Month: September 2024

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Informed Consent: A Monthly Review
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October 2024 :: Issue 70

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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_October 2024

SPOTLIGHT – Upcoming Meeting

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SPOTLIGHT – Upcoming Meeting

The spotlight this month is shining on an important upcoming meeting at the US Food and Drug Administration. On October 30th the FDA Patient Advisory Committee will “provide recommendations on the informed consent process and the areas of focus of the informed consent” from a patient/trial participant view. The committee will also provide specific recommendations for how the informed consent process be undertaken given these considerations.

The meeting will be open to the public for both observation and participation. We see this as an opportunity to have a real impact in the informed consent policy making space and we invite you to consider participating. We have applied to give oral testimony and will submit written comments as below.

Ways to participate

Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee, or individuals may participate in virtual breakout scenario discussions

  • Written submissions may be made on or before 3 October 2024 to letise.williams@fda.hhs.gov
  • Sign up to participate in virtual breakout session on or before 16 October 2024
  • Oral presentation requests should be submitted on or before 25 September 2024 [deadline passed]

Patient Engagement Advisory Committee Meeting: Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products
Food and Drug Administration
30 October 2024 [Virtual], 10:00-17:00 EST
Summary
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee).  The general function of the Committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.  The meeting will be open to the public.
Agenda
     The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.  On October 30, 2024, the Committee will discuss and make recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.”  The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need.  Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community.  Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand.  FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.
The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent.  The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research…

For Further Information Contact: Letise Williams [Letise.Williams@fda.hhs.gov; 301-796-8398] or FDA Advisory Committee Information Line [1-800-741-8138 (301-443-0572 in the Washington, DC area)]

The Need for an Evolving Informed Consent Process in a Fetal Therapy Trial

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The Need for an Evolving Informed Consent Process in a Fetal Therapy Trial
Case Commentaries
Meredith A. Atkinson, Erika Ezumba, Jena L. Miller
The American Journal of Bioethics, 16 September 2024
Excerpt
… In the face of uncertainty about the longer-term burden of morbidity and mortality in surviving neonates, the study team had to consider what level of detail regarding neonatal outcomes observed in infants born to trial participants to share with potential participants during the study screening process, while the study continued active recruitment. In addition, they had to determine if and how such information should be modified over the course of the trial as additional neonates were born to trial participants, and an increasing amount of data on the clinical course and outcomes of the neonates became available. Given the high potential burden in neonatal survivors and their families, including the need for intensive caregiver-provided, at-home care for infants who survive to hospital discharge and a need for life-long renal replacement therapy, the consent discussion takes place over days and in collaboration with multiple specialists… More

information is required to deeply characterize long-term outcomes among survivors and the psychosocial impact on the family, whether the amnioinfusion intervention is offered through a research protocol or as clinical care. This will require systematic collection of prospective data beyond the primary outcome defined in the RAFT trial, including observational data from institutions where the intervention is offered as clinical care.

Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective

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Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective
Kun Li, Mingtao Huang, Xiaomei Zhai, Chen Wang
Developing World Bioethics, 13 September 2024
Abstract
In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long-term, large-scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust-based informed consent and emphasizes the needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants’ autonomy. Informed consent in long-term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants’ rights despite the complexity of modern biomedical research.

Readability of informed consent documents and its impact on consent refusal rate

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Readability of informed consent documents and its impact on consent refusal rate
Original Article
Yash V. Kamath, Yashashri C. Shetty, Ishita C. Lanjewar, Ankita Kulkarni
Perspectives in Clinical Research, 30 August 2024
Abstract
Introduction
Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same.
Methods
We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch–Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant.
Results
Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal–Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = −0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014).
Conclusion
Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance.

Informed consent and coercion in recruitment advertisements for oocyte donors

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Informed consent and coercion in recruitment advertisements for oocyte donors
Research
Ruby Lake, Isa Berzansky, Andrea Lanes, Serene Srouji, Elizabeth Ginsburg, Iris Insogna
BMC Women’s Health, 20 September 2024
Open Access
Abstract
Background
As the use of donor eggs for in vitro treatment has increased, both medically affiliated and private donor egg agencies have turned to online advertisements to recruit donors. The American Society for Reproductive Medicine provides recommendations encouraging ethical recruitment of donors, however there is no formal regulation for the informed consent process for egg donor recruitment and compensation. Underrepresentation of risks and targeted financial incentives may pose a risk to the informed consent process.
Methods
Data from online advertisements for egg donors active between January 1 – August 31, 2020, were collected to analyze content related to risks, Covid-19 precautions, donor payment, and desired donor characteristics. Advertisements for egg donors on Google, Craigslist, and social media were analyzed. Primary outcomes included the mention of the risks of egg donation, including the risk of Covid-19 exposure, in donor egg advertisements. Secondary outcomes included language targeting specific donor characteristics and financial compensation.
Results
103 advertisements were included. 35.9% (37/103) of advertisements mentioned some risk of the egg donation process, and 18.5% (19/103) mentioned risks or precautions related to Covid-19 exposure. Of advertisements for private donor egg agencies, 40.7% (24/59) mentioned any risk, compared to 29.6% (13/44) of medically affiliated egg donation programs; the difference was not statistically significant (p-value = 0.24). Agencies targeting students and donors of a specific race were more likely to offer payments over $10,000 for an egg donation cycle. Among advertisements offering over $20,000 for donor compensation, 72.7% (8/11) recruited women under the age of 21.
Conclusion
Egg donor recruitment advertisements, for both medically affiliated programs and private agencies, were unlikely to mention risks including the risk of exposure to Covid-19. Non-medically affiliated private donor egg agencies were more likely to violate multiple American Society for Reproductive Medicine ethics guidelines, including offering higher than average compensation, and recruiting donors from young and vulnerable populations.

Co-designing body donor program consent processes

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Co-designing body donor program consent processes
Georgina C. Stephens
Anatomical Sciences Education, July 2024
Abstract
Objective
It is widely accepted that body donation programs should obtain informed consent from prospective donors during life. However, consent forms vary in detail, are typically developed by anatomical and legal experts, and may not include features valued by prospective donors. Concomitantly, anatomy students report concerns that prospective donors are not adequately informed about dissection procedures. To address these issues, this study aimed to bring together prospective body donors, anatomy students, anatomy educators, and a governance expert to co- design a donor-centered consent process.
Methods
Utilizing participatory co- design, focus group discussions were used to explore participants’ perspectives on informed donor consent. The facilitator worked with participants to identify priorities for inclusion in donor consent processes. Framework analysis is being used to analyze data, and priorities identified in each group will inform the development of a draft donor consent process, on which further participant feedback will be sought.
Results
Forty-one people expressed interest in study participation. Two focus groups (n = 11 participants) have been held, wherein prospective body donors emphasized their desire for their bodies to contribute to anatomical education, including dissection and representation in educational resources. Group members agreed consent forms should explicitly detail how donor bodies are utilized for learning and include personalized elements such as naming preferences. Further focus groups are planned for September and October 2023.
Conclusion
This ongoing study is expected to yield recommendations for community involvement in developing body donor program consent processes, and how community participation can enhance educational activities, such as preparing students for dissection.

Patient Autonomy in Medical Education: Navigating Ethical Challenges in the Age of Artificial Intelligence

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Patient Autonomy in Medical Education: Navigating Ethical Challenges in the Age of Artificial Intelligence
Review article
Hui Lu, Ahmad Alhaskawi, Yanzhao Dong, Xiaodi Zou, Haiying Zhou, Sohaib Hasan Abdullah Ezzi, Vishnu Goutham Kota, Mohamed Hasan Abdulla Hasan Abdulla, Sahar Ahmed Abdalbary
INQUIRY: The Journal of Health Care Organization, Provision, and Financing, 18 September 2024
Open access
Abstract
The increasing integration of Artificial Intelligence (AI) in the medical domain signifies a transformative era in healthcare, with promises of improved diagnostics, treatment, and patient outcomes. However, this rapid technological progress brings a concomitant surge in ethical challenges permeating medical education. This paper explores the crucial role of medical educators in adapting to these changes, ensuring that ethical education remains a central and adaptable component of medical curricula. Medical educators must evolve alongside AI’s advancements, becoming stewards of ethical consciousness in an era where algorithms and data-driven decision-making play pivotal roles in patient care. The traditional paradigm of medical education, rooted in foundational ethical principles, must adapt to incorporate the complex ethical considerations introduced by AI. This pedagogical approach fosters dynamic engagement, cultivating a profound ethical awareness among students. It empowers them to critically assess the ethical implications of AI applications in healthcare, including issues related to data privacy, informed consent, algorithmic biases, and technology-mediated patient care. Moreover, the interdisciplinary nature of AI’s ethical challenges necessitates collaboration with fields such as computer science, data ethics, law, and social sciences to provide a holistic understanding of the ethical landscape.

Patient Consent and The Right to Notice and Explanation of AI Systems Used in Health Care

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Patient Consent and The Right to Notice and Explanation of AI Systems Used in Health Care
Target Article
Meghan E. Hurley, Benjamin H. Lang, Kristin Marie Kostick-Quenet, Jared N. Smith, Jennifer Blumenthal-Barby
The American Journal of Bioethics, 17 September 2024
Abstract
Given the need for enforceable guardrails for artificial intelligence (AI) that protect the public and allow for innovation, the U.S. Government recently issued a Blueprint for an AI Bill of Rights which outlines five principles of safe AI design, use, and implementation. One in particular, the right to notice and explanation, requires accurately informing the public about the use of AI that impacts them in ways that are easy to understand. Yet, in the healthcare setting, it is unclear what goal the right to notice and explanation serves, and the moral importance of patient-level disclosure. We propose three normative functions of this right: (1) to notify patients about their care, (2) to educate patients and promote trust, and (3) to meet standards for informed consent. Additional clarity is needed to guide practices that respect the right to notice and explanation of AI in healthcare while providing meaningful benefits to patients.

Rethinking Informed Consent in the Big Data Age

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Rethinking Informed Consent in the Big Data Age
Book
Adam J. Andreotta
Routledge, 23 December 2024
Abstract
    In the “big data age”, providing informed consent online has never been more challenging. Countless companies collect and share our personal data through devices, apps, and websites, fuelling a growing data economy and the emergence of surveillance capitalism. Few of us have the time to read the associated privacy policies and terms and conditions, and thus are often unaware of how our personal data are being used. This is a problem, as in the last few years, large tech companies have abused our personal data. As privacy self-management, through the mechanism of providing online consent, has become increasingly difficult, some have argued that surveillance capitalism, and the data economy more broadly, need to be overthrown.

This book presents a different perspective. It departs from the concept of revolutionary change to focus on pragmatic, incremental solutions tailored to everyday contexts. It scrutinizes how consent is currently sought and provided online and offers suggestions about how online consent practices can be improved upon. These include: the possibility of subjecting consent-gathering practices to ethics committees for review; the creation of visual-based consent agreements and privacy policies, to help with transparency and engagement; the development of software to protect privacy; and the idea of automated consent functionalities that allow users to bypass the task of reading vast amounts of online consent agreements. The author suggests that these “small-scale” changes to online consent-obtaining procedures, could, if successfully implemented, provide us with a way of self-managing our privacy in a way that avoids a revolutionary dismantling of the data economy. In the process, readers are encouraged to rethink the very purpose of providing inform consent online.

Rethinking Informed Consent in the Big Data Age will appeal to researchers in normative ethics, applied ethics, philosophy of law, and the philosophy of AI. It will also be of interest to business scholars, communication researchers, students, and those in industry.