UGA’s Human Research Protection Program ramped up & ready to serve
UGA’s Human Research Protection Program (HRPP) earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPPs) four years ago and was reaccredited earlier this year. This designation is given only to institutions that have demonstrably built extensive safeguards into every level of their human research operations and that adhere to high standards for such research, so it is a well-deserved recognition of significant time, thought and energy spent by our HRPP leaders and team, including our many volunteer committee members. Congratulations and a big thank you to UGA Human Subjects Office Director Kim Fowler and all our HRPP staff and faculty, who worked tirelessly to ensure a smooth and successful review process.
At UGA, we strive to engage in greater levels of research involving human participants, especially clinical and translational research that help our discoveries make real impact in the health of people in Georgia and beyond. This is evidenced by our growing participation in the Georgia Clinical and Translational Science Alliance, for example, a National Institutes of Health-supported initiative, support for which recently was renewed for another five years, a $73.7 million award, including institutional commitments.
To meet this aspiration, we need an HRPP that not only has effective measures built in for the protection of human participants, but also one that operates at a level of efficiency and service that meets the needs of our investigators, whether they’re engaged in educational research, social-behavioral studies, consumer behavior research, clinical work or any of the myriad other types of human research.
Supporting and investing in our Human Subjects Office is an Office of Research priority. The AAHRPP accreditation process helps us continually improve and promote excellence with human research programs; for example, when our HRPP was reaccredited just a few months ago, AAHRPP suggested that we monitor and periodically assess two areas:
· Our quality improvement plan related to compliance (e.g. alignment of approved protocols/plans with the actual processes of implemented protocols) and the HRPP’s quality, efficiency and effectiveness
· Outreach activities designed to enhance the understanding of human research by participants, prospective participants or their communities, and which promote the involvement of community members (when appropriate) in the design and implementation of research and the dissemination of results. In other words, we want and need the participants to partner with us to help identify and solve real-world, relevant problems. We want our work to be impactful!
Led by Director Kim Fowler, UGA’s HRPP has fully recovered from pandemic-related staffing shortages. In fact, new positions allowed an exciting reorganization; the office now has an embedded team of professionals to provide one-on-one or group assistance to prepare submissions for Institutional Review Board review or to respond to Institutional Review Board (IRB – the committee that reviews methods proposed for biomedical or behavioral research to ensure they are ethical) requests for clarifications. This Protocol Assistance and Compliance Team, or PACT, offers personalized support through scheduled appointments, as well as educational presentations to classes or groups upon invitation.
If your work involves or could involve human subjects, we need your input. To assist in making our HRPP offerings as helpful as possible, please provide your feedback! Please take a few moments to visit our website and complete this survey (look for the survey link midway down the page), which is also being distributed through multiple campus listservs. Your opinions will help ensure that we can be as efficient and effective as possible and meet your needs.
Regarding outreach activities, the HRPP is working with both investigators and campus communications offices to determine how we can more effectively share our results and connect with communities around our human research. These include the participants themselves, the broader Athens-Clarke County community and the more dispersed populations that may benefit from the work we do.
If you have a passion for debugging and optimizing, we could use your help. The HRPP is seeking volunteers for a task force to evaluate existing resources (e.g., the IRB submission portal application, HRPP website and training presentations) and identify ways to engage our community in the prioritization, design and implementation of research projects and dissemination of results.
Task force members will meet via Zoom, review and provide input on existing policies and materials via document sharing, and help identify webinar topics for future outreach efforts. The anticipated time commitment for task force members is eight hours, spent between late October and mid-January. To volunteer, please contact Kim at email@example.com.
A culture of ethical human research is vital and means that we all pledge to protect the rights and welfare of human research participants and uphold responsibilities, such as conducting research as approved by the IRB and openly communicating about research so potential volunteers can make informed decisions about participating. I’m proud of the efforts of all the people who contribute to our HRPP, who worked so tirelessly and creatively during the pandemic to keep UGA human subjects research operating.
I’m also confident that, in partnership with the investigators and communities they serve, our HRPP will reach new heights and facilitate even greater levels of impact for UGA biomedical and behavioral research in Georgia, across the country and around the world.
Karen J. L. Burg
Vice President for Research
Harbor Lights Chair in Biomedical Research