Department:

UAMS Human Research Advisory Committee

Policy Number:

1.1

Section:

Principles and Authority

Effective Date:

July 31, 2002

Revision Date:

November 18, 2002

SUBJECT:  Principles Governing the Committee

The University of Arkansas, its staff, employees, faculty, and students are guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the “Belmont Report”) regardless of whether the research is subject to Federal regulation or with whom conducted or the source of support (i.e., sponsorship).

The three basic principles relevant to the protection of human subjects in biomedical and behavioral research as set forth in the Belmont Report are:

Respect for Persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;

Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and

Justice: fairness in the distribution of research benefits and burdens.

The HRAC operates under a Federal Wide Assurance (FWA) in which it agrees to uphold the ethical principles of the Belmont Report and to apply Federal Regulations (Title 45 of the Code of Federal Regulations) to all research involving human subjects regardless of sponsorship [45CFR46.103(a)].The HRAC operates under a Federal Wide Assurance (FWA) in which it agrees to uphold the ethical principles of the Belmont Report and to apply Federal Regulations (Title 45 of the Code of Federal Regulations) to all research involving human subjects regardless of sponsorship [45CFR46.103(a)].  In addition, the HRAC operates according to state and institutional regulations, Good Clinical Practices (GCP) guidelines, and the Tripartite International Conference on Harmonization (ICH).