Internal Review Boards
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IRBs Are Scrutinizing Digital Tools for Informed Consent
Compared to paper-based informed consent, a multimedia digital tool resulted in higher satisfaction, was perceived as easier to use, gave more people the ability to complete the consent independently, and was perceived as taking less time to complete the consent process, according to the results of a recent study.
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IRBs Are Reviewing Artificial Intelligence Research, Outside Expertise Needed
How might IRBs be adapted to address ethics oversight of health-related artificial intelligence research?
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Survey Indicates Americans Favor Including Children in Clinical Trial Research
But as risk rises, respondents were less supportive of the notion.
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Notification Practices Vary for Emergency Research, Few Participants Withdraw
Find consent processes that protect and preserve patients’ autonomy to the extent possible, while also allowing medical progress to occur and giving participants access to potentially beneficial therapies. Doing so may require
a more creative process than just following the rules. -
Single IRB Concerns Include IT Limitations, Process Variations
Consistency, standardization, speed and efficiency, and simplification are reported benefits. Challenges include timeliness of the research review process, insufficient communication, and uncertainty at local institutions.
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Researchers Can Remove Recruitment Barriers in Alzheimer’s Trials
What can be consolidated, made simpler, or translated? What data can be collected outside your research setting? How can you communicate better with prospective and current research participants?
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Screening Tests to Determine Study Eligibility Are Not Foolproof
IRBs and researchers should expand eligibility criteria to diversify representation, remove extraneous inclusion/exclusion criteria, and eliminate some screening tests if they are not strictly necessary, particularly tests that produce many false-negative or false-positive results.
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New Data on IRB Members’ Perceptions of Violations
Failure to properly store data and neglecting to maintain project records are the two most common IRB violations, according to a recent survey of 242 faculty members at research-intensive universities in the United States.
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IRBs Often Reluctant to Approve Inclusion of Pregnant Participants in Research
Some IRB members cite uncertainty on whether inclusion of pregnant participants could affect the study’s scientific validity. Others acknowledge they rely on the common, default practice of excluding pregnant individuals without requiring justification. Guidance is needed for characterizing the risk level of research procedures in the context of pregnancy.
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Positive STI Test Results Not Always Shared with Study Participants
Investigators should develop a plan to return test results to participants, and document their actions in protocols and manuscripts. IRBs should require researchers to include these details in their proposals.