The Assistant Vice President of Human Research Administration is responsible for the Human Research Protections Program (HRPP), which includes the following offices: Institutional Review Board (IRB), Participant Advocacy, Regulatory Affairs Support, and Regulatory Monitoring at the University of Texas Southwestern Medical Center (UTSW). The individual is responsible for assuring regulatory compliance for all issues involving the ethical conduct and protections of research participants, and achieving the HRPP mission in protecting the rights, safety and welfare of individuals that participate in research
Key responsibilities include planning, developing and implementing processes, systems, educational programs and other activities in collaboration with other institutional research offices. This position provides guidance and support to researchers to ensure the safety of human subject research participants as required by applicable laws, regulations, and University policies, and Association for the accreditation of Human Research Protection Programs (AAHRPP) standards regarding human subject research.
Experience and Education
Master’s degree required with ten (10) years progressively responsible, experience that is directly related to the duties and responsibilities specified, to include at least three (3) years in the oversight and leadership of human research within a large and complex academic medical center. CIP (Certified IRB Professional) certification required.
The following are required: 1) Prior HRPP management or IRB experience; 2) Knowledge of AAHRPP standards and accreditation requirements; 3) Knowledge of HIPAA regulations and state laws governing privacy; 4) Working knowledge conducting audits and investigations in a research setting, and working with regulatory agencies.
- Acts as the primary liaison with federal and state agencies on human research protection issues.
- Oversees administration and research compliance applicable to the Office for Human Research Protection Program (OHRP), Food and Drug Administration (FDA) regulations, federal funding agency requirements, state law and University policies during IRB reviews, monitoring reviews, and administrative reviews.
- Consults with federal agency staff, as necessary, regarding the interpretation and implementation of guidelines. Interpreting and applying federal, state and local regulations, policies and procedures related to human subject research.
- Serving as the Human Protection Administrator (HPA), acts as the steward of UTSW’s Federal-Wide Assurance (FWA) with OHRP; maintaining institutional assurances, registration and approvals needed for human research. Guides and provides strategic direction and support to the Institutional Official for the IRB panels in preparation of reports to oversight agencies, renewals of assurances and communications with accrediting organizations.
- Develops, implements and communicates policies, procedures and systems that assure the integrity of the institution, protect the safety and welfare of employees and research subjects, and promote compliance with regulations governing human research protections. Monitor and respond to regulatory changes in the research environment.
- Serves as the primary resource to the University on research involving human subjects from a regulatory and ethical point of view.
- Advises the University research community on federal regulations and institutional policies and procedures to ensure institutional compliance with the ethical and regulatory requirements for human subject research. Working collaboratively with investigators, departments, centers and cores to find creative ways to advance research goals while meeting compliance needs and challenges.
- Collaborates with the University’s research administration, quality, audit, and compliance offices on clinical research matters, as appropriate. Offices include, but are not limited to, Office of Clinical Research, the Office of Sponsored Programs Administration, the Office of Compliance, Internal Audit, and Conflict of Interest Office.
- Collaborates with the University’s hospital partners, other academic research institutions and community organizations in managing human subjects research and maintaining good working relationships with those organizations.
- Lead regular HRPP steering committee meetings of HRPP component leadership.
- Maintains AAHRPP accreditation status. This includes managing the AAHRPP re-accreditation application and site visit processes.
- Ensures the use of best practices to support investigators for compliance with the ClinicalTrials.gov program
- Oversees the institution’s Research Privacy Boards (IRBs) and research privacy oversight according to HIPAA regulations for research.
- Develops and manages the budget within department budget guidelines. Oversees budget expenditures and scheduling.
- Implements and oversees an ongoing educational and training program for faculty and staff relating to conducting research involving human participants in partnership with Office of Clinical Research.
- Leads, manages, and oversees regulatory functions and activities for the human research activities and to ensure compliance with applicable laws, regulations, policies, and procedures related to governing agencies, including documentation, resolution and federal reporting.
Institutional Review Board Office:
- Responsible for administration of the IRB panels, including, but not limited to, administration of the pre-review, initial and continuing human subject research protocol review, managing IRB membership, OHRP IRB membership roster as required by regulation.
- Functions as the convened Research Privacy Board for UTSW and affiliates complying with regulatory oversight according to HIPAA regulations for research.
- Manages the single patient/emergency use program to ensure appropriate regulatory requirements are met.
- For collaborative research, manages IRB reliance agreements for institutions relying on UTSW as the IRB of record as required by regulations (sIRB). Assisting the IRB on overseeing studies deferred to the UTSW IRB.
- For collaborative research, manages third party IRB reliance agreements and oversight of UTSW research when it is deferred to external (central) IRBs in compliance with the FWA.
- Responsible for regulatory analysis and documentation for all human research studies and non-research and non-human research activities.
- Responsible for administration of the Institutional Quality Improvement Committee.
- Provides scientific, regulatory and ethical consultation to faculty, research teams, staff and IRB members, including assistance with protocol development and feasibility assessments, in coordination with HRPP leadership.
- Provides oversight for the ongoing work of the IRBs on human subject research including administrative operations.
- Ensures appropriate documentation and reporting of IRB actions, and maintain records and correspondence related to IRB activity in accordance with applicable law and accreditation standards.
- Provides orientation and continuing education to IRB members and research community.
Regulatory Monitoring Office:
- Performs routine study monitoring and for-cause study audits.
- Performs routine QA assessment of IRB and HRPP processes and recommend improvements when needed.
- Performs periodic reviews of eIRB data and update the system as needed.
- Provides reports on monitoring activities and events of noncompliance to the Institutional Official for presentation at the Executive Compliance Committee meeting.
- Provides orientation and continuing education to IRB members and research community.
Participant Advocacy Office:
- Receives and manages participant complaints. Prepares reports for complaints and shares reports with HRPP leadership as required. Coordinates with other UTSW offices such as Compliance, Internal Audit, Risk Management, Patient Assistance, etc., as required, addressing complaints to the satisfaction of the participant. Assist investigators with modifications of studies to address concerns raised by participants as needed.
- Manages UTSW participant outreach website and social media accounts. Participate in Community Outreach and Engagement Committee to ensure consistent outreach messaging from UTSW.
- Manage translations of participant materials.
- Review informed consent documents to ensure acceptability from layperson perspective.
- Plans, coordinates and completes participant outreach activities.
Regulatory Affairs Support Office:
- Provides assistance to investigators with compliance with clinicaltrials.gov registration and updates as required by federal regulations and policies. This assistance includes registration, changes, annual updates, and final results.
- Provides assistance to investigators before, during, and after FDA audits of their research studies. Develops tools, templates, manuals, and oversees investigator responses to the FDA when a 483 is issued.
- In collaboration with the Office of Clinical Research, provide support for Sponsor-Investigators to ensure compliance with FDA requirements. This includes start-up meetings, tracking, reminders, and assistance with FDA communication.
- Provides training to the research community regarding regulatory requirements and processes to maintain compliance.
- Other Duties: Performs other duties as assigned.
Knowledge, Skills & Abilities
- Work requires good organizational skills.
- Work requires effective communication skill