26. Responsibilities - Research Integrity & Security Director and HRPP Staff

Updated July 24, 2026

Through broad delegation of authority from the Vice President for Research and Innovation (VPRI), the Research Integrity & Security Director is responsible for leadership and oversight of the University’s human research protection program (HRPP). The HRPP Manager is responsible for operational management of the HRPP. The Research Compliance Officer manages the HRPP’s Quality Assurance/Quality Improvement Program. Research Compliance Program Coordinators provide comprehensive administrative and regulatory support to the HRPP.  General responsibilities of each position are as follows. A full list of each position’s responsibilities is available in the position’s job description.

Responsibilities of the Research Integrity & Security Director

The Research Integrity & Security Director (Director) is responsible for leadership and oversight of the HRPP. The Director establishes an environment conducive to ethical and compliant research by working with the Institutional Official to ensure the HRPP has sufficient resources, and maintaining institutional accreditation with AAHRPP and Federal-wide Assurance with the U.S. Department of Health and Human Service Office for Human Research Protections (OHRP). The Director reviews and approves new HRPP policies and procedures, as well as substantive revisions to current policies and procedures.

The Director is responsible for informing the Institutional Official and University administrators of compliance issues, audits, conflicts, and emergency situations.

The Director supervises the HRPP Manager and Research Compliance Officer, and in consultation with the Institutional Official, evaluates the IRB Chair and Co-Chair.

Responsibilities of the HRPP Manager

Functioning as a subject matter expert, the HRPP Manager (Manager) oversees the operational administration of the University’s human research protection program and supervises Research Compliance Program Coordinators. In addition to performing the tasks of a Coordinator, the Manager has the authority to lead the development of policies and procedures to align the HRPP with regulatory requirements and accreditation standards. The Manager prepares and submits required regulatory reports to federal agencies and accreditation bodies, as well as leads inspections and program review activities.

In collaboration with the Director, the Manager establishes short- and long-range program goals, evaluates operational effectiveness, and implements program improvements as needed. The Manager advises the Director when additional resources are needed.

In collaboration with the IRB Committee Chairs and HRPP staff, the Manager recruits and trains new IRB members, including Chairs and co-Chairs, develops procedures to improve committee efficiency and member satisfaction, and evaluates committee members’ performance. The Manager provides guidance to the Director and IRB members on emergent issues and provides training to IRB members in areas in which the Manager is a subject matter expert. When the IRB or Manger lacks expertise on a particular area research, the Manager is responsible for identifying subject matter experts to advise the board.

When the University relies on an external IRB, the Manager ensures the external institution and the external IRB meet the relevant accreditation standards, as well as institutional and local requirements.

The Manager collaborates with the COI Designated Official to manage conflict of interests related to human research projects.

Responsibilities of the Research Compliance Officer

The Research Compliance Officer (Compliance Officer) manages the HRPP’s Quality Assurance/Quality Improvement program. The Compliance Officer provides ongoing monitoring of compliance and quality improvement initiatives, including performing random and directed audits of protocols and HRPP operations, to ensure compliance with relevant regulations and policies. The Compliance Officer reviews all unanticipated problems, deviations, and exceptions reported by investigators or others, and provides recommendations to the IRB Chair pursuant to IRB policy regarding necessary actions.

The Compliance Officer collaborates with the HRPP Manager to collect data for the University’s annual report to AAHRPP, to complete internal self-evaluations and other materials required for AAHRPP accreditation, and to prepare responses to AAHRPP following accreditation renewal evaluations. 

The Compliance Officer collaborates with the HRPP Manager in identifying departmental patterns regarding HRPP compliance issues; investigates HRPP related problems and complaints; and prepares detailed reports to the Director and IRB Chairs on the results of investigations. The Compliance Officer develops and implements proactive compliance strategies aimed at reducing the number of directed audits and other compliance issues.

The Compliance Officer may conduct post-audit monitoring of project activities to verify and promote the ethical and compliant conduct of human subjects research.

The Compliance Officer helps ensure an environment conducive to ethical and compliant research by assisting with the training and orientation of new IRB members and HRPP staff, and participating in outreach activities to the University research community.

Responsibilities of Research Compliance Program Coordinators

Research Compliance Program Coordinators (Coordinators) provide comprehensive administrative and regulatory support to the institution’s HRPP. Coordinators provide support to researchers throughout the protocol submission and review process, provide support to the IRB, participate in outreach activities, and contribute to compliance with HRPP AAHRPP accreditation and OHRP assurance.

Responsibilities of Coordinators include:

• Assisting researchers with the protocol submission process, including technical support with the submission software, identifying protocol and training deficiencies, and communicating remediation requirements.
• Identifying and processing protocol submissions that can be administratively handled without IRB review.
• Making determinations of “Not Human Subjects Research”.
• Reviewing and approving research projects that are exempt from IRB review.
• Assigning primary, secondary, and expedited reviewers for protocols that require IRB review.
• Facilitating reliance agreements between compliance committees of external institutions.
• Providing administrative support to the IRB by scheduling meetings, preparing agendas, distributing materials, facilitating meetings, accurately recording committee actions, preparing meeting minutes, and communicating committee decisions to researchers.
• Assisting with the recruitment, onboarding, and training of new IRB members.
• In collaboration with the Manager and Compliance Officer, developing and presenting training materials and outreach activities to the research community.
• Delivering continuing education presentations and trainings at convened IRB meetings.
• Assisting with reporting obligations to federal agencies and accrediting agencies.
• Identifying and reporting non-compliance concerns to the Manager, and assisting with investigations into compliance concerns
• Coordinators may also serve as voting or alternate members of the IRB, and conduct Expedited reviews, depending on experience.

HRPP Staff Training

Orientation

All new HRPP staff will undergo in-office orientation training conducted by senior staff that includes an overview of pertinent electronic systems as well as the following information:

• DHHS regulations (45 CFR 46)
• IRB Policy and Procedure Manual;
• FDA regulations (21 CFR 50 and 56);
• Belmont Report;
• University Conflict of Interest Policy;
• HIPAA;
• IRB Forms and Templates.

Observation of IRB Meetings

New HRPP staff are also invited to observe IRB committee meetings as an opportunity to further familiarize themselves with regulatory and policy requirements, and institutional procedures.

Continuing Education

HRPP staff will receive, on an ongoing basis, continuing education related to human research protection issues and requirements via attendance of webinars, workshops, and/or conferences (e.g., offered by PRIM&R, AAHRPP, or other organizations) and completion of relevant courses (e.g., offered by CITI Program or other vendors).

Director and Staff Performance Evaluations

The Research Integrity & Security Director, HRPP Manager, Research Compliance Officer and Research Compliance Program Coordinators are subject to the University requirements for comprehensive annual employee performance reviews according to staff positions as Administrative Faculty or Classified Staff.