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  1. Apple’s ResearchKit Could Change How We Study

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    Apple’s ResearchKit Could Change How We Study

    QIRB-jim-gearhart-blog2Earlier this month, Apple announced ResearchKit, an app-builder that could change fundamentally how research teams gather data and communicate with participants. After exploring the five studies that are showcasing the ResearchKit, it strikes me that this software toolkit can support medical research in at least three ways:

    – It could enable medical studies to reach unprecedented numbers of users/participants
    – It can make it much easier to create and administer electronic consent forms
    – It could help transform smart devices into participant study tools

    When Apple announced ResearchKit, it also released a packet of apps that came from it. The apps are for five studies run by respected research institutions. These studies help demonstrate the potential of ResearchKit and the iPhone:

    • Mount Sinai’s Icahn School of Medicine worked with LifeMap Solutions to create Asthma Health, which is studying patterns of asthma symptoms. Among other plans, the study aims to match up a participant’s report of symptom severity with the air quality at that location at that moment.
    • Massachusetts General Hospital has designed GlucoSuccess to help manage diabetes symptoms and study how personal habits affect glucose levels.
    • Stanford has MyHeart Counts, which track how personal habits affect cardiovascular health. MyHeart Counts monitors daily activities, tracks behavior through surveys, and correlates that data with reported cardiovascular health. (I enrolled in this one, as I was eligible.)
    • Sage Bionetworks and the University of Rochester are studying Parkinson’s Disease with mPower. This study uses the iPhone’s accelerometer and touch screen to assess participants’ balance and dexterity.
    • In a collaboration with the Dana-Farber Cancer Institute, Penn Medicine, and UCLA’s Jonsson Comprehensive Cancer Center, Sage Bionetworks also has created Share the Journey, a program to track the daily impact of breast cancer.

    Judging from these first five examples, the ResearchKit can provide a straightforward template for creating study-related apps. According to Apple’s Technical Overview, ResearchKit has three modules for a study app: conducting surveys; completing tasks on the iPhone; and managing informed consent. These inaugural studies have all three modules on clear display.

    The five apps look similar and essentially follow the same workflow. They have introductory screens that cover study procedures, eligibility requirements, risks and benefits. They guide the user/study volunteer through an informed consent process and confirm eligibility. Then they settle into the data-gathering part of the study. Three of the studies include videos that reinforce the essential study information. From what I’ve seen so far, the ResearchKit can lead to new ways to conduct research. Here are some possibilities:
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    Huge Number of Participants

    Apple’s promotional video touted the potential to bring more volunteers into a study than ever before. Indeed, the cardiovascular study MyHeart Counts exceeded its target of 10,000 participants within 24 hours of Apple’s announcement. The Parkinson’s study, mPower, attracted four times the volunteers as any similar study had before. A large chunk of those numbers likely came from the excitement of the product launch, but even a fraction of those enrollment numbers would represent an impressive recruitment program.

    Electronic Informed Consent

    Interest in eConsent is growing in the area of clinical research. Some tools are available on the market, more studies are starting to try electronic consent, and the FDA just released draft guidance on using them. It looks like the ResearchKit will offer a way to create and offer eConsents with relative ease. Videos, interactive screens, and comprehension tests are all possible. For documentation, each of the studies delivers a PDF of the consent, and Apple promises electronic signatures will be available.

    Participant Study Tools

    The iPhone (and other devices, if Apple makes good on its promise to release the ResearchKit as open source) could become a portable monitoring device, just by utilizing the features it already contains (i.e., accelerometer, touch screen, GPS, microphone, camera). This could simplify data gathering on a wide range of studies, and help realize the potential of BYOD (bring your own device) convenience in research.

    Of course, these are the first days of ResearchKit, with questions and uncertainties remaining. In an upcoming post I’ll take a closer look at some of the issues, mainly from the perspective of an IRB.