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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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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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Study says schools often stray from set guidelines; Bioterrorism funding up, clinical relevance goal.
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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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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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U.S. human research funding has a global reach. Each year, millions of dollars, both public and private, go to institutions conducting human subjects research outside this country.
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When IRB members and investigators discuss potential risks and benefits, they typically break down the benefits into two categories: individual and societal. But there is a third category that should be considered for some research projects: community.
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As IRBs prepare for their first accreditation surveys or consider the pros and cons of applying for accreditation, some who have gone through it say that preparation can be its own reward.
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IRB approval of human-subject study protocols may be insufficient to truly protect research participants and the integrity of the investigators, particularly when an outside corporation sponsors the trial, a new study by researchers at Durham, NC-based Duke University claims.
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IRBs that are not quite ready to apply for an accreditation might take advantage of a free quality improvement (QI) program established by the Office for Human Research Protection (OHRP) in Rockville, MD.