Summary
There are several ways to enroll and consent participants in a study using mobile technology. This article will review best practices and examples of enrolling and consenting participants using mobile or web applications.
Details
Inviting Participants to your Study
Email
Requires email from prospective participants. Ideal for studies that are able to screen and identify participants that may be eligible.
Text
Requires phone number from prospective participants. Ideal for studies that are able to screen and identify participants that may be eligible.
QR code
Ideal for large studies recruiting participants in clinics, community events, etc. A QR code can be embedded in flyers, emails, and digital advertisements to maximize outreach.
Searching for the study in mobile platform
Ideal for large studies recruiting participants in clinics, community events, etc. However, prospective participants must already have the mobile platform/app installed in order to search for the study.
eConsent Methods and Best Practices
Reading and signing a consent on a mobile device can be challenging, especially for participants with visual impairments. Additionally, you want participants to take their time in reviewing the information instead of scrolling to the bottom of a text-heavy document without reading. To help mitigate this, you can choose to break up your informed consent into multiple screens.
Many mobile health tools offer electronic consent features, such as REDCap, MyDataHelps, and more. In the following example, the study team has used MyDataHelps to configure their consent into 10 different sections. The participant views the summary level information on each screen, and they also have the option to tap or click on “Learn more” to view more details on each section.
The method above is typically supplementary to and not meant to replace a signed document, because it is usually required by the IRB or your sponsor depending on the nature of your study. This method is ideal for studies that receive a waiver of written consent. However in most cases, you will need to keep a record of signed consents and potentially an audit trail of the coordinator that administered the consent. Make sure the tool you are using has these capabilities before selecting a mobile health platform for your study.
In the example below, the study team has added a step that follows the summary screens, which includes the entire IRB-approved informed consent in a single screen. The participant must then scroll to the bottom, tap or click “Accept”, and virtually sign the consent. A pdf of the signed document is then generated, which can be accessible to the coordinator and the participant at any time.
Assessment of Understanding Questions
Assessment of understanding questions are questions that are administered after the participant has read the informed consent and serve to ensure the participant understands their involvement in the study. These questions cover the most important topics of informed consent (risks, compensation, study tasks/time line, etc.) and are not meant to challenge or burden the participant. It is best practice to allow the participant to retake the assessment until they’re able to answer all questions correctly. This supplement to the consent is particularly useful for studies where participants are able to self-consent.
eConsent FDA Compliance - MyDataHelps
Studies that are U.S. Food and Drug Administration (FDA) regulated and are consenting patients electronically must comply with the 21 CFR Part 11 regulation. 21 CFR Part 11 is a regulation that establishes criteria for accepting electronic records and electronic signatures as equivalent to paper records and handwritten signatures on paper. Its primary purpose is to ensure the integrity, authenticity, and confidentiality of electronic records within the pharmaceutical, biotechnology, and medical device industries.
If you are using MyDataHelps for your mobile study, your study team is able to configure your eConsent in a way that is compliant with 21 CFR Part 11. In your consent survey, follow these instructions:
- Select the "Consent Step" step type to use compliance-related fields.
- In the "Digital Signature" section of the consent builder, select the "Require typed name" and "Require drawn signature" checkboxes. Unselect the "Bypass drawn signature on web" checkbox.
- If you want to include any additional information, add a "form step" prior to the signature with additional fields.
Please see CareEvolution's user guide for more details on configuring an eConsent.
Resources
About the Author
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Nicole Eyrich, MPH is a clinical research program manager and technology specialist in the Department of Anesthesiology at the University of Michigan. She has overseen the implementation of novel mobile health technology and wearable devices for more than 9,000 patients across multiple studies and centers. She has been the primary clinical research liaison to the UM IRB, ensuring that novel mobile health studies adhere to rigorous ethical standards, while innovating consent, enrollment, and data collection techniques. Nicole serves as an administrative lead for the Mobile and Technologies Research Innovation Collaborative (MeTRIC).
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