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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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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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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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Researchers often criticize IRBs and see them as barriers to research.
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IRBs at academic research centers often review international infectious diseases research that can raise red flags regarding privacy, confidentiality, and vulnerability.
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IRBs dealing with international or high-risk research can find some guidance on how to handle all stakeholders in studies in the recently-revised Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP).
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An IRB looking to recruit a good non-scientist to the board may have to look no further than its own institution's medical library.
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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.
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As more sophisticated imaging technologies are used in research, investigators and IRBs must grapple with an unintended side effect an increase in incidental findings (IF), or new health data unrelated to the study that is revealed about participants.
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Recruiting patients for Phase I oncology studies which are unlikely to provide therapeutic benefit to participants and which carry the risk of significant side effects raises unique issues in informed consent.
