IRB certification exam coming in November
The certification examination for institutional review board professionals will be administered Nov. 16 in San Diego during the Applied Research Ethics National Association (ARENA)/ Public Responsibility in Medicine and Research (PRIM&R)/ IRB Conference. The test, developed a decade ago by the Council for Certification of IRB Professionals (CCIP), an affiliate of ARENA, is designed to support IRB efforts by ensuring that those undergoing certification testing have the experience and training to oversee clinical trials.
The certification examination is made up of 250 questions covering all areas of human subject research and IRB administration, including the historical basis for IRBs, the Common Rule, IRB functions and operations, and records and reports. Certification is open to anyone associated with IRB administration, from coordinators to chairs to community members. Additionally, applicants must have a bachelor’s degree plus two years of IRB experience within the previous seven years. Those without a bachelor’s degree should have four years of IRB experience within the previous 10 years.
The test is offered twice yearly in various cities around the country and costs $300 for ARENA members, $400 for nonmembers. Certification is valid for three years. The application deadline for the November exam is Oct. 1. For more information, visit ARENA’s web site at www.arena.org.
NIH launches conflict-of-interest web site
The National Institutes of Health (NIH) launched a conflict-of-interest web site last summer. The web site lists resources available on the web that present conflict-of-interest policy from federal organizations, including the NIH, the Food and Drug Administration, the General Accounting Office, and the Office of Human Research Protections.
Also listed are web site addresses of the Association of American Medical Colleges and the Association of American Universities and their respective comments on conflict-of-interest issues.
Finally, the web site provides a listing of articles written on the subject, among them "An Incomplete Bibliography of On-Line Readings Related to Conflicts of Interest" from the Activism and Medicine web site, "Institutional Conflict of Interest" from the New England Journal of Medicine, and a summary of federal laws governing independent colleges and universities from the Catholic University of America Office of General Counsel. The web site address is http://grants.nih.gov/grants/policy/coi/resources.htm.
Public confidence slipping due to lack of information
The public has become more reticent about volunteering for research studies, says Philip Noguchi, MD, director of the Division of Cellular and Gene Therapies at the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research. In a recent report appearing on bmj.com (formerly the British Medical Journal), Noguchi attributed this lack of confidence to a failure of those involved in research to fully inform the public about studies.
"If they don’t know, they assume the worst," he said recently at a meeting of the Regulatory Affairs Professional Society in Washington, DC. "For the public to feel reassured, we need to be able to talk more clearly and transparently about what’s really going on."
He pointed out that adverse events — particularly those resulting in death — receive widespread media attention and tend to stay in the minds of the public. To counter that effect, the FDA last year proposed making details of ongoing clinical trials available to the public. Though the initial proposal extends to gene therapies and xenotransplantation, all clinical investigations will likely be included in the future if the rule is passed.
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