Human experiment guidelines reviewed

Critics worry new rules may encourage under-reporting of side effects

Trevor Stokes
Jan 12, 2006
The public commentary period ended Friday (January 13) for the new draft guidelines from the Office for Human Research Protections (OHRP) on reporting adverse events during clinical trials -- with some critics expressing concern that the new rules, if passed, may discourage researchers from reporting side effects.Under the new guidelines, researchers do not need to report some expected adverse events as long as they have consent from their institutional review boards IRBs. The purpose of the change is to reduce data overload, a common complaint from many IRBs.Reducing workload is a good goal, but not if it means cutting important corners, critics say. ?Any filter that you put up runs the risk of filtering out valuable data,? Eric M. Meslin, director of Indiana University Center of Bioethics, told The Scientist. ?This is the challenge whenever you put a semi permeable membrane into this stream of data.?The problem of data overload...

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