As a researcher interested in using the FDA COVID MyStudies app for recording participant consent for your study, you can follow these steps to explore our Demo Study and understand what your users' experience would be like. The app is used for requesting and granting informed consent. Your study will collect the actual study data associated with the participant via some other mechanism.
Download the App
Locate and download the COVID MyStudies
from your device's app store. Searching for "MyStudies" may be helpful.
User Consent Process
When you (or your users) download the app to your device, the welcome screen will look like the following.
Click New User?
. You'll complete a verification step after receiving an email. You can opt to use a passcode, touch verification, and receive notifications as with other apps for your device.
Select a Study
The first step is to select the study of interest. To explore, click the "Example COVID-19 Consent Form Study".
You'll see the description of the "Covid-19 Consent Form Demo" along with a button to Join Study
. Click it to continue.
- Two other optional links are available for this screen. Either or both may be hidden in your study:
- A "Visit Website" link to your own content (it will open your page in the user's default browser).
- A "Visit Consent" link to view the full text of the consent form. This link lets the user review it prior to deciding whether to walk through the process.
On the Eligibility
page, you will enter the enrollment token
that was provided to you and click Submit
- In practice, you as the study administrator will provide a token like this to your candidate subjects.
- Delivery of the token to the subject can be done in a variety of ways. Learn more about your options in this TBD resource about delivering tokens
- You will need to remember the tokens you provide because for security purposes, there is no way for us to recall them on your behalf.
Next, you will see one or more Consent Components
. These are pages (screens) of details about the study and what you would be granting consent to participate in.
- When you design your own study to use the app, you can customize these panels, including links to expand and show additional information if necessary.
- You can include up to 10 custom consent panels.
- Learn more in this topic: Completing the Intake Form.
The consent panels you will see in the example have the following titles and demonstration text. On each page, if you scroll to the bottom, you will see a link to Learn More
opening another page of even more text.
- What is this study about?
- Will there be any costs to me?
- What will happen if I take part?
- Will being in this study help me?
- How does HIPAA apply to this study?
- How will you protect my confidentiality?
- Do I have to be in this study?
- What happens if I say yes, but change my mind later?
Review and Sign
After reviewing all screens, you will see the Review
panel that will look something like this. The entire consent document is available to scroll through.
Once the user clicks Agree
, they will sign the consent itself, then have the option to email themselves a copy of the form they signed.
What Happens Next?
Within the app, you will see a single "Study Activity". Clicking Start
opens a thank you page and gives a contact email. If you are interested in using this app for your own study, please get in touch to get started.
- Contact the support team at "FDAMyStudiesContact@harvardpilgrim.org".
- Contact FDA at "CDERMedicalPolicy-RealWorldEvidence@fda.gov".
You can customize the content of this final page to provide your own contact information to your own study participants. After the consent process has been completed, the user can delete the app.
As you evaluate using this application, learn more about the support and troubleshooting assistance that will be available to you.