Observational Study
Simplified consent for non-interventional research focused on data collection and privacy. Ideal for surveys and registry studies.
Consent Form Sections
This template includes 8 sections covering all required elements
Introduction
You are being invited to participate in a research study. This study involves observation and data collection only - there are no experimental treatments or procedures.
Please read this form carefully. Feel free to ask questions before deciding whether to participate.
Purpose of the Study
The purpose of this study is to [STUDY_PURPOSE].
We hope to learn [EXPECTED_OUTCOMES]. This information may help [POTENTIAL_BENEFITS_TO_SCIENCE].
What Will Happen
If you agree to participate, you will be asked to:
- Complete questionnaires about [TOPICS]
- [OTHER_ACTIVITIES]
This will take approximately [TIME_COMMITMENT]. You can complete the questionnaires [LOCATION/METHOD].
Risks
This study involves minimal risk. Possible risks include:
- Discomfort when answering personal questions
- Time required to complete questionnaires
- [OTHER_MINIMAL_RISKS]
You may skip any questions you do not wish to answer.
Benefits
There are no direct benefits to you for participating. Your participation will contribute to research that may benefit others in the future.
Privacy and Data Protection
Your responses will be kept confidential. Your data will be:
- Stored securely with encryption
- Identified only by a coded participant number
- Accessible only to authorized research staff
- Never sold or shared for commercial purposes
Your name will not appear in any reports or publications from this study.
Voluntary Participation
Your participation is voluntary. You may:
- Choose not to participate
- Skip questions you do not want to answer
- Withdraw at any time without penalty
Withdrawing will not affect any services you receive.
Contact Information
For questions about this study: [RESEARCHER_NAME] [RESEARCHER_CONTACT]
For questions about your rights as a participant: [IRB_CONTACT]
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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