1. E6(R2) good clinical practice: integrated addendum to ICH E6(R1) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Clinical Trials as Topic -- ethicsClinical Trials as Topic -- methodsEthics Committees, ResearchInformed ConsentRandomized Controlled Trials as Topic -- ethicsRandomized Controlled Trials as Topic -- methodsResearch DesignResearch SubjectsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
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.
