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The Department of Health and Human Services (HHS) has asked the Institute of Medicine (IOM) for independent guidance on ways to strengthen medical research oversight, with an eye toward possibly requiring some form of accreditation. The collaborative effort is in response to growing public concern over the safety of research subjects.
Working with the IOM is the first step in a two-year effort, the HHS reports. In a report recently released at a briefing in Washington, DC, the IOM Committee on Assessing the System for Protecting Human Research Subjects endorsed accreditation as a way to potentially improve the protection of human participants in research trials.
The IOM committee suggested that draft standards set forth by the National Committee for Quality Assurance (NCQA) could be used as a framework to develop accreditation standards for research oversight. The committee recommends that accrediting organizations be nongovernmental bodies whose standards draw on federal regulations, such as the NCQA’s standards. They also recommend that the HHS commission perform studies to gather baseline data on the current research oversight process and consider launching pilot accreditation programs.
The IOM study will continue for another 18 months, during which time the committee will look at the whole system of human subject protection more generally rather than focusing just on accreditation. A final report is due in 2002.
"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," Daniel D. Federman, MD, chair of the IOM committee, said in a National Academies press release. "Over the years, any number of attempts have been made to improve the quality of research oversight. The latest approach — accreditation — holds real promise."