IRB Administrator

About the position Position Purpose The Reliance Administrator works under the general direction of the Reliance Team Lead Operations (R-TOL) to support the review of multi-site and collaborative research trials where the UW is serving as the reviewing IRB. Position Complexities The IRB Reliance Administrator must understand many complex regulatory and ethical issues and how they apply to UW research. The position requires balancing the need to assure the UW’s compliance with state laws and several different sets of federal regulations with the need to facilitate research and with ethical considerations. This requires high-quality independent conceptual thinking that is aligned with the general perspective of HSD, analysis, and problem-solving. Daily work involves making judgment calls in ambiguous situations and applying a multi-faceted understanding of the concepts of “risk” and “engagement.” Daily contact with researchers requires diplomatic, professional, and timely interactions based on concise, accurate, and intelligible communication that must usually be documented in writing. Almost all responsibilities require extensive reading. The IRB review process and reliance agreement process use an electronic web-based system, which requires individuals to be comfortable reading on a screen rather than paper and to easily switch back and forth between multiple screens to obtain and synthesize information. Position Dimensions and Impact to the University HSD is a service and compliance unit within the Office of Research. It reports directly to the Assistant Vice Provost for Research Integrity. HSD, and the IRBs it manages, perform the federally required confidential institutional management and review of research activities involving human subjects that are conducted by UW faculty, staff, and students as well as researchers from a few other local or affiliated institutions. There are about 9500 human research studies at the UW. The research is remarkably diverse. It is distributed across almost every department and academic unit, including the Bothell and Tacoma campuses. It may occur anywhere in the world; a significant percentage of UW research occurs outside of the U.S. The ability of the University to receive grants and to conduct human research depends upon ensuring compliance with federal and state regulations. The IRB Reliance Administrator is responsible for adhering to and promoting best practices and compliance for UW human subjects research. This includes management of regulatory relationships with non-UW IRBs as well as non-UW institutions and researchers who are participating in UW research; and coordination with some non-IRB regulatory requirements such as clinical trials registration and financial conflict of interest review. This position is primarily responsible for establishing and managing regulatory relationships with non-UW IRBs across the United States who will review UW research as well as with non-UW institutions and individuals (participating in UW research) for whom the UW IRB will provide regulatory review and oversight.

Responsibilities

• Review and approve reliance requests for non-UW IRB review of UW research (instead of the UW IRB). The review requires evaluation of requests against established criteria and may also involve drafting agreements using established templates, reviewing other non-UW institutional templates to ensure HSD-required elements are present, and communicating with non-UW IRB staff, researchers, and other administrative offices to negotiate any changes. Coordinate these agreements with other compliance and regulatory requirements. Provide UW local context to other IRBs. Document outcomes and communicate decisions to researchers. May require coordination with other UW (e.g., Office of Sponsored Programs, Clinical Trials Office) and non-UW offices (e.g., IRB, institutional offices) as appropriate. Ongoing management includes reviewing proposed changes to the research, assisting researchers with meeting the terms of the reliance, and management or triage of reports of research-related noncompliance, unanticipated problems, inquiries, and complaints.
• Review and approve reliance requests for UW IRB review of research on behalf of non-UW institutions. The review requires evaluation of requests against established criteria, preparing some requests for formal approval by a member of HSD’s management team, and may also involve drafting agreements using established templates, reviewing other non-UW institutional templates to ensure HSD-required elements are present, and communicating with non-UW IRB staff, researchers and other administrative offices to negotiate any changes. Coordinate these agreements with other compliance and regulatory requirements. Obtain local context from relying institutions. Document outcomes and communicate decisions to HSD staff and researchers. May require coordination with other UW (e.g., Office of Sponsored Programs, Clinical Trials O

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