Bridging the Gap Between Silicon Valley and Human Subjects Research
by Jeremy N. Block, PhD, MPP
Digital and mobile health studies, including those announced as part of Apple’s new ResearchKit, use technology advances to fundamentally change the way research is conducted. Institutional Review Boards (IRBs) should be looking for opportunities to improve study designs and take advantage of new technologies. But before doing so, there are some important considerations that should go into bridging the gap between Silicon Valley and human subjects research.
People working in Silicon Valley (broadly defined here as the culture or attitudes associated with the tech industry) go about their work in a fundamentally different way than human subject researchers. Those working in tech may primarily have experience in programming apps and websites while human subject researchers may be solely focused on research. The two cultures need to work together a little more and keep an ongoing dialogue to learn where the boundaries are. In no other area is this more striking than in consent processes.
EULAS and Consents Are Very Different
The End User Licensing Agreement (EULA) used in most of the tech industry is the long legalistic language (in tiny print) that users may simply click to accept without thoroughly reading. This got Facebook in a bit of controversy this past summer since “research” was buried in the EULA. In the world of human subjects research, consent is seen as a process and not a click-box. This is where IRBs need to teach their tech counterparts and help them learn about what they do. In fact, some of the more exciting developments in digital and mobile health will result from the consenting process.
It’s my opinion that we should be doing multi-modal consenting, using both visual (charts, graphics, videos) and interactive written (quizzes, checkboxes, discussions) consenting in e-consenting platforms. “The Block Rule,” to be bold, is to use three different modalities to adequately ensure that subjects understand and comprehend the study, and is enough to achieve informed consent. Which three and how they are implemented is the fun part of developing this new technology. There’s the challenge, now accept it and start creating.
It’s All About the Data: Collection / Sharing / Security / Privacy
Hand-in-hand with these new studies are new methods for data collection, sharing, security, and privacy. Because the technology is evolving, IRBs must continue to learn and remain updated on developments so that they can ensure privacy and confidentiality, and address data security issues to keep subjects protected. Here again is a cultural difference between Silicon Valley and human subjects research. The tech industry is used to collecting all possible data and using it without oversight. In human subjects research, only the minimal amount of data necessary to answer the research question is allowed and all data collection must be justified. To get over this hurdle, encourage investigators to map out all the data collection and sharing points in a flowchart. Then, in tabular form, describe all data, how it’s collected and shared, who it’s shared with and has access, and when it’s shared. This will go a very long way in terms of explaining the more complicated workings of the apps researchers develop and seek to use.
It’s Time to Have IT Professionals on IRBs
The sophistication presented by new technology used in digital health and mobile apps is at a level where IRBs likely do not have the expertise to evaluate it. We’ve reached the moment where we need IT professionals to become voting members of IRBs or to be consultants for protocols involving digital health and mobile apps. They should be tasked with assessing the technology and issues surrounding data collection, storage, analysis, security, privacy, and confidentiality.
Next Steps to Consider
Continued dialogue and collaboration between IT and IRB professionals is clearly needed, creating a space where each may share expectations. In the meantime, IRB professionals need to consider their organization’s policies and procedures, and develop SOPs for digital and mobile health studies to guide investigators and set clear expectations. This is truly a “Brave New World.”
About the Author
Jeremy N. Block, PhD, MPP is an Assistant Professor of Population Health Science & Policy at the Icahn School of Medicine at Mount Sinai. He also serves as an IRB Chair in the Mount Sinai Health System.