1. 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.
2. Medicare advantage: CMS should use data on disenrollment and beneficiary health status to strengthen oversight : report to Congressional Requesters Publication: Washington, D.C. : U.S. Government Accountability Office, April 2017 Subject(s): Health StatusInsurance Selection BiasMedicare Part C -- statistics & numerical dataGovernment RegulationRiskHumansUnited StatesUnited States. Department of Health and Human Services.Centers for Medicare & Medicaid Services (U.S.)