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ety of the issues surrounding the MMR-autism hypothesis, and the committee's conclusions and recommendations based on those assessments.

OVERVIEW OF THE IMMUNIZATION SAFETY REVIEW PROJECT

Since the mid-1990s, an increasing number of challenges to the safety of vaccinations have gained attention in various settings. The Committee on Government Reform of the U.S. House of Representatives held seven hearings on vaccine-safety issues during 1999–2000, and the media—including news programs such as 60 Minutes, 20/20, and Nightline—have covered these issues as well. Also, many consumer and professional organizations have sponsored related conferences and scientific symposia, and the Internet is playing an increasingly important communications role.

With these growing concerns about vaccine safety, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) recognized the need for an independent group to address safety concerns in a timely and objective manner. In 1999, as a result of previous IOM work on vaccine safety and the Institute's access to independent scientific experts, CDC and NIH began a year of discussions with IOM to develop the Immunization Safety Review project to address existing and emerging vaccine-safety concerns.

The Immunization Safety Review Committee, convened in the fall of 2000, comprises 15 members with expertise in pediatrics, neurology, immunology, internal medicine, infectious diseases, genetics, epidemiology, biostatistics, risk perception and communication, decision analysis, public health, nursing, and ethics. To preclude any real or perceived conflicts of interest, committee members were subject to strict selection criteria that excluded anyone who had financial ties to vaccine manufacturers or their parent companies, previous service on vaccine advisory committees, or prior expert testimony or publications on issues of vaccine safety.

The committee is charged with examining three vaccine-safety hypotheses each year during the 3-year study period (2001–2003). The Interagency Vaccine Group (IAG) comprising officials from the National Vaccine Program Office at the U.S. Department of Health and Human Services (DHHS), the National Immunization Program and the National Center for Infectious Diseases at the CDC, the National Institute for Allergy and Infectious Diseases at the NIH, the Department of Defense, the Food and Drug Administration, the National Vaccine Injury Compensation Program at the Health Resources and Services Administration, the Health Care Financing Administration, and the Agency for International Development, will select the hypotheses to be examined by the committee. The committee's findings will be released to the public in a series of brief consensus reports.

In contrast to previous IOM vaccine-safety studies (e.g. IOM, 1991, 1994a,b), which limited their conclusions to causality assessments and recommendations on



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