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.