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Patients with psychiatric illness pose a particular problem to researchers and to the IRBs that review studies involving them. They can have widely varying capacity to give informed consent and that capacity can wax and wane depending upon the progression of the illness and the patients current treatment. Issues such as the use of placebo and the role of surrogates can be thorny.
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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 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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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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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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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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More than one-third of American medical students are not required to study medical ethics, according to survey results compiled by the American Medical Student Association (AMSA).
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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.
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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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The Environmental Protection Agency has released a draft of its proposed rule limiting the use of intentional dosing research on human subjects.
