Medical Ethics
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Ethical Responses if Surrogate Is Unfit for Role
Surrogates may be ill-suited for the role due to lacking capacity themselves or failing to act in the patient’s best interest.
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Providing Care Viewed as Futile or Unnecessary Linked to Physician Burnout, Intention to Quit
About one-third of clinicians considered leaving their jobs due to providing care they saw as futile or potentially inappropriate, found the authors of a recent survey.
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Earning the Trust of Research Subjects
Achieving trust in human research can be challenging in an age of precision medicine that calls for long-term relationships and potential unintended consequences far beyond a simple informed consent document.
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Research Program Closely Monitors ClinicalTrials.gov Compliance
Compliance with the 2017 changes to ClinicalTrials.gov registration can be time-consuming, as at least one organization has learned over the past year.
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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.