Studies involving more than a handful of sites require significant additional staffing to manage the complex communications, coordination, and document management associated with the use of a single IRB (sIRB) across sites. This person serving this role is commonly referred to as an “IRB Liaison” and is typically a staff member on the lead study team. Generally, the lead study team is is designated by the Overall Principal Investigator of the study to work in collaboration with the sIRB, ensure coordination of communication to and from all study teams relying on sIRB, routing all IRB submissions to the sIRB and communicating IRB determinations to study teams.
The IRB Liaison may be 0.1 – 1.0 FTE, depending upon the size and complexity of the study. See the template Communication Plan
for Single IRB Review for a description of the key communication roles related to sIRB review, in which the IRB liaison often has a key role.
Study teams may find the broad job description below helpful when putting together staffing for larger multisite studies, especially when thinking about a personnel that may need to be budgeted for in a grant. If you have questions about the IRB liaison and the needs for your specific study, please contact the Health Sciences IRBs Reliance Team (email@example.com).
Working Position Title: IRB Liaison
Estimated Full Time Equivalent (FTE): Depends upon the complexity of the study and the number of sites. Most studies with 10 or more sites will require 1.0 FTE dedicated to this role. Smaller studies may be able to combine this role with another role, such as general study coordination or regulatory support.
Summary of job duties: The IRB Liaison will work directly with the lead site PI as part of the lead site study team to facilitate and coordinate IRB review and other compliance requirements across all participating sites. The IRB Liaison will serve as a central hub for communication among sites as well as between the sites, the sIRB and relying institution contacts (often in local IRB offices), and other compliance offices.
Primary duties may include:
- Understand and communicate the policies and processes of the sIRB, and be familiar with the research and the sites
- Work with the sites and their research compliance or IRB offices to establish reliance agreements with the sIRB
- Coordinate the timing of initial review and modifications across all sites
- Assist the participating sites with completing and submitting materials to the reviewing IRB, which may include preparing and submitting all materials on their behalf
- If required, facilitate the continuing review for the entire study by collecting information from all sites and submitting it to the sIRB
- Serve as an intermediary between the sIRB and the participating sites
- Obtain local context considerations (e.g., a state’s age of majority) for each site and ensure that the information is provided to the sIRB
- Assist the participating sites with responding to sIRB requests
- Plan IRB and other regulatory approval timelines and troubleshoot challenging situations
Qualifications: The most qualified individuals will have significant regulatory experience related to multi-site studies and/or clinical trials. This person needs strong knowledge of the regulatory requirements for sIRB review and must be able to nimbly respond to changes in the implementation of this new policy across many different institutions. They also need to have enough scientific and regulatory background to understand the study and anticipate other regulatory and institutional requirements that may apply at each site and affect the IRB process (e.g., Radiation Safety review, Institutional Biosafety Committee review, etc.). The IRB Liaison will need to establish relationships and maintain close communications with a wide variety of people and offices quickly. Outstanding demonstrated ability to communicate quickly and effectively with a wide range of stakeholders is strongly recommended.
Suggested Additional Qualifications:
- Specific education or training in regulatory affairs
- Project management experience or certification