In this report the committee was specifically charged with the following tasks:

  1. Review the ethical foundations for protecting human participants in research.

  2. Assess and describe the current system for protecting human participants and make recommendations for potential enhancements and improvements to

    1. ensure informed consent,

    2. monitor ongoing research,

    3. accommodate private Institutional Review Board (IRBs), multicenter research, and nonmedical research,

    4. ensure continuous improvement in the system, and

    5. educate researchers, participants, and others involved in research with human participants.

  1. Assess the potential impact of recommended changes on resource needs and determine how to address them.

  2. Consider the effects of accreditation on improving human participant protection activities.

  3. Determine the need and develop potential mechanisms for continual independent review of the national system.


It is widely recognized that research involving humans must follow general ethical principles. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978) (National Commission) was charged by the U.S. Congress to investigate the ethics of research and to study how research was conducted and reviewed in U.S. institutions; it was also charged with determining the basic ethical principles that should govern research with humans. In response, the National Commission developed a schema of basic ethical principles and related it to the subject areas of research ethics to which the principles apply. The principle of respect for persons states that informed consent should be received from subjects before their involvement in research. The purpose of consent provisions is the protection of autonomy and personal dignity, including the dignity of incompetent persons who are incapable of acting autonomously. The principle of beneficence requires that an appropriate risk-benefit assessment be conducted in order to protect subjects from harm, and the principle of justice requires that there be an appropriate selection of subjects so that certain populations of participants are not over- or underused (National Commission, 1979). These three principles have come to form the ethical foundation upon which participant protection mecha-

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