Medical Ethics
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What You Don’t Know About NIH RAC Review Changes Could Hurt
IRBs might not have asked for it, but the National Institutes of Health and the FDA have handed them a new responsibility when it comes to oversight of clinical trials involving human gene transfer.
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Who was Dan Markingson?
On May 8, 2004, Dan Markingson killed himself while participating in a University of Minnesota Department of Psychiatry drug study.
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U. of Minnesota Fights Bill Giving State Oversight of Psych Research
Reeling from a decade-long series of investigations and allegations after the suicide of a psychiatric research patient, the University of Minnesota is now facing a proposed state law that would assign oversight for its psychiatric drug research program to an independent ombudsman’s office.
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Ethics tool could enhance protocols and subject protection
A multiple stakeholder group developed a protocol ethics tool kit to ensure there is no missing information regarding ethics considerations in protocols.
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‘Optimistic bias’ may subvert informed consent in early-phase cancer trials
There is a gray area where optimism in a research patient in early phase cancer trials crosses over to a misperception of benefit and raises ethical questions about informed consent.
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Maryland Gets a New View of Conflicts of Interest
An investigative committee at the University of Maryland in College Park recommends mandatory education on conflicts of interest for research faculty.
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Sounding the alarm about suicide risk
Given that EDs are among the most likely places for patients at risk for suicide to present, experts say training staff to recognize and manage such patients is critical.
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IRBs and germline editing research: The outer limits of oversight
Guest columnist J. Benjamin Hurlbut, PhD, discusses human germline editing research and the role IRBs could play in research ethics.
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Human germline gene editing holds great promise, dire possibilities
An international summit on human gene editing recently concluded with a consensus statement to continue basic research in the controversial area, but warned against any clinical trials or human experiments because “once introduced into the human population, genetic alterations would be difficult to remove and would not remain within any single community or country.”
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Using eFeedback helps promote subject safety
Seattle Children’s Research Institute in Seattle found that an eFeedback tool helps the organization improve and ensure the safety of pediatric patients who are enrolled in clinical trials.