April 20, 2001
IOM Releases Report On Accreditation Standards For Human Research
The Institute of Medicine (IOM) Committee on Assessing the System for Protecting Human Research Subjects released its report April 17 at a news conference endorsing proposed performance and accreditation standards for human research review programs.
In response to a request from the Secretary of Health and Human Services and amid increasing concern over patient safety, the IOM committee recommended that standards be strengthened with regard to the review of investigators, institutional review boards (IRBs), sponsors, and oversight mechanisms, and that the organizations formulating accreditation standards be independent and nongovernmental.
The committee reviewed and considered available draft standards developed independently by the National Committee for Quality Assurance (NCQA) and Public Responsibility in Medicine and Research (PRIM&R). The IOM Committee specifically endorsed the standards proposed by the for VA facilities and found them to be "more suitable" than those prepared by PRIM&R for not only pilot testing in VA facilities but also, with modification, for the accreditation of other research institutions.
Although the IOM committee acknowledged that veterans were not necessarily representative of the range of people involved in research, the report indicated that those standards could be adapted over time for use in other organizational contexts.
Some have raised concerns regarding the IOM's endorsement of the NCQA effort over that of PRIM&R, noting that both were, at this stage, rooted in existing federal regulations related to IRB function. Neither has progressed far enough to incorporate broader data on human research protection activities. There is a need for pilot testing before endorsing any standards.
Roger E. Meyer, M.D., AAMC senior consultant on clinical research, expressed at the news conference that accreditation should not present research institutions and their affiliated VA hospitals with incompatible standards. Greg Koski, M.D., Ph.D., director, HHS Office for Human Research Protections, also urged that the pilot testing be used to move the standards to a common ground as quickly as possible.
The IOM will be working on a more comprehensive assessment of the overall system for protecting human research and will issue a separate report in 2002.
Information: Roger E. Meyer, M.D., AAMC Division of Biomedical and Health Sciences Research, 202-828-0567.
