All submissions must be in English. The Contestants must not use HHS’s logo or official seal or the logo of NIH or NIDA in the submissions, and must not claim federal government endorsement.
Due to sensitivities surrounding addictions information, only fictitious data may be used for app development. The submission must not contain any data from or about real people, and the Contestant must not use data from or about real people in the development or testing of the app. However, the app should be designed such that it could be used in future potential clinical research studies with real human subjects. Entries that include data from or about real people will be disqualified.
Each submission for this Challenge requires a complete “Submission Package.” The Submission Package includes:
- A white paper describing the app built upon the proposed design of future scientific research studies. The white paper must describe a scientific research agenda and study design that could be undertaken using the developed app in future human subject research. Components of the white paper include, but are not limited to:
- Research design or conceptual framework
- Research agenda
- Description of ResearchKit modules and add-apters incorporated and otherwise considered
- Statement about compliance with substance abuse and other applicable laws and regulations
- Data collection and management plan
- Recruitment and retention advantages of the proposed approach
- A video of the app prototype. A brief demo video (via a link to YouTube) must be no more than five (5) minutes and clearly demonstrate the app functionality. The Contestant must have permission to use all content in the video, including footage, music and images. The video must not contain any information or images directly identifying the Contestant.
- App software. The working software must operate on a mobile device using Apple’s ResearchKit framework. The Contestants must upload their app to their personal dropbox/onedrive/box and provide the share URL where prompted in the submission form. The submission may be disqualified if the software application fails to function as expressed in the prototype description submitted by the Contestant.
The white paper must consist of a PDF file, not contain any information directly identifying the Contestants. The PDF document must be formatted to be no larger than 8.5” by 11.0”, with at least 1 inch margins. The white paper must be no more than 12 pages long. Font size must be no smaller than 11 point Arial.
For official information, please see the Federal Register Notice.