1. OHRP generally conducted its compliance activities independently, but changes would strengthen its independence Publication: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2017 Subject(s): Human Experimentation -- standardsPatient RightsResearch SubjectsEthics Committees, ResearchGuideline AdherenceHuman Experimentation -- ethicsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Department of Health and Human Services. Office for Human Research Protections.
2. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Clinical Trials as Topic -- standardsHuman Experimentation -- standardsInformed Consent -- standardsEthics Committees, ResearchEthics, ResearchInformed Consent -- ethicsResearch SubjectsRiskHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
