Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives

ABSTRACT

Vast quantities of personal health information and private identifiable information are being created through mobile apps, wearable sensors, and social networks. While new strategies and tools for obtaining health data have expanded researchers' abilities to design and test personalized and adaptive health interventions, the deployment of pervasive sensing and computational techniques to gather research data is raising ethical challenges for Institutional Review Boards (IRBs) charged with protecting research participants. To explore experiences with, and perceptions about, technology-enabled research, and identify solutions for promoting responsible conduct of this research we conducted focus groups with human research protection program and IRB affiliates. Our findings outline the need for increased collaboration across stakeholders in terms of: (1) shared and dynamic resources that improve awareness of technologies and decrease potential threats to participant privacy and data confidentiality, and (2) development of appropriate and dynamic standards through collaboration with stakeholders in the research ethics community.

KEYWORDS:

• research ethics
• pervasive sensing
• social media
• location tracking
• IRB

Acknowledgments

We thank the UC San Diego Human Research Protections Program's Director, IRB members and analysts, and the Public Responsibility in Medicine and Research (PRIM&R) leadership for their contributions to the design and implementation of our focus group protocols and ongoing support of the CORE initiative. Likewise, we acknowledge the Robert Wood Johnson Foundation and involvement of Lori Melichar and Deborah Bae for their insights during the design of this study, as well as during subsequent phases of the project.

Funding

This research was supported by the Robert Wood Johnson Foundation (Title: Connected and Open Research Ethics [CORE]), Principal Investigator: Nebeker, #72876, 2015–2017) and the UC San Diego Chancellor's Interdisciplinary Collaboratory Fellowship Program (Co-PIs: Nebeker, Weibel, and Bloss).

Conflicts of interest

The authors declare no conflicts of interest.

Ethical approval

This study was approved by the institutional review board(s) at the University of California, San Diego. The research study was certified as Exempt (45 CFR 46.101) by the UC San Diego Human Research Protections Program.

Notes

¹ http://thecore.ucsd.edu/platform

Additional information

Notes on contributors

Camille Nebeker

Dr. Nebeker contributed to the conceptualization of the study, data collection, analysis, and interpretation, wrote the initial draft of the article, and revised the article for intellectual content.

John Harlow

Dr. Harlow contributed to the conceptualization of the study, data collection, and interpretation, and revised the article for intellectual content.

Rebeca Espinoza Giacinto

Dr. Espinoza Giacinto contributed to data analysis and interpretation and revised the article for intellectual content.

Rubi Orozco-Linares

Ms. Orozco-Linares contributed to data collection and interpretation and revised the article for intellectual content.

Cinnamon S. Bloss

Dr. Bloss contributed to the conceptualization of the study, data interpretation, and revised the article for intellectual content.

Nadir Weibel

Dr. Weibel contributed to the conceptualization of the study, data analysis, and interpretation, and revised the article for intellectual content.