Medical Ethics Advisor
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Ethicists Asked to Weigh in on Medical Necessity of Abortion
If ethicists are asked to weigh in, they should suggest a second medical opinion (if time permits) and encourage the institution to clarify any legal questions, ideally before there is an emergency. Institutions also should assure clinicians they will have support from the ethics committee in the event of overzealous prosecution.
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Fraud Allegations Involving Alzheimer’s Disease Study Raise Concerns
In a paper published in 2006, the authors provided evidence indicating accumulation of a specific form of beta-amyloid protein was a cause of Alzheimer’s disease. However, recent accusations suggest images allegedly were altered, raising doubts about the initial conclusions. Regardless of what happened, this case has jumpstarted a conversation about instituting more preventive measures, conducting faster investigations into fraud allegations, and levying more severe consequences for researchers found guilty of misconduct.
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For Individualized Therapy Trials, Remain Mindful of Transparency, Reporting Bias
Individualized therapy studies should be publicly and prospectively registered in a clinical trial database. The authors should report results regardless of outcomes. If these trials are not handled right, it might be a step backward in terms of transparency and reporting bias.
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Updated Tactics for Parkinson’s Disease Study Recruitment
Remote, decentralized studies allow for the recruitment of large, geographically dispersed cohorts from a single location. In considering whether to use a decentralized design or to include remote assessments, the research team must determine if these methods can adequately answer the question under study.
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IRBs Must Review Study Protocols Rapidly and Ethically During Public Health Emergency
Conducting clinical research during an infectious disease outbreak takes careful planning and coordination. The entire process hinges on excellent communication among everyone involved.
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New Tools to Facilitate Single IRB Process
The intent of the revised Common Rule requiring institutions to rely on a single IRB for review of multisite research was to make the process simpler and prevent redundancies. Yet several years after the requirement became effective, research teams still struggle with frustrating operational challenges.
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How Should Researchers Proceed if They Suspect Neglect or Abuse?
If researchers interview a child during a minimal risk study at a school, and they suspect the child is a victim of abuse or neglect, investigators are ethically obligated to respond to this.
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Be Careful About Informed Consent if Pelvic Exams Happen While Patients Are Under Anesthesia
Incorporate explicit discussions with patients about pelvic exams conducted while patients are under anesthesia. These discussions should occur during consent processes for gynecologic procedures. Specifically, patients would be told about the potential for medical student involvement in these exams.
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Financial Conflicts Reported Inconsistently
It might be time to consider another approach to transparency on financial conflicts.
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The Trouble with Electronically Tracking Study Medications
Digital pills allow data to be recorded automatically about patients’ medication adherence, but patients and providers have expressed significant ethical concerns.