Minimal Risk / Exempt Study
Simplified consent for minimal risk research such as anonymous surveys, interviews, and educational research. Ultra-short format for exempt studies.
Consent Form Sections
This template includes 6 sections covering all required elements
Research Study Information
You are invited to participate in a research study conducted by [RESEARCHER_NAME] at [INSTITUTION].
Study Title: [STUDY_TITLE]
This study has been determined to be minimal risk research.
What Is This Study About?
PURPOSE: [BRIEF_PURPOSE - 1-2 sentences]
WHAT YOU WILL DO: [BRIEF_DESCRIPTION]
TIME REQUIRED: Approximately [TIME]
Risks and Benefits
RISKS: This study involves minimal risk. The main risk is [MINIMAL_RISK - e.g., "the time required to complete the survey" or "possible discomfort discussing personal experiences"].
BENEFITS: There are no direct benefits to you. Your participation will help [BENEFIT_TO_RESEARCH].
Your Information
[SELECT APPROPRIATE OPTION:]
ANONYMOUS: Your responses are completely anonymous. We do not collect any identifying information.
OR
CONFIDENTIAL: Your responses are confidential. Your name will not be connected to your answers and will not appear in any reports.
Data will be stored securely and used only for research purposes.
Voluntary Participation
Your participation is completely voluntary.
- You may skip any questions you prefer not to answer - You may stop at any time without penalty - [FOR STUDENTS: Your grades/academic standing will not be affected] - [FOR EMPLOYEES: Your employment will not be affected]
By proceeding, you indicate that you have read this information and agree to participate.
Contact
Questions? Contact: [RESEARCHER_NAME] [RESEARCHER_EMAIL]
Research oversight: [IRB_NAME]: [IRB_EMAIL]
Regulatory Compliance
- Includes all FDA-required elements per 21 CFR 50.25
- Complies with ICH-GCP E6(R2) guidelines
- Written at appropriate reading level (8th grade or below)
- Customizable for your study-specific requirements
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✓ 21 CFR Part 11 compliant
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