Regulations Protecting Human Subjects in Research

The federal regulations protecting human subjects in research are contained in Title 45: Part 46 of the Code of Federal Regulations and are administered by the United States Department of Health and Human Services. These regulations have developed over time since the passing of The National Research Act in 1974. In 1979 The National Commission for the Protection of Human Subjects deliberated over the ethical principles which ought to dictate human subject’s research. The Belmont Report is the document that the commission produced. Its contents form the philosophical underpinnings of Title 45: Part 46 of the Code of Federal Regulations.

In addition to the federal regulations, individual academic and professional disciplines have agreed upon ethical standards which govern research conduct as it pertains to the protection of human subjects. As most of these standards are quite similar between discipline, HARRC has concentrated its efforts on the guidelines of the American Psychological Association. All HARRC decisions regarding research protocols will be made, therefore, in an attempt to uphold both federally mandated and discipline-specific ethical standards.

Title 45: Part 46 of the Code of Federal Regulations can be viewed at:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

The Belmont Report can be viewed at:
http://ohsr.od.nih.gov/guidelines/belmont.html

The American Psychological Association statement of research ethics as they pertain to human subject’s protection can be viewed at:
http://www.apa.org/ethics/code2002.html#8