Medical Ethics Advisor
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IRBs Strive to Improve Consistency of Study Protocol Decisions
Is a study protocol OK to go forward? Or are many changes needed for recruitment, consent, or other processes? IRB decisions often are inconsistent on these points — even at the same institution, and sometimes at the same IRB.
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Too Many Scientific Articles End Up Retracted
Over five decades, the authors of a meta-analysis discovered guidelines represented a small percentage of total retractions (0.3%). Scientific misconduct (including data fabrication, plagiarism, and duplication) was found in 62.3% of retracted studies. The number of retractions and misconducts increased from 1980 to 2014, but declined after 2015. The median time from publication to retraction significantly decreased over the study period.
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Analyses: Older Patients Excluded from Many Research Studies
Investigators learned age disparities were worse for industry-funded trials; for trials with enrollment criteria restrictions based on age cutoffs or performance status; for trials that evaluated a targeted, systemic therapy; and for lung cancer trials.
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Lack of Basic Knowledge on Clinical Trials Makes Study Recruitment Harder
Survey respondents with a history of cancer and those who have heard of ClinicalTrials.gov knew more about trials. Such knowledge also was more abundant among college graduates and those who had been asked to participate in a trial.
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Survey: OB/GYN Residents Feel Unprepared to Care for LGBTQ+ Patients
Lack of experienced faculty and curricular crowding were the two most commonly identified barriers.
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Chaplains Distinctly Equipped to Address Moral Injury
When healthcare professionals experience moral injury, they experience spiritual and existential distress in the forms of self-doubt, guilt, frustration, anger, depression, and burnout. Collaborating with chaplains is crucial in supporting staff when they believe they have compromised their moral integrity.
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More Than 2,000 Consent Forms Posted Publicly
Creators of federally funded studies have been mandated to post informed consent documents on ClinicalTrials.gov ever since the revised Common Rule requirements became effective in January 2019. However, it was unclear how many or what kind of consent forms were posted — and who was posting the forms. A group of investigators set out to answer these rudimentary questions.
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Much Remains for IRBs to Learn About Performance Measurement
One researcher argues a more appropriate definition of IRB quality is how well the board implements the Common Rule — not just mere compliance, but how well boards put the Common Rule into effect.
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Children Undergoing Stem Cell Transplant Lack Palliative Care
Palliative care teams can shorten length of stay, prevent readmissions, improve patient satisfaction, lower costs, and reduce burnout rates.
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Clinicians, Researchers Need New Framework for Ethical Management of Sickle Cell Disease
A new tool characterizes sickle cell disease pain as its own distinct problem, deserving of appropriate treatment. The tool suggests healthcare providers use the patient’s subjective report of their pain experience as data for informing treatment recommendations.