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Efforts to improve clinical trial participation among medically underserved populations often overlook one group in particular, say some cancer researchers in California.
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Genetic therapies are rapidly moving from the laboratory into the clinical setting, with more investigators testing experimental gene delivery systems and therapies designed to fundamentally alter our bodies to prevent or treat disease.
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A basic tenet of research involving human subjects is those who agree to be participate must give their informed consent after being informed about the known and unknown risks inherent in their participation. One category of risk is the possibility of injury.
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Drug and biotech companies that have paid government scientists for consulting services soon will receive a request from a House subcommittee to voluntarily release financial details of such agreements.
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IRB members and others in the research community sometimes have misconceptions about the use of the expedited review process, including the idea that an expedited review is different from a review by the full IRB.
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The consent form is the IRBs document, but the sponsor may say, If youre not willing to include this language, this disclaimer, then we wont open the trial at your institution, Joffe explains. Then the IRB can think of creative ways to put it in there without distracting from the message they want to convey in the consent form.
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Improving consent form should be top priority: Think outside the box and go beyond regulations
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IRBs are no different from other boards in how their psychological structure could lead to personality clashes and conflicts. However, unlike many organizations, when IRBs ignore such conflicts, the outcome might be a less-effective human subjects protection program or regulatory problems.
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OHRP is seeking comments from IRB members and others about proposed changes to the agencys registration requirements, which apply to all IRBs that review human subjects research conducted or supported by HHS.
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Gene transfer research offers new hope for people suffering from some rare or deadly diseases, but the research also has suffered major setbacks due to serious adverse events, including subjects illnesses and deaths, and this creates a greater burden for IRBs reviewing such protocols, experts say.
