26. Responsibilities: RIO Director and Staff
Roles and Responsibilities of the RIO Director
Through broad delegation of authority from the VPRI, the RIO Director is responsible for oversight and day-to-day management of human research protection at the University.
The RIO Director is authorized to sign all documents relevant to the review and approval of human subject research projects (e.g., waivers of HIPAA authorization), including documents submitted for post-approval monitoring (e.g., IND safety reports that are not unanticipated problems; notifications from external IRBs). NOTE: Electronic signatures procured via IRBNet require access through secure login procedures and are therefore considered valid.
The RIO Director
- ensures regulatory requirements at (45CFR46.103 items (b)(4) and (5) are met, including requirements for written assurance with OHRP through its FWA, designation and registration of the University IRBs, IRB rosters, and written policies and procedures for the review, oversight, and reporting of human research;
- 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
- when the University relies on an external IRB, ensures the external institution and the IRB meet the relevant accreditation standards;
- guides RIO staff in implementing their respective duties related to
o maintaining the operational functions of the Office,
o managing submissions from investigators,
o coordinating activities of the University's IRBs including expedited and full-board reviews,
o providing training and education to researchers as individuals and in groups,
o coordinating community outreach activities,
o maintaining complete and accurate documentation of IRB decisions and related correspondence,
o responding promptly to reports of noncompliance or unanticipated problems,
o conducting quality assessment and improvement activities,
o managing applications for projects that do not constitute human subjects research, and
o ensuring ethical standards are met for exempt research involving human subjects.
As a member of both of the University's IRBs, the Director reviews and approves submissions for new projects, and amendments and continuing reviews for approved projects. In this capacity, the Director is responsible for insuring that all requirements for IRB approval are met and investigator responses to IRB requested revisions. As an IRB member, the Director also makes "not-human-subjects-research" determinations; reviews and approves research projects that are exempt from IRB review; and acknowledges requests to rely on an external IRB.
The Director may assign IRB members as primary, secondary, and expedited reviewers as appropriate for the type of research being reviewed.
The RIO Director also submits an annual report and proposed budget to the VPRI. The report includes a summary of the previous year's IRB activities and an evaluation of the adequacy of resources for the HRPP.
Roles and Responsibilities of the RIO Staff
RIO staff assign IRB members as primary, secondary, and expedited reviewers as appropriate for the type of research or submission being reviewed.
RIO staff who are responsible for quality improvement/quality assessment (i.e., QI/QA Officer) assist the director in ensuring the University, the IRBs, and investigators comply with applicable regulations, laws, and policy; and in evaluating and improving the University's HRPP. (For details, see Quality Improvement Program in the online IRB policy manual.)
RIO staff who are voting members of one or both of the University's IRBs review submissions for new projects, and amendments and continuing reviews for approved projects. In this capacity, RIO staff are responsible for insuring that all requirements for IRB approval are met.
RIO staff who are voting members of the IRB review and approve investigator responses to IRB requested revisions when projects and packages are approved with conditions.
RIO staff who are voting members of the IRB have the authority to make "not-human-subjects-research" determinations, review and approve research projects that are exempt from IRB review, and acknowledge requests to rely on an external IRB.