Important Information
Study Title: [Insert Study Title]
Sponsor/Organization: [Insert Sponsor or Organization Name]
Principal Investigator: [Insert Name]
Study Contact Email: [Insert Email]
Study Contact Phone: [Insert Phone Number]
Introduction
You are invited to take part in a research study. Before you decide whether to participate, please read this form carefully. It explains why this study is being done, what you will be asked to do, possible risks and benefits, and your rights as a participant.
Taking part is voluntary.
Why is this study being done?
The purpose of this study is to learn more about [insert brief study purpose in plain language].
Why have I been asked to participate?
You are being asked to participate because [insert basic eligibility reason, such as age range, symptoms, interest, or product use].
What will happen if I take part?
If you agree to participate, you will be asked to:
- Review and sign this consent form
- Complete [surveys/questionnaires/interviews/lab tests/device use]
- Use [product/service/device] as directed
- Complete follow-up assessments over [insert timeframe]
The study will last about [insert duration]. Your total time commitment is expected to be about [insert time estimate].
What are the possible risks or discomforts?
The risks of this study are expected to be [minimal/low/moderate]. Possible risks may include:
- Mild discomfort from answering personal questions
- Inconvenience or time burden
- Possible side effects or discomfort related to [product/service/device]
- Risk of loss of confidentiality, although steps will be taken to protect your information
There may also be risks that are not yet known.
Are there any benefits?
You may or may not receive a direct benefit from participating. Possible benefits may include:
- Learning more about your own [health/status/experience]
- Access to study-related information or results
- Helping researchers learn more about [topic]
However, benefit is not guaranteed.
Do I have to take part?
No. Participation is completely voluntary. You may choose not to participate. If you do join the study, you may stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
What are my alternatives?
Your alternative is simply not to participate in this study.
Will my information be kept private?
Reasonable efforts will be made to protect your privacy and the confidentiality of your study information. Your data may be stored securely and shared only with authorized members of the research team, the study sponsor, oversight bodies, or service providers involved in study operations.
No system can guarantee complete confidentiality.
Will I be paid? Will there be any costs?
Costs: [Insert whether there are costs to participate, including product, lab, shipping, or device costs.]
Compensation: [Insert whether participants are paid, reimbursed, or receive a gift card or other benefit.]
What happens if I am injured or harmed?
If you believe you have been harmed as a result of this study, contact the study team right away at [insert contact information]. [Insert any applicable statement about medical treatment or compensation.]
Who can I contact with questions?
If you have questions about the study, contact:
Study Contact: [Name]
Email: [Email]
Phone: [Phone]
If you have questions about your rights as a research participant, contact:
[IRB or Ethics Contact Name]
Email: [Email]
Phone: [Phone]
Consent
By signing below, you confirm that:
- You have read this form, or it has been read to you
- You have had the opportunity to ask questions
- Your questions have been answered to your satisfaction
- You voluntarily agree to participate in this study
- You are at least [18] years old
Participant Name: __________________________
Participant Signature: _______________________
Date: ___________________
Person Obtaining Consent: ____________________
Signature: _________________________________
Date: ___________________
Here is a shorter online consent version if you want it:
Consent to Participate
You are invited to participate in a research study about [insert topic]. If you agree, you will be asked to [briefly describe tasks]. The study will last about [duration].
Participation is voluntary. You may choose not to participate or stop at any time.
Possible risks include [brief risks]. Possible benefits include [brief benefits], but benefit is not guaranteed.
Your information will be handled as securely as reasonably possible, but complete confidentiality cannot be guaranteed.
By selecting “I agree” below, you confirm that:
- You are at least [18] years old
- You have read this information
- You voluntarily agree to participate
[ ] I agree to participate
[ ] I do not agree to participate