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The regulations regarding the use of prisoners in research have not changed since 1978, but the research communitys awareness and perception of these have changed. As a result its a good idea for IRBs to update policies regarding such research.
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IRBs and institutions might take away two important thoughts from the NIHs recent experience: First, it doesnt take more than the appearance of a conflict to harm ones reputation. Secondly, some of the measures NIH has taken in response might guide institutions in their own conflict of interest (COI) policy-making.
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The IRB at Oakwood Healthcare System in Dearborn, MI, reviews protocols for four hospitals, including protocols written by masters level, doctoral level, nursing students, and the 150-plus residents.
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Whether an IRBs protocol volume is small, medium, or large, its not easy to decide whether to have the entire board read every page in a protocol submission or have a primary and/or secondary reviewer system in which point people take on the bulk of the work.
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While the mapping of the human genome provided scientists with a blueprint for understanding disease, Swedish researchers are trying to take the knowledge one step further, with the human proteome.
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Patients who participate in clinical trials not only have access to newer, experimental treatments, they also have access to more routine medical checkups and state-of-the-art technologies. For people with serious illnesses, and those without access to routine medical care, participation can make a significant difference in their care. Yet for many women, participation in medical research studies is still not an option.
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One of the challenges faced by clinicians and investigations in accumulating data that might be used for research, is to determine the rules that apply to ensure its availability if and when the research moves forward.
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Several leading medical and science journals fail to enforce their own policies for disclosing financial conflicts of interest among contributing authors, according to a study released July 12 by the nonprofit Center for Science in the Public Interest (CSPI).
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The very idea of deciding when to waive parental permission or allow investigators to inquire into a teenagers sexual history and drug use may make some IRBs a little nervous. But experts in socio-behavioral research involving adolescents say such situations are common and typically involve less than normal risk.
