Subjects: Ethics Committees, Research and Humans - Digital Collections - National Library of Medicine Search Results

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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 -- standards
Patient Rights
Research Subjects
Ethics Committees, Research
Guideline Adherence
Human Experimentation -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Health and Human Services. Office for Human Research Protections.

2. 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 -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. 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 -- standards
Human Experimentation -- standards
Informed Consent -- standards
Ethics Committees, Research
Ethics, Research
Informed Consent -- ethics
Research Subjects
Risk
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019
Subject(s):: Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.