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Date: April 17, 2001
Contacts: Saira Moini, Media Relations Officer
Mark Chesnek, Media Relations Assistant
(202) 334-2138; e-mail <>


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.

Read the full text of Preserving Public Trust: Accreditation and Human Research Participant Protection Programs for free on the Web, as well as more than 1,800 other publications from the National Academies. Printed copies are available for purchase from the National Academy Press Web site or by calling (202) 334-3313 or 1-800-624-6242. Reporters may obtain a pre-publication copy from the Office of News and Public Information (contacts listed above).

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

Daniel L. Azarnoff, M.D.*
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

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

Roderick J.A. Little, Ph.D.
Professor and Chair
Department of Biostatistics
School of Public Health
University of Michigan
Ann Arbor

James McNulty
Depressive/Manic Depressive Association of Rhode Island

Anne C. Petersen, Ph.D.*
Senior Vice President for Programs
W.K. Kellogg Foundation
Battle Creek, Mich.

Bonnie W. Ramsey, M.D.
Pediatric General Clinical Research Center and Cystic Fibrosis Research Center
Children's Hospital and Regional Medical Center;
Department of Pediatrics; and
Program Director
Core Center for Gene Therapy
School of Medicine
University of Washington

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.
National Breast Cancer Coalition
Washington, D.C.

Expert Advisers

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.
Division of Clinical Quality Improvement, and
Director of Research
Kaiser Permanente


Laura Lyman Rodriguez, Ph.D.
Study Director

* Member, Institute of Medicine