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The editors of the prestigious British medical journal Lancet recently issued a public statement acknowledging a failure to disclose conflict-of-interest concerns about a 1998 study they published connecting autism to childhood vaccines.
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New IRBs and new IRB members, as well as those who have been working in the field of human research protection for years, often have questions regarding the use of the exempt category when research protocols are reviewed.
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As IRB staff and members find their workload increasing more quickly than their resources, some may consider using a centralized IRB model as a way to allow them to spend their time and energy where it is most needed.
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Attendees to the 2004 Annual IRB Conference, sponsored by the Public Responsibility in Medicine and Research and held Oct. 28-31 in San Diego, will find a great deal of discussion about improving communication between IRBs and principal investigators in both biomedical and social-behavioral research areas. IRB Advisor spoke to several people who are scheduled to be PRIM&R panel members before the conference convened in late October, and this issue features stories that explore how to remove communication barriers and strategies for improving the relationship between PIs and IRBs, as well as strategies for helping the IRB process run more smoothly.
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One possible explanation for why IRB reviews of social-behavioral research pose complications and some confusion among IRBs and researchers can be found in the very different mindsets of the two parties.
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Copernicus Group IRB of Cary, NC, sought accreditation to validate that the 8-year-old, independent IRB and human research protection program was on the right track with its human research protection program.
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Pharmaceutical researchers will have to register their clinical trials with a publicly accessible database if they expect to ever publish their findings in a top-flight medical journal, according to new requirements issued Sept. 8 by the International Committee of Medical Journal Editors (ICMJE).
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IRBs may want to re-think their policies on evaluating research conflicts of interest in light of new studies indicating disclosure may not have its intended effect.
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The relationship between IRBs and principal investigators often seems strained and adversarial, but IRB and research experts say the problems mostly can be solved with a few creative changes.
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From an IRB members perspective, these are trying times. On the one hand, investigators complain that regulations for human subjects research and IRBs are too stringent, making it difficult for them to do their studies. Alternatively, human subjects advocates continually complain that IRBs and institutions are too lax in monitoring clinical studies.
