HUMAN RESEARCH PROTECTION PROGRAM or Welcome! If you are a Principal Investigator or research staff, an Institutional Review Board (IRB) member, or involved in any way in the design, conduct, review, approval, education or facilitation of human research at UGA, then you are a part of UGA’s Human Research Protection Program (or HRPP), and this presentation is for you. This presentation will introduce you to the concept of an HRPP, how it came about, and specific information about UGA’s HRPP.

History and Background Emerged in late 1990s and early 2000s IRB review and approval is not enough Studies of the IRB system Death in an IRB-approved study The concept of an HRPP first emerged in the late 1990s and early 2000s in response to two studies of the IRB system, and the tragic death of a research participant in an IRB-approved study. The two studies, separately conducted by the then Government Accounting Office and by the Inspector General of the Department of Health and Human Services, arrived at the same conclusion that the IRB oversight system was flawed and in need of revision. Shortly after these investigations were published, Jesse Gelsinger died while participating in research at the University of Pennsylvania. His death in an IRB- approved research study at one of the most prestigious research institutions in the country also highlighted the flaws in the IRB system. It became apparent that IRB review is not enough to ensure the ethical conduct of research and safety of research participants. The IRB’s role is important but what is required is an overall program for the protection of human subjects where responsibility is shared by the entire institution –– a Human Research Protection Program (HRPP).

What is an ? A Human Research Protection Program (HRPP) is a comprehensive and organized system to ensure the protection of human subjects participating in research. The HRPP is based on shared responsibility and accountability. It is only by having an effective HRPP that an institution can fulfill its ethical responsibility in ensuring the protection of human subjects who volunteer in research. At UGA, the HRPP is a campus-wide integrated effort of all components that participate in the conduct, review, approval, education, quality improvement, and facilitation of human research to ensure that UGA complies with applicable federal, state, and local regulations and requirements. As such, this includes principal investigators (PIs) and their research team members and University leadership.

What is “not” an ? Is not an office Is not limited to the IRBs and Human Subjects Office (HSO) Accreditation is for the HRPP The UGA HRPP is not an office. The HRPP is not limited to the Institutional Review Boards(IRBs and the Human Subjects Office (HSO). It is UGA’s HRPP which is seeking AAHRPP accreditation, not the IRB.

Mission and Aims of UGA’s HRPP To protect the rights and welfare of research subjects Compliance with applicable ethical and regulatory standards Belmont Report Federal regulations (OHRP, FDA) Apply to all research regardless of funding To help facilitate research at UGA Resources Support Education The central charge of UGA’s HRPP is to protect the rights and welfare of research subjects by promoting compliance with the applicable ethical and regulatory standards including the Belmont Report, and the regulations set by the federal Office for Human Research Protections (or OHRP) and the Food and Drug Administration (or FDA). The ethical and regulatory requirements of the HRPP apply to all human research regardless of funding. Another equally important aim of the HRPP is to help facilitate research throughout UGA by providing resources, support and education. To accomplish these goals, it is essential for all members of the research community to utilize these offerings through UGA’s HRPP.

UGA HRPP Components HRPP Institutional Leadership Human Subjects Office IRBs Sponsored Projects Administration Investigators and Research Team HRPP COI Deans and Department Chairs UGA’s HRPP is comprised of all persons and departments engaged in the planning, design, review, conduct and administrative support of any research involving human participants. At UGA, the HRPP is supported by the Office of Research but a number of different individuals, departments, units, and offices contribute to the program including the principal investigators and their research team that are engaged in human research, the academic units (Deans and Department Chairs), the two IRBs at UGA, the institutional leadership, the Sponsored Projects Administration, the Office of the Legal Counsel, and the conflict of interest review committee (COI). The Human Subjects Office facilitates communication/coordination throughout the HRPP and serves as liaison between the HRPP and the other components. However, in order to ensure that the university is able to meet the requirements for the protections of human subjects, active participation and collaboration is required of all stakeholders across all these components, especially the faculty, staff, and students involved in the research because ultimately, it is the investigator and his/her team who are responsible for the ethical conduct of the research. Legal Counsel

https://research.uga.edu/docs/policies/compliance/hso/HRP-101-Human-Research-Protection-Program-Plan.pdf UGA has an HRPP Plan that describes UGA’s commitment to comply with the ethical and legal requirements for the conduct of human research, and detailed information about its scope, purpose, and mission, as well as the various components, authorities and responsibilities associated with the HRPP for the research community at UGA. It is available at https://research.uga.edu/docs/policies/compliance/hso/HRP-101-Human-Research-Protection-Program-Plan.pdf.

For additional information and resources on UGA’s HRPP, visit https://research.uga.edu/hrpp/.

Thank you! Thank you for viewing this presentation. Please view also the presentation on the HRPP accreditation process which is available at https://research.uga.edu/docs/units/hso/Presentation-AAHRPP-no.2.pptx.