Date: April 17, 2001 Contacts: Saira Moini, Media Relations Officer Mark Chesnek, Media Relations Assistant (202) 334-2138; e-mail <email@example.com>
FOR IMMEDIATE RELEASE
Accreditation Is One -- But Not the Only -- Potential Tool For Strengthening System to Protect Research Participants
WASHINGTON -- Strengthening the system responsible for protecting volunteer participants in human research studies could be accomplished, in part, by implementing accrediting programs to certify that research entities meet certain performance standards, says a new report from the Institute of Medicine of the National Academies. However, accreditation is only one possible solution, and such programs should first be pilot-tested before being universally adopted.
"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," said Daniel D. Federman, chair of the committee that wrote the report and senior dean for clinical teaching and professor of medicine and medical education at Harvard Medical School, Boston. "Over the years, any number of attempts have been made to improve the quality of research oversight. The latest approach -- accreditation – holds real promise. But we see it as an evolving tool, and one that cannot be viewed as a panacea or overnight solution. It must be part of a long-term strategy."
A set of draft standards developed by the National Committee for Quality Assurance (NCQA), a private accrediting body, for use by the U.S. Department of Veterans Affairs (VA) appears to present a framework most readily applicable to the initiation of other accreditation programs, said the committee. This framework should, however, be strengthened and also adapted to differing research environments and disciplines. The resulting accreditation programs should be initially pilot-tested and then assessed after three to five years. Establishing an accreditation process typically takes several years, according to the report. The process must be continually adjusted to meet changing needs, if it is to succeed in improving performance at the national level.
Participants in studies should be more thoroughly integrated into the research oversight process, the committee said. Moreover, accreditation standards should be made applicable to all research programs involving human participants -- by one estimate, a total of more than 10,000 programs, including those conducting biomedical research and drug trials as well as studies in the behavioral and social sciences. By offering a recognized seal of approval, accreditation could establish a measure of excellence sought by research organizations, raising the bar for all and laying a path for continuous improvement.
Amid increasing concern over patient safety and shutdowns of research operations at a number of academic and VA medical centers, calls for accountability and oversight have grown louder. Presidential committees, Congress, the U.S. Department of Health and Human Services (HHS), and the VA have explored different approaches to improving the system; ultimately, last year, HHS approached the Institute of Medicine (IOM) for independent guidance on the matter.
The IOM committee compared sets of draft accreditation standards developed by two private organizations, NCQA and Public Responsibility in Medicine and Research (PRIM&R). NCQA's standards were deemed, on the whole, to be more immediately applicable for pilot-testing than those drafted by PRIM&R. NCQA's standards not only draw upon existing federal regulations, said the committee, but also rely on rigorous quality improvement programs at research sites and have the potential to elevate the enterprise beyond a system focused on administrative compliance. As part of its study, the committee examined other models of accreditation, including hospitals and clinics participating in Medicare, mammography facilities, treatment programs for opiate dependence, institutions for higher education, and laboratory-animal care facilities.
Among its slate of 11 recommendations, the committee also urged that:
> accrediting organizations be nongovernmental entities whose standards build upon federal regulations;
> HHS commission studies for collecting baseline data on the current system of protections; and
> consideration be given to having pilot programs evaluated by the U.S. General Accounting Office and the HHS Office of the Inspector General.
A more comprehensive assessment of the overall system for protecting human research participants is under way by the IOM committee and will be issued in 2002. That study will delve into improving the informed consent process, easing the burdens on institutional review boards, ensuring that investigators are educated about the ethics and practices involved in conducting research with humans, enhancing research monitoring, and bolstering institutional support and infrastructure. Additionally, special attention will be given to issues relating to behavioral and social science research.
The study was sponsored by the U.S. Department of Health and Human Services and the Greenwall Foundation. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.
INSTITUTE OF MEDICINE Board on Health Sciences Policy
Committee on Assessing the System for Protecting Human Research Subjects
Daniel D. Federman, M.D.* (chair) Senior Dean for Alumni Relations and Clinical Teaching, and Carl W. Walter Distinguished Professor of Medicine and Medical Education Harvard Medical School Boston
Daniel L. Azarnoff, M.D.* President D.L. Azarnoff Associates, and Senior Vice President of Clinical and Regulatory Affairs Cellegy Pharmaceutical Co. San Francisco
Tom L. Beauchamp, Ph.D. Professor of Philosophy, and Senior Research Scholar Kennedy Institute of Ethics Georgetown University Washington, D.C.
Timothy Stoltzfus Jost, J.D. Newton D. Baker-Baker and Hostetler Professor of Law, and Professor of Health Services Management and Policy College of Medicine and Public Health Ohio State University Columbus
Patricia A. King, J.D.* Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy Georgetown University Law Center Washington, D.C., and Adjunct Professor Department of Health Policy and Management School of Hygiene and Public Health Johns Hopkins University Baltimore
Roderick J.A. Little, Ph.D. Professor and Chair Department of Biostatistics School of Public Health University of Michigan Ann Arbor
James McNulty President Depressive/Manic Depressive Association of Rhode Island Bristol
Anne C. Petersen, Ph.D.* Senior Vice President for Programs W.K. Kellogg Foundation Battle Creek, Mich.
Bonnie W. Ramsey, M.D. Director Pediatric General Clinical Research Center and Cystic Fibrosis Research Center Children's Hospital and Regional Medical Center; Professor Department of Pediatrics; and Program Director Core Center for Gene Therapy School of Medicine University of Washington Seattle
Lydia Villa-Komaroff, Ph.D. Professor of Neurology, and Vice President for Research Office of Research Northwestern University Evanston, Ill.
Frances M. Visco, J.D. President National Breast Cancer Coalition Washington, D.C.
Kay Dickersin, Ph.D. Associate Professor Department of Community Health School of Medicine Brown University Providence, R.I.
Alberto Grignolo, Ph.D. Senior Vice President and General Manager for Worldwide Regulatory Affairs PAREXEL International Waltham, Mass.
Mary Faith Marshall, Ph.D. Professor of Medicine and Bioethics School of Medicine Kansas University Medical Center Kansas City
Carol Saunders, R.N. President and Chief Executive Officer Center for Clinical Research Practice Wellesley, Mass.
Dennis Tolsma, M.P.H. Director Division of Clinical Quality Improvement, and Director of Research Kaiser Permanente Atlanta