In this brochure you will find background and guidelineson the ethical and regulatory aspects of research on fellowhuman beings. The NIH has a long history as a leaderin promulgating ethical safeguards in the conduct of thisresearch; in fact, 40 years ago with the opening of theClinical Center, the NIH created one of the earliest policiesfor research involving human subjects.Investigators must balance their interest in gathering dataand answering research questions with society's mandateto protect the rights and safeguard the welfare of researchsubjects. To help investigators maintain this balance, the NIHhas organized a human research protection program (HRPP)which includes policies and procedures related to the pro-tection of human research subjects. This booklet discussessome aspects of NIH’s HRPP.Society has granted a conditional privilege to performresearch on human beings. As described in the followingpages, the condition is that it must be conducted in a waythat puts the rights and welfare of human subjects first.Michael M. Gottesman, M.D.
Deputy Director for Intramural Research,
National Institutes of HealthAlan L. Sandler, D.D.S.
Director,Office of Human Subjects Research
National Institutes of Health5thPrintingAugust 2004