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The 1999 research-related death of Jesse Gelsinger achieved one more step toward resolution with the announcement of a settlement between the federal government and researchers and research institutions involved in the case.
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As technological advancements make it possible to quickly and easily scan large numbers of medical records to conduct research, there is increasing public concern about the possible intrusions to patient privacy.
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With only nine organizations receiving accreditation through its Partnership for Human Research Protection (PHRP), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and its partner in the effort, the National Commission on Quality Assurance (NCQA) have jointly decided to dissolve the agency.
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A new study released by the Centers for Disease Control and Prevention shows that deaths due to poor diet and physical inactivity rose by 33% over the past decade and soon may overtake tobacco as the leading preventable cause of death.
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The line between quality improvement (QI) activities, which are intended to improve health care within an institution, and true research, which seeks to contribute knowledge to others outside the institution, has always been blurry.
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Deception has long been a tool of investigators conducting social and behavioral research. Subjects agreeing to a study may not know exactly what it is about, in order to elicit unguarded responses.
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The goals of palliative and end-of-life research are unimpeachable discovering methods to ease the suffering of dying patients and their families.
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The Environmental Protection Agency has released a draft of its proposed rule limiting the use of intentional dosing research on human subjects.
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There are federal regulations that are supposed to ensure IRBs have appropriate staffing levels, but respondents to the IRB Advisor 2005 Salary Survey could easily make one believe there are very few IRBs that meet that regulation.
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As IRBs grapple with the issues raised by social-behavioral research, they may also want to consider the concerns of researchers who in a recent study charged that delays in processing proposals and overly intense risk aversion have impeded valuable research.