Abstract
As organizations steadily adopt remote and virtual capabilities, informed consent processes are increasingly managed by digital technologies. These digital methods are generating novel opportunities to collect individuals' permissions for use of private information but are blurring traditional boundaries of consent communication and documentation. Therefore, the rapid growth of digital technologies used for informed consent as well as the sheer volume of data resulting from electronic data capture are generating complex questions about individual engagement and data practices. This chapter presents emerging risks, benefits, and ethical principles about digital informed consent methods and technologies. For the areas where digital informed consent creates ethical uncertainties, ethical guidelines and user-design recommendations are provided.
TopIntroduction
The practice of obtaining informed consent is a fundamental legal and ethical responsibility for organizations that provide personal services and for uses of personally identifiable information in many jurisdictions. The process of obtaining an individual's agreement starts with providing information for the individuals to make an autonomous informed decision about their options. This is followed by offering opportunities for individuals to ask questions, and culminates with obtaining their consent (De Sutter et al., 2020; Skelton et al., 2020). With advances in digital technologies, the informed consent process can be conducted electronically for the efficiency and convenience of pertinent stakeholders. In a 2019 eConsent survey on industry attitudes, more than 90% of respondents from biotechnology sponsors and contract research organizations stated that they planned to implement electronic consent for some or all research in 2020 (Pundir et al., 2020). However, the emergence of digital methods has created opportunities to both enhance ethical protections and detract from intended protections.
While the nature of consent and permissions spans many industries, this chapter primarily focuses on informed consent processes that require a complex exchange of information, such as informed consent for healthcare delivery and participation in human subjects research. For the purposes of this chapter, health-related informed consent pertains to obtaining agreement for treatment, which may include medical, behavioral, and/or ancillary services (Anabo et al., 2019). Informed consent for research is an agreement between an individual and a researcher that includes specific elements of information, including procedures, risks, benefits of participation, and several more elements designed to assist an individual in making an informed decision (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).
The authors' stance throughout this chapter aligns with Edenburg & Jones' (2019) “moral core” of consent: the adoption of emerging digital technologies for informed consent does not alter ethical principles, since these retain the moral compass shaped by societal values rooted in autonomy and justice. Digital informed consent methods instead require adaptations of consent processes and appropriate uses of permissioned data to adhere to ethical principles. While legal frameworks of consent vary across countries, this chapter limits discussions of privacy, individualism, human dignity, etc. to countries that have established governance to regulate and enforce these concepts (Edenberg & Jones, 2019). Last, for the purposes of this chapter, the terms “digital” and “electronic” informed consent are used interchangeably.
Key Terms in this Chapter
Re-Identification: The condition where data thought to be anonymous are linked with other data that allow individuals to be identified.
Digital Data: Information created and stored in a computer mediated environment that can potentially be transmitted as discrete information signals over the internet, and may be subsequently processed and/or stored for a range of known and unforeseen purposes.
Human Subjects Research: Research where a human subject is “a living individual about whom an investigator (whether professional or student) conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” (45 CFR §46.102(e)(1))
Informed Consent: Informed consent is a fundamental ethical practice in biomedical research. It is the process of providing meaningful information to the potential participant in order to enable an autonomous well-informed decision on whether or not they wish to participate in the research study
Autonomy: The ability to make an independent, self-governing decision based on an individual's assessment of information or situation.
Digital / Electronic Informed Consent: Electronic systems which may incorporate multimedia in order to convey information and to obtain informed consent.
Dynamic Consent: The ability for individuals to independently change informed consent options over time.
Ethical Risks: Outcomes resulting in legal, cultural, economic, or reputational harm to individuals or organizations or that create moral controversies for other reasons.