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The FDA has mandated a Black Box warning for all estrogen and estrogen/progestin products for use by postmenopausal women. The new warnings are based on analysis of data from the Womens Health Initiative (WHI) study that was published July 2002.
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In the best of all worlds, there wouldnt be research conflicts of interest. Investigators would be focused on the intent of research uncovering previously unknown information. However, the reality falls a little short of the ideal, which is why many IRBs have had to deal with conflict of interest issues in addition to their primary goals and duties.
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Changes to federal regulations regarding research protections for pregnant women and fetuses now require investigators to obtain the informed consent of a fetus or neonates father before certain types of research may proceed.
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Certain broad categories of research are exempt from full review of an institutional review board. Though federal regulations regarding exemptions are spelled out for investigators and IRBs alike, IRBs still are responsible for reviewing proposed protocols and approving exemptions.
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The Task Force on Financial Conflicts of Interest in Clinical Research for the Association of American Medical Colleges (AAMC) of Washington, DC, has issued new guidelines. Called Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institutions Financial Interests in Human Subjects Research, the October 2002 recommendations contain the following points.
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Institutional and individual conflicts of interest perhaps always will plague human subjects research. Until there are uniform rules that all institutions must follow, it will be up to conflict of interest committees and IRBs to make certain that ethical abuses do not result from conflicts of interest that are both unacceptable and preventable.
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Study says schools often stray from set guidelines; Bioterrorism funding up, clinical relevance goal.
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Synopsis: To Magnusson and colleagues surprise, they found an unacceptably high rate of recurrent instability of 17% with long-term follow-up from open Bankart procedures.
