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A federally funded national clinical trials registry may soon be a reality if the American Medical Association (AMA) and several Democratic senators have their way.
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At institutions across the country, research administrators now are using Internet-based or local computer software modules to facilitate annual education in human subjects protections for investigators and IRB members.
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IRB Advisor asked IRB and human subjects protection experts from across the nation to discuss the state of human subjects protection regulations and how IRBs are interpreting federal requirements. This article, which is the last in the three-part series, will discuss investigator certification and training.
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Emergency research may raise a number of issues for IRBs that either review such protocols or are asked to assess criteria for emergency room use of an investigational drug or device, experts say.
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A report in the March 25 Philadelphia Inquirer regarding the use of experimental treatment on an infant in connection with a heart repair highlights a series of issues related to both the use of devices not approved by the FDA and, in turn, their use on minors, including infants.
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The Havasupai Indian tribe of northwestern Arizona, and some of its individual members, have filed two federal lawsuits seeking a total of $75 million in damages against Arizona State University (ASU), the Arizona Board of Regents, and three university researchers, claiming that blood samples taken from tribe members as part of a diabetes study were destroyed, lost, or used in studies of schizophrenia, inbreeding, and population migration without the donors consent.
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When the National Institutes of Health (NIH) recently became the target of intense public criticism and scrutiny over potential conflicts of interest (COI) among NIH directors and staff and clinical trials, it became apparent to the research world that this is an issue that could be a problem for any institution. The best prevention strategy is to be proactive by having policies, procedures, and possibly a special committee that reviews COIs, experts say.
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As the number of international research protocols increase, the problems faced by reviewing IRBs increase. International research is taking more and more IRB time, says Howard Guenther, PhD, MBA, associate vice chancellor for research and interim executive secretary of the Institutional Review Board at the University of Illinois at Urbana-Champaign.
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Bernard Schwetz to head OHRP.
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Add up the number of citations of noncompliance related to IRB issues that the Office of Human Research Protections (OHRP) at the Department of Health and Human Services in Rockville, MD, handed out between October 1998 and June 2002 and the numbers are pretty staggering. Of the 1,120 citations given to 155 institutions, 1,014 of them say something about IRB noncompliance and deficiencies.
