What are IRBs thinking about tech-enabled research?
Mobile, Imaging, pervasive Sensing, Social media and location Tracking or “MISST” technologies enable the collection of personal health data in real-time, 24/7. Using these tools, researchers design and test personalized and iterative health interventions to improve human health. This tech-enabled research is often referred to as mHealth and is increasing. (1) However, navigating the ethics and regulatory review process has proven to be a major challenge for both scientists designing this research and the Institutional Review Boards tasked with making sure research participants are informed and protected from harm. (2)
We have conducted a few studies revealing that: 1- research participants may not fully understand the type or amount of PHD collected and, there are concerns about the rights of bystanders who are nearby the research participant, (3) 2- IRB risk assessment of MISST used in research is inconsistent, (4) and, 3- there are unique cultural aspects to consider. (5) Using a participatory design process involving stakeholders, we developed a research commons called the Connected and Open Research Ethics or CORE so that IRBs and researchers could share questions, protocols and institutional practices. As part of that process, the CORE team conducted focus groups at the annual “Advancing Ethical Research” conference convened by the Public Responsibility in Medicine and Research (PRIM&R) professional organization.
In 2015, we convened 4-focus groups with IRB administrators, analysts, members and directors to learn about their familiarity with MISST technologies, experiences and concerns reviewing MISST-related studies, and subsequent solutions to address those concerns. The responses were organized based on their alignment with the ethical principles of the Belmont Report (e.g., respect for persons, beneficence, and justice). (6) Overall, the findings revealed ethical and regulatory concerns related to privacy and confidentiality and the lack of IRB preparedness.
While concerns were noted, participants offered insights into best practices for reducing risks. These key takeaways include:
- We need to develop effective strategies to convey study information to individuals with low literacy, limited English proficiency and/or limited technology familiarity.
Use technology to support the consent process like interactive platforms that are dynamic. Moreover, informed consent content should use plain language to convey risks to participants to increase the chance that low-tech and research literate people understand what’s involved.
- IRB-members are generally uncertain about the risks related to research with MISST technologies because they are new and unfamiliar. This leads to inconsistencies and delays in assessing the potential risks and benefits and, delays the research from commencing.
- The guidance for digital data management (e.g., data transfer, storage, and sharing) is lacking. While PHI is regulated under the Health Insurance Portability and Accountability Act (HIPAA), there is a lot of PHI that falls outside of HIPAA including data collected by app and device makers.
Seek guidance from technologists and security experts as well as legal and regulatory experts to address the issue of unfamiliarity with MISST technologies.
- There are potentially disproportionate risks to vulnerable populations (e.g., undocumented citizens, the elderly, children) as well as bystanders, whose activities may be captured without consent by pervasive sensing technologies (e.g., wearable cameras).
Conduct developmental research with prospective participants to identify the potential risks and acceptable risks management strategies as well as potential barriers to access.
Participants expressed the desire for an adaptable, research ethics “learning community” to foster collaboration and shape best practices.
In 2015, Dr. Camille Nebeker and her team at the University of California San Diego launched the Connected and Open Research Ethics (CORE) project, with the support of the Robert Wood Johnson Foundation. CORE was informed by the PRIM&R study as well as key informant interviews conducted with researchers. CORE provides a web-based resource for stakeholders (researchers, ethicists, legal scholars, participants, IRB affiliates, and regulators) who are sharing their expertise and resources (e.g., policies, methods, consent language).
Not on CORE yet? Join the network today by clicking here! Make sure to check out the following features:
- CORE Network of 500+ individuals contributing their expertise and resources, including IRB-approved protocol and consent language as well as institutional policies that support ethical digital health research strategies.
- CORE Q&A Forum where you can post questions or share expertise.
- CORE Resource Library containing IRB-approved research protocol and consent language shared by the Network members. If you have content to share, upload or send it to firstname.lastname@example.org
- CORE Webinar Series: bringing together experts in the digital health research ecosystem to hear about the ethical dimensions of digital health research.
- Dunseath, S., Weibel, N., Bloss, C. and Nebeker, C. (2018). NIH support of Mobile, Imaging, pervasive Sensing, Social media and location Tracking (MISST) research: Laying the foundation to examine research ethics in the digital age. Nature Digital Medicine, 1:1; DOI: 10.1038/s41746-017-0001-5.
- Nebeker, C., Harlow, J., Giacinto, R. E., Orozco- Linares, R., Bloss, C. and Weibel, N. (2017). Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives, AJOB Empirical Bioethics, 8:4, 266-276, DOI: 10.1080/23294515.2017.1403980.
- Nebeker, C., Linares-Orozco, R., & Crist, K. (2015). A multi-case study of research using mobile imaging, sensing and tracking technologies to objectively measure behavior: Ethical issues and insights to guide responsible research practice. Journal of Research Administration 46(1):118-137.
- Nebeker, C., Lagare, T, Takemoto, M., Lewars, B., Crist, K., Bloss, C. and Kerr, J. (2016). Engaging participants to inform the ethical conduct of mobile imaging, pervasive sensing and location tracking research. Translational Behavioral Medicine: Policy, Practice and Research. DOI: 10.1007/s13142-016-042604.
- Nebeker, C., Murray, K.E., Holub, C., Haughton, J., and Arredondo, E. (2017). Acceptance of Mobile Health in Communities Underrepresented in Biomedical Research: Barriers and Ethical Considerations for Scientists, JMIR mHealth uHealth, 5(6):e87, DOI: 10.2196/mhealth.
- National Institutes of Health. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research, 4–6. DOI:10.1002/9780471462422.eoct093.