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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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Question: Should an IRB have a conflict of interest (COI) policy? If so, what should be in it?
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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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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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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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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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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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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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Our institutions IRB is merging with another IRB. What can we do to make the transition efficient? (In other words, what can go wrong and how can we minimize the possibility?)