Leaving Study Participants to Their Own Devices: Can Mobile Technology Improve Consenting?

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It’s not much to say that smart devices–phones, tablets, e-readers, and the like–have become part of our lives. Buffalo-based blogger Steve Cichon found a fantastic example of how much mobile devices now do for us. He compares a smart phone’s features with all of the electronics products that appeared in a 1991 Radio Shack ad.

By Steve’s count, his smart phone has replaced 13 of the 15 products that Radio Shack featured that week, including a compact CD player, a video camera, a still camera, a PC with a 20MB hard drive, an answering machine, a calculator, an alarm clock, a cassette recorder, and, of course, a cell phone. This glimpse at the functions that mobile devices have subsumed show how technology can converge to save resources and time.

It’s exciting to think about how mobile devices could simplify some complexity of clinical research. In the November 2013 issue of Applied Clinical Trials, Tim Davis heralds what the rise of device independent technology, or Bring Your Own Device (BYOD), could do for clinical trials. Tim Davis shared a vision where one smart device replaces all or most of what a participant receives during a trial. The Bring Your Own piece of this means that participants who already have smart devices do not need another one. They can use their own phones or tablets to access study-specific apps, and so relieve both participants and site personnel the hassle of tracking one more piece of equipment.

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Since over half of Americans own smart phones, the potential here is impressive. Leaving people to their own devices could take on a whole new meaning.

An electronic consent form can be an IRB’s contribution to this increased simplicity. An all-electronic consent form could improve the overall consenting process. Not only could an electronic consent eliminate the filing and versioning headaches of paper versions, a device-based consent could create a more interactive consenting process and greater participant understanding. The participant can highlight and look up a phrase that she or he doesn’t understand. Or watch a video of a study procedure. Or take a quiz to see what areas study staff should review in detail for complete understanding. Every Internet surfer and smart phone user knows how these features work, and in a consenting environment they all could make a site’s day easier.

To help sites, CROs, and sponsors who are interested in electronic consenting, Quorum Review and its strategic partner Consent Solutions can offer a number of resources. Quorum and Consent Solutions have prepared webinars, discussions and guidelines about electronic consenting, and we have outlined our submission process (Slides from the webinar are also available, and Rebar Interactive has provided a great overview).Doctor_Child_Tablet_1

As sponsors, CROs, sites, and IRBs begin to develop the possibilities of mobile devices, our collections of files, function-specific devices, and myriad study materials someday may seem as quaint as that 23-year old Radio Shack ad.

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