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There isn't a black and white answer when an IRB discovers that a human subjects research site has collected some data that is tainted by a protocol violation.
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A federal undercover investigation into possible vulnerabilities in the IRB review system has led to the closure of one independent IRB, and has left other IRBs wondering whether the due diligence they exercise is diligent enough.
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The office of protocol research at the University of Texas M.D. Anderson Cancer Center in Houston, TX, has created comprehensive guidelines that IRB members can use as they present their findings and opinions of protocols.
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In trying to streamline the IRB process, institutions should look to other industries as an example, says David Dilts, PhD, director of the Center for Management Research in Healthcare at Vanderbilt University in Nashville, TN.
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A significant minority of IRBs at some of the nation's biggest medical institutions lack sufficient procedures to determine when IRB members have industry relationships that could pose a conflict in their work.
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When they set out to create a research network to conduct clinical trials in the psychiatric care of children and adolescents, researchers at Duke University's Clinical Research Institute (DCRI) knew IRB issues would play a major role.
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The University of Louisville in Louisville, KY, has developed a program that serves as a dual-purpose human subjects research educational program, helping both doctoral students and experienced research professors and others.
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The Association for the Accreditation of Human Research Projection Programs (AAHRPP) of Washington, DC, has found in an ongoing study that federal investigators find fewer problems in studies conducted at AAHRPP-accredited organizations.
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The conventional wisdom in research circles is that IRBs are the main drag on the process, slowing down the progress of a clinical trial with an unnecessarily complicated review system.
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A major pharmaceutical company is leading the way to making accreditation as ubiquitous among IRBs as it is among health care organizations.
