26. Responsibilities: RIO Director and Staff
Roles and Responsibilities of the RI Director
Through broad delegation of authority from the VPRI, the RI Director is responsible for oversight and day-to-day management of human research protection at the University.
The RI 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 RI Director identifies new IRB members. She/he may be assisted by the University Faculty Senate, the Vice President for Research and Innovation, IRB Chairs, and University and Affiliate administrators.
The RI Director appoints and evaluates the Chair and Vice Chair. In appointing the Chair/Vice Chair, the Director considers IRB experience, knowledge/understanding of regulatory requirements, professional expertise, and the needs of the IRB based on the type of research the IRB reviews.
The RI 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 IRB, 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 IRB on emergent issues;
- serves as primary reviewer of exempt research when the investigator indicates there may be a conflict of interest (COI) to determine if the research qualifies as exempt or requires review by the convened IRB;
- previews-non-exempt research when the investigator indicates there may be a COI to assess the relatedness of the COI to the research and when warranted, ensures the project/package is reviewed by the convened IRB;
- when the University relies on an external IRB, ensures the external institution and the IRB meet the relevant accreditation standards; and
- guides RI 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 IRB 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
- ensuring ethical standards are met for exempt research involving human subjects.
As a member of the University's IRB, 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 are satisfactory. 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 RI 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
RI staff assign IRB members as primary, secondary, and expedited reviewers as appropriate for the type of research or submission being reviewed.
RI staff notify IRB members of changes in policies, researcher forms, and review worksheets through announcements at IRB meetings but also through direct correspondence when relevant to a specific review or project.
RI staff notify the Sponsored Projects of IRB approval for exempt and non-exempt sponsored research that involves human subjects.
RI staff who are responsible for quality improvement/quality assessment (i.e., QI/QA Officer) assist the director in ensuring the University, the IRB, 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.)
RI staff who coordinate submissions determine if additional approvals are required. For example, approvals may be required from internal or external committees (e.g., biosafety/radiation safety committees) or oversight bodies (e.g., VA, PRS Committee, school districts); or federal sponsors (e.g., EPA, DoD). When additional approvals are required, RI staff confirm the review results are available in IRBNet. RI staff ensure exempt or IRB approval are not finalized until the requirements for additional approvals are satisfied and documented.
RI staff who are voting members of one or both of the University's IRB when they have the relevant expertise review submissions for new projects, and amendments and continuing reviews for approved projects. In this capacity, RI staff are responsible for insuring that all requirements for IRB approval are met.
RI 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.
RI 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.
RI staff notify the RI Director of COI identified in exempt forms or IRB applications.
Director and Staff Responsibilities for Research Involving Data Sharing
When University or Affiliate investigators plan to conduct exempt research that involves providing data/specimens to or obtaining data/specimens from an external entity, AND the data-set includes Protected Personally Identifiable Information or Protected Health Information (see the online Policy Manual Definitions), the Director or staff reviewing the exempt application must confirm the following before approving the research:
- The submission includes a fully-executed research agreement that specifies the responsibilities of both the Data Provider and the Data Recipient.
- The research agreement confirms that the Data Provider complied with DHHS requirements for informed consent as it relates to the use of the data/specimens as specified in the agreement.
Director and Staff Performance Evaluations
The RI Director and staff are subject to the University requirements for comprehensive annual employee performance reviews according to staff positions as Administrative Faculty or Classified Staff.