McLean Becomes First Psychiatric Hospital to Earn Accreditation for Research Subject Protection Program

July 21, 2011

McLean Hospital, the largest psychiatric affiliate of Harvard Medical School, has become the first psychiatric hospital in the nation to receive accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The voluntary accreditation, announced last month, is for a three-year period. McLean joins its parent institution, Mass General Brigham (formerly Partners HealthCare), in receiving accreditation from the AAHRPP.

According to AAHRPP, an independent, non-profit accrediting body, it promotes high-quality, ethically sound research through an accreditation process that helps organizations worldwide strengthen their human research protection or institutional review board programs.

“We have always strived to protect human research subjects according to the highest ethical standards but this offers an opportunity to make sure that we measure up to the best standards out there,” said Dr. James I. Hudson, director of the Biological Psychiatry Laboratory at McLean and the hospital’s director of Human Research Ethics.

AAHRPP uses a voluntary, peer-driven, educational model to ensure that human research protection programs (HRPP) or independent review boards (IRB) 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.

“Preparation for the surveys involved a team approach that included participation from investigators across the research community,” said Michele Gougeon, executive vice president and chief operating officer for McLean. “This achievement speaks to the many positive changes that have been implemented by Dr. Hudson and the IRB staff.”

As the “gold seal,” AAHRPP accreditation offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an HRPP is focused first and foremost on excellence.

McLean was one of just four institutions to have their accreditations announced this quarter by AAHRPP.

“We are extremely proud to have received this accreditation,” said Peter Paskevich, McLean’s Senior Vice President for Research Administration. “It affirms that we are doing everything possible to protect our patients who enroll in research studies. Everyone at McLean who has been involved in this important effort should be commended.”

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 says. The accreditation process typically results in system-wide improvements that enhance protections for research participants and promote high-quality research, it adds.

The accreditation process requires organizations to take a comprehensive look at their human research protection programs to identify and address any weaknesses and to build upon their strengths, according to the organization.

Accreditation is available to organizations worldwide that conduct biomedical, behavioral or social sciences research involving human participants.

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