Technology, Ethics, and Regulations

Introduces the importance of focusing on ethics when developing and utilizing emerging technologies. The module examines several past technologies, including their associated ethical questions and regulatory approaches, to help learners anticipate and identify ethical issues associated with emerging technologies.

Recommended Use: Required
ID (Language): 20107 (English)
Author(s): Josephine Johnston - The Hastings Center; Karen J. Maschke, PhD - The Hastings Center

Describes new genome-editing technologies and key applications, core moral and ethical issues around particular uses of genome editing, and several governance responses to new genome-editing technologies.

Recommended Use: Required
ID (Language): 20108 (English)
Author(s): Josephine Johnston - The Hastings Center; Karen J. Maschke, PhD - The Hastings Center

Describes several types and purposes of human-animal chimera research, ethical and policy issues pertaining to human-animal chimera research, and regulatory and oversight responses to human-animal chimera research.

Recommended Use: Required
ID (Language): 20109 (English)
Author(s): Karen J. Maschke, PhD - The Hastings Center; Josephine Johnston - The Hastings Center

Discusses nanotechnology advances with a focus on biomedical applications and nanomedicine. The module covers the use of nanomaterials in clinical trials, potential benefits and risks, regulatory oversight, and ethical considerations for use in nanomedicine.

Recommended Use: Required
ID (Language): 20110 (English)
Author(s): Nanda Gudderra, PhD, MSc, MS

In many cases, developing AI technologies involves research with human participants. Within the field of research ethics, ethical questions related to human subjects research (HSR) have been widely studied. Both philosophical and regulatory tools have been developed to determine when research with human participants is ethically permissible. While these tools are useful guidelines for human subjects research, AI HSR poses novel questions that the existing philosophical and regulatory tools do not fully answer.

This module describes the common ethical issues that relate to AI HSR, the extent to which current ethical approaches to human subjects research resolve the issues that AI HSR poses, and the aspects of the current ethical approaches to human subjects research that need to be reexamined in the context of AI HSR.

Recommended Use: Required
ID (Language): 20111 (English)
Author(s): Cansu Canca, PhD - AI Ethics Lab; Tamiko Eto, MS, CIP - The Mayo Clinic; Brenda Leong, JD, CIPP/US - Luminos.Law

While AI may lead to better quality of life and improved health, the technology has potential risks. In response, Institutional Review Boards (IRBs) must address these risks during their review of research applications, develop appropriate internal policies, and guide investigators on adequate protections for research participants. With the relatively new and unique issues that come with AI, IRB administrators and committee members must have sufficient expertise to comprehend both the field of AI and its intersection with long-standing human subjects research (HSR) regulations.

This module discusses the regulatory, ethical, and other emerging challenges related to the use of AI, particularly in the context of HSR. It examines existing regulations and how they apply to AI HSR in both medical (healthcare-related) and non-medical settings.

Recommended Use: Required
ID (Language): 20112 (English)
Author(s): Tamiko Eto, MS, CIP - The Mayo Clinic; Cansu Canca, PhD - AI Ethics Lab; Brenda Leong, JD, CIPP/US - Luminos.Law

Robots play an ever-increasing role in society, moving from behind the scenes on the manufacturing line into retail, education, healthcare, restaurants, and other settings. The increasing application of robotics, whether those robots are machines that augment the abilities of the humans operating them (such as da Vinci surgical systems) or are sophisticated machines that move in a seemingly autonomous fashion guided by multiple forms of machine learning or artificial intelligence, is raising new concerns for researchers and society.

This module examines the current and projected roles of robots in the patient-facing healthcare context and anticipates features and roles that may raise new questions for the conduct of ethical research on or with robots. Specifically, this module focuses on how robots may be involved with, or the subject of, biomedical research with human subjects.

Recommended Use: Required
ID (Language): 20113 (English)
Author(s): Brenda Leong, JD, CIPP/US - Luminos.Law; Tamiko Eto, MS, CIP - The Mayo Clinic; Cansu Canca, PhD - AI Ethics Lab

Wearables are technology that travel on or with a person. Although generally quite small, wearables are powerful tools that generate a significant amount of data—and where data exist, potential insights abound. From smartphones to fitness trackers to connected pacemakers, wearables are changing the ways we learn about and manage human health and behavior.

This module explores what wearables are and what roles they play in research and healthcare. It discusses pertinent ethical considerations and highlights some key questions to ask when considering incorporating wearables into your research or health practice. Finally, the module discusses the general regulations for wearable technologies as well as those most salient for researchers and healthcare providers.

Recommended Use: Required
ID (Language): 20526 (English)
Author(s): Megan Doerr, MS, LGC - Sage Bionetworks; Sara Meeder, CIP - Maimonides Medical Center

As an emerging technology with ever-increasing applications, digital biometric technology is used for personal identification, authentication, and tracking. While the use of biometric measurements, developed to identify serial offenders, has a long history in law enforcement, the modern applications raise concerns for many people. However, the use of these systems is also making it easier for people to access the devices and accounts they rely on, thereby helping them do things like unlock smartphones, access bank accounts, enter physical workspaces, and travel. Biometrics do many things well but there are areas where organizations should be cautious about their adoption and use. This is particularly important when organizations use these systems to track people’s health and behavioral habits; diagnosis medical conditions; or evaluate emotions, personal characteristics, and preferences.

This module discusses biometric technologies including their application in different contexts, privacy and ethical implications, operations and risks, and regulation in research and healthcare.

Recommended Use: Required
ID (Language): 20527 (English)
Author(s): Brenda Leong, JD, CIPP/US - Luminos.Law

Facial recognition is a particular type of digital biometric technology that entities can use for the identification, authentication, and tracking of individuals. Like other biometric technologies, facial recognition has various practical applications and benefits. For example, healthcare providers and other organizations may use facial recognition or other face analysis technology to track people’s health and behavioral habits; diagnose medical conditions; and evaluate emotions, personal characteristics, and preferences. However, the increased adoption of facial recognition technology also raises unique and substantive concerns, even relative to other biometrics. Notably, the use of facial recognition raises concerns about surveillance and civil rights impacts, particularly as current systems still exhibit biases and inaccuracies that affect different populations at different rates. It is critically important to address and mitigate such concerns, particularly as government agencies, commercial entities, and healthcare organizations increasingly adopt facial recognition technologies.

This module covers facial recognition technologies including their application in different contexts, data use issues, operations and risks, and regulation in research and healthcare.

Recommended Use: Required
ID (Language): 20528 (English)
Author(s): Brenda Leong, JD, CIPP/US - Luminos.Law