Reliance Determination Form

When multiple institutions are engaged in human subjects research, it is important that the OHSP understands the roles and responsibilities of each site to provide administrative support to Investigators and simplify the IRB reliance submission process. The purpose of the IRB Reliance Determination Form is to determine if the Single IRB (sIRB) process should be implemented for a multi-site research study. This form should be completed by the UTD PI or appropriate study personnel prior to submission via Cayuse.

Please note: It is recommended that an individual from the study team (UTD or non-UTD personnel) contact the non-UTD institution(s) to confirm if they are willing to enter into a reliance agreement for this research. All institutions must agree to participate to proceed with the Single IRB review / approval process.

For questions about this form or the Single IRB process, please contact the Office of Human Subjects Protections (OHSP).

Reliance Determination Process

UTD investigators who plan to submit an initial study that involves human research performed at more than one site, or who plan to be a sub-contracted site on a proposal submitted by a non-UTD investigator, must submit the IRB Reliance Determination Form. Once submitted, the OHSP will review the form within one week. Each submission is reviewed individually to determine whether the UTD IRB is appropriate to serve as the Reviewing IRB for the proposed multi-site or collaborative study, or if IRB oversight should be ceded to a non-UTD institution.

The main evaluation criteria consist of:

• The risk level of proposed research
• Number of participating sites
  • Please note: Per OHSP Policy, UTD may serve as the Reviewing IRB for up to 3 non-UTD study sites.
• The location of participating sites
  • UTD oftentimes will not be able to serve as the Reviewing IRB for sites or personnel in countries outside of the US. Instead, review and approval by a review board or board of ethics in the country in which the research will be conducted should be obtained (a list of international standards on human subjects protections can be found on the Office of Human Research Protections website).
• Funding
• Other considerations such as the involvement of an IND or IDE, vulnerable populations, biospecimens, COI, etc.

After reviewing the IRB Reliance Determination Form, the OHSP will contact the investigator to request any necessary additional information and provide guidance on whether UTD will cede IRB oversight to the non-UTD institution or serve as the Reviewing IRB.

It is recommended that UTD investigators submit the IRB Reliance Determination Form well in advance as coordination with collaborating institutions may require additional time.