Pediatrics research
Dr. Ken Lucas, right, checks Sam Rosebrock of Morganton, N.C., at the University of Louisville’s Kosair Charities Pediatric Clinical Research Unit. Sam is a patient in a cancer vaccine research study. The Human Subjects Protection Program at UofL that oversees patient participation in clinical trials has earned reaccreditation from the Association for the Accreditation of Human Research Protection Program.

Research involving human subjects at the University of Louisville continues to follow the most stringent ethical and professional guidelines in existence, as evidenced by the UofL Human Subjects Protection Program earning reaccreditation by the Association for the Accreditation of Human Research Protection Programs.

The UofL Human Subjects Protection Program Office (HSPPO) was awarded full accreditation for the maximum period allowed, five years. The HSPPO was the first such program in Kentucky accredited by the association when it received its original accreditation in 2005.

“Accreditation by the Association for the Accreditation of Human Research Protection Programs means that people who volunteer to participate in research studies are assured that the highest standards of professionalism are maintained,” said William M. Pierce Jr., PhD, executive vice president for research and innovation.

“We are proud of our staff in each of our research programs who work diligently to protect participants in research studies and maintain compliance with all regulations that govern research involving human subjects.”

An independent, non-profit accrediting body, the Association for the Accreditation of Human Research Protection programs (AAHRPP) uses a voluntary, peer-driven, educational model to ensure that facilities conducting research with human participants meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence — through policies, procedures, and practices — of their commitment to scientifically and ethically sound research and to continuous improvement.

More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process. Sponsors and other funders recognize that AAHRPP-accredited organizations have more efficient operations, provide more comprehensive protections and produce high-quality data.

At UofL, the Human Subjects Protection Program Office helps to ensure that research involving human participants is conducted in accordance with federal and state regulations and university and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants.

HSPPO upholds this commitment to the protection of human participants involved in research regardless of the funding source or location of the research. HSPPO supports two established and independent Institutional Review Boards (IRB), which review and approve protocols for all research involving human participants, the Social/Behavioral/Educational IRB on UofL’s Belknap campus and the Biomedical IRB on the Health Sciences Center campus.