Biomedical Research Alliance of New York

AAHRPP Profiles BRANY

For nearly a decade, the Biomedical Research Alliance of New York (BRANY) has served as a successful, unique IRB model, providing comprehensive, centralized administration and IRB services for research sponsors and institutions. BRANY is profiled here, in part, because of interest in alternative IRB models, as evidenced by the recent 2006 National Conference on Alternative IRB Models: Optimizing Human Subject Protection.
-
In 1998, six prominent New York institutions— the Council on Biomedical Research and Development at the New York Academy of Medicine, Montefiore Medical Center, Mount Sinai School of Medicine, NYU Medical Center, North Shore-Long Island Jewish Health System, and Saint Vincent Catholic Medical Centers—joined forces to create the nation’s first combined IRB owned and operated by medical centers.
In the years since then, BRANY has emerged as the world’s largest alliance of research sites, with more than 200 affiliated centers. It also remains the only IRB of its kind.
According to Eileen Hilton, M.D., BRANY President and CEO, the IRB is unique not just for its ownership model and structure but also for the experience, efficiency, and quality that it provides.
“We took the chairs, vice chairs, and members of the collaborating institutions and formed a single IRB that draws on the expertise of individuals from many organizations,” she explains. “They bring an incredible depth of knowledge to the table—of the review process, their own organizations and communities, and the local research context.”
Dr. Hilton cites the convenience and efficiency of dealing with one IRB, one contract, and one budget, as well as the advantages of objective review by external IRB members who are free from the prejudices and politics that can unintentionally influence discussions of internal IRBs. She points to BRANY’s rigorous quality assurance program (see article Continuous Quality Improvement at BRANY, VA NJHCS) and accreditation as indicators of the IRB’s unwavering commitment to compliance and human research protections. She also emphasizes that BRANY supports the work of the internal IRBs by freeing staff time to focus efforts where they can be most effective.
“Typically, the studies that present the greatest risk to institutional IRBs are those initiated by individual investigators, some of whom may not have the necessary experience to make sure the appropriate controls are in place,” Dr. Hilton says. “By outsourcing the review of industry-sponsored protocols, the institutional IRB can concentrate its resources where they’re needed most and, in the process, provide the greatest protections for research participants.”
-
AAHRPP Advance Spring 2007