A wrist device collects more, more often, than any clinic visit. Participants should know exactly what it records, who receives it, what the study team will and will not do with it, and how to stop.
Free sandbox · No credit card · 21 CFR Part 11 aligned
What the device records, and when
Wearing, charging and syncing
Who receives your data
The device company's own terms
What we will not watch for
Stopping and returning the device
Key points
Template sections
| Section | Cover | Example wording to adapt |
|---|---|---|
| What the device records | Data types, frequency, when recording happens | The ring records your heart rate, temperature and movement during sleep, every night of the study. |
| What we do not collect | Features switched off or not used | We do not collect your location, and the study app does not access your contacts. |
| Wearing, charging, syncing | Time commitment, practical steps | Please wear the device every night and open the app once a day so your data can sync. |
| Who receives your data | Device company, study data system, sponsor | Your data goes to [manufacturer] and then, under your study number, to the study team. |
| Device company terms | Separate account and privacy terms, if any | To use the device you will create an account with [manufacturer] and accept its terms. |
| What we will not watch for | No real-time monitoring, not a medical device alert | The study team does not review your data every day. If you feel unwell, contact your doctor. |
| Incidental findings | Whether unusual results are shared, and how | If we notice a result that may matter for your health, the study doctor will contact you. |
| Stopping and returning | Withdrawal, data already collected, device return | You can stop at any time. Please return the device in the prepaid envelope. |
Example wording is illustrative; adapt it to your device and study and have it reviewed by your ethics committee.
Privacy
Sensor streams can be surprisingly identifying: activity patterns reveal routines, and some devices record location. Under GDPR, health data from wearables is special category data; under HIPAA it may be protected health information once linked to a covered entity's study. The consent form should explain the protections the study uses (study numbers instead of names, minimal data types, no location unless needed) in plain language.
The incidental findings question deserves care. A device might show an irregular heart rhythm or very low oxygen levels. If the study will not review data in real time, the form must say so clearly, so participants do not rely on the study for monitoring. If it will act on certain findings, say which ones and how. See EDC for wearable device studies for how device data fits into a study.
| Needed | Collected | |
|---|---|---|
| Heart rate | ||
| Sleep stages | ||
| Steps | ||
| GPS location |
eConsent
Wearable studies usually combine device data with questionnaires and diaries. Capture runs eConsent, ePRO and EDC in one study: participants consent on their own device with a verified signature, then complete diaries in the same browser-based experience, with no app to install.
From: Capture.Study · Sleep and Recovery Study
Your questionnaire is ready
Hi Anna, your evening diary is open until midnight. Tap the button to start. The link signs you in, no password needed.
Open my tasksQuestions? Reply to reach your study site.
My tasks
Evening diary
Due tonight
Week 4 questionnaire
Opens Monday
Sign a test consent and complete a sample diary in the free sandbox.
Before submission
What is collected and what is switched off.
Data is not watched in real time unless it is.
Whether participants accept the vendor's own terms.
Disabled or explained.
What happens to data already collected, and the device.
Wear time, charging and syncing expectations.
What the device records and when, wearing and charging burden, who receives the data, device company terms, what the study will not monitor, incidental findings, and withdrawal and device return.
Often, for commercial devices. The consent form should say so and explain the company's role.
Usually not. The consent form should say so clearly and explain what to do if a participant feels unwell.
Yes. Under GDPR, health data from wearables is special category data, even when labelled with a study number.
Yes. Adapt the sections to your device and study and have them reviewed by your ethics committee.
Keep exploring
EDC for wearable device studies
Device data in a study.
Decentralized trial consent template
Other remote elements.
Digital biomarker validation software
Validating sensor measures.
Genomic research consent
Another data-heavy consent.
GDPR compliant trial software
Special category data.
HRV companion template
Diary alongside a wearable.
eConsent, diaries and EDC in one study. Free sandbox.