| 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).