History of Human Subjects Protection
The national focus on the protection of human subjects in research settings is a result of work initiated during the Nuremberg Military Tribunal. At that time, it was necessary to establish standards by which to judge the human experimentation conducted by Nazi doctors and others. The Nuremberg Code, which resulted from that effort, established what are now taken to be the basic principles that guide and govern research efforts with human subjects. Among the most significant standards established by the Code are the expectation of voluntary consent with includes the capacity to consent, freedom from coercion and comprehension of the risks and benefits involved. The Code further provides that research with human subjects should minimize potential risk and harm, be undertaken by qualified investigators using appropriate research designs, and make provision for participants to withdraw at any time. Similar recommendations were made by the World Medical Association in a document known as the Declaration of Helsinki. This document was first adopted in 1964 and revised in 1975 and 1989.
The United States first established regulations to protect human subjects in 1974. From 1974 to 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research met and developed recommendations and guidelines for human research. Their final report is titled The Belmont Report and is available online. In 1981, both the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) published revisions of their regulations consistent with the recommendations of The Belmont Report. These regulations have been reviewed and revised on multiple occasions and are codified in the Code of Federal Regulations. Additional details can be found at the website of the Federal Office for Human Research Protections (OHRP).
Statement of Ethical Principles
The GGC Institutional Review Board (IRB) has as its mission ensuring that research conducted at GGC or by researchers affiliated with GGC will be in compliance with the principles laid out in the documents referenced above. In particular, the GGC IRB is committed to being certain that research conducted at, by and for Georgia Gwinnett College:
- is done with the voluntary consent of participants who are properly informed about the purpose, risks, and benefits of the study;
- protects the privacy and dignity of participants;
- minimizes the risk to study participants while maximizing the study’s benefits;
- uses equitable procedures for recruitment and selection of participants so that it does not discriminate on the basis of sex, gender, race, sexual orientation, national origin or any other factor; and
- is sensitive to the setting in which it takes place.