Medical Ethics
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FDA Unveils Real-World Data Initiative
The FDA recently opened a promising path to capture real-world data and evidence to complement traditional clinical trials and open new avenues of research.
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Right to Try Off to a Cautious Start
While the federal Right to Try law enacted last year essentially bypassed IRB oversight of patients seeking investigational drugs, research ethics panels and their institutions can codify a requirement for local oversight into their policies and procedures.
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Study Sheds Light on Improving Informed Consent Readability
A small study about improving readability of informed consent examines how investigators and IRBs can make research understandable to people with very limited reading skills.
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Low Health Literacy Is Major Barrier to Research Participation
Researchers may design an informed consent form at a fifth-grade reading level, but even that is too high, according to experts.
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IRBs Can Learn to Deal With Medical Innovation Ambiguity
The lines between research and medical innovation can be blurry. When does a new surgical practice cross from case study to a study that must adhere to human research protection regulations?
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Children’s Hospital Improves Assent-Consent With Animation Board Video
When a children’s hospital needed to approach research informed consent and pediatric assent with more creativity and flair, the research office asked children for input.
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HIV Research Poses Unique Ethical Issues
When IRBs review HIV studies, particularly those aimed at finding a cure to the disease, there are some tricky ethical challenges that might not be seen in other types of research.
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HIV Cure Research Includes Tricky Ethical Challenges
Some geneticists compared the work by He Jiankui of the Southern University of Science and Technology in Shenzhen, China, to the pioneering in vitro fertilization efforts that resulted in the birth of Louise Brown in 1978. Many others criticized the scientist for the ethical issues his experiment raised.
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Burnout Intervention Dramatically Reduced ICU Turnover
A recent study paints a clear picture of the financial impact on hospitals if burnout goes unaddressed.
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Up to 20% of Patients Excluded From Transplant Due to Lack of Social Support
Social support is one of the factors providers use to determine whether a patient is a candidate for transplant. Recent research suggests this longstanding practice is ethically problematic and should be reconsidered.