Does a mobile health (mHealth) program work and how do you know? The traditional scientific process provides a systematic way of determining which research and evaluation methods work (and which don’t). The advent of mobile devices has created unique and exciting opportunities for conducting research and evaluation, along with challenges for researchers to address. We outline three key considerations in developing mHealth research initiatives: 1) innovative methods for mHealth research; 2) human subject protection issues – institutional review board (IRB) review and approval; and 3) trans-disciplinary research and diverse audience expectations.

Innovative Methods for New Technology

The rapid pace of development in the mobile world has been astounding (the iPhone was only released in 2007!). As the relevance of some mHealth studies, particularly in applied research, may depend on using technology, it has been suggested that technology development may be outpacing research. Results from randomized clinical trials (RCTs; the “gold standard”) can take several years to be available. So, the technology initially proposed may well be obsolete when final results are published. Last summer, NIH co-sponsored the “mHealth Evidence” workshop to discuss and consider “alternative study designs and methodologies that ensure that research studies are able to provide timely information within a rapidly evolving field”. Are there solutions here to accelerate and improve mHealth research? Check out the video of the workshop and dial-in your thoughts and comments below.

Institutional Review Boards (IRBs)

IRBs examine the risks/ethics of proposed research, and provide oversight over the protection of human subjects – see HHS OHRP website. With the rich, real-time data (e.g., geolocation, videos) that can be collected using mHealth tools, the related privacy/security issues have come under much scrutiny. A common sentiment among researchers is that variability currently exists in how IRBs review mHealth research, particularly in the IRB’s assessment of potential risks to the participants using the technology. Further evidence on mHealth privacy/security risks and how they are perceived by the general public may be helpful in assisting IRBs in developing a greater understanding of these issues. Given limited data on this topic, the HHS ONC is conducting a study to better understand consumers’ attitudes/concerns on mHealth privacy/security issues. As IRBs develop a means to discuss how to ensure appropriate privacy/security protections, much can be learned from other sectors (e.g., finance) that have confronted similar issues related to the use of mobile technology. Stay tuned for more on mHealth privacy/security issues in future blogs!

Trans-disciplinary Research & Diverse Audiences

mHealth research requires collaborations among groups that have typically been separate and may appreciate different aspects of evaluation. mHealth researchers will increasingly find value in partnering with each other (e.g., medical, behavioral, and biological science), and also with engineers, clinicians, NGOs, and industry. Fortunately, “Trans-Disciplinary Collaborations” and the study of “Team Science” have emerged. mHealth researchers may wish to incorporate principles from these areas into the development of scientific teams and research studies. Consumers of mHealth research may also include regulators, policy makers, and the public at large, who each have different expectations of evaluations. Thus, mHealth researchers need to be mindful of their study’s relevance and limitations to specific audiences.

As mobile technology further evolves and proliferates, additional research opportunities and challenges will arise. Have thoughts for ways to address these research challenges or wish to note other opportunities and challenges, provide a comment below!

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