When starting a mHealth research project at WUSTL please make sure to consider the following resources:
The OVCR oversees research policies, procedures, operations, support infrastructure and educational programs at WUSTL. Check out SPIN to identify funding opportunities. SPIN can be accessed via the WUSTL Research Management System (RMS).
It’s necessary for a member of the WUSTL legal team, namely the Joint Research Office for Contracts (JROC), review and approve a contract with a 3rd party vendor. Below are links and information about these legal resources.
- Joint Research Office for Contracts (JROC)
- All 3rd party vendors used to develop a new technology platform will need to complete a Master Services Agreement (MSA) with the University.
- All 3rd party technology vendors who will be handling, transferring, or storing data will need to complete a Business Associates Agreement (BAA) and may need to complete a Data Processing Agreement (DPA) or Data Usage Agreement (DUA) with the University, as appropriate.
- Check out the WUSTL HIPAA Privacy Office for more information and for the WUSTL BAA template.
- All 3rd party vendors will want to draft a scope of work for your technology project. This scope of work outlines the work to be completed and the cost and timeline associated with that work. JROC will need to review and approve this scope of work.
When formulating your mHealth assessment tool or clinical intervention, it’s important to start the process with open discussions about ownership of the technology product. These conversations need to occur between co-creators, and then with the 3rd party vendor building or licensing the technology platform. The Office of Technology Management (OTM) is a helpful resource at WUSTL.
- Office of Technology Management (OTM)
- OTM is a University resource to help guide you through business decisions related to ownership of Intellectual Property (IP) of your mHealth assessment tool or clinical intervention.
Every mHealth research study needs to be approved by the WUSTL IRB. Below are links to helpful WUSTL regulatory resources.
- IRB/HRPO
- Center for Clinical Studies
- InfoSec IRB Review Form for Technology
- This form will need to be completed before the 3rd party vendor scope of work will be approved.
Often times research studies are beholden to additional regulatory bodies, such as the Federal Drug Administration (FDA) or the General Data Protection Regulation (GDPR). Our external regulatory resource is coming soon, and will highlight helpful resources in navigating compliance to FDA regulations and GDPR!
Becker Library’s Data Management and Sharing services recently held two webinars related to the WUSTL REDCap E-Consent Template. The webinars were recorded and posted to the REDCap Workshop Recordings webpage.
Email Chris Sorensen at sorensenc@wustl.edu with any questions.
- Formatting a REDCap E-Consent Survey to Match the Informed Consent Document
Learn to format the e-consent survey provided in the WUSTL REDCap E-Consent Template to match the informed consent document submitted to the myIRB application.
- Modifying a REDCap E-Consent Survey
Learn to modify the e-consent survey created using the WUSTL REDCap E-Consent Template while maintaining functionality and not altering existing fully executed consents.
If your study involves technology used to collect data, then you will need a safe place to store that data. Below are WUSTL resources for data storage.
- Research Infrastructure Services