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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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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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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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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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One of the keys to successful surveys is to spend time, sometimes as much as a year, preparing for the process. Here are some tips from IRB officials who have either been through the process or who have begun it, as well as from other experts, on how to best prepare for an accreditation survey.
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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.
