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Industry sponsored research and the IRB

industry sponsored IRB privacy

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Jejo Koola

Posts: 1

Hello all,

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:
* geolocation
* 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.


Jejo Koola

John Torous

Posts: 15


With an industry sponsor, you may first want to make sure that your university is ok with whatever plan you have in place for sharing intellectual property and sharing patient data. Many projects get hung up here. In terms of presenting your project to the IRB, it may be useful to make a chart of each data stream (eg GPS), explain why you need it, outline potential risk, and then how you protect against that risk. This will also make for a useful handout for informed consent.

I am also attaching a paper I worked on that is more mental health specific - but the points are very generalizable for your question of how to present mhealth research to IRBs


Rubi Linares-Orozco

Posts: 34
posted in reply to jejo koola

Hi Jejo,

If you haven't set up a meeting with the IRB I would highly recommend you do so early on (IRB analyst or Associate Director). They can guide you on some of the ethics and risk concerns that you can then incorporate into the development and design of your protocol and consents.

Best of luck,
~ Rubi