I am new to the forum so please bear with me as I navigate this new resource. I am getting ready to spin-up an investigator initiated but industry sponsored trial. It involves using wearable technology and smartphone data to diagnose confusion in patients with advanced liver disease. The datastreams will collect highly personal information including:
* typing speed
* typing accuracy (number of mistakes)
* smartphone gestures used (taps, swipes, etc.)
* phone orientation
* acceleration of the phone (detecting drops, etc.)
* number of phone calls/emails/texts
* smartphone applications used
* sleep/wake cycle from activity tracker (e.g. FitBit)
* activity level from activity tracker (e.g. FitBit)
Note, though we will be collecting the metadata from smartphones, we will not be collecting the actual content. i.e. though we collect number of spelling mistakes or typing speed we do not collect what subjects are typing.
I was wondering if any of you have experience submitting IRBs and/or creating consents in the scenario where this information will be collected and transmitted to the industry sponsor? I've tried looking through the resources and I couldn't find quite what I was looking for. I've attached a draft of the research plan for any that are interested.