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Furthermore, 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. However, these technologies also present new privacy, confidentiality, safety, and social challenges. Technology is always evolving, and existing federal regulations from the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) do not explicitly prescribe risk assessment of technological risk. As such, Institutional Review Boards (IRBs) are in need of guidance and training on technological risk assessment and security review. 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. Note: As technology rapidly evolves, the examples of novel technologies in this module are subject to change. Learning Objectives By the end of this module, you should be able to: Identify the ethical and regulatory dimensions of data confidentiality and security relating to technology. List strategies for technology-based risk assessment and mitigation, with a focus on supporting compliance and security for technology. Describe the rapidly evolving landscape of novel technologies and human subjects research protection. Ethical Dimensions of Technology Use IRB review of research generally includes consideration of the three ethical principles from the Belmont Report (The National Commission 1979): • Respect for Persons • Beneficience • Justice This section discusses how these principles may apply to research with using technology. Keep in mind that the developing realities of novel technology all but guarantee that IRBs will need to find balance among these principles. Respect for Persons The principle of respect for persons means that individuals should be treated as autonomous agents, and vulnerable populations and/or persons with diminished autonomy are entitled to additional protections. Example Children who are old enough or mature enough can understand what a research study is and decide if they want to participate or not. Additional protection of children would include obtaining parental permission to enroll them in a research study. However, treating children as "autonomous agents," or individuals who can make their own decision to participate, means that if a child said no and the parent said yes, the child';s decision not to participate would stand. Participants must understand that the research involves a technology component. The study's consent form must describe the technology, regardless of complexity, in language that the participants can comprehend. Example If the research involves use of an FDA-regulated combination product, such as an insulin pump and medical device software application to regulate dosage, then the consent form must include all required elements in language the participant can understand as they pertain to the drug, device, and application technology. It is important to not obfuscate, omit, or minimize information that participants provide or how the technology uses that information. Example If the research involves a wearable to track GPS location, participants need to be aware of this level of surveillance. The risks of technology utilization must be comprehensive, clear, and complete. Example If a study requires access to participants' Facebook accounts, they should know that this access may include their full social network, wall postings, photos, direct messages, and group memberships. There must be full disclosure regarding what the researchers can view, as a participant may perceive this access to be too invasive. Participants should be aware that they may need to sign an end-user license agreement (EULA) for research purposes for a study that utilizes certain technologies. Example If the research involves tracking exercise and nutrition on the MyFitnessPal app, the participant may need to sign both the research consent form and the MyFitnessPal EULA. The researchers must ensure the participant comprehends the content of both. Participants may have already signed a EULA for personal technology use, but another may be necessary for a research use. Eligibility criteria for a study should include considerations for the participant's ability to comprehend and use the technology that is part of the study. Example If the research utilizes a tablet puzzle designed for children ages six and above, the eligibility criteria should exclude children under the age of six. Furthermore, researchers should describe how participants ages six and above will demonstrate that they understand how to use the tablet before enrollment. Beneficence The principle of beneficence states that research should do no harm to the subjects, maximize possible benefits, and minimize possible harms. Example Research cannot pose egregious and unjustified risk to participants. The use of technology in research should not present avoidable risks of harm to participants. Example A lack of security controls, like a passcode, thumbprint, or Face ID protection, on a tablet used to collect research data on recovering addicts would be unacceptable because it is easy to enable such security controls. Researchers using technologies should recognize that technologies may inherently increase risk and should implement additional risk mitigation strategies. Example If the research utilizes an app where teenagers log feelings of suicidality, a monitoring plan for immediate triage and referral to emergency services should be in place if a participant provides time-sensitive and concerning indications of potential self-harm. Justice In the Belmont Report, the principle of justice states that there should be fairness in distribution of who benefits from the research and who bears its burdens. Example Recruiting participants out of convenience is not a justifiable recruitment strategy for a research study. Researchers should not include or exclude any participant based on an assumption of technology literacy or availability. The protocol should explain how the researchers will assess a digital divide that may impact participation. Example Researchers should not exclude a participant who is an older adult from a smartphone study based on an assumption that the participant does not have one or does not know how to use one. The same concept applies for participants from different socioeconomic backgrounds. Researchers should not assume individuals cannot participate because they cannot afford a smartphone. Regulatory Dimensions of Technology Use IRBs must conduct regulatory and ethical review of human subjects research (45 CFR 46 [Protection of Human Subjects 2021]; 21 CFR 56 [Institutional Review Boards 2021]). There are several sources available to IRB members and administrators to support the foundational knowledge required to conduct such reviews. These include training materials like those from the CITI Program, conferences by professional organizations such as Public Responsibility in Medicine and Research (PRIM&R), and accreditation standards provided by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). However, there is little guidance on IRB review, risk assessment, and human subject protections with respect to technology specifically. The following sections present a snapshot of the current requirements, implications, and considerations when reviewing research that involves technology. When reviewing such research, it is important to know and consider which regulatory requirements and laws apply to ensure compliance. HHS and FDA Regulations The HHS regulations (45 CFR 46.111(a)(6-7)) and FDA regulations (21 CFR 56.111 (6-7)) require that research plans make adequate provision for monitoring data to ensure subject safety as well as providing adequate privacy and data confidentiality protections. When applying these criteria to research with technology, the IRB should assess the study with regard to the following • Identifiability of the data collected • Use of technology for research purposes • General provisions for data collection • Use of data security technologies • Technical specifications of the technology • Access to research data • Data storage, retention, and destruction The following sections provide some additional information on some of these areas. Use of Technology for Research Purposes Some IRB considerations related to the use of technology for research purposes include: