February 2008, Volume 5 Issue 1

Striving for Excellence Through Accreditation

Hospitals need it. Libraries want it. Even preschool programs recognize the value of having it. Accreditation provides an external “seal of approval” to organizations in many fields, and now, human research protection programs (HRPPs) are getting on board with it too. It is a move that is long overdue. CISCRP Advisory Board member and Academy of Pharmaceutical Physicians and Investigators (APPI) President Greg Koski, MD, PhD, recalls a time in the 1990s when federal oversight of HRPPs had few ways to protect the interests of research volunteers. “They spent most of their time reviewing and approving several different kinds of paper documents,” says the former Office for Human Research Protections (OHRP) director.

“It was more about compliance with regulations than anything else and did nothing directly to protect human subjects.”

Things began to change when it was discovered that more than half of the top 20 federal research fund recipients were seriously deficient in their efforts to protect human subjects. Under Koski’s leadership, the newly formed OHRP shifted the focus to performance rather than compliance, and emphasized voluntary third-party accreditation of HRPPs as a way to promote excellence rather than minimal compliance with regulatory requirements.

Today, 81 HRPPs representing more than 300 entities in the U.S., Canada, Korea and Singapore have been accredited by the six-year-old Association for the Accreditation of Human Research Protection Programs (AAHRPP). Hundreds more are undergoing the process. Although achieving accreditation remains the objective for hospitals, independent review boards, research institutes, contract research organizations, and universities, Koski maintains that the process of getting ready for accreditation has value, too.

“Every institution that is preparing for accreditation reviews their operating policies and procedures, their resources, the training of their investigators, and the commitment of their senior leadership towards doing research right. As they prepare for accreditation, they’re getting better every day,” he relates. “Accreditation is a voluntary way for institutions to demonstrate their commitment to achieving excellence rather than compliance, and it provides a non-governmental, non-regulatory way to do it.”

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