Powering studies using a sensor to generate data to inform the endpoints

Interested? Who to contact

@Becky Upton

@Ashley George (Unlicensed)

The problem

The shift of data collection from tools designed by investigators to a variety of digital platforms has been accompanied by a commensurate transfer of risk from traditional research institutions to the individual. End-user license agreements (EULA) and Terms of Use (TOU) of the digital technologies powering these studies are currently serving as a proxy for informed consent in citizen science, though they are neither intended nor suitable to do so. In traditional, institutionally led research, the benefits leveraging these technologies are being delayed due to the language in the EULAs and TOUs frequently conflicting with the language in informed consent documents in areas of confidentiality, privacy and data sharing.

The idea

This project will make recommendations on developing EULAs and TOUs for digital technologies used in health and biomedical research. This will serve to better protect participants in citizen health science and accelerate digitally-powered investigator-initiated and sponsored research for the betterment of public health.

Objectives / proposed deliverables

Run a demonstration project to:

1. Identify and synthesize existing best practices from across bioethics, health, technology, data science, and cyber-security disciplines with regards to protecting user confidentiality, privacy, and control over their data

2. Develop consensus recommendations and resources for the development of EULAs and TOUs that reduce the risk to research participants using digital tools for data capture and facilitate the collection of meaningful informed consent

3. Disseminate recommendations and resources to all change agents including but not limited to the manufacturers of digital tools, patient communities conducting citizen science, regulators and policymakers, IRBs, research sponsors, and investigators Necessary expertise and/or resources for the proposed demonstration project Bioethicists, patients, IRB / ethics board experts, commercial technology manufacturers Any other comments NIH's All of Us Study was a visible example of this issue in action. FitBit donated tens of thousands of units, but nearly were pulled from the study until they changed their TOU and EULAs to be consistent with the IRB's requirements.