Informed Consent: A Monthly Review
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March 2024 :: Issue 63

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_March 2024

AI-Enhanced Healthcare: Not a new Paradigm for Informed Consent
M. Pruski
Journal of Bioethical Inquiry, 1 February 2024
Abstract
With the increasing prevalence of artificial intelligence (AI) and other digital technologies in healthcare, the ethical debate surrounding their adoption is becoming more prominent. Here I consider the issue of gaining informed patient consent to AI-enhanced care from the vantage point of the United Kingdom’s National Health Service setting. I build my discussion around two claims from the World Health Organization: that healthcare services should not be denied to individuals who refuse AI-enhanced care and that there is no precedence to seeking patient consent to AI-enhanced care. I discus U.K. law relating to patient consent and the General Data Protection Regulation to show that current standards relating to patient consent are adequate for AI-enhanced care. I then suggest that in the future it may not be possible to guarantee patient access to non-AI-enhanced healthcare, in a similar way to how we do not offer patients manual alternatives to automated healthcare processes. Throughout my discussion I focus on the issues of patient choice and veracity in the patient–clinician relationship. Finally, I suggest that the best way to protect patients from potential harms associated with the introduction of AI to patient care is not via an overly burdensome patient consent process but via evaluation and regulation of AI technologies.

The Understanding of Informed Consent as a Practical Bioethical Problem: A Case Study of Hospital Pedagogy on Cancer Patients in Cuenca (Ecuador)
Alejandro Recio Sastre, Mónica Bustamante Salamanca, Nadia Micela Álvarez Pelaez, Edgar Mateo Guamán Barros
European Journal of Bioethics, 14 February 2024
Abstract
The relationship between the informed consent sheet and education is crucial. Our objective is to highlight how patients’ educational backgrounds impact the ethical rights within medical processes. Some patients face significant challenges in comprehending the significance and contents of the informed consent sheet. It’s likely that they may not fully grasp the potential symptoms resulting from their treatment or even be aware of their inherent rights. This issue isn’t merely psychological but rather a matter of education, requiring a comprehensive approach to educational development. Consequently, it becomes a social issue wherein both education and health play vital roles. This research delves into assessing the patients’ literacy indicators, thereby evaluating their educational backgrounds. We address this within the framework of an ethical problem in hospital pedagogy, integrating educational and philosophical concepts. Employing qualitative analysis, we aim to understand patients’ reading skills by conducting interviews, particularly focusing on circumstances of vulnerability due to illiteracy. These circumstances are categorized based on identified reading capabilities. By intertwining two knowledge domains, we aim to highlight human vulnerabilities that may not always be considered within the technical processes of healthcare workers and are rarely emphasized by educators or philosophers.

INSERM – Public consultation of the Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
   The draft Charter is open for public comments up to March 30, 2024. 
Download the draft Charter (pdf, 201 Ko)  [Attached with response template]
The « Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials » is a key deliverable of the VolREthics initiative that was set up to promote ethical guidelines to protect healthy volunteers in biomedical research.
…The central ethical question raised by the involvement of healthy volunteers in biomedical research is that of respect for the person’s free will to decide to participate in the research, without any direct or indirect pressure. Another ethical imperative is to ensure the safety and well-being of the healthy volunteers both during and after the research. This is because all biomedical research involves a certain number of risks that, even if kept to a minimum by the researchers and authorities, can never be ruled out entirely. The two main risks to which healthy volunteers are exposed are:
:: That of being exploited in a context of vulnerability, for example economic, educational, cultural or related to age…
:: That of experiencing adverse events during or after the study in which they are taking part.. 

Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards
21 CFR Part 50  [Docket No. FDA-2022-D-2997] Comments due: May 1, 2024
SUMMARY:
   The Office for Human Research Protections, Office of the Assistant Secretary for Health (OHRP), and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent.”
This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.” FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act). The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.

Informed Consent: A Monthly Review
_________________

February 2024 :: Issue 62

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_February 2024

Blockchain-Based Dynamic Consent for Healthcare and Research
Book Chapter
Wendy M. Charles
Blockchain in Healthcare, 30 December 2023 [Springer]
Abstract
As individuals gain greater access control over their health information, dynamic consent solutions are increasingly offered to allow individuals to make informed choices about their permissions over time. Blockchain-based tools and technologies are emerging to enhance the capabilities of dynamic consent solutions to offer individuals more engagement. While blockchain-based systems cannot replace all human interactions, blockchain features can increase granularity, transparency, and trust. This chapter describes the benefits and drawbacks of dynamic, informed consent and proposes several design and feature considerations to optimize blockchain-based features.

From informed to empowered consent
Original Article
Chelsea O. P. Hagopian
Nursing Philosophy, 29 December 2023
Abstract
Informed consent is ethically incomplete and should be redefined as empowered consent. This essay challenges theoretical assumptions of the value of informed consent in light of substantial evidence of its failure in clinical practice and questions the continued emphasis on autonomy as the primary ethical justification for the practice of consent in health care. Human dignity—rather than autonomy—is advanced from a nursing ethics perspective as a preferred justification for consent practices in health care. The adequacy of an ethic of obligation (namely, principlism) as the dominant theoretical lens for recognising and responding to persistent problems in consent practices is also reconsidered. A feminist empowerment framework is adopted as an alternative ethical theory to principlism and is advanced as a more practical and complete lens for examining the concept and context of consent in health care. To accomplish this, the three leading conceptions of informed consent are overviewed, followed by a feminist critique to reveal practical problems with each of them. The need for a language change from informed to empowered consent is strongly considered. Implications for consent activities in clinical practice are reviewed with focused discussion on the need for greater role clarity for all involved in consent—beyond and inclusive of the patient-physician dyad, as the practice and improvement of consent is necessarily a transdisciplinary endeavour. Specific concrete and practical recommendations for leveraging nursing expertise in this space are presented. Perhaps what is most needed in the discourse and practice of consent in health care is nursing.

We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].

Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
Food and Drug Administration, HHS. 
Scheduled Pub. Date: 12/22/2023   FR Document: 2023-28210   PDF: https://downloads.regulations.gov/FDA-2023-D-5259-0002/attachment_1.pdf     8 Pages (109 KB)
Submit either electronic or written comments on the draft guidance by February 20, 2024
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Master Protocols for Drug and Biological Product Development.” The draft guidance addresses the design and analysis of trials conducted under a master protocol as well as the submission of documentation to support regulatory review. The primary focus is on randomized umbrella and platform trials that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness. The considerations in this guidance apply to a range of therapeutic areas. The draft guidance is intended to clarify the Agency’s thinking on the use of master protocols in drug and biological product development, which was previously addressed in FDA’s guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.” FDA is also announcing the withdrawal of the guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.
Excerpt
250  C. Informed Consent
252  The informed consent process should cover all treatment arms in the trial to which the subject
252  could be randomized.^13,14 In a platform trial allowing drugs to enter and leave the trial over time,
253  the consent form should be modified over time to reflect the drugs currently under evaluation…
256  The informed consent process should occur prior to a subject’s randomization and avoid
256  substudy-specific consent. Consent that occurs after subjects have been randomized to one of the
257  substudies may result in subjects with different prognostic characteristics across substudies,
258  raising concern about the comparability of each drug group with the shared control group
259  (comprised of control subjects from different substudies). To illustrate the concern, consider a
260  master protocol with two drugs (drug A and drug B) in which the subject consents to screening
261  and randomization to a substudy as part of the master protocol, with a substudy-specific
262  informed consent process to occur after randomization to that substudy; after the substudy-
263  specific consent, the subject is then randomized to the drug or its matched control. With this
264  process, comparing drug A against the shared control arm (including subjects who received
265  either control for drug A or control for drug B) may result in noncomparable groups if subjects
266  who would consent to participating in the drug A substudy differ from subjects who would
267 consent to participating in the drug B substudy.

13 Some consent processes allow a subject to be randomized in the trial even if the subject only consents to a subset of the drugs under evaluation; under such a process, subjects should not have the potential to be randomized to drugs for which they do not consent.
14 See the guidance for IRBs, Clinical Investigators, and Sponsors Informed Consent (August 2023).

Informed Consent: A Monthly Review
_________________

January 2024 :: Issue 61

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_January 2024

Foundations of Preemptive Compassion: A Behavioral Concept Analysis of Compulsion, Consent, and Assent
Anna M. Linnehan, Awab Abdel-Jalil, Sheila Klick, Jonathan Amey, Richele Yeich, Kyle Hetzel
Behavior Analysis in Practice, 15 December 2023
Abstract
The recent changes to the Behavior Analysis Certification Board Ethics Code for Behavior Analysts along with the calls to action for compassionate care have highlighted the need for a reevaluation of behavior research and clinical programs. We propose a behavior analytic definition of compassion where the relieving or prevention of distress is the reinforcer for the professional. One way of minimizing distress may be to require that assent be provided by a participant in an intervention. The definition of assent typically includes reference to willingness to participate in an intervention or activity. We provide a framework that goes beyond simple willingness to participate and distinguishes between apparent/implicit coercion and genuine assent by considering the alternatives described as degrees of freedom available to the participant. We distinguish between compulsion/explicit coercion, consent, and assent. Additionally, we will differentiate genuine consent and assent from apparent consent and assent in the design of compassionate behavioral programs.

Editor’s Note: [Excerpts from Ethics Code]
2.11 Obtaining Informed Consent
Behavior analysts are responsible for knowing about and complying with all conditions under which they are required to obtain informed consent from clients, stakeholders, and research participants (e.g., before initial implementation of assessments or behavior-change interventions, when making substantial changes to interventions, when exchanging or releasing confidential information or records). They are responsible for explaining, obtaining, reobtaining, and documenting required informed consent. They are responsible for obtaining assent from clients when applicable
6.04 Informed Consent in Research (see 1.04, 2.08, 2.11)
Behavior analysts are responsible for obtaining informed consent (and assent when relevant) from potential research participants under the conditions required by the research review committee. When behavior analysts become aware that data obtained from past or current clients, stakeholders, supervisees, and/or trainees during typical service delivery might be disseminated to the scientific community, they obtain informed consent for use of the data before dissemination, specify that services will not be impacted by providing or withholding consent, and make available the right to withdraw consent at any time without penalty.