NLM Digital Collections

Search

Start Over Subjects Ethics Committees, Research ✖Remove constraint Subjects: Ethics Committees, Research Genre Guideline ✖Remove constraint Genre: Guideline

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 -- 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.

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 -- 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. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):
Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States