AAHRPP gives full accreditation to Syracuse University’s human subjects research protection program

Sara Miller
(315) 443-9038

The Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) has granted Syracuse University full accreditation for its human subjects research protection program for the next three years. In meeting AAHRPP’s high accreditation standards, SU is recognized for exceeding federal requirements for safeguarding research participants in all research studies.

AAHRPP is a nonprofit organization that works with organizations that conduct human research to raise the level of protection for research participants and to promote ethically sound research. The accreditation program utilizes a voluntary, peer-driven educational model. SU received full accreditation from AAHRPP at its June council meeting in Washington, D.C. (the council meets quarterly to review applications and make decisions about granting accreditation.)

“Accreditation holds organizations to the highest standards of protection, so each accreditation marks another milestone for research participants and for all of us who are committed to safe, ethical excellent research,” says AAHRPP President and CEO Marjorie A. Speers. To date, 129 organizations representing more than 550 entities have earned AAHRPP accreditation, with 42 percent of the nation’s research-intensive universities currently accredited.

Through the rigorous accreditation process, organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to the highest standards for research. AAHRPP’s standards exceed federal regulations by requiring organizations to address conflict of interest, to provide community outreach and education, and to apply the same stringent protections to all research involving human participants (under federal regulations, such protections are mandated only for federally sponsored or regulated research). The accreditation process typically results in system-wide improvements that enhance protections for research participants and promote high-quality research.

Tracy Cromp, director of SU’s Office of Research Integrity and Protections (ORIP), headed the application process for the University under the direction of Ben Ware, vice president for research and dean of the Graduate School. ORIP ensures the University’s commitment to compliance with all applicable regulations and accreditation standards, providing protocol and standards assistance to faculty, staff and students who are working with humans or animals in social, behavioral or biomedical research projects.

Cromp initiated the application process in January 2005. In December 2005, a preliminary application–a self assessment of SU’s standard operating procedures, program overview and information on 75 AAHRPP application elements–was submitted. After feedback from AAHRPP’s accreditation council, Cromp and her colleagues began making the needed procedural revisions and preparing the final application, which was submitted in August 2007. In December 2007, three representatives from AAHRPP conducted a three-day site visit on campus to further evaluate standards such as:

• organization: the processes that involve monitoring, evaluating and continually improving the protection of human research participants;
• research review unit/institutional review boards: how ethical review and oversight of research is delegated and how these functions are carried out within an institution;
• investigator: the environment in which investigators conduct research and the type of research they conduct;
• sponsor research: how human participants are protected when an outside organization or sponsor is involved in the research; and
• participant outreach: to what levels the human participants are engaged in the different stages of the research project.

Following the site visit and campus interviews, SU was granted qualified accreditation at the organization’s March 2008 meeting, which meant that the University met almost all the accreditation standards and that issues requiring corrective action were minor and administrative in nature.

To complete the effort of accreditation, Cromp and the ORIP staff investigated and corrected the five suggested areas for improvement and in June 2008 received full accreditation by the AAHRPP.

“The application process is a very thorough process; we submitted 430 pages of materials. It certainly takes huge institutional commitment,” says Cromp. “AAHRPP was impressed by the University’s culture of compliance, evident by the knowledge and commitment of everyone involved in the human research protection program. This accreditation standard was ‘met with distinction.'”

“I am extremely proud of all of our staff and IRB members who contributed to the achievement of this milestone,” says Ware. “I also am grateful to the AAHRPP staff, leaders and site visitors in guiding us through the process of bringing this program to such a high level.”

Accreditation is available to U.S. and international organizations that conduct biomedical or behavioral and social sciences research involving human participants. The list of accredited organizations includes community, VA and teaching hospitals; universities; independent institutional review boards; research institutes; and contract research organizations.

Other higher education institutions in New York state that have received full accreditation are the University of Rochester and New York University’s School of Medicine. Among the benefits of full accreditation are that human participants can be confident in efficient operation and reliable and credible research data, and that AAHRPP-accredited organizations exceed federal requirements, which permits expedited site selection.

For more information on SU’s ORIP, visit http://orip.syr.edu.