Recently, PRIM&R hosted a webinar titled Institutional Review Board (IRB) Review of mHealth Research: Best Practices and Future Challenges , presented by John Wilbanks and Jeremy Block, PhD, MPP.

In recent years, digital and mobile health (mHealth) technologies have increased dramatically with the proliferation of smartphones, apps, and wearable data devices where users generate data. Rapid, widespread collection of personal health data from a broad cross-section of individuals is now possible on a scale unthinkable only a few years ago. As our society as a whole and the research community adopts these technologies, IRBs need to anticipate and address the challenges in achieving compliance and protecting human subjects in mHealth research protocols while also providing an environment where development can flourish.

This webinar provided attendees with strategic and operational best practices for reviewing mHealth research in the areas of informed consent, study design, data security, and subject confidentiality, as well as a snapshot of what has been accomplished in the field of mHealth research review, and what challenges remain.

After the webinar, the speakers answered some of the questions from webinar attendees that time didn’t allow us to answer live. We’re pleased to share those answers with the readers of Ampersand. If you’re interested in listening to the entire webinar, you may purchase access to the recording.

1. Have you seen any studies that utilize the kind of consent process shown in the webinar on an Android platform?

John Wilbanks (JW): None that have launched, but we at Sage Bionetworks are actively working with Open mHealth, which just received funding to create the ResearchStack framework for Android, akin to ResearchKit. We are looking forward to the day when we can launch all our studies on both Android and Apple platforms from day one, because that means we can continue working to consent and enroll ever larger and ever more diverse cohorts of participants.

Jeremy Block (JB): The exciting thing about the approach that John and I have to this work is to make it a method, and to give real, tangible examples and durable recommendations that are platform agnostic. While it may seem like a daunting task, someone merely needs to build this for Android and use the same methods. That’s a much easier to solve technical implementation than coming up with a durable method.

2. How tolerant do you believe stakeholders will be of the variety of invasive identity verification methods?

JB: Truthfully, I don’t know. If a more patient-centered approach is taken to development, those preferences can be incorporated. Over time, some identity methods will become more prevalent and acceptable while others will become less so. Our job is to listen and collaboratively build. The IRB’s job is to protect subjects and ensure that the process is eliciting feedback and pushing back when the board or a reviewer thinks it has gone too far. An easy way to do that is to make sure the methods being used are justified properly in the research protocol.

JW: I don’t know, either. My hypothesis is that it will depend on the study type. For a simple observational study, I don’t expect a lot of tolerance for identity verification that asks for a bank account, for example. But for a study that is testing a medicine? That’s a pretty invasive study— you’re putting something new into your body—and I believe that participants won’t be as fazed by the surrounding study methods also being a bit more intrusive than in observational contexts. But these are just hypotheses. We need to test them, and to make this kind of work as evidence-based as possible. I hope everyone who does these kinds of studies considers sharing their data around consent and identity verification, and not just the “hard” science data.

3. Do you have any thoughts on how to extend this platform to pediatric research?

JW: I don’t know, but I do have a hypothesis. I think that pediatric research can leverage these kinds of apps as a way to connect with parents and caregivers, manage assent, collect data, and more. The regulations are very different for minors, however, and for good reasons.

JB: Sure, send me an email and I’ll work with you and others to pull together a group of people to think about how to address this. That’s the first step. It cannot be a top-down approach. That said, the group will be tasked with looking at the regulations and doing an overlay of the technology to see if there are places where it makes sense to do things that still fit within the regulations. My hunch is that there is space to innovate and do something here. To what extent, under what conditions, with what type of studies, and utilizing which technical solutions is still fuzzy.

4. I work at a small institution. Is any of this even possible for an institution of my size?

JB: Yes and no. Like all other technological developments, it’s costly to develop initially in terms of time, money, and effort. Over time that cost goes down as it becomes more widespread. The community of people who created open-source and open-access resources over the last two decades are the ones who compress the timeline between when the big, resource-rich institutions have access to these resources and the when the smaller institutions do. That’s a great thing. Functionally, that means it will take longer to reach a small institution. One way to expedite that process is to get in on a study with someone else who already has the technology and extend it to your institution. Often, the additional incremental costs of adding people are negligible. That’s one of the most amazing (and Belmont justice-pleasing) aspects of digital and mobile health technology.

JW: It’s possible. The key factor is skills distribution. The main advantage of a large institution is that you have a larger pool to draw from. If you’ve got a talented mobile programmer, you can make the application. If you’ve got an investigator who can think creatively about how to use the phone to measure, you can make the science happen. If you’ve got ethicists and IRB members who can wade in early, you can make a good clinical protocol happen. A lot of this work has already been done—it’s available in the commons , and it’s at least somehwat reusable. If you’re at a small institution, you may want to draw in collaborators from other places to diversify your team’s skillset. That’s what we have done at Sage Bionetworks. We’re only 43 people!

PRIM&R would like to thank Mr. Wilbanks and Dr. Block for sharing their expertise. PRIM&R members can access Mr. Wilbanks’ keynote from the 2014 Advancing Ethical research Conference in the Knowledge Center to learn more about mHealth work as it pertains to research ethics.