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Consent Form Guides, Samples, and other Helpful Links
Consent Form Help
- Guide to Informed Consent
- Consent Form Checklist
- Guide to Assent for Minors
- Sample Consent Form for Clinical Study
- Sample Consent Form for Non-Clinical Study
- Sample Parental Permission Form
- Sample Child Assent Form
- Sample Consent Guide for Mail & Telephone Surveys
Research Information
- Use of Human subjects: basic requirements & procedures
- Research with cognitively impaired persons
- Rules concerning use of pregnant women in research
Federal Documents (Apply to IRB-regulated studies)
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Title 45 Code Of Federal Regulations Part 46 - Protection of Human Subjects
- Office for Human Research Protections (OHRP)
- Additional ED Protections for Children
FDA Documents (Apply to studies that use FDA-regulated drugs, devices, or clinical studies)
- Regulations for Clinical Studies- Studies that use FDA approved drugs
- FDA Regulations 21CFR 50.24
- Code of Federal Regulations (searchable - via GPO)
