the accreditation of programs that are charged with the responsibility of protecting individuals who volunteer for research. This first chapter provides the relevant background preceding this work, as well as discussion pertaining to the committee's concept of a human research participant protection program (HRPPP) and related terminology. Chapter 2 explores various models of accreditation. It also focuses on how accreditation might apply to activities surrounding protection of human research participants and explores the process for such a system.

Chapter 3 centers on the issue of standards; that is, what values and measurements should be used to address an organization's level of performance and expectations for activities that affect the protection of participants in human research? In response to its charge, the committee reviewed the draft Public Responsibility in Medicine and Research (PRIM& R) standards and those developed by the National Committee for Quality Assurance (NCQA). Chapter 3 presents the committee's recommendations about standards for accreditation.

Chapter 4 focuses on issues in evaluating and analyzing a system of accreditation. In response to the committee's third task, this chapter includes committee recommendations for steps that the federal government should take to collect and analyze data that can be used to monitor and evaluate how well the system for protecting human research participants is operating.

A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES

In response to the atrocities committed by Nazi scientists during World War II, the Nuremberg Military Tribunal created the Nuremberg Code, a set of 10 principles for research involving human participants, including an absolute requirement for voluntary consent (Nuremburg Code, 1946–1949; United States v. Karl Brandt et al. The Medical Case 1946–1949). The Nuremberg principles placed primary responsibility on the investigator to ensure that research was ethically conducted. At the same time that the Nuremberg Trial was proceeding, anticipating the need for a rapid response to concerns about research abuses, the American Medical Association adopted its first code of research ethics for physicians in 1946, outlining principles to be followed in conducting research with human subjects (AMA Judicial Council, 1946).

Over the ensuing two decades, U.S. policy in this area evolved, addressing prohibitions on research involving vulnerable or special populations and eventually requiring independent review of research and written consent for “hazardous” research (ACHRE, 1995). The Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act required the Food and Drug Administration (FDA) to evaluate new drugs for safety as well as efficacy, significantly expanding the power of the federal government to influence the conduct of clinical



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