiver of authorization, some institutions have a different interpretation and a waiver may be required. This is information the relying site typically provides to RELIANT during the cede review process.

For more information, see HRP-815-FORM-IAA Implementation Checklist.

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Fees and Budget Considerations

The institution does NOT charge fees to serve as the sIRB, whether for external sites or individuals. Since the institution, however, may not be the best sIRB option for your study, please be aware that commercial IRBs and some academic institutions do charge fees for IRB review. When planning your study – especially if it will involve a large number of sites and/or locations outside Wisconsin – you should consider whether you will need to use a commercial/independent IRB or an IRB at an academic institution that charges fees. The study team is solely responsible for paying any IRB fees, although NIH may pay direct costs for IRB review.

Study teams are encouraged to keep in mind that studies involving three or more sites will likely require additional staff support to manage coordination and communicating across sites as well as document management. This role is being called the “IRB Liaison” by many institutions and is typically a staff member who is part of the overall study/lead study team. This may be 0.1 – 1.0 FTE, depending upon the size and complexity of the study. See Appendix C for an example job description.

When working with a commercial/independent IRB as the lead site of a federally funded study, keep in mind that a protocol level submission (protocol review) may be made prior to having all sites and contracts in place. This review is limited to the overall protocol and does not approve sites. However, it is typically acceptable to federal funders as an IRB approval to be able to release additional funds to support further site submissions to the IRB of record.

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