IRB Analyst ll, Research Reliance

Job Description Summary

Office of Human Research ( OHR ) supports The George Washington University research community in the conduct of innovative and ethical research by providing guidance, education, and oversight for the protection of human subjects. The IRB Analyst ll, Research Reliance is responsible for the oversight, implementation, and management of the reliance process and relationships between the GW IRB and external IRBs (institutional and commercial), including the administrative and analytical review and processing of reliance agreements, independent investigator agreements, and memorandums of understanding. This position will develop policies, guidelines, and procedures related to the reliance process; serve as key liaison/point of contact during the reliance process between the GW IRB , GW researchers, and external institutions/IRBs, including relationships utilizing the sIRB model.

This position will exercise independence and discretion in managing relationships with external organizations and processing reliance agreement documentation. This position will develop educational materials and serve as a resource in outreach sessions and in meetings with research teams about the reliance agreement process.

GOALS : To develop and solidify GW OHR reliance policies and procedures. To present to GW researchers and external institutions/researchers a clear, consistent, and transparent reliance process. To serve as an educational resource and expert to the GW research community regarding the reliance agreement process.

DUTIES AND RESPONSIBILITIES : Determines eligibility to rely on external reviewing IRBs based on institutional policies and standard operating procedures. Reviews and manages requests from GW researchers to rely on an external IRB ; ensures GW researchers have completed and submitted the required reliance forms, that GW researchers have completed their required training, and that GW required information, if applicable, is incorporated into the local consent forms approved by the reviewing IRB and performs routine follow-up as needed to minimize delays. Submits reliance agreements to the GW institutional official for final review and signature, and/or processes the agreement through SMART IRB or IREx.

Conducts reviews of applications for relying sites overseen by the GW sIRB, in compliance with all applicable federal, state, and local regulations as well as institutional policies, procedures, and guidelines. Reviews and manages requests from external institutions to rely on the GW IRB ; reviews reliance forms to assure that the required information has been completed and submitted and verifies that GW training requirements have been met by the relying sites. Ensures that site-specific consent language is included in the GW IRB approved consent forms as applicable (such as payment for injury, HIPAA ).

Meets with GW researchers, OHR Staff, and external organizations to develop a clear reliance agreement plan and foster and promote collaboration with external organizations. Solicits local context information and requirements from external participating sites; when GW is reviewing sIRB, identifies requirement(s) for review by the ancillary committees, or communication or coordination with other departments, groups, or individuals within the institution that share responsibility for human subject protections. Reviews and manages requests from independent investigators to rely on the GW IRB ; reviews reliance forms to assure that the required information has been completed and submitted and verifies that GW training requirements have been met by the independent investigators when appropriate.

Maintains GW OHR reliance documentation, files, and logs; reviews and acknowledges updates to reliance agreements, including changes in personnel (internal and external). For reliance agreements where GW is IRB of Record, verifies finalized agreements are in place and are kept up to date. Assists with the preparation of budget estimates when the GW IRB acts as the reviewing sIRB.

Serves as the primary liaison for GW investigators relying on external IRBs and for investigators at sites relying on the GW IRB for sIRB oversight in multi-site research. Tracks external IRB initial and post-approval reviews; updates records for reporting purposes; requests information from reviewing IRBs, as needed. Establishes and manages a process to oversee research projects reviewed by a commercial IRB .

Creates a process for running metrics and assessments of the reliance portfolio. Interprets and applies federal and state regulations, and institutional policies, relevant to human research and reliance agreements. Communicates areas of improvement and growth to GW OHR staff and GW researchers with the goal of improving the reliance process.

Approves administrative and procedural modifications. Advises and provides guidance to GW OHR