ResearchKit, an open-source software framework aimed at furthering our understanding of health and disease, provides researchers a tool to conduct research utilizing Apple's iPhone that developers hope will help revolutionize how that research is conducted.
First introduced at an industry event in March, ResearchKit consists of three modules: the first focuses on providing potential subjects with information about participation and obtaining subject consent; the second administers surveys using a pre-built user interface; and the third allows researchers to invite subjects to perform tasks utilizing the iPhone’s advanced sensors, including the accelerometer, microphone, gyroscope, and GPS. With its wider release, researchers and developers can now access these modules, which can be customized, and work toward the development of new modules.ResearchKit is also integrated with the iPhone's HealthKit. Apple explained in a March 2015 press release: "When granted permission by the user, apps can access data from the Health app such as weight, blood pressure, glucose levels and asthma inhaler use, which are measured by third-party devices and apps."
At the time of ResearchKit's unveiling, five applications ("apps") utilizing the framework were made available: mPower, GlucoSuccess, MyHeart Counts, Share the Journey, and Asthma Health. Through these apps, iPhone users can participate in minimal-risk, IRB-approved research related to Parkinson's disease, diabetes, cardiovascular disease, breast cancer, and asthma, respectively. Since Apple's announcement last month, recruitment across the five apps has exceeded expectations: more than 60,000 subjects have enrolled, highlighting the enormous potential ResearchKit holds for subject recruitment.
Using traditional research models, it can be difficult to recruit large numbers of research subjects. ResearchKit seek to address that issue by leveraging the popularity of the iPhone, as well as the software's accessibility and ease of use. mPower, which uses ResearchKit for research on Parkinson's disease, offers a compelling example of the framework's potential for subject recruitment: Prior to the public announcement of ResearchKit, the highest enrollment in a single study on Parkinson’s disease was 1,700. Mere hours after launch, the app had already accrued over 7,000 subjects.
By minimizing barriers to subject recruitment, ResearchKit has the potential to enable researchers to more efficiently and cost-effectively conduct large-scale research studies. Additionally, by using technologies that are already a part of many Americans' lives to conduct research, ResearchKit allows researchers to collect more frequent and, arguably, more accurate data.
In a recent interview with FasterCures, John Wilbanks, a 2014 Advancing Ethical Research (AER) Conference keynote speaker and chief commons officer at Sage Bionetworks, discussed the value of ResearchKit: "We need to understand variation in order to treat, and we need sufficient sample sizes in order to understand variation. That's what [a] mobile [platform] does – it offers the promise of sufficient sample size and the ability to center the studies on the people, and groups of people, in ways that are much more a part of their daily lives."
However, with thousands already enrolled, the release of the framework also raises some challenging questions. For instance, will studies using it suffer from selection bias, given the socioeconomics of Apple users? Specifically, will low-income and otherwise financially disadvantaged individuals be inadvertently excluded from this new wave of medical research? The privacy of data shared over the framework has also been a central concern: How will the privacy of subject data be maintained?
Others, however, contend that the traditional process of consent has long been broken, and that the development of apps using ResearchKit is an opportunity to rethink the process and better integrate many of the elements that have been demonstrated to foster subject understanding, such as videos and interactivity. In his interview with FasterCures, Wilbanks, who played an integral role in the development of the consent processes used in the mPower and Share the Journey apps, discussed the process of reimagining consent: "….we wanted to explore how a better [informed consent] process could be merged with the phone to create simpler, more intuitive ways to describe the essential elements of clinical study, highlight the impact it might have on a participant's life, and secure the permissions involved. I like to think that this user-centered approach is at least as good – and hopefully better – as the lengthy, legal, jargon-filled documents that patients who join a study at their doctor's office are handed now."
Consideration also needs to be given to the process of IRB review for studies using apps developed with the ResearchKit framework, as the use of this technology will likely represent uncharted territory for many IRBs. What sort of challenges will review of studies using the ResearchKit framework pose for these boards, especially as studies become increasingly complex? And how best can those challenges be navigated?
While the use of apps in the conduct of research is not new, the ability to conduct entire studies using the ResearchKit framework is a noteworthy step in the use of innovative mobile technologies in research. However, as with many new technologies in the research world, considerations and questions related to human subjects protections must be weighed, including the central question: how can we benefit from this new innovation, while ensuring that adequate protections are maintained?
This post was adapted from a piece titled "Revolutionizing Medical Research with Apple's ResearchKit," which appeared in the March 2015 edition of the PRIM&R Member Newsletter. The PRIM&R Member Newsletter is distributed once a month to PRIM&R members. To learn more about the PRIM&R Member Newsletter, as well as other member benefits, please visit our website.