IRB Advisor – June 1, 2004
June 1, 2004
View Archives Issues
-
Is the problem overregulation or one of overinterpretation by IRBs?
From an IRB members perspective, these are trying times. On the one hand, investigators complain that regulations for human subjects research and IRBs are too stringent, making it difficult for them to do their studies. Alternatively, human subjects advocates continually complain that IRBs and institutions are too lax in monitoring clinical studies. -
Should IRB regulations be tweaked or revised?
Human subjects research protection experts agree that IRBs are overburdened and that something should be done to improve the regulations and rules governing their work. However, there is less agreement on how this could be accomplished. IRB Advisor asked IRB and research professionals to discuss how IRB regulations or the interpretation of them might be improved. -
UPenn creates integrated clinical research program
For the University of Pennsylvania School of Medicine in Philadelphia, there was no question that the only acceptable solution to the problems in human subjects research was to establish a comprehensive program that included all areas, including investigators, IRBs, and the institutions leadership. -
Public outcry, confusion stops an Oregon study
A 1999 National Institutes of Health-sponsored project to evaluate the results of a drug-testing program in Oregon public high schools was ultimately suspended after the federal Office for Human Research Protections (OHRP) decided that the goals of the research protocol appeared to have become intertwined with the drug-testing policy it was intended to study. -
No need to panic when OHRP comes a calling
Its a rare occurrence, but each year some institutions are subjected to a for-cause audit by the Office for Human Research Protections (OHRP). Such audits often turn up documentation problems and review process problems with the IRB, but occasionally they also highlight very serious problems relating to the clinical trials management, such as failure to provide adequate informed consent or failure to seek an IRB review, according to OHRP officials.