PHRP Accreditation Program Awards Decision; Biomedical Research Alliance of New York (BRANY) Earns Accreditation

5/4/2004

From: Charlene D. Hill of the Joint Commission on Accreditation of Healthcare Organizations, 630-792-5175, Brian Schilling of the National Committee for Quality Assurance, 202-955-5104

OAKBROOK TERRACE, Ill., May 4 -- The Partnership for Human Research Protection, Inc. (PHRP), has awarded accreditation to Biomedical Research Alliance of New York (BRANY). PHRP is a collaboration between the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and National Committee for Quality Assurance (NCQA).

BRANY, located in Great Neck, New York, demonstrated its commitment to safeguarding the interests of human research participants by achieving PHRP accreditation. To earn accreditation, the organization completed a thorough review to evaluate their compliance with PHRP standards and an on-site accreditation review took place shortly thereafter. During the on-site review, a team of PHRP surveyors-research clinicians and others experienced in biomedical research-validated performance against the national standards.

"By becoming one of the first organizations to earn PHRP Accreditation, BRANY is demonstrating its commitment to protecting the safety and rights of research participants," said PHRP Chief Executive Officer Esther Emard. "We commend its staff and leadership and encourage other organizations to follow its example."

"Maintaining the highest standards of quality is central to our mission and we are pleased to be one of the first organizations to gain accreditation from PHRP," said Eileen Hilton, M.D., President and CEO of Biomedical Research Alliance of New York (BRANY), a unique, centralized institutional review board (IRB) formed by the New York Academy of Medicine that draws its members from the IRBs of affiliated academic institutions.

The PHRP launched its accreditation program in 2003 to provide a national set of standards and a voluntary oversight process that creates a credible, objective framework for ensuring that processes are in place to inform and protect the thousands of volunteer human subjects who participate in clinical trials and other research activities every year. The rapid expansion of medical research, drug trials and other studies involving human subjects has increased demand to ensure that studies' risks and benefits are thoroughly weighed, that volunteers are properly informed, that adverse events are carefully monitored, and that research risks are minimized. Both the federal Office of Human Research Protections and the Food and Drug Administration have supported private accreditation-such as the new PHRP Accreditation Program-as a critical component of an overall national strategy to better protect human research participants and promote greater accountability.

"At BRANY, we have always prided ourselves on self-assessment and improvement. The Web-based tool from PHRP and subsequent site evaluation added substantially to the processes already in place and will be invaluable in our efforts to ensure the protection of human subjects," said Bernard Rosof, MD, institutional official of the BRANY IRB representing one of BRANY's founding members-the North Shore-Long Island Jewish Health System.

The Patient Advocacy Council Inc. (PAC) in Mobile, Alabama became the first organization to receive PHRP accreditation earlier this year and nearly 10 other organizations are also now in the process of seeking PHRP accreditation. The organizations include both research organizations and independent review boards.

For more information about PHRP, please contact Jessica Briefer French, Assistant Vice President, PHRP, at 202-955-5177.

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The Partnership for Human Research Protection, Inc. (PHRP) is an independent entity that was originally formed by the two most trusted names in health care quality and safety, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA). PHRP helps organizations that conduct research to protect the safety, confidentiality and interests of study participants. PHRP offers a uniform national set of standards for accrediting human research protection programs that complements regulatory efforts and minimizes the need for additional government oversight. PHRP accreditation promotes best practices and continuous performance improvement to foster excellence within human research protection programs, helping them become as good as they can be.