IOM Panel Urges Accreditation System for Clinical Research

A panel of "scientific experts" convened by the Institute of Medicine called yesterday for a "new accreditation system for clinical research" that would address safety concerns about individuals who volunteer for medical experiments, the New York Times reports. Speaking at a press conference in Washington, researchers said that an accreditation system similar to the those used for hospitals and universities could help to standardize research practices and improve the current "patchwork oversight system" made up of hospital review boards and federal regulations, which is "fraught with weaknesses and lapses," the Times reports. There are currently "no national standards for excellence" for clinical researchers (Stolberg, New York Times, 4/18). A report issued by the panel called for HHS to study a possible accreditation system to be run by a nongovernmental entity and built upon existing federal regulations. The report suggested that any program be "pilot-tested" for three to five years and that the accreditation system apply to all research programs with human participants, estimated to be more than 10,000 programs. Panel chair Daniel Federman, senior dean for clinical teaching and a professor at Harvard Medical School, said, "The responsibility for protecting research participants looms especially large and is particularly complicated in clinical research, where risks are often highest, professional roles frequently conflicted and ethical lapses most salient" (Schmid, Associated Press, 4/17). While an accreditation system "could take years to put into place," the Times reports that "there is movement in that direction," as the Department of Veterans Affairs recently began a test project to accredit medical research in its hospitals and a "consortium of medical schools" is putting together a not-for-profit accreditation agency (New York Times, 4/18). The full IOM report can be found at http://www.nap.edu/books/0309073286/html/, and a summary is available at http://www.iom.edu/iom/iomhome.nsf/WFiles/IRB-6Pager/$file/IRB-6Pager.PDF. Note: You will need Adobe Acrobat Reader to view the summary.