26. Responsibilities - Research Integrity & Security w88 and Staff

Updated w88 31, 2024

Roles and Responsibilities of the Research w88 & Security w88

Through broad delegation of authority from the Vice President for Research and Innovation (VPRI), the Research Integrity w88 is responsible for oversight and day-to-day management of human research protection at the University.

The Research w88 & Security w88 is authorized to sign all documents relevant to the review and approval of human research projects (e.g., waivers of HIPAA authorization), including documents submitted for post-approval monitoring (e.g., Investigational New Drug 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 Research w88 & Security w88 identifies new IRB members. She/he/they may be assisted by the University Faculty Senate, the Vice President for Research and Innovation, IRB Chairs, and University and Affiliate administrators. Concurrence for the new member’s appointment from the Institutional Official (IO) is received and documented by invitation letter executed by his office for all new members. Veterans Affairs (VA) Representative member appointment is endorsed and documented by VA w88’s letter of appointment prior to solicitation of the VA employee for IRB membership by the w88.

The Research w88 & Security w88 (with consultation with the IO) appoints and evaluates the Chair and Co-Chair. In appointing the Chair/Co-Chair, the w88 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 Research w88 & Security w88:

• ensures regulatory w88 at 45 CFR46.103 are met, including requirements for written assurance with the Office for Human w88 Protections (OHRP) through its Federalwide Assurance (FWA), designation and registration of the University IRB, IRB rosters, and written policies and procedures for the review, oversight, and reporting of human w88;
• informs the University research community of current regulatory and policy requirements, changes to such requirements, and training opportunities through the Research w88 & Security website, the VPRI list serve, other electronic correspondence, and upon request;
• provides guidance to the w88 on emergent issues;
• serves as primary reviewer of exempt w88 when the investigator indicates there may be a conflict of interest (COI) to determine if the w88 qualifies as exempt or requires review by the convened IRB;
• previews non-exempt w88 when the investigator indicates there may be a COI to assess the relatedness of the COI to the w88 and when warranted, ensures the project/package is reviewed by the convened IRB;
• when the University relies on an external w88, ensures the external institution and the w88 meet the relevant accreditation standards; and
• guides Research w88 & Security w88 in implementing their respective duties related to:
  • maintaining the operational functions w88 office, including adequate resources for support w88 operations,
  • managing submissions w88 investigators,
  • coordinating activities of the University's w88 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 w88 decisions and related correspondence,
  • responding promptly to reports of noncompliance or unanticipated problems,
  • conducting w88 assessment and improvement activities,
  • managing applications for projects that do not constitute human w88, and
  • ensuring ethical standards are met for exempt w88 involving human participants.

As a member of the University’s IRB, the w88 reviews and approves submissions for new projects, and amendments and continuing reviews for approved projects. In this capacity, the w88 is responsible for ensuring that all requirements for IRB approval are met and investigator responses to IRB requested revisions are satisfactory. As an IRB member, the w88 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 w88 may assign IRB members as primary, secondary, and expedited reviewers as appropriate for the type of research being reviewed.

The Research w88 & Security w88 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 Human Research Protection Program (HRPP).

Roles and Responsibilities of the Research w88 & Security w88

Research w88 & Security w88 assign IRB members as primary, secondary, and expedited reviewers as appropriate for the type of research or submission being reviewed.

Research w88 & Security w88 notify IRB members of changes in policies, researcher forms, and review worksheets through announcements at IRB meetings, correspondence with contact persons at each affiliate institution, and through direct communications when relevant to a specific review or project.

Research w88 & Security w88 notify Sponsored Projects of IRB approval for exempt and non-exempt sponsored research that involves human participants.

Research w88 & Security staff who are responsible for quality improvement/quality assessment assist the w88 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 policies in the online IRB policy manual.)

Research w88 & Security w88 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, Research Integrity & Security w88 confirm the review results are available in IRBNet. Research Integrity & Security w88 ensure exempt, or IRB approval are not finalized until the requirements for additional approvals are satisfied and documented.

Research w88 & Security w88 who are voting members 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, Research Integrity & Security w88 are responsible for ensuring that all requirements for IRB approval are met.

Research w88 & Security w88 who are voting members of the IRB review and approve investigator responses to IRB requested revisions when projects and packages are approved with conditions.

Research w88 & Security w88 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.

Research w88 & Security w88 notify the Research Integrity & Security w88 of COI identified in exempt forms or IRB applications.

w88 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 dataset includes Protected Personally Identifiable Information or Protected Health Information (see the online Policy Manual Definitions), the w88 or staff reviewing the exempt application must confirm the following before approving the research:

• The submission includes a fully executed w88 agreement that specifies the responsibilities of both the Data Provider and the Data Recipient.
• The w88 agreement confirms that the Data Provider complied with Department of Health and Human Services (DHHS) requirements for informed consent as it relates to the use of the data/specimens as specified in the agreement.

w88 and Staff Performance Evaluations

The Research w88 & Security w88 and staff are subject to the University requirements for comprehensive annual employee performance reviews according to staff positions as Administrative Faculty or Classified Staff.