The IRB Administrator is part of the Human Subjects Division and supports the University of Washington’s IRBs. The HSD workforce/team is a community of diverse disciplines, professional fields, and areas of expertise who manage and/or conduct the confidential institutional review and approval process of proposed research activities involving human subjects at the UW and some affiliated institutions. The purpose of the review is to protect the safety, rights, and welfare of research subjects and to ensure institutional compliance with federal and state regulations and University policy.
The IRB 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 at least five different sets of federal regulations with the need to facilitate research and with ethical considerations. To successfully accomplish this, the individual must be: (1) comfortable with making judgment calls in ambiguous situations; (2) highly organized at tracking and prioritizing work; (3) outstanding attention to detail; (4) able to write and speak in concise, accurate, and intelligible manner; (5) able to work independently with minimal supervision; (6) analytical and have problem-solving skills; (7) diplomatic and have professional interpersonal skills; (8) able to work well as part of a team; (9) have computer proficiency including MS Word, Excel, internet browsers, and email.
Duties and Responsibilities:
IRB reviews (40%)
Independently conduct and document expedited IRB reviews of human subjects research (new applications, modifications, periodic continuing reviews), according to all applicable federal and state criteria for approval, as independently identified by the reviewer. Includes making decisions about whether waivers of specific regulatory requirements are appropriate and allowable under the applicable regulations.
Oversight and guidance of IRB committee reviews (15%)
Oversee and guide reviews conducted by the fully convened IRB committee for research that involves more than minimal risk. For each set of application materials, this includes: (1) Rigorous pre-review screening of all materials and interaction with the research team to identify for the IRB all regulatory issues and determinations; ensure that the materials provide all information required for the IRB to makes its decisions; and identify whether a consultant is needed to supplement the IRB's expertise; (2) Brief and advise the IRB on the application materials, issues, and regulatory requirements; (3) Write review letters to the researcher that succinctly, accurately, and intelligibly communicate the IRB's determinations, questions, and conditions of approval; (4) Accurately capture for required meeting minutes the IRB's decisions, determinations, vote tallies, and controverted issues; (5) Verify on behalf of the IRB that its conditions of approval have been met by the research team; and (6) Serve as an alternate voting member of the IRB. This participation is limited to infrequent substitutions as needed and appropriate when IRB meeting requirements will not otherwise be met.
Regulatory determinations (30%)
Independently make and document numerous required regulatory determinations about proposed research and scholarly activities, including: identification of activities requiring IRB review; identification of which participating groups must be considered human subjects; whether the activity is eligible for use of the UW IRB; required type of IRB review; and identification of all applicable state and federal regulations.
Consultation and training (10%)
Provide direct consultation, education, and problem-solving through phone calls, in-person meetings, and classroom presentations to UW faculty, research staff, residents/fellows, and students about specific planned research and/or about human subjects research ethics, regulations, and review processes. May include assistance with developing "review-ready" applications and permission/assent/consent forms. Educational activities are delivered as part of HSD's broader system of education and training, and do not generally involve independent development of educational materials and programs outside of that system.
Other duties as required (5%)
Examples include: organizational effectiveness activities; participation in the development or revision of policies, procedures, and forms; training interactions with new HSD staff.
Minimum Qualifications · Bachelor's degree in sciences, healthcare, communications, or art's & sciences and 4-5 years’ work experience · Human subjects research review/oversight; · Interaction with human subjects as a research staff person; · Any position involving the application of complex regulatory systems to individuals and work activities; · Experience with research ethics and methodologies.
As a University of Washington (UW) employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world.
UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.
The oversight of human subjects research and protection of research participants is strongest and most successful when performed in an open culture and framework that values and embodies diversity, equity, and inclusion. The Human Subjects Division (HSD) expects its leaders, supervisors, staff, and Institutional Review Board members to be guided by this fundamental principle. The HSD community flourishes when a diverse group of people work together to fulfill its mission.