Medical Ethics Advisor
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Parents, IRBs Hold Different Views on Phase I Pediatric Oncology Trials
IRB members are more likely than the public to think the risks outweigh the potential medical benefits. Parents think about the possibility of caring for a child with severe cancer and no treatment alternatives. IRBs ensure trials are ethical and that pediatric subjects are not exposed to excessive risk.
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Ethics Consults During Pandemic Inform Preparation for Future Crises
Lessons learned on ethics consults during the COVID-19 pandemic carry important implications for future disasters.
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New Guidance on Incorporating Patient-Reported Outcomes in Clinical Research
Patient-reported outcomes can be used to develop healthcare policy and regulatory decisions, and also to monitor symptoms to provide timely care tailored to the patient’s needs.
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Few People with Limited English Proficiency Participate in Stroke Studies
Rather than making the IRB processes more difficult for researchers who wish to include underrepresented populations in their study, IRBs should work with researchers to overcome obstacles.
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Updated Guidance Provides Sense of Urgency to Improve Clinical Trial Diversity
Organizations must invest in research infrastructure to support investigators in enrolling and retaining diverse study populations.
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Ethical Precision Medicine Requires Relying on Scientific Evidence, Safeguarding Information
American College of Physicians offers guidance as genome sequencing technology progresses quickly.
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Patients Share Preferences About Data Privacy
Most want security and accountability, are concerned about who can access their information and for what purposes.
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Financial Conflicts of Interest Are Major Contributor to Academic Success
Reporting many conflicts with drug companies correlated well with publishing more papers and publishing more high-impact research. Those are key metrics for success and promotion for university-based researchers. The report findings suggest relationships with the pharmaceutical industry also are the key to a successful career for some cancer researchers.
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When Machine Learning Tools Are Used to Predict Suicide Risk
As advanced as these tools can be, they are prone to producing high rates of false-positives and false-negatives. Thus, these tools cannot be the only way that risk is evaluated, and should be paired with psychometrically sound risk assessment and strong clinical judgment.
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Researchers Need a Plan to Monitor Participants’ Mental Health Risks
Consider the characteristics of the trial and study population to determine the likelihood and magnitude of risks that may emerge. Identify triggers, thresholds, and responsibilities for action in response to risk-signaling data. Also, consider appropriate response mechanisms and capabilities, along with data privacy-related concerns.