subjects: (1) Respect for Persons, (2) Beneficence, and (3) Justice. Application of these principles in the conduct of human research requires: (1) that the process of informed consent be prerequisite to an individual's participation; (2) that additional protections be employed for persons who cannot provide this consent; (3) that risks and benefits be responsibly and ethically assessed; (4) that research populations have been selected equitably; and (5) that equity exists for all individuals in consideration of the burdens and benefits of the research. Each of these principles carries equal moral force, and difficult ethical dilemmas may arise when they conflict.

Careful and thoughtful application of the principles of The Belmont Report cannot be exclusively relied upon to resolve particular ethical problems without conflict. The principles, however, do provide an analytical framework that will help guide the resolution of most ethical problems arising during the development and review of research, and that will increase the likelihood that individuals who agree to be studied in research will be treated in an ethical manner.

These voluntary accreditation standards incorporate the ethical principles of The Belmont Report. Therefore, seeking accreditation is an organization's public declaration that it endorses and implements the Belmont principles.

GLOSSARY

Accreditation

An assessment process in which an agency uses experts in a particular field of interest or discipline to define standards of acceptable and applicable operation/performance for an organization/system and to measure compliance with them.

Data and Safety Monitoring Board (DSMB)

A group of experts, independent of the research project, who review the safety data and critical efficacy end-points of a research protocol at specified intervals and recommend whether to continue, modify, or terminate that research. It should be noted that DSMBs are usually convened in phase III and in large multicenter studies, and not routinely in phase I and II trials. In addition, it should be noted that a DSMB should not be confused with a data and safety monitoring plan, which is required for all NIH clinical trials.

Human Research Protection Program (HRPP)

A system that includes all components critical to protecting individuals studied in research and that is managed in accordance with these standards and with applicable federal, state, and local laws and regulations. In general, the HRPP has a central authority, Institutional Review Board(s) (IRB), IRB staff, and researchers and research personnel. Some components of the HRPP may be external to the organization seeking accreditation, but the essential components of an HRPP should be identifiable in all cases.



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