IRB Advisor – March 1, 2003
March 1, 2003
View Issues
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Keep it simple: Make consent documents easy as possible
Although some researchers are doing a better job of presenting informed consent documents in language that subjects can understand, too many still rely on jargon and overly technical language that can stymie people with limited literacy. -
IRBs support IOM recommendations
As research institutions begin to digest the new recommendations from the Institute of Medicine (IOM) of the National Academies in Washington, DC, theres general agreement that many changes it promotes in IRB structure and research activities are necessary to better protect human subjects. -
Common Rule: New year, new legislation in the works
One of the major changes promoted in the Institute of Medicine (IOM) report Responsible Research: A Systems Approach to Protecting Research Participants, is a call for federal legislation expanding protections to all human subjects involved in research, regardless of funding or setting. -
IRB review not mandatory for listings on the Internet
Its as simple as typing in an Internet URL, entering a few keywords, and hitting return across any persons computer screen comes a nationwide listing of clinical trials under way at various research institutions. Some sites even offer matching services. Could use of these listing services be considered recruitment? -
Spotlight on Compliance: OIG solicits comments on use of inducements
It would seem that two recent publications by the Office of Inspector General (OIG) indicate a desire by the agency to be less stringent when it comes to the use of inducements for clinical trial participation involving Medicare and Medicaid patients. -
News Briefs
Schwetz named acting director of OHRP; Books help prepare for FDA inspections; NEJM retracts study after authors point to forgery;