Articles Tagged With: consent
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Steps for IRBs to Better Safeguard Participants
Technology is moving far faster than federal human research protection laws and regulations. But there are a few things IRBs can do that will help protect study participants.
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Combining Large Data Sets Challenges IRBs, Researchers to Ensure Privacy
The problems with HIPAA and current methods of protecting the privacy of individuals in research are being challenged in ways that were not possible in previous decades due to the ease and use of big data. Data scientists and other savvy investigators can combine de-identified data in a way that makes cross-references and re-identification possible.
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FDA Releases Q&A for COVID-19 and Clinical Trials
The Food and Drug Administration recently released updated guidance on conducting clinical trials of medical products during the COVID-19 pandemic. The new version of the guidelines includes a question-and-answer section that clarifies some emergency changes affecting human research protection policies and procedures.
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SBER Programs Face Challenges with Revised Common Rule
Social-behavioral-educational research programs have always faced challenges fitting their work into the parameters of human research protection rules and regulations devised with biomedical research in mind. But the revised Common Rule has produced new issues with informed consent.
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Enhance Health Literacy Among Study Participants
IRBs can help improve health literacy among potential research participants using several tactics, including asking studies to use plain language in informed consent forms. IRBs can review informed consent and subject recruitment materials to ensure the study information is clear and adheres to regulatory requirements.
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Study Reveals Preferences for Simpler Research Language
Boilerplate language for informed consent documents is simple, but not always easy for study participants to understand. The goal for IRBs is to help researchers simplify the words and scientific jargon they use to describe studies to participants, but it is unclear how this can be accomplished. One solution is the Consent Language Explicit And Reasonable Initiative.
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Real-Time IRB Process Reduces Turnaround by 71%
The IRB of the Medical College of Wisconsin in Milwaukee experienced a protocol review turnaround time of 70.6 days, despite using a robust pre-review system. A real-time review process decreased turnaround to 20 days, a 71% reduction through 2018.
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Four Risks That Could Lead to Unexpected Readmissions for Elderly Patients
Researchers uncover pre- and post-surgery trouble areas that could result in older patients returning to the hospital one month after a procedure.
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Residents’ Compassionate Behaviors Vary During Informed Consent
The authors of a recent study examined how compassionate 65 anesthesia residents were during a simulated preoperative evaluation of a patient in acute pain scheduled for urgent surgery. They found substantial variability in the compassionate care behaviors of anesthesiology residents during the informed consent procedure.
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Researchers Identify Ethical Concerns With Pragmatic Trials
Research participants reported ethical concerns about how “minimal” risk is determined, when it is appropriate to alter traditional informed consent practices, and how to distinguish between quality improvement and research.