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Michelle Takemoto

Posts: 7
posted

I'm struggling to convince the IRB to approve a physical activity intervention using fitbits. Does anyone have any recommendations for convincing language to use in our proposal?

Michelle Takemoto

Posts: 7
posted in reply to michelle takemoto

Emphasize their unobtrusive data collection approach.

Michelle Takemoto

Posts: 7
posted in reply to michelle takemoto

Emphasize their unobtrusive data collection approach.

Most participants don't mind wearing the device.

Camille Nebeker

Posts: 49
posted in reply to michelle takemoto

What are the IRB concerns? We do have consent and protocol language that we can share - just want to be sure it is responsive to their concerns.

Rubi Linares-Orozco

Posts: 31
posted

In looking over the Fitbit Privacy policy, there are some things you may want to consider.
1) FitBit cannot be used for children under the age of 13: "You may use the Fitbit Service if you are over 13 years of age and are not barred from receiving services under applicable law."

2) FitBit Privacy includes excuplatory language: "You are responsible for all activity that occurs in association with your account. Fitbit is not liable for any loss or damages caused by your failure to maintain the confidentiality of your account credentials."

3) FitBit takes no responsibility over the accuracy of their data: "The accuracy of the data collected and presented through the Fitbit Service is not intended to match that of medical devices or scientific measurement devices...We are not responsible for the accuracy, reliability, effectiveness, or correct use of information you receive through the Fitbit Service. Maps, directions, and other GPS or navigation data, including data relating to your current location, may be unavailable, inaccurate or incomplete. If you rely on any Fitbit Content or the Fitbit Service, you do so solely at your own risk."
--- IF the data is not accurate, why would you want to use this type of technology in your research, from the get go your research data would e flawed if you cannot account for the inaccuracies. It may be worth looking into other devices that provide more validity and quality control of the health data.

4) Any FitBit user should consult their doctor before using "The Fitbit Service is not intended to diagnose, treat, cure, or prevent any disease. If you have a medical or heart condition, consult your doctor before using the Fitbit Service, engaging in an exercise program or changing your diet...If you engage in any exercise program you receive or learn about through the Fitbit Service you agree that you do so at your own risk and are voluntarily participating in these activities."
--- You will need to include a physician clearance as part of your screening/eligibility of participants.

5) Risks associated with wearing device: "Prolonged contact with wearable devices may contribute to skin irritation or allergies in some users. To reduce irritation, follow four simple wear and care tips: (1) Keep it clean; (2) keep it dry; (3) don’t wear it too tight, and (4) give your wrist a rest by removing the band for an hour after extended wear... If you notice any skin irritation, remove your device. If symptoms persist longer than 2-3 days after removing the device, consult your doctor...Fitbit products using PurePulse™ technology have a heart rate tracking feature that may pose risks to users with certain health conditions. Consult your doctor prior to use if you (1) have a medical or heart condition, (2) are taking any photosensitive medicine, (3) have epilepsy or are sensitive to flashing lights, (4) have reduced circulation or bruise easily, or (5) have tendonitis, carpal tunnel syndrome, or other musculoskeletal disorders. If you feel soreness, tingling, numbness, burning or stiffness in your hands or wrists while or after wearing the product, please discontinue use."
---- These identified risks will need to be incorporated into your Research Plan and consent form.

6) FitBit Notifications: "As part of your use of the Fitbit Service, you may receive notifications, text messages, alerts, or emails. You agree to the receipt of these communications. You can control receipt of non-service related communications from your account settings. You are responsible for any messaging or data fees you may be charged by your wireless carrier."
--- The consent should provide a statment informing subjects that they are financially responsible for any data or cellphone charges when participanting in the research study.

7) ThirdParty Advertising: "The Fitbit Service contains links to third-party websites, apps, services and resources (collectively “Third-Party Services”) that are not under Fitbit’s control. We provide these links only as a convenience and are not responsible for the content, products or services that are available from Third-Party Services. You acknowledge sole responsibility and assume all risk arising from your use of any Third-Party Services."
--- Also more exculpatory language.

If you have any questions regarding the FitBit terms of service can be directed to Fitbit, Inc. support@fitbit.com
Terms of Service can be found here: https://www.fitbit.com/legal/terms-of-service