Penn State Human Research Protections Program reaccredited; all standards met

By A'ndrea Elyse Messer
June 10, 2015

UNIVERSITY PARK, Pa. -- The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) has given Penn State full reaccreditation for the next five years.

"It is gratifying to be recognized for the consistently excellent work performed by all of the people involved in the Human Research Protections Program across the University," said Candice Yekel, associate vice president for research. "The cooperation and collaboration required to attain and maintain AAHRPP accreditation is superb and proves that together we are striving to constantly improve human research protections at the University and in the community at large."

Accreditation is a complicated process that includes preparing extensive documentation, intensive review by AAHRPP, university responses and multiple individual and group interviews.

"Step one is to submit all the policies and procedures of the HRPP and additional supporting documentation related to AAHRPP accreditation standards," said Sara Horn, assistant director, Office for Research Protections. "We show how we meet these standards."

The reaccreditation process started in early 2014 and concluded last November with site visits lasting two and a half days. This process involves not just the Office for Research Protections, the Human Subjects Protections Office and the Institutional Review Boards, but other university personel including staff, researchers and IRB members representing each of the many components of the HRPP across all campus locations.

"During the site visit, the visitors compare what is in our documentation with actual practice," said Josy Lyons, assistant director, Office for Research Protections. "They also do a records review, looking at the records of the Institutional Review Boards, including study protocols and the records of other HRPP components."

All researchers at the university who conduct research with human subjects must submit for approval from the Institutional Review Boards. This includes research in many domains, including medical, educational and other types of social and behavioral research.

"There are federal regulations governing human subjects experimentation that must be followed, but AAHRPP accreditation is voluntary," said Kathy Hay, director, Human Subjects Protections Office. "Institutions that want to demonstrate that they are meeting and exceeding the requirements seek accreditation."

AAHRPP completed their visit with zero findings, meaning that the university met all applicable accreditation standards. The final report indicates "the HRPP leadership was committed to engaging all stakeholders of the HRPP in a thoughtful and systematic approach to the review and improvement of the program. This approach created a culture of buy-in and transparency with the research community that contributed significantly to the success of recent and ongoing substantial changes in the HRPP." They end with the statement "All standards were met."

This accreditation process was made a bit more difficult because of the recent installation of a new electronic protocol management system, which necessitated coordinating records from both the old and the new system.

"AAHRPP accreditation demonstrates Penn State's leadership and devotion to the highest standards of clinical research and affirms to participating patients and families that we are committed to protecting their well-being and safety," said Sheila L. Vrana, Interim Vice Dean for Research and Graduate Studies, Interim Associate Vice President for Health Sciences Research, Associate Dean for Research and Associate Professor of Pharmacology, Penn State College of Medicine. "Many thanks go out to those who shared our commitment to reach the ethical and professional standards required to achieve this recognition."

(Media Contacts)

Last Updated June 24, 2015