UW Research

Responsibilities of the Lead Study Team

As part of the grant preparation process, the overall PI for a multi-site study that will use a single IRB (sIRB) should identify who will take on the role of the Lead Study Team. This may be the PI’s own study team, a coordinating center, both, or a Contract Research Organization (CRO).

Contents

New responsibilities

The Lead Study Team has responsibilities associated with the use of a sIRB. You can find a list of many of these described in the Overall Principal Investigator/Lead Study Team Guidance and Checklist provided by SMART IRB.

Adequate attention to these new responsibilities is essential for realizing the potential efficiencies of using a sIRB. The lead PI should carefully consider the staffing of the Lead Study Team when constructing the grant budget.

IRB Liaison

HSD anticipates that studies with more than a handful of sites will require significant additional staffing resources to manage the complex communications, coordination, and document management associated with the use of a sIRB across sites. This role is being called the “IRB Liaison” by HSD and many other institutions. It is typically a staff member on the Lead Study Team. This may be 0.1 – 1.0 FTE, depending upon the size and complexity of the study. Review the template Communication Plan for Single IRB Review provided by SMART IRB for a description of the key communication roles related to sIRB review.

HSD has developed the basics of a job description to assist with filling this role. HSD is available to advise on individual study needs; send your request to hsdrely@uw.edu.

Working Position Title: IRB Liaison

UW Professional Staff Payroll Title: Research Coordinator Read full description

Estimated Full Time Equivalent (FTE): Depends upon the complexity of the study and the number of sites. HSD estimates that 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.

Salary Range: $75K+ (not including benefits)

Summary of job duties:

The IRB Liaison will work directly with the lead site PI as part of the lead site team in order to facilitate and coordinate IRB review and other compliance requirements across all participating sites of a multi-site clinical trial. The IRB Liaison will serve as a central hub for communication among sites as well as between the sites, the IRB and other compliance offices. This liaison will serve as the primary point of contact between the reviewing IRB and the overall study.

Primary duties may include:

    • Understand and communicate the policies and processes of the reviewing IRB, 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 reviewing IRB
    • 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
    • Facilitate the continuing IRB review for the entire study by collecting information from all sites and submitting it to the reviewing IRB
    • Serve as an intermediary between the reviewing IRB 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 reviewing IRB
    • Assist the participating sites with responding to IRB requests
    • Plan IRB and other regulatory approval timelines and troubleshoot challenging situations
    • Coordinate the payment of IRB fees by the lead site

May require travel in order to accomplish job duties, e.g., when assisting a participating site in responding to an inspection request from the reviewing IRB.

Qualifications:
Because this is a crucial role that requires a complex set of skills, the most qualified individuals will have significant regulatory experience related to multi-site studies and/or clinical trials. This person needs a strong knowledge of the regulatory requirements for single IRB 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 biomedical regulatory affairs
    • Project management experience or certification

For grant applications

HSD suggests this sample language for the Key Personnel or Budget Justification sections of the grant application.

TBN, Research Study Coordinator/IRB Liaison
Effort = 12.0 months calendar (100% FTE) in Years 1-5 [adjust FTE & years to match the study]

A Research Study Coordinator will be hired to serve as the IRB Liaison for all participating sites in order to facilitate the complex and time-sensitive communications among sites, and between the participating sites and the single IRB (sIRB). Under the direction of the Lead PI, the IRB Liaison will facilitate and coordinate IRB approval and related regulatory compliance activities for all participating sites. This includes serving as an intermediary between the sIRB and the sites in order to: (1) establish reliance agreements; (2) facilitate timely initial review, modifications, and continuing review; and (3) establish and maintain communication plans among all stakeholders to ensure consistency among IRB-approved consent forms, other materials, and procedures among all sites.