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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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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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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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Drugmaker GlaxoSmithKline (GSK) has announced its intentions to start publishing clinical study reports (CSRs) and clinical trial results in an effort for increased transparency, making it the first major drug company to do so.
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In days not so long ago, when all IRB members received heavy stacks of paper packets containing protocol submissions before each meeting, research institutions and regulatory compliance officials never questioned whether they would read the work before meetings. It was assumed they would be well-prepared for discussions.
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It is vital for providers caring for pediatric patients not to jump to a diagnosis just because it is in the Diagnostic and Statistical Manual of Mental Disorders (DSM)V, argues Harold J. Bursztajn, MD, associate clinical professor of psychiatry at Harvard Medical School in Cambridge and co-founder of the Program in Psychiatry and the Law at Beth Israel Deaconess Medical Center.
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In the eyes of cost-cutting hospital administrators, bioethics programs are sometimes perceived as a luxury rather than a necessity. During periods of austerity, bioethics programs are often the first to not receive funding or not be maintained, says Joseph J. Fins, MD, MACP, the E. William Davis, Jr. Professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medical College, and director of medical ethics and attending physician at New York Presbyterian Hospital-Weill Cornell Medical Center in New York City. A number of programs have recently come under threat.
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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.
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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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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.
