Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
Human Subjects Regulations Decision ChartsSupplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan
Guidance on NIH Office of Extramural Research (OER) on-line tutorial Protecting Human Research Participants (PHRP)
Office for Human Research Protections (OHRP)