Beneficence - Protecting Human Subject Research Participants

Protecting Human Research ParticipantsRespect for PersonsMain Menu | Glossary | HelpInformed ConsentPrevious Page 3 of 25NextThe Belmont principle of respect for persons is primarily applied by requiring that all human subjectsresearch participants provide voluntary informed consent to participate in research.The three fundamental aspects of informed consent are:VoluntarinessIndividuals’ decisions about participationin research should not be influenced byanyone involved in conducting theresearch: “...consent must be freelygiven or truly voluntary.” 1ComprehensionIndividuals must have the mental ordecisional capacity to understand theinformation presented to them in order tomake an informed decision aboutparticipation in research.DisclosureHHS regulations (45 CFR 46.116(a)) require that researchers disclose:1. The purpose of the study2. Any reasonably foreseeable risks to the individualhttp://phrp.nihtraining.com/respect/03_respect.php (1 of 2)6/20/2008 2:05:33 PM