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IRBs run on data and paper and lots of it. Some organizations may find themselves running out of space to store the reams of paper that are needed to catalog the scores of research and submission data. This has led some IRBs to look for alternative methods of data storage. But an IRB cant live without paper or can it?
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What IRBs and the research ethics community commonly believe is evidence of therapeutic misconception among research participants often is the result of misinterpretation by the experts, a researcher says.
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A study conducted by the Clinical Trials Transformation Initiative (CTTI) identified some of the barriers IRBs may face when choosing a central IRB for multicenter studies.
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Research institutions with concerns about an IRBs preparation for reviews and regulatory compliance could learn a few lessons on how to assess their performance and improve any problems from the experience of the IRB at WellSpan Health in York, PA.
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As research institutions become more thoroughly electronic in their IRB and clinical trial systems, they should not lose sight of the importance of securing all transmitted data, an expert says.
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Some bioethicists argue that it is not ethically justifiable to offer reused pacemakers overseas since these are not approved for use in the United States, but this goes on every day in the developing world, says James N. Kirkpatrick, MD, an assistant professor of medicine at the Hospital of the University of Pennsylvania.
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By refurbishing and repackaging pacemakers, we are de facto creating a new product, which no longer adheres to the original specifications, says Thomas Crawford, MD, an assistant professor of medicine in the Cardiovascular Division at the University of Michigan School of Medicine in Ann Arbor and co-chair of Project My Heart Your Heart, a program which collects used devices from patients and funeral directors to be someday donated to developing countries.
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Because overtreatment imposes unnecessary harms upon a patient, it violates the normative rules of beneficence and nonmaleficence that pervade medical ethics, argues Erin Fuse Brown, JD, MPH, assistant professor of Law at Georgia State University College of law in Atlanta and former Visiting Fellow in Ethics and Health Policy with the Lincoln Center for Applied Ethics at Arizona State Universitys Sandra Day OConnor College of Law.
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While Americans typically support organ donation, data show the number of actual donations is actually quite low and cannot keep up with demand, says Leslie M. Whetstine, PhD, an assistant professor of philosophy at Walsh University in North Canton, OH.
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The debate over medical futility has in large part been neglected, and should be expanded beyond pull the plug decisions to include doctors involvement in the details of end-of-life care, argues Lawrence J. Schneiderman, MD, founding co-chair of the University of California, San Diego Medical Center Ethics Committee.
