This section of the Reliance Manual covers responsibilities for the UW-Madison PI and study team, relying site responsibilities, lines of communication, training requirements, and letters of cooperation.

UW-Madison PI & Study Team Responsibilities

When the institution agrees to serve as the reviewing IRB for external sites or personnel, the UW-Madison study team must follow relevant UW-Madison requirements and assume several responsibilities, including, but not limited to:

  • Contacting RELIANT (irbreliance@wisc.edu) to:
    • Discuss whether UW-Madison can act as the single IRB for all or some institutions or personnel participating in this study or whether another external IRB would be appropriate.
      • Consultation with RELIANT is required before study teams submit a grant or other funding application when UW-Madison is being proposed as the single IRB. If study teams have not consulted with RELIANT, UW-Madison cannot guarantee it will agree to serve as the single IRB.
    • Identify who will act in the role of the Lead Study Team (e.g., your own study team, a coordinating center). Due to the additional responsibilities that a Lead Study Team assumes, an IRB liaison may need to be hired. To review a sample job description language, please see Appendix C: IRB Liaison Job Description.
    • Provide RELIANT with details about the study, including the study-wide protocol and template consent document(s), which will help facilitate the discussion of single IRB review options.
  • Identify all sites that will be engaged in human research.
  • If the institution agrees to serve as the sIRB, the UW-Madison study team must:
    • Include the relevant reliance request in the IRB application and protocol.
    • Work with the IRB and RELIANT to determine specific roles and responsibilities for communicating key information to relying sites, including developing a communication plan (i.e. regular conference calls, site initiation). For template communication plans, see HRP-830-WORKSHEET-Communication and Responsibilities or SMART IRB template communication plan.
    • Promptly respond to questions from relying site study teams and IRB/Human Research Protection Program personnel.
  • When preparing the UW-Madison IRB application, the UW-Madison study team must:
    • Obtain from the relying site study team information regarding how the study will be
      conducted at that site if different from the study-wide protocol (e.g., recruitment processes may differ among sites). See HRP-811-FORM-Basic Site Information. This form does not need to be submitted to the IRB; rather it is a tool to assist you in collecting and tracking information for relying sites.
    • Assist relying site study teams in ensuring consent documents for that site use the approved UW-Madison template and is revised to include applicable site-specific required language for that site.
  • Provide relying sites with links to UW-Madison HRPP policies.
  • Provide relying site study teams with the IRB-approved versions of all study documents (e.g., consent and authorization forms, protocol, recruitment materials).
  • Notify site investigators of all IRB determinations.
  • In coordination with the IRB and RELIANT, promptly notify the relying site study team of any unanticipated problems involving risks to subjects or others or significant subject complaints that may affect subjects at the relying site, including potential impact on willingness to continue study participation.
  • If the study requires continuing review, the UW-Madison study team must notify relying site study teams of any lapse in IRB approval and, if applicable, any resulting corrective action plans.
  • Promptly notify relying site study teams of any change in the continuing review requirement for the study.
  • Provide access, upon request, to study records for audit by relying sites.

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Relying Site Investigator Responsibilities

The lead study team must provide the forms below to the relying site study team. The relying site study team is then responsible for completing and returning the following documents to the lead study team at initial review:

  • Site-specific study documents, such as consent and authorization forms and recruitment
    materials.

The documents below are tools that you as the lead study team may use to collect information from the relying site. The relying site study team would then be responsible for completing and returning the relevant document to the lead study team; these tools would be for your reference only and do not need to be submitted to the IRB:

Each relying site remains responsible for ensuring safe and appropriate performance of the research at their site. Relying site study teams are responsible for following their own institution’s process and requirements for relying on an external IRB, including completion of locally required ancillary reviews.

The relying site study team also is responsible for coordinating closely with you as the lead study team and promptly responding to your communications with them. For more information, see SMART IRB’s Relying Site Investigator Checklist.

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Letters of Cooperation

When studies are conducted in whole or in part at sites external to the institution, study teams may need to provide a letter of cooperation from those sites. The purpose of a letter of cooperation is to document that the site is aware of the research and supports its participation in the study. NOTE: This does not apply to studies conducted in K-12 settings. See the Investigator Manual for details.

  • When and For What Types of Sites May Letters of Cooperation Be Needed?

    Letters of cooperation typically need to be submitted for the following types of sites when study activities beyond recruitment and/or consenting of participants will occur at that site:
    • Sites that do not have an IRB or other committee or group (e.g., ethics committee, research review committee, etc.) reviewing the study; AND
    • For which UW-Madison is not serving as the reviewing IRB.
      • For sites that meet the above criteria, letters are needed for studies that are:
        • Federally funded;
        • FDA-regulated; and/or
        • Involve the access or disclosure of protected health information held by the external site.
  • Are Letters of Cooperation Needed for Other Types of Sites or Studies?

    Even if not required, we recommend that you obtain permission from sites at which study activities will be conducted (including recruitment), to ensure the site is aware and supportive of the research. These kinds of permissions do not need to be provided to the IRB.
  • Who Should Write the Letter of Cooperation?

    A letter of cooperation should be signed by someone at the site who can provide permission for that site to be involved in the study (e.g., director or head of community center or organization, manager of a pharmacy). The letter of cooperation should not be signed by a member of the study team conducting research at the site.
    • Template Language
      • A letter or email of cooperation can be brief and should include the following elements:
        • Study title
        • A brief description of the research and/or activities to be conducted at the site
        • Person or entity providing permission (including title, contact information, and confirmation of appropriate authority to provide permission)
        • For studies involving access to or disclosure of protected health information held by that site, the following statement should be included: I also understand that if the IRB has granted a waiver of authorization, [name of entity] may rely on that waiver in using or disclosing PHI. If any PHI will be disclosed pursuant to the waiver, [name of entity] must account for such disclosures.

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Lines of Communication

Multisite studies involve communication among many stakeholders and, as a lead study team, you will be responsible for developing clear lines of communication. Therefore, when you are planning a multisite study for which UW-Madison will serve as the reviewing IRB, one of the most important documents you need to create is a communication plan. A robust communication plan helps ensure that your collaborations with relying sites will run as smoothly as possible. The communication plan needs to be included in your study protocol or, for non-protocol based studies, uploaded in your IRB application. For guidance on developing this plan, see HRP 830-WORKSHEET-Communication and Responsibilities. The purpose of a communication plan is to clearly outline the roles of the four main groups involved in multisite studies:

  • Lead study team (including the lead PI)
  • Relying site study team (including a local PI)
  • Reviewing IRB (UW-Madison when serving as the sIRB)
  • Relying site IRB/HRPP

Some of the elements of a communication plan include:

  • Who provides IRB documentation to relying sites as well as how and when
  • How changes to the overall study and/or sites will be prepared and submitted
  • Management of continuing review information
  • Plan for handling reportable events

Please keep in mind that while RELIANT provides support to UW-Madison study teams navigating reliance and institutional requirements for human research, we cannot answer questions from relying site study teams about their own institutional requirements or IRB submission processes, including how to request IRB review be ceded to UW-Madison. We encourage you to work closely with your collaborators to ensure they are in contact with their own IRB early in the reliance process; this will help make the review process move more efficiently.

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Training Requirements for External Personnel

External personnel must complete required training before the institution can serve as their reviewing IRB.

  • External Sites: Personnel affiliated with an academic institution or other organization with an IRB or FWA must complete human protections training as required by their institution. The relying site’s HRPP is responsible for ensuring its personnel have completed the training required by their institution. Training certificates do not need to be provided to the UW-Madison IRB.
  • External Individuals: Personnel affiliated with an organization without an IRB or not affiliated with any entity (e.g., independent consultant) must complete human participant protection training and, if applicable, Good Clinical Practice (GCP) training. Training certificates will need to be uploaded in the IRB application for external individuals. For more information on training for external personnel, please see the HRPP Training Options for External Personnel page. In rare cases, external individuals may also need to complete the following training:
    • HIPAA Training: External individuals for whom the institution is serving as the reviewing IRB and will use or disclose PHI must complete UW-Madison HIPAA training. For more information, see the HIPAA training website.
    • Conflict of Interest (COI) Disclosure and Training Requirements for NIH Funded Studies: If your study is funded by NIH AND external personnel (whether affiliated with a site or not) will be a subrecipient of the NIH award, NIH COI requirements may apply. We recommend consulting with campus COI staff to determine what requirements may apply in these circumstances.

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