The use of technologies, such as mobile apps, wearable devices, artificial or augmented intelligence (AI), machine learning, and nanotechnology, will soon be standard in biomedical and social-behavioral-educational human subjects research. The use of such technologies enables researchers to electronically capture research data that could help to control data reliability, ensure data integrity, perform remote monitoring, and comply with the requirements for regulatory documentation. These technologies also present new privacy, confidentiality, safety, and social challenges.
This module provides IRB members and administrators with a framework for assessing the risks of technologies, whether the technology is helping conduct the research or is itself the subject of the research. It also identifies strategies to mitigate such risks. For researchers, this module provides context for how the IRB will review their work on and/or involving technology. It identifies ethical and regulatory dimensions of novel technology and considers ways to assess the risk of technology in research. The case studies in this module illustrate examples of using a risk assessment framework for both social-behavioral-educational and biomedical research.
Recommended Use: Supplemental
ID (Language): 20480 (English)
Author(s): Kimberley Serpico, EdD, CIP - Harvard T.H. Chan School of Public Health; Barbara Bierer, MD - Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), Vivli, Inc., Harvard Medical School; Joseph Zurba, CISSP, CISA - Harvard Medical School; Tonya Ferraro, MEd - Boston Children’s Hospital; Aaron Kirby, MSc - Harvard Medical School; Anna Suojanen, MPH - Harvard University