IRB Advisor – October 1, 2003
October 1, 2003
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Human subject protection gets a boost with research advocates
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. -
Supply and demand: IRB fees now are the norm
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. -
Teleconferencing, web broaden member roster
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. -
OIG developing ethics guide to prevent fraud
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. -
Once enrollment and data collecting stop, then what?
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? -
COI policy: Address potential conflicts
Question: Should an IRB have a conflict of interest (COI) policy? If so, what should be in it?