Write a Protocol or IRB Application for Studies Involving External Individuals

The study team must describe the role of external individuals (i.e., those not affiliated with an institution with an IRB or HRPP) in the study, including how they will be involved in any study interactions with participants (e.g., obtaining informed consent) or interventions (e.g., administering surveys). If external individuals (unaffiliated with an IRB/HRPP) will be conducting data or sample analysis for the study, you also should describe this in your protocol or application. Depending on their role in the study, external personnel may not be engaged in human research and not need IRB oversight. Nonetheless, their involvement in the study must be described in your protocol or application. For information about how to request UW-Madison serve as the reviewing IRB for individuals as well as training requirements, please see other sections in this manual.

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Write a Consent Template

As the lead study team, you will need to develop consent and other template documents. Each relying site enrolling participants will have its own consent and, if applicable, authorization documents and these will be based on the template documents you create. Template documents are created using UW-Madison template forms, which are later customized to develop site-specific forms including each site’s
institutionally required language.

To draft the consent template, start with the UW-Madison template form (HRP 502-TEMPLATE CONSENT DOCUMENT). If your study requires multiple consent and/or assent documents, then you need to create a template for each document. Relying site study teams will only be able to edit a few areas of the template to include their required institutional language. (Other edits may be allowed if the
relying site has, for example, language required by state law.) To indicate which areas of the consent template may be edited, include brackets or other placeholder text in the following:

• Contact information for the study team at the relying site
• Contact information for concerns or complaints about the research
• Costs to participants, if this will differ for relying sites
• Compensation for research-related injury

If a relying site requires a standalone authorization form rather than including that language in the consent document, start with the UW-Madison authorization template form (see the HIPAA website) UNLESS the relying site requires its own authorization form be used. (The IRB will accept site-specific authorization forms in lieu of following UW-Madison’s template, if required.) If your study requires multiple authorization documents, then multiple templates should be created.

Consent and authorization templates must be approved by the IRB before you can provide them to the relying site study team. Upload template consent (including combined consent/authorization) documents in the initial review application as follows:

• Protocol-Based and Non-Protocol-Based applications
  • Consent templates should be uploaded where indicated in the application. Please clearly label the document by including “TEMPLATE” in the name of the document. This will ensure that the template document is not stamped by the IRB.
• sIRB application:
  • Consent templates should be uploaded in response to the consent template question.
• For all application types, template authorization forms should be uploaded in the application where requested and clearly labeled by including “TEMPLATE” in the name of the document.

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Prepare and Submit Site-Specific Documents

After the template documents have been approved by the IRB, we recommend following the steps below. Please note, however, that each relying site may have a different process so these steps are only recommendations.

Step 1: Working with the relying site study team, create consent and, if applicable, authorization forms for each site. To create site-specific documents, the relying site study team will use the UW-Madison approved consent and, if applicable, authorization document templates. The relying site study team will:

• Revise the consent template using track changes to include its site-specific language in the three areas of the consent template with placeholder language. Generally, ONLY these three areas of the consent template can be revised by the relying site: contact information for the local PI and for local concerns or complaints about the research, study costs, and compensation for injury.
  • If the relying site requires additional revisions other than these three areas (e.g., to address state law requirements), the relying site IRB must contact RELIANT to discuss before proceeding. RELIANT staff will not review consent or authorization documents for relying site if they have extensive revisions and RELIANT has not been previously consulted.
  • If a standalone authorization form is required by the relying site, the relying site study team will revise the UW-Madison’s approved authorization document using track changes to include site-specific language OR provide an authorization document for the relying site using that site’s preferred format.

Step 2: The relying site study team should begin the cede request process at their institution. As part of this process, the relying site study team will provide its own IRB with the site-specific consent/authorization documents that you have created with them. The relying site’s IRB will then review the site-specific documents to ensure they meet its institutional requirements.

• If the relying site’s IRB has questions about the site-specific documents, these should be directed to that site’s study team. The relying site study team should consult with you – as the lead study team – in addressing questions raised by the relying site IRB.
• In the event the relying site’s IRB has significant concerns, you may contact RELIANT for assistance. (Do not ask the relying site study team to contact us directly; this will complicate communication moving forward.)
• Note: At this stage in the process, RELIANT and the relying site’s IRB are typically already in contact and working on any needed reliance agreement.

Step 3: After the cede request has been reviewed by the relying site’s IRB and it has indicated to their study team that the consent/authorization documents are acceptable, you will need to formally add the site to your study and obtain approval for site documents as follows:

• Protocol-Based and Non-Protocol-Based applications:
  • Submit an expedited change and upload the site-specific documents in the relevant pages of the application.
  • All changes to the approved template must be tracked.
• sIRB application:
  • Submit an “add a site” form for the site being added. Within that form, you will upload the site-specific documents where prompted.
  • All changes to the approved template must be tracked.

After UW-Madison’s IRB has approved the change to add the site and its documents, it will stamp the site-specific consent documents. As the lead study team, you are responsible for then distributing these documents to the relying site. Note: Subject enrollment at relying sites cannot begin until the consent-documents for those sites have been approved by the UW-Madison IRB and a reliance-agreement completed.

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How and When to Submit Requests for UW-Madison to Serve as the Reviewing IRB for Other Sites

To request that UW-Madison serve as the reviewing IRB for an external site, you must include this request in your IRB submission, whether via an initial review application or a change. Before submitting your application, please do the following:

• Ensure your study protocol or application describes the role of any external sites. See HRP 503-TEMPLATE-Biomdedical Protocol, HRP 503a – TEMPLATE – Registries and Repositories Protocol, the NIH clinical trial protocol template, and the NIH behavioral and social sciences protocol template for more information on how to include external sites/personnel in your protocol document.
  • A protocol is not required for the Non-Protocol-Based application (nPBA).
• Confirm that external study teams or individuals have consulted with their own IRB to a) ensure that the site would be willing to cede IRB review to UW-Madison and b) understand what steps are required to cede IRB review to UW-Madison. Every site has its own process for relying on another IRB. The reliance process goes more smoothly if you work with your collaborators to understand their site’s requirements in advance. The same process applies to individuals affiliated with an entity with its own IRB.

The IRB will typically use what is called a parent-child model for approving the main study and relying sites. This means that the overall study (including UW-Madison’s role in the study) is approved by the IRB first, with a list of relying sites approved in theory. After the overall study is approved, relying sites are formally approved via a change (see below) and a reliance agreement is put in place at that time. Note that for some studies involving one or two external sites or individuals (e.g., UPH Meriter), it may be more efficient for the sites to be approved with the initial review application if the sIRB application is not used.

Although where sites are listed in the application is similar, where the actual reliance process starts differs.

• Where to list sites in the initial application
  • For all application types, list external sites and individuals in the external collaborations section.
• Changes
  • For the regular initial review application, sites not formally approved as part of the initial review process need to be added via a change. With the change, you will need to upload the applicable site-specific study documents (e.g., consent documents).
  • For the sIRB application, approval for sites will not be finalized until add a site forms are submitted after the UW-Madison IRB approves the study. You will submit one add a site form for each site and upload site-specific documentation in the add a site form.

Upon submission of the request to add a site, RELIANT manages the process for securing the appropriate reliance agreement, including working with the relying site’s IRB. While the UW-Madison study team will need to work with the relying site’s study team on their request to cede IRB review and developing site-specific study documents, RELIANT will handle any communication with the relying site IRB. Please note we recommend not submitting a change to add a site until the relying study team has started the cede review process at their own institution. The reliance agreement process cannot begin until the relying site’s IRB has received a cede request from their study team and submitting a change before this has happened may cause unnecessary delays for your study.

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Submit a Request for UW-Madison to Review for External Individuals

The UW-Madison IRB may agree to serve as IRB of record for external personnel engaged in human research. For more information, see the When UW-Madison Will Review for External Individuals section.

To submit a request for UW-Madison to serve as the reviewing IRB for external personnel, please include this in your initial review or change of protocol as follows:

• When you reach the external collaborations section of the application:
  • In response to question 1.2, answer “Yes” to indicate you are requesting UW-Madison serve as the reviewing IRB for external sites or personnel.
  • In response to question 1.2.1, check the appropriate box(es) to indicate you are requesting UW-Madison serve as reviewing IRB for external individuals (e.g., people working with community organizations).
  • You will then be branched to the appropriate page of the application to provide details about the external personnel.
• Please note that you will need to upload human research and, if applicable, GCP training certifications in the application. For more information, see the “Training Requirements” section.
• RELIANT will assists you in getting the appropriate agreement with external personnel, allowing the UW-Madison to serve as their reviewing IRB.

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