Consent Form & Guides

Consent Forms

• Consent Form Checklist
• Sample Consent Form for a Clinical Study
• Sample Consent Form for a Non-Clinical Study
• Sample Parental Permission Form
• Sample Child Assent Form
• Physical Activity Readiness Questionnaire (PAR-Q)

Guides for Asking Consent

• Guide to Informed Consent
• Guide to Assent for Minors
• Guide to Consent Script
• Guide to Consent 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)
• HIPAA Authorization for Research
• 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)

Data Security

LSU requires that all researchers (students and faculty) read and sign the security of data agreement.  Send the signed agreement along with your application to the IRB office. No applications will be approved without the signed agreement.

Security of Data Agreement

Human Subjects Training

LSU requires that all researchers (students and faculty) complete the NIH on-line human subjects training. It takes about 3 hours to complete the course. Upon successfully completing the course, you will receive an electronic certificate. Send the completed certificate to the IRB Office. No IRB applications will be approved until all of the researchers’ certificates are obtained

NIH Protecting Human Research Participants