IRB Considerations for Studies with Mobile Devices and Mobile Apps

Summary

This article provides general IRBMED guidance for investigators planning to include mobile apps, mobile devices, and other mobile technologies in human health research. It is not intended to address all aspects of an IRB review, only those related to mobile technologies.

IRBMED evaluates risks to research study participants. When risks are identified, IRBMED representatives will guide investigators in the development of study protocols that address risks. Visit the IRBMED website. 

IRBMED does not evaluate risks associated with participant identity fraud or information and data security. 

For study-specific guidance, contact Monica Stiddom or your assigned IRBMED representative. 

NOTE: This article was written with input from Michigan Medicine IRBMED. Other IRB offices may have different guidance. 

Preparing for IRBMED Review

Equity

Consider equity implications associated with the utilization of mobile devices. Document how you will address inequity or why it isn’t possible to address equity concerns. e.g.: Some mobile device sensors have inaccurate readings on participants with dark skin.

Compensation & Incentives

  • Determine if provided technology is:
    • compensation, which may have tax and coercion implications. 
    • a study device required for participants to take part in the study. 

Device & Technology Descriptions

To reduce the need for amendments as technologies change, use generic names for study management platforms, apps, and devices.

Commonly used mobile device types: 

  • smartphone
  • fitness tracker 
  • smartwatch 
  • blood pressure cuff
  • heart rate chest strap
  • continuous glucose monitor
  • smart scale
  • sleep mat
  • smart ring

Other commonly used technology in mobile studies:

  • mobile app
  • study management platform, such as RedCap or MyDataHelps
  • survey software, such as Qualtrics
  • texting software, such as Twillio or Mosio

Case report forms, which require more detailed information, are not currently required.

It is assumed that studies collect personally identifiable demographic information.

Mobile Apps

  • If any mobile app is being utilized, IRBMED assumes the study falls under FDA regulation as a medical device. The study does not qualify for an exemption. 
    • This includes apps that passively collect data and do not deliver interventions. 
    • This assumption is made because:
      • The FDA does not provide a specific definition for medical devices.
      • Treating all mobile apps as medical devices ensures data collected through the apps can be used in future studies. 

Data 

Data Classification

Data Management & Sharing

  • It is a best practice to develop a data management and sharing plan for mobile technology studies.
    • Plans should address how a study will collect, use, and share the data. 
    • If the plan is not yet complete, make a note in the protocol and in the eReasearch application. When the plan is complete, submit an amendment to update the IRB application.
  • Sharing study data, unless required by a funder, is currently at the discretion of the investigator. 
  • Investigators are responsible for tracking who they release data to and what data is provided.

Data Use Agreement (DUA) 

  • To share data with non-U-M collaborators or vendors, a data use agreement must be in place.
  • It is a best practice to initiate data use agreements as soon as the study is funded to ensure it is in place at the time data needs to be shared. Data use agreements can take several months.

Study Protocols

Study protocols should include the following:

  • The methods that will be used for participant communications. e.g.: email, two-way text, in-app notifications.
  • Participation communications intended to impact study compliance or retention.
  • Specific measures being collected from mobile app, wearable, or mobile device.
  • Participant instructions for any manual downloads of data.
  • Instructions for coordinators and participants to ensure data sharing is set up in accordance with the study protocols and participants' preferences. 
  • Participant instructions for how to opt out of sharing optional data. 
  • Brief description of the types of information available in participant-facing mobile app or website.
  • Compensation and incentive plan.

 

Participant Informed Consent Considerations

Broad Consent

  1. The standard consent form (4.4) is set up for broad consent. 
  2. This means it includes language indicating data may be used in future research. 

Study-Specific Consent

Be specific about participant expectations, including:

  • Inclusion / exclusion criteria for participant-provided technology. (e.g.: smartphone / tablet / computer)
  • Willingness to download study-specific app(s) to participant-provided devices.
  • Wifi access.
  • Participant responsibilities for data fees.
  • Device wear time requirements.
  • Frequency of data collection
    • How often does participant need to connect to wifi or manually download information?
  • Mobile App(s)
    • Names of all required apps
    • EULAs (software end-user agreements) for all required apps
    • Include URLs as well as hyperlinks
  • Data Collection
    • Specify data that is required for primary study objectives.
    • Specify optional data the study team would like to collect, but is not required for primary study objectives. Participants can opt-out without impacting their participation in the study.
  • External Data Sharing
    • If the protocol requires sharing data with non-U-M collaborators or vendors, the informed consent must include who the data will be shared with.

eResearch Application

If your study requires a custom mobile app, contact Innovation Partners at 734-763-0614 or um-software@umich.edu. Innovation Partners will help you navigate intellectual property licensing and assist with U-M branding, publishing the app (Apple / Google app stores), and assessing commercialization opportunities.

Section 7-2.2.2:

  • Indicate the purpose and general function of all study management technology, apps, wearables and other mobile technologies that will be utilized in the study.
    • e.g.: A study management platform with a participant-facing mobile app will act as an interface between the provided smartwatch and the study team. The platform will deliver surveys via notifications to the participants' personal smartphone. A separate 3rd party mobile app will be used by participants for guided meditation.

Section 13

  • Describe participant incentives, including devices provided as an incentive.

Section 44

  • Upload a sampling of screenshots from participant-facing mobile app or website.
    • Example provided in the box titled attachments on the right of the screen.
  • Upload images of participant incentives.

 

Uploaded Image (Thumbnail)

Definitions

  • App refers to a mobile application that is downloaded to a computer, tablet, or smartphone.

About the Author

                                                
            

As the Mobile Technologies Core Manager at the University of Michigan’s Eisenberg Family Depression Center, Victoria Bennett helps investigators navigate the university’s robust resources while perpetually looking for opportunities to curate new resources. She aims to reduce friction for investigators who wish to utilize mobile technologies in health research. Drawing from her extensive experience with entrepreneurship, Victoria applies an entrepreneurial mindset to create efficient systems, improving operational effectiveness and impact. 

            

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