Biomedical Research Alliance of New York

BRANY accredited by AAHRPP

1/19/2007 - Patients who participate in North Shore-LIJ clinical trials can be assured their safety is top priority.

 

 

The North Shore-Long Island Jewish (LIJ) Health System, a founding member of the Biomedical Research Alliance of New York (BRANY), today announced full accreditation of a major branch of its human research protection program by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). A watchdog group, AAHRPP accredits institutions that oversee human research to ensure protection of the rights and welfare of research participants.

“Full accreditation signifies that the Biomedical Research Alliance of New York is committed to the most comprehensive protections for research participants and the highest quality research,” said Eileen Hilton, MD, BRANY’s president and chief executive officer. “AAHRPP’s systematic review process is meticulous, and we are pleased with the result.”

BRANY is the first organization in the state of New York to receive full accreditation by AAHRPP. A research administration organization for the protection of human research subjects, BRANY is owned in part by the North Shore-LIJ Health System. BRANY oversees those clinical trials offered at North Shore-LIJ facilities that are sponsored by pharmaceutical and biotechnology companies.

“The North Shore-LIJ Health System is dedicated to continuous quality improvement. AAHRPP’s standards exceed federal requirements, so patients who participate in clinical trials at North Shore-LIJ can be assured that their safety is our top priority,” said Bernard M. Rosof, MD, MACP, the health system’s senior vice president of corporate relations and health affairs and the institutional official for BRANY. As BRANY’s institutional official, Dr. Rosof is the most senior ranking administrator overseeing the use of BRANY’s institutional review boards (IRBs) by BRANY’s 230 affiliate members, consisting of hospitals, medical schools and research centers across the United States. An IRB is a committee that reviews and ensures the integrity and safety of proposed research studies as they relate to human subjects protections.

BRANY’s IRB model is unique in that its IRB committees are comprised of members from participating institutions’ IRBs. This structure promotes diversity and impartiality, enhancing the safety of research subjects and the efficiency of the research process. In the industry, this is referred to as an “alternative IRB,” and BRANY’s is the first in the nation to receive full accreditation from AAHRPP. Alternative IRBs are gaining momentum across the United States. The U.S. Department of Health and Human Services recently held a national conference on this topic, called “National Conference on Alternative IRB Models: Optimizing Human Subject Protection.”

Throughout the intensive accreditation process, BRANY staff had to demonstrate that extensive safeguards are built into every level of their research operation. AAHRPP standards exceed federal regulation in two significant ways: AAHRPP extends to all research the protections for research participants that the federal government requires only for federally sponsored or regulated research, and AAHRPP requires additional protections, such as conflict-of-interest rules and community education.

In addition to the North Shore-LIJ Health System, BRANY has four other founding members — Montefiore Medical Center, Mount Sinai School of Medicine, New York University School of Medicine and Saint Vincent Catholic Medical Centers. But North Shore-LIJ is the only founding member to mandate the use of the BRANY IRBs for all industry-sponsored studies involving human subjects. BRANY’s streamlined and efficient processes for administering research contracts and reviews have brought greater numbers of investigational therapies to the people of Long Island, Queens and Staten Island.