ABSTRACT
This chapter highlights some of the regulatory considerations in the Department of Health and Human Services (DHHS) regulations for the protection of human subjects at Title 45 Code of Federal Regulations Part 46 (45 CFR Part 46; OPRR Reports, 1994). These regulations are available from the Office for Protection from Research Risks, as well as the Belmont Report, which sets forth the basic guidelines for the conduct of research (OPRR Reports, 1979). As noted in chapter 1, these regulations provide merely the minimum standards for investigators; application of ethical thinking to research issuses, on the other hand, is a continual process of reevaluation.
