HRPP awarded four areas of distinction during reaccreditation

The UNMC Human Research Protection Program, with the Institutional Review Board at the hub, has been awarded full reaccreditation by the Council on Accreditation of the Association for Accreditation of Human Research Protection Programs (AAHRPP).

The primary purpose of AAHRPP accreditation is to strengthen protections for research participants. AAHRPP accreditation indicates that the organization follows rigorous standards for ethics, quality, and protections for human research.

The process of reaccreditation began more than a year ago, with re-evaluation and revision of policies and procedures throughout the program. More than 1,600 pages of documents were submitted to and reviewed by AAHRPP. In preparation for the three day site visit, the Office of Regulatory Affairs conducted extensive education sessions for more than 50 IRB members, IRB administrators and staff, and investigators. Also involved were leaders and members of other committees and departments, including Sponsored Programs Administration, Pharmacy & Therapeutics Committee, Fred & Pamela Buffett Cancer Cencer Scientific Review Committee, which make up the program.

The council recognized UNMC’s strengths by awarding four areas of distinction:

• Creation of a rapid-response IRB in order to provide ethical review in a compressed timeline for research on special-pathogens patients. This demonstrates “a unique approach to integrating ethical review with the need to conduct ‘cutting edge’ research in the highly specialized environment of a potential national emergency,” the report said.
• Using an inclusive and comprehensive process for developing policies that address key procedural and ethical issues. This includes ongoing education of IRB members and the encouragement of free discussion and dissent;
• A Conflict of Interest Committee, which includes a community member as a voting member, to offer an outside perspective and encourage transparency;
• Additional components in the consent document to enhance informed consent and consideration whether or not to participate.

Chris Kratochvil, M.D., the HRPP institutional official responsible for ensuring compliance with federal regulations governing human subject research, lauded the efforts of the IRB leadership and staff.

“The feedback from the AAHRPP council speaks to the level of quality of UNMC’s IRB in their ability to provide ethical oversight in human protections on behalf of institution and investigators,” Dr. Kratochvil said.

Jennifer Larsen, M.D., vice chancellor for research, echoed Dr. Kratochvil’s praise.

“Accreditation is essential, but UNMC continues to be a leader in human subjects protection and we are privileged to have such an outstanding program,” she said. “Kudos to the entire team!”

Bruce Gordon, M.D., assistant vice chancellor for regulatory affairs and director of the UNMC Office of Regulatory Affairs, credited the IRB administrators and staff.

“They are an incredibly dedicated and talented group,” Dr. Gordon said. “They are customer focused and at the same time absolutely committed to the protection of human subjects. Their value to the research enterprise at UNMC cannot be over-estimated.”

Dr. Gordon also recognized the fundamental importance of “conscientious and responsible investigators for whom the rights and welfare of their subjects is of paramount importance.”