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Outpatient surgery programs will have to look for physicians with a combination of skills before granting privileges for natural orifice surgery, says Marc Bessler, MD, director of laparoscopic surgery and director of Obesity Center, New York Presbyterian Hospital at Columbia University, New York City.
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The very first step to becoming accredited is to collect all of your institution's policies and procedures related to the human research protection program in a searchable electronic format, an expert advises.
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The growing field of biobanking has added new wrinkles to issues of withdrawal from research. Withdrawing from participation in a biobank or a large cohort study is a very different matter from withdrawing from a clinical trial. Because of the technology involved, it may not be possible to completely remove one's information from the research.
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Two or more IRBs reviewing the same study might reach strikingly different conclusions about the study's risks and suitability for human subjects.
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Every study participant has seen some variation of this assurance in informed consent documents: "You are free to participate in this research or to withdraw at any time without penalty or loss of benefits you are entitled to receive."
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From a bioethical perspective, payments to research participants are complicated, an expert says.
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Ethicists and others continue to find it troubling that payments to research participants are part of the recruitment process.
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The FDA's amended rule for acceptance of foreign clinical studies not conducted under an investigational new drug (IND) application has drawn fire from health advocates who say it weakens ethical protections.
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CIGNA and Dartmouth-Hitchcock have joined forces to improve care coordination and quality of care for patients through a "patient-centered medical home" pilot project.
