standards will serve as a guidepost to aid organizations and other entities in building and/or strengthening their programs for the protection of protections for individuals studied in research.

The on-site review portion of the accreditation program is the second phase, and, as mentioned above, be voluntary, educational, and constructive.

Standards are prerequisite to the successful operation of an accreditation system, as they provide a means by which expectations can be stated, and by which performance in accordance with those expectations can be measured.

When evaluating the applicability of these standards to a given research program, the responsible institutional individual(s) should take into account the types of research with which that human research protection program is involved. For example, in light of the continuing increase of multicenter and cooperative studies, organizations participating in such trials must first assess the manner in which the various components of their Human Research Protection Program interact in order to provide appropriate protective mechanisms.

GOALS

The goal of voluntary accreditation is to improve the systems that protect the rights and safeguard the welfare of individuals who participate in research. Secondary goals may include:

  • To communicate to the scientific community and to the public a strong declaration of a research organization's commitment to the protection of human research participants;

  • To help organizations understand the need to commit adequate resources to maintain quality human research protection programs;

  • To enhance an organization's ability to attract students to graduate research training programs; and

  • To promote a higher quality of research, which will in turn result in better scientific outcomes and, ultimately, better healthcare.

PRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCH

In the United States the conduct of research involving humans is a conditional privilege requiring that research is conducted in keeping with well-established ethical principles, applicable federal, state, and local laws, and/or relevant policies and procedures.

The Belmont Report—Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979) provides the philosophical basis for current laws governing human subjects research. This Report identifies three fundamental ethical principles that are relevant to all research involving human



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