Important Information
INFORMED CONSENT FORM
Study Title: [Lifestyle Habits and Sleep Quality Study]
Principal Investigator: [Name, Degrees]
Institution: [Institution / Company Name]
Contact Information: [Email] | [Phone]
Introduction
You are being invited to take part in a research study. Taking part is completely voluntary. Please read this form carefully and ask any questions you have before deciding whether to participate.
Purpose of the Study
The purpose of this study is to learn more about how daily lifestyle habits (such as physical activity, screen time, and caffeine intake) are related to adults’ sleep quality.
Approximately [N] participants will take part in this study.
Who Can Take Part?
You may be eligible if you:
- Are [18] years of age or older
- Are able to read and understand English
- Have regular access to a smartphone or computer with internet
You should not take part if you:
- Have been advised by a medical professional not to change your activity or sleep habits
- Have a medical or psychiatric condition that would make participation difficult or unsafe, in your opinion or your doctor’s opinion
What Will Happen if You Take Part?
If you agree to participate, you will be asked to:
- Complete an online baseline survey (about [15–20 minutes]) about your sleep habits, mood, and lifestyle behaviors.
- Wear a consumer sleep-tracking device or app (for example, a smartwatch, ring, or phone app) for [30 days] to record your sleep duration and timing.
- Log brief daily check-ins (about [2–3 minutes per day]) about your mood, caffeine use, and screen time before bed.
- Complete a follow-up survey at the end of the [30-day] period (about [15–20 minutes]).
Your total time commitment is approximately [2–3 hours] spread over [30 days].
You are free to skip any question you do not wish to answer.
Risks and Discomforts
This study is considered minimal risk. However, potential risks or inconveniences may include:
- Loss of privacy or confidentiality if study data were accidentally disclosed. We describe below how we work to protect your information.
- Mild discomfort or fatigue from answering personal questions about your sleep, mood, or lifestyle.
- Minor frustration or inconvenience from wearing or remembering to use a device or app daily.
There are no known physical risks beyond those of everyday life. If any survey question makes you uncomfortable, you may skip it or stop participating at any time.
Potential Benefits
You may or may not receive a direct benefit from participating. Possible benefits include:
- Increased awareness of your own sleep patterns and habits
- Access to a brief summary of your sleep data at the end of the study, if you choose
- Satisfaction from helping researchers better understand how lifestyle factors relate to sleep
The information we learn may help improve recommendations for sleep and lifestyle in the future, but we cannot promise any specific benefits to you.
Alternatives to Participation
Participation in this study is optional. The alternative is not to participate. Your decision will not affect your relationship with [Institution/Company Name], your medical care, or any services you receive now or in the future.
Confidentiality and Data Protection
We will take steps to protect your privacy:
- Your data will be labeled with a study ID number, not your name.
- Any file that directly identifies you (such as your name or email) will be stored separately from your survey and device data.
- Data will be stored on [secure, password-protected servers / encrypted databases] and accessible only to authorized study staff.
- Results from this study may be published or presented at meetings, but your individual identity will not be disclosed.
Despite these protections, no system can guarantee perfect confidentiality. There is a small risk that your data could be accessed or disclosed without authorization.
[If applicable, add:]
Some data (such as device step counts or sleep durations) may be collected by third-party services (for example, the manufacturer of your wearable device). Their use of your data is governed by their own privacy policies, which you should review.
Compensation
You will receive [describe compensation: e.g., a $25 electronic gift card] if you complete the study procedures, including the baseline and follow-up surveys.
[If prorated:]
If you complete only part of the study, you may receive [describe prorated amount].
Compensation may be considered taxable income. You are responsible for reporting this, if applicable.
Costs
There is no cost to you for participating in this study other than your time and any normal data or internet charges from your service provider.
Voluntary Participation and Right to Withdraw
Participation is entirely your choice. You may:
- Decline to participate
- Skip any question you do not wish to answer
- Stop participating at any time, for any reason, without penalty
If you choose to withdraw, data already collected may still be used in analyses in de-identified form, unless you specifically request that it be removed (where feasible and consistent with applicable laws and regulations).
The investigators may also withdraw you from the study without your consent if:
- You no longer meet the eligibility criteria
- You do not follow study instructions
- The study is stopped for any reason
What If I Have Questions?
If you have questions about this study or experience any problems, please contact:
- Principal Investigator: [Name] – [Email], [Phone]
For questions about your rights as a research participant or to discuss problems, concerns, or suggestions, you may contact:
- [Name of IRB or Ethics Board]
[Address / Email / Phone]
Statement of Consent
By signing below, you acknowledge that:
- You have read and understood this consent form.
- You have had the opportunity to ask questions, and your questions have been answered.
- You are 18 years of age or older (or meet the minimum age specified above).
- You voluntarily agree to take part in this study.
You will receive a copy of this form for your records.
Participant Name (print): _______________________________
Participant Signature: _________________________________
Date: __________________
[Optional, if needed]
Researcher/Study Staff Signature: ______________________________
Date: __________________
