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Policies and Principles for mHealth Studies

Conducting a research study in human health comes with serious obligations and responsibilities to safeguard the rights of study participants, which include the rights of participants to privacy. Developers should be aware that the obligations of designing an appropriate and ethical medical study exceed those of most app development projects. Bridge is designed to facilitate the development apps that adhere to these principles, but ultimate responsibility rests with the app developers and study’s Principal Investigators.

Formal ethical review is required to launch a mHealth study

All medical studies on human subjects must be reviewed by an Institutional Review Board (IRB). This is a legal and ethical obligation which is not optional. Sage does not permit the use of Bridge in any study which has not undergone appropriate IRB review, and can assist with IRB filings for your study.

The Bridge API is set up such that no data can be uploaded by an app until the app makes a call to indicate the electronic-consent process has been completed by the user. It is critical that app developers implement an appropriate informed consent process as part of the app onboarding process, and have this process formally reviewed by the study's IRB. Templates for informed consent that have been successfully used in prior studies are included in our SDKs. Once consent is recorded by the server, data will be continuously uploaded by the app on the user's behalf as a background process on the client.

Participants may access their own data

A study participant should always have the right to obtain the data that he or she provided to the study. The Bridge API therefore allows any individual user to retrieve his or her own data from the server. In practice, for most participants access to their own data will depend on the support for data retrieval provided by their study's app. Study designers should give careful consideration to how study data can be most effectively returned to the participants.

Researchers should only access coded study data for analysis

Scientific research does not typically require knowledge of participant identity by the research / data analyst team or access to data in real time. Bulk exports of de-identified study data are produced by Bridge server for each study, and posted daily on Synapse, Sage's data sharing platform. This design allows the separation of access to the study data for research purposes from access to the roster of study participants for participant support purposes.

Participants have the right to revoke and resume data sharing with the study

The server provides API calls allowing the user the ability to suspend or resume sharing data with investigators. Suspending data sharing does not disable the account, but it does block user data from being included in any future data set exported from the study. Participants may continue to use the app, and resume data sharing at a later date. Bridge apps are expected to provide a mechanism for withdrawal or suspension of participation in a study.

An administrative-only API call can be made by Bridge technical admins to permanently delete a user's account and all associated data from Bridge server if requested by a user. Note, even after a Bridge account has been deleted, it is not possible to pull back data already distributed to researchers. This fact is explained to users during the informed consent process which must be completed to enroll.

Bridge is not intended to be a long-term storage solution for mobile health studies. At the end of a study, all data in the system for that study will be purged from the system. Coded study data may be maintained as a researcher resource by Sage in our Synapse system, or managed by the study team. This design reduces the chances of inadvertent breach of participant privacy.