The rapid proliferation of new digital health applications, tools, and technologies is reshaping the health care and research environments. Companies that develop these products may not have strong foundations in health care norms and ethics standards, and, in the the absence of FDA oversight, these products may not have been developed with an explicit focus on safety and effectiveness. New digital health technologies hold potential for improving aspects of human subjects protections but many IRBs may lack the capability to properly assess novel tools and products. Equipping IRBs with knowledge and strategies in this area can improve their ability to evaluate a tool’s adequacy to protect the data, privacy, and confidentiality of research subjects in trials involving digital health technologies.

On February 8, PRIM&R hosted the webinar Digital Health Technology and Human Subjects Research: What IRBs Need to Know to provide guidance for IRBs in the assessment of new technologies in the health care field. The speaker panel was made up of Jeremy Block, PhD, MPP, managing partner of Venture Catalyst and an adjunct professor of public and international affairs at Baruch College, and Jennifer S. Geetter, Esq., a partner in the law firm of McDermott Will & Emery LLP, focusing on ethical and legal issues in connection with the life sciences.

After the webinar, Dr. Block and Ms. Geetter responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand.

What is the PI’s responsibility when conducting research where an end-use license agreement (EULA) is in place?
Jeremy Block (JB): The PI ultimately is responsible for all the research activities conducted in their studies. They should look through the EULA, engage their local institution to assess the impact it has on the study, and, where needed, include information in the protocol and consent form that describes the EULA needed for the study to be performed.

How should an IRB address the conflict between the EULA and the requirement that consent contain no exculpatory language?
Jennifer Geetter (JG): There is no easy answer to this question, and the IRB’s approach will be informed by a number of factors, including whether the EULA is for a retail version of the digital product that the subject can and does purchase/download as a consumer, or whether the digital health technology is being offered on a research-only platform with a tailored EULA. In either case, the IRB will need to consider how the data usage terms and other risk factors described in the EULA interact, inform, or change the discussion of similar considerations in the informed consent and authorization, and how updates to the EULA should be handled from a consent amendment perspective.

Under what circumstances might the health care providers be subjects in a digital health study?
JG: In certain cases, a study aim might be to assess the impact of a digital health technology on physician decision-making. The primary aims of the study might be to assess the safety and effectiveness of the technology in improving patient care, but a secondary aim might look at how the interaction of the technology and the health care provider changed the provider’s approach to delivering care. In those cases, and depending on how the study is designed, the health care providers might themselves be subjects, entitled to human subject protections. 

How would this look when the study is multi-center, or going through a central IRB? What level of review and responsibility would our institutions have?
JB: Institutions should really do a few things. First, create reliance agreements where you do your best to cede review and avoid duplicative review. This is hard to accomplish at times as some institutions cannot seem to let go. This will go a long way to make your lives easier and avoid adding work for investigators in the review process. There are a few useful ways to do that right now, including the SMART IRB process for reliance. Second, more things can be run centrally when using digital tools. If your IRB can become more aware of the tools and have a standardized process for assessing them, you can create a list of tools that you already know investigators can use. This too can simplify multi-center review. Third, consider developing SOPs that allow certain types of communications to occur in multi-center digital studies and the use of different tools; for instance, SOPs allowing for emails between study sites about the study and research activities, or the sharing of documents electronically to operate a study together from multiple sites. This will help avoid confusion over meeting the standards of the HIPAA security and HIPAA privacy rules. The nature of collaborative workforce tools is changing rapidly and making conscious decisions about what is allowable will make the researchers’ lives easier and your review processes more streamlined and less fraught with worry.

PRIM&R thanks Dr. Block and Ms. Geetter for sharing their expertise.

The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to registration@primr.org.