This section of the Reliance Manual outlines how you can help with the reliance process each step of the way.
Choosing Collaborating Sites
RELIANT supports study teams by facilitating the reliance agreement process with other institutions. When the agreements are in progress, we track them closely and reach out to the other institution if the process is not moving efficiently. You also can play an important role in helping the process go as smoothly as possible.
An efficient reliance process depends in part on carefully choosing collaborating sites. Due to differences among institutional requirements as well as experience with reliance processes, some sites may take longer to onboard than others. If the success for your study depends on getting sites up and running as quickly as possible, you should assess whether the site and the local study team will be able to contribute to an efficient reliance process. Factors to consider include the following:
- Does the site have a process for ceding IRB review to an external IRB?
- You can find this information on the site’s IRB or HRPP website.
- Is the local PI actively involved in study preparation activities (e.g., working with you to get funding set-up at the site, responding promptly to your queries)?
- Lack of involvement and lack of good lines of communication early on can be a sign that the site will take some time to onboard.
- Does the local study team have regulatory support staff?
- If the regulatory work (e.g., development of site-specific study documents, submitting a cede application) will fall to the PI, this may slow-down the reliance process.
- Is the local study team experienced with their site’s process for ceding IRB review?
- If a study team is new to the process, you will likely need to support them as they work through the cede process at their site.
If any of your sites will not be academic institutions (e.g., community hospital or organization), encourage your potential collaborator to reach out to their IRB or human research administrator to determine if that site is familiar with ceding IRB review and has a process in place for doing so. We encourage you to contact us if you plan to work with these types of sites so we can assist you in determining whether and/or how to move forward.
After You Select Your Sites
After you select your sites, implementing your communication plan early to get lines of communication established typically ensures the add a site process will go more smoothly. These early communications can help you identify any trouble spots (e.g., delays in funding, turnover in regulatory staff) and address those promptly. You can also encourage your collaborators to reach out to their IRB/HRPP to discuss the cede review process so those sites are ready to move forward as soon as your overarching study is approved.
After the Study is Approved
After your overarching study is approved, reach out to your sites to find out if they are ready to move forward with submitting a cede request at their institution. If so, provide them with the UW approved consent and other study templates so the local site can revise them to meet their site-specific requirements. They will need to submit these documents with their cede request so you may need to provide assistance as they put these together.
When the local site study team either submits or is close to submitting their cede request, you should submit the change or add a site form to the UW-Madison IRB. Closely coordinating the timing of these submissions will help RELIANT and the relying site IRB approve the site more quickly. On the other hand, if a site is not yet ready to submit its cede request, do not submit the change or add a site form at UW-Madison. Neither RELIANT nor the relying site IRB can move forward with a reliance agreement until the relying site study team has submitted or is close to submitting a cede request.