| The mission of the BRANY IRB is to protect the rights and ensure the welfare of all human research subjects.
BRANY is the first IRB in the state of New York to receive full accreditation by AAHRPP. This is the second full accreditation awarded to BRANY, with the first issued in 2004 from NCQA.
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 is the first of this type of IRB 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.”
BRANY Quality Improvement profiled by AAHRPP
Continuous quality improvement at BRANY, VA NJHCS At Biomedical Research Alliance of New York (BRANY) and the Department of Veterans Affairs, New Jersey Health Care System (VA NJHCS) – both awarded full AAHRPP accreditation on December 14, 2006 – quality improvement efforts are effective because they are systematic and comprehensive, yet have just the right degree of flexibility. Both organizations take an uncompromising view of compliance and standards of human research protections. Both also acknowledge that there’s always room for improvement – even in quality improvement processes.
“Our quality improvement process has allowed us to identify our strengths and weaknesses and make our processes more efficient,” explains Raffaella Hart, C.I.P., BRANY IRB Director. “As a result, we've taken our monitoring program to the next level. We have streamlined the paperwork so we can spend more time focusing on global issues.”
Both BRANY and VA NJHCS have developed processes that target certain elements for routine audits and others for periodic spot checks. Some of the latter are part of random, comprehensive reviews designed to ensure that standard operating procedures are followed in the field. Others are in response to questions that arise during inspections of documents, such as IRB minutes, consent forms, and protocol applications. Still others are prompted by specific concerns or complaints.
Results are shared with the audited parties, the IRB, various committees, and individuals throughout the organization who either could benefit from knowledge of the findings or could provide insight into possible improvements.
“Our process is evolving, flexible, and inclusive,” says Orval Gautier, M.Ed., C.I.P, VA NJHCS Research Compliance Officer. “We’re not just checking for individual compliance, although that certainly is important. We’re also looking for trends, for ways to continually improve the process.”
In fact, Mr. Gautier says it’s common during audits for investigators to suggest changes that streamline procedures while ensuring maximum protection for research participants.
For BRANY, quality improvement is as much about education as evaluation. “We look at it as a learning experience” says Portia Rindos, R.N., C.C.R.C., C.C.R.A., BRANY Manager of Quality Improvement and Auditing. “At a research site, we serve as a resource, assisting investigators in meeting the requirements, explaining why certain documentation is required, sharing best practices, and making sure the research is of the highest quality. Once they realize we’re here to help, investigators understand and even appreciate the process.”
Both BRANY and VA NJHCS apply their quality improvement efforts not just to research studies, but to the workings of their organization as a whole. The result is a corporate culture that values ongoing self-assessment and the positive change that can occur.
At VA NJHCS, “we examine every aspect of our human research protection program, starting with the infrastructure, to confirm that we consistently meet our obligations to everyone involved, particularly research participants,” Mr. Gautier says.
At BRANY, “we’ve developed a self-critical culture, one which recognizes that in the research enterprise, change happens every day,” Ms. Hart says. “Our quality improvement program – as well as our decision to seek accreditation – assures research participants, sponsors, and investigators that we keep up with the regulations and guidance, that we’re constantly seeking a better way, and that we adhere to the highest standards and practices.”
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