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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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The National Center for Research Resources (NCRR) of Bethesda, MD, established several years ago the role of research subject advocates (RSAs) for the purpose of providing an additional level of monitoring for research projects involving human subjects.
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The four-year-old Goodwyn IRB of Cincinnati has a unique challenge when its time for the board to meet and discuss protocols because the members are scientific and ethical experts who are spread out across North America.
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The four-year-old Goodwyn IRB of Cincinnati has a unique challenge when its time for the board to meet and discuss protocols because the members are scientific and ethical experts who are spread out across North America.
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One of the major fraud prevention efforts over the past decade has been the development and publication of compliance program guidance (CPG) for various aspects of the health care industry. Most recently, we have seen this effort with respect to the pharmaceutical industry and a focus on its relationship to health care providers.
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As long as local protocols continue to enroll subjects and collect data, they must submit to annual reviews by the institutional review board. But what happens once the study concludes, enrollment is closed, and all data are collected? What obligation does the IRB have to continue monitoring the study?
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Question: Should an IRB have a conflict of interest (COI) policy? If so, what should be in it?
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IRB members who are accustomed to dealing with the serious potential physical risks associated with many biomedical research projects may give little thought to the risks inherent in social-behavioral research.
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Thanks to the volunteer work and sponsorship of community advocate and IRB member Isaac Hopkins of Plainfield, NJ, there is an inner-city Little League team where the 7- and 8-year-old players wear T-shirts that say, Do No Harm.
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More institutional review boards are seeing proposals for studies involving some type of genetic research, but many IRB members feel unprepared to appropriately review the study design and assess the potential risks involved.
