The Cohen problem of informed consent
William Simkulet
BMJ Medical Ethics, 26 August 2020; 46(9) pp 617-622
Abstract
To avoid potential abuse and respect patient autonomy, physicians have a moral obligation to obtain informed consent before performing any significant medical intervention. To give informed consent, a patient must be competent, understand her condition, options and their expected risks and benefits and must freely and expressly consent to one of those options. Shlomo Cohen challenges this conception of informed consent by constructing cases based on Edmund Gettier’s classic counterexamples to traditional theories of knowledge. In this paper, I argue Cohen-style cases are not genuine threats to the concept of informed consent, however they provide an interesting challenge to theories of conscientious objection.

Informed Consent: A Monthly Review
___________________________

September 2020

This digest aggregates and distills key content adressing 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: GE2P2 Global_Informed Consent – A Monthly Review_September 2020

“Let’s Get the Consent Together”: Rethinking How Surgeons Become Competent to Discuss Informed Consent
Erin M. White, Samuel M. Miller, Andrew C. Esposito, Peter S. Yoo
Journal of Surgical Education, 1 August 2020
Objective
Eliciting informed consent is a clinical skill that many residents are tasked to conduct without sufficient training and before they are competent to do so. Even senior residents and often attending physicians fall short of following best practices when conducting consent conversations.
Design
This is a perspective on strategies to improve how residents learn to collect informed consent based on current literature.
Conclusions
We advocate that surgical educators approach teaching informed consent with a similar framework as is used for other surgical skills. Informed consent should be defined as a core clinical skill for which attendings themselves should be sufficiently competent and residents should be assessed through direct observation prior to entrustment.

Why ‘understanding’ of research may not be necessary for ethical emergency research
Dan Kabonge Kaye
Philosophy, Ethics, and Humanities in Medicine, 26 August 2020; 15(6)
Open Access
Abstract
Background
Randomized controlled trials (RCTs) are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented.
Methods
Conceptual review.
Discussion
Research is necessary to identify how the illnesses may be prevented, to explore the causes, and to investigate what medications could be used to manage such illness. Voluntary informed consent requires that prospective participants understand the disclose information about the research, and use this to make autonomous informed decision about participation, in line with their preferences and values. Yet the emergency context affects how information may be disclosed to prospective research participants, how much participants may comprehend, and how participants may express their voluntary decision to participate, all of which pose a threat to the validity of the informed consent. I challenge the claim that the ‘understanding’ of research is always necessary for ethical informed consent for research during emergency care. I argue for reconceptualization of the value of understanding, through recognition of other values that may be equally important. I then present a reflective perspective that frames moral reflection about autonomy, beneficence and justice in research in emergency research.
Conclusion
While participant ‘understanding’ of research is important, it is neither necessary nor sufficient for a valid informed consent, and may compete with other values with which it needs to be considered.

In Defence of informed consent for health record research – why arguments from ‘easy rescue’, ‘no harm’ and ‘consent bias’ fail
Thomas Ploug
BMC Medical Ethics, 20 August 2020; 21(75)
Open Access
Abstract
Background
Health data holds great potential for improved treatments. Big data research and machine learning models have been shown to hold great promise for improved diagnostics and treatment planning. The potential is tied, however, to the availability of personal health data. In recent years, it has been argued that data from health records should be available for health research, and that individuals have a duty to make the data available for such research. A central point of debate is whether such secondary use of health data requires informed consent.
Main body
In response to recent writings this paper argues that a requirement of informed consent for health record research must be upheld. It does so by exploring different contrasting notions of the duty of easy rescue and arguing that none of them entail a perfect duty to participate in health record research. In part because the costs of participation cannot be limited to 1) the threat of privacy breaches, but includes 2) the risk of reduced trust and 3) suboptimal treatment, 4) stigmatization and 5) medicalisation, 6) further stratification of solidarity and 7) increased inequality in access to treatment and medicine. And finally, it defends the requirement of informed consent by arguing that the mere possibility of consent bias provides a rather weak reason for making research participation mandatory, and that there are strong, independent reasons for making.
Conclusion
Arguments from the duty of easy rescue in combination with claims about little risk of harm and potential consent bias fail to establish not only a perfect duty to participate in health record research, but also that participation in such research should be mandatory. On the contrary, an analysis of these arguments indicates that the duty to participate in research is most adequately construed as an imperfect duty, and reveals a number of strong reasons for insisting that participation in health records research is based on informed consent.

Consenting and ethical considerations in embryo cryopreservation
Arian Khorshid, Ruben Alvero
Current Opinion in Obstetrics and Gynecology, 27 July 2020
Abstract
Purpose of review
An emerging body of literature has elucidated the growing burden of surplus embryos left in storage without any clear disposition. An out dated consent process is a significant but easily remedied contributor to this problem. We propose a novel approach to consenting for disposition of surplus embryos.
Recent findings
Decisional conflicts that stem from the moral status of embryos and from evolving personal values contribute to surplus embryos being left in storage. Barriers to donation of embryos to research or to other patients also discourage embryo disposition decisions. A flawed informed consent process compromises the physician–provider relationship and complicates decision-making.
Summary
Centralizing the process of donating embryos to research and to patients would lower barriers to these disposition options. The informed consent protocol must be redesigned as a longitudinal, narrative process compatible with the evolving values and fertility outcomes of patients. Counselors should be integrated into all discussions regarding embryo disposition from the onset of fertility treatment through its conclusion to facilitate the decision-making process.

Desperate Times: Protecting the Public From Research Without Consent or Oversight During Public Health Emergencies
Ideas and Opinions
Mary Catherine Beach, Howard M. Lederman, Megan Singleton, Roy G. Brower, Joseph Carrese, Daniel E. Ford, Bhakti Hansoti, Craig W. Hendrix, Ellen Verena Jorgensen, Richard D. Moore, Philip Rocca, Jonathan M. Zenilman
Annals of Internal Medicine, 27 July 2020; (57) pp 163–165
Open Access
Excerpt
…Obtaining informed consent may be impracticable in some public health surveillance activities. The ethical basis for using surveillance data without consent, particularly in emergency situations, is that it serves a compelling common good. Many—including the authors—agree that public health activities should proceed without informed consent when it is not possible or would undermine effective public health response. However, in the absence of a legal requirement, consent should be considered if possible. Obtaining consent may not be difficult, especially when data are collected prospectively. Even if informed consent is impracticable, information about the scope and purpose of the surveillance should be available to participants and to the public…

20th Anniversary Update of the Ottawa Decision Support Framework Part 1: A Systematic Review of the Decisional Needs of People Making Health or Social Decisions
Review Article
Lauren Hoefel, Annette M. O’Connor, Krystina B. Lewis, Laura Boland, Lindsey Sikora, Jiale Hu, Dawn Stacey
Medical Decision Making, 13 July 2020
Abstract
Background. The Ottawa Decision Support Framework (ODSF) has been used for 20 years to assess and address people’s decisional needs. The evidence regarding ODSF decisional needs has not been synthesized. Objectives. To synthesize evidence from ODSF-based decisional needs studies, identify new decisional needs, and validate current ODSF decisional needs. Methods. A mixed-studies systematic review. Nine electronic databases were searched. Inclusion criteria: studies of people’s decisional needs when making health or social decisions for themselves, a child, or a mentally incapable person, as reported by themselves, families, or practitioners. Two independent authors screened eligibility, extracted data, and quality appraised studies using the Mixed Methods Appraisal Tool. Data were analyzed using narrative synthesis. Results. Of 4532 citations, 45 studies from 7 countries were eligible. People’s needs for 101 unique decisions (85 health, 16 social) were reported by 2857 patient decision makers (n = 36 studies), 92 parent decision makers (n = 6), 81 family members (n = 5), and 523 practitioners (n = 21). Current ODSF decisional needs were reported in 2 to 40 studies. For 6 decisional needs, there were 11 new (manifestations): 1) information (overload, inadequacy regarding others’ experiences with options), 2) difficult decisional roles (practitioner, family involvement, or deliberations), 3) unrealistic expectations (difficulty believing outcome probabilities apply to them), 4) personal needs (religion/spirituality), 5) difficult decision timing (unpredictable), and 6) unreceptive decisional stage (difficulty accepting condition/need for treatment, powerful emotions limiting information processing, lacking motivation to consider delayed/unpredictable decisions). Limitations. Possible publication bias (only peer-reviewed journals included). Possible missed needs (non-ODSF studies, patient decision aid development studies, 3 ODSF needs added in 2006). Conclusion. We validated current decisional needs, identified 11 new manifestations of 6 decisional needs, and recommended ODSF revisions.

Informed Consent: A Monthly Review
___________________________

August 2020

This digest aggregates and distills key content around 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: GE2P2 Global_Informed Consent – A Monthly Review_August 2020

Evaluation of donor informed consents and associated predonation educational materials in the United States and Canada: variability in elements of consent and measures of readability and reading burden
Original Research
Mary Townsend, Terri Buccino, Louis Katz
Transfusion, 4 July 2020
Abstract
Background
Every day, approximately 30,000 donors present to blood collection establishments in the United States or Canada, where they are provided information about donation and asked to sign a consent before donating. We evaluated elements of informational and consent documents and measures of readability that may influence their comprehension.
Materials and Methods
Consents for whole blood (WB) and automated collections and predonation reading materials (PRMs) representing over 93% of WB collections in the United States and Canada were evaluated. Elements, including risks of donation, were cataloged. Word count, Flesch‐Kinkaid (F‐K) reading ease/grade level scores, Simple Measure of Gobbledygook grade, and percentage of complex words were measured.
Results
F‐K grade levels ranged from 9.2 to 16.9 for WB consents, 7.8 to 16.0 for apheresis consents, and 6.7 to 10.9 for PRMs, above the recommended level of eighth grade or lower for general audiences. F‐K reading ease scores were below the cutoff of 60 for readability. Reading burden was substantial, with word count ranging from 131 to 885, 131 to 996, and 649 to 2743 for WB and apheresis consents and PRMs, respectively. Use of jargon and the absence of consent elements such as confidentiality, voluntariness, ability to withdraw consent, and risks of deferral were common.
Conclusions
Donor consent documents and associated materials vary widely, are written at challenging grade levels, present considerable reading burden, contain substantial jargon, and are missing key elements of consent. The authors recommend an organized effort, including blood donors, legal experts, and blood collection experts, to reach consensus on the minimal requirements for standardized clear and concise consent documents in an optimized format.