To be eligible to use the COVID MyStudies app, your study must comply with all applicable requirements for IRB review and approval. When you contact the FDA to get started, you will reference your pre-IND or IND number if applicable.
To set up your own study to obtain consent via the FDA COVID MyStudies app, there are a few decisions to make. When you enroll, you fill out and submit an Intake Form
where you present the answers to many of these questions. For details about completing the Intake Form, see the topic: Completing the Intake Form
How Will Participants Find the App and Your Study?
Decide how you will be promoting the work and what mechanism you will use to tell your own users how to download and use the app. You will need a unique title for your study. Note that within the app, all users will be able to see the titles and branding of all studies participating.
You will provide the title, image, and brief description on the Intake Form
. A few examples are shown here.
For instance, this topic shows how to use our Example Study that you may have tried when evaluating this program: Explore the Example
Creating something similar, but customized to your own study language and branding can help users get started.
What Background Information Will You Present?
The app can present up to 10 pages of background information prior to requesting conset, including descriptions of the planned study, links to outside resources, etc. It should provide everything the study participant should know to make an informed consent decision. The sequence of panels in the example includes:
- 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?
You will provide the panels your study should present on the Intake Form
How Will You Distribute Tokens to Participants?
You will obtain batches of tokens and need to manage them yourself. Decide how you will keep track of which ones have been used and what mechanism you will use to deliver them. Options include:
- Securely emailing or texting a token to each candidate participant.
- Printing a paper 'ticket' with each token and handing batches to data collectors.
Register With Us
When you adopt the application, your intake form will provide the names and email addresses for your staff. Each staff member will be invited to create an account on our LabKey Support site, www.labkey.org, and given access to the shared support portal where you will find more detailed usage information, training materials, and troubleshooting tips.
Learn more about support resources here:
Learn More First
- Frequently Asked Questions
- Contact us at "FDAMyStudiesContact@harvardpilgrim.org" to learn more and find out how to enroll your study.