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26. Responsibilities: RIO Director and Staff

Through broad delegation of authority from the VPRI, the RIO Director is responsible for oversight and day-to-day management of human research protection. In this capacity, the RIO Director

  • ensures regulatory requirements at (§46.103(b)(4) and §46.103(b)(5) are met for written policies and procedures;
  • informs the University research community of current regulatory and policy requirements, and training opportunities through the website and electronic correspondence, and upon request;
  • provides guidance to the IRBs on emergent issues;
  • assists with the recruitment and retention of IRB chairs and members;
  • ensures consistency across the two University IRBs; and
  • guides RIO staff in implementing their respective duties related to
    • maintaining the operational functions of the Office,
    • managing submissions from investigators,
    • coordinating activities of the University's IRBs including expedited and full-board reviews,
    • providing training and education to researchers as individuals and in groups,
    • coordinating community outreach activities,
    • maintaining complete and accurate documentation of IRB decisions and related correspondence,
    • responding promptly to reports of noncompliance or unanticipated problems,
    • conducting quality assessment and improvement activities,
    • managing applications for projects that do not constitute human subjects research, and
    • insuring ethical standards are met for exempt research involving human subjects,

The RIO Director submits an annual report and proposed budget to the VPRI to describe the previous year's activities and to allow the VPRI to evaluate the adequacy of resources for the HRPP. The report provides summary information and an assessment of resources for

  • office space;
  • RIO personnel;
  • training and education for investigators, RIO staff, and IRB members;
  • use of legal counsel;
  • conflicts of interest;
  • the QA/QI program including activities (e.g., internal and external reviews, complaints, reportable events);
  • community outreach activities;
  • IRB chair and member performance, relationships with affiliates, including the VA, and use of external IRBs; and
  • IRB performance metrics including number of submissions by IRB and review type, and number of active protocols by level of review and University department.

The RIO director and staff may serve as members of one or both of the University's IRBs and as such, are responsible for insuring that all requirements for approval are met for new protocols, modifications, and continuing reviews.

RIO staff who are IRB members have the authority to make "not-human-subjects-research" determinations and to approve research projects that are exempt from IRB review.

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