Introduction & Statement of Principles
Northeast Georgia Health System Institutional Review Board (NGHS IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Northeast Georgia Health System, Inc. (NGHS).
This document contains written policies and procedures to provide guidance and direction in safeguarding the rights and welfare of human participants in research. 45 CFR 46.114 Biomedical and/or behavioral research involving human participants at NGHS is guided and directed by principles and concepts agreed upon and established as ethical, moral and legal. These codes of conduct include, but are not limited to:
A. Principles of the World Medical Association - Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. http://www.wma.net/en/30publications/10policies/b3/.
B. Belmont Report, adopted by the National Commission on Protection of Human Subjects of Biomedical and Behavioral Research.http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm.
C. Requirements of the Common Rule as found in 45 CFR 46 and its subparts are considered to be a minimum standard. http://ohrp.osophs.dhhs.gov/index.htm.
D. Requirements of the FDA for all research on regulated test articles are to be a considered a minimum standard. Federal Regulations related to the FDA authority Title 21 CFR Parts 50,56, 312, 600 and 812.60-66 are available on the World Wide Web. http://www.access.gpo.gov/nara/cfr/. 45 CFR 46.103 (b)(1)