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Researchers often criticize IRBs and see them as barriers to research. One way to turn that attitude around is through the creation of a study start-up consultation. This has another advantage: it can improve clinical trial site compliance with human subjects protection regulations and policies.
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Researchers might find it tempting to collect data for socio-behavioral studies from social websites like Facebook. Their appeal is having fairly easy access and viewing a broad range of behavioral information. However, there are big ethical issues with regard to informed consent and privacy, an expert says.
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Many physicians are making the decision to implant defibrillators specifically, implantable cardioverter defibrillators (ICDs) in patients in cases where established guidelines based on the results of previous clinical trials do not appear to support implantation, according to a recent study.
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Last November, the Centers for Medicare & Medicaid Services (CMS) issued finalized new rules for Medicare- and Medicaid-participating hospitals designed to protect patients' right to choose their own visitors.
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Patients hospitalized with depression may need extra help understanding the informed consent process for research, due to cognitive impairments that affect their ability to understand information being given to them about a study.
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When a group of researchers set out to study effective ways to screen HMO members for substance abuse problems and to refer them for treatment, they expected that sensitive topic would require strict confidentiality measures.
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IRBs often do a good, or at least adequate, job of maintaining required documentation for studies they review, but there are several key documentation areas in which many IRBs need to improve, according to experts.
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The Office for Human Research Protections (OHRP) has posted its updated and finalized guidance on the IRB continuing review process.
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When and how to release biomarker results is complicated issue for researchers, IRBs
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IRBs can learn a great deal from each other. One research institution's hard-earned lesson and resolution can be another organization's best practices.