Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?
Article
Stephanie R. Morain, Emily A. Largent
The Hastings Center Report, 11 April 2021
Abstract
Research that is integrated into ongoing clinical activities holds the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet integrating research into clinical care presents difficult ethical and regulatory challenges, including how or whether to obtain informed consent. Multiple empirical studies have explored patients’ and the public’s attitudes toward approaches to consent for pragmatic research. Questions remain, however, about how to use the resulting empirical data in resolving normative and policy debates and what kind of data warrants the most consideration. We recommend prioritizing data about what people consider acceptable with respect to consent for pragmatic research and data about people’s informed, rather than initial, preferences on this subject. In addition, we advise caution regarding the weight given to majority viewpoints and identify circumstances when empirical data can be overridden. We argue that empirical data bolster normative arguments that alterations of consent should be the default in pragmatic research; waivers are appropriate only when the pragmatic research would otherwise be impracticable and has sufficiently high social value.

The Consent Continuum: A New Model of Consent, Assent, and Nondissent for Primary Care
Article
Marc Tunzi, David J. Satin, Philip G. Day
The Hastings Centre Report, 11 April 2021
Abstract
The practice around informed consent in clinical medicine is both inconsistent and inadequate. Indeed, in busy, contemporary health care settings, getting informed consent looks little like the formal process developed over the past sixty years and presented in medical textbooks, journal articles, and academic lectures. In this article, members of the Society of Teachers of Family Medicine (STFM) Collaborative on Ethics and Humanities review the conventional process of informed consent and its limitations, explore complementary and alternative approaches to doctor‐patient interactions, and propose a new model of consent that integrates these approaches with each other and with clinical practice. The model assigns medical interventions to a consent continuum defined by the discrete categories of traditional informed consent, assent, and nondissent. Narrative descriptions and clinical exemplars are offered for each category. The authors invite colleagues from other disciplines and from the academic ethics community to provide feedback and commentary.

[A few reflective remarks on the notion of consent].
Berard K
Soins Psychiatrie, 23 March 2021; 42(333) pp 12-15
Abstract
Medical paternalism has given way to the autonomy of the patient, who remains master of the decisions he makes concerning his health. His consent, free and informed, has no value unless it is preceded by information adapted to his degree of understanding. The notion of consent raises the question of freedom, and therefore of the autonomy left to patients in their choices. Individual freedom occupies a particular place in psychiatry where it comes into confrontation with constraint. The tensions generated must lead caregivers to ask themselves the right questions in accordance with the principles of medical ethics.

Editor’s note: This is a French language publication

Assessment of the All of Us research program’s informed consent process
Megan Doerr, Sarah Moore, Vanessa Barone, Scott Sutherland, Brian M. Bot, Christine Suver, John Wilbanks
American Journal of Bioethics, 4 December 2020; 2 pp 72-83
Abstract
Informed consent is the gateway to research participation. We report on the results of the formative evaluation that follows the electronic informed consent process for the All of Us Research Program. Of the nearly 250,000 participants included in this analysis, more than 95% could correctly answer questions distinguishing the program from medical care, the voluntary nature of participation, and the right to withdraw; comparatively, participants were less sure of privacy risk of the program. We also report on a small mixed-methods study of the experience of persons of very low health literacy with All of Us informed consent materials. Of note, many of the words commonly employed in the consent process were unfamiliar to or differently defined by informants. In combination, these analyses may inform participant-centered development and highlight areas for refinement of informed consent materials for the All of Us Research Program and similar studies.

Informed Consent: A Monthly Review
___________________________

April 2021

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: GE2P2 Global_Informed Consent – A Monthly Review_April 2021

Editor’s Note:
Informed consent for neonatal trials – Practical points to consider was the latest webinar in the Center’s continuing series held on March 17^th 2021. The invited speakers were Dr. Beate Aurich of the Institut National de la Santé et de la Recherche Médicale (INSERM) in Paris, France, and Dr. Eric Vermeulen of the Dutch Patient Association for Rare and Genetic Diseases (VSOP) in Soest, The Netherlands. The presentation was followed by a rich discussion with call participants regarding areas such as parental consent, assent and reconsent, and the role of patient and parent involvement in trials and the design of the informed consent process.

Online Extremism and Terrorism Research Ethics: Researcher Safety, Informed Consent, and the Need for Tailored Guidelines
Maura Conway
Terrorism and Political Warfare, 24 March 2021; 33(2) pp 367-380
Abstract
This article reflects on two core issues of human subjects’ research ethics and how they play out for online extremism and terrorism researchers. Medical research ethics, on which social science research ethics are based, centers the protection of research subjects, but what of the protection of researchers? Greater attention to researcher safety, including online security and privacy and mental and emotional wellbeing, is called for herein. Researching hostile or dangerous communities does not, on the other hand, exempt us from our responsibilities to protect our research subjects, which is generally ensured via informed consent. This is complicated in data-intensive research settings, especially with the former type of communities, however. Also grappled with in this article therefore are the pros and cons of waived consent and deception and the allied issue of prevention of harm to subjects in online extremism and terrorism research. The best path forward it is argued—besides talking through the diversity of ethical issues arising in online extremism and terrorism research and committing our thinking and decision-making around them to paper to a much greater extent than we have done to-date—may be development of ethics guidelines tailored to our sub-field.

The Case for Consent Pluralism
Jessica Keiser
Journal of Ethics and Social Philosophy, 2021
Abstract
A longstanding debate regarding the nature of consent has marked a tri-fold division among philosophical and legal theorists according to whether they take consent to be a type of mental state, a form of behaviour, or some hybrid of the two. Theorists on all sides acknowledge that ordinary language cannot serve as a guide to resolving this ontological question, given the polysemy of the word “consent” in ordinary language. Similar observations have been noted about the function of consent in the law and use of the word “consent” in legal contexts. This paper makes a parallel argument regarding consent’s characteristic normative role: roughly, to transform moral prohibitions into permissions. This role is neither unique nor essential to any one particular kind of thing, be it a mental state, form of behaviour, or hybrid of the two—rather, it is played by mental states and behaviour in independent and context-sensitive ways. The upshot is that insofar as we are interested in its normative implications, we ought to adopt a pluralistic approach to consent which gives independent weight to the moral contributions of facts about mental states and facts about behaviour relative to a context.

Informed Consent: A Monthly Review
___________________________

March 2021

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: GE2P2 Global_Informed Consent – A Monthly Review_March 2021

The readability of informed consent forms for research studies conducted in South Africa
A E Fischer, W D F Venter, S Collins, M Carman, S T Lalla-Edward
South African Medical Journal, February 2021; 111(2)
Open Access
Abstract
Background
Informed consent forms (ICFs) are used to obtain consent from participants. However the complexity and comprehensiveness of these forms may not be appropriate. Readability can be quantified by formulas in Microsoft (MS) Word, such as the Flesch Reading Ease ­test. The South African (SA) ethics guidelines suggest that the MS Word Flesch-Kincaid Reading Grade score should be used to assess the complexity of ICFs and should be the equivalent of grade 8 level, or lower.
Objectives
To use readability formulas to determine whether current SA ICFs are appropriate for the general population.
Methods
This was a descriptive study of a sample of English ICFs (solicited from our studies, as well as from local researchers) which received approval from local ethical review boards during the past 5 years, for prospective (≥6 months) drug studies that explored treatment and prevention of HIV, tuberculosis, diabetes or cardiovascular disease. ICFs were evaluated in MS Word for Flesch Reading Ease and Flesch-Kincaid Reading Grade, with the Simple Measure of Gobbledygook (SMOG) index calculated using www.readabilityformulas.com. Recommended targets for easy readability are above 60 for the Flesch Reading Ease score, and less than or equal to a grade 8 reading level for the Flesch-Kincaid Reading Grade and SMOG.
Results
A total of 75 consent forms from 35 individual research studies conducted in SA over the last 5 years were included. The consent forms had been approved by six ethics committees across seven of the SA provinces. The median (interquartile range (IQR)) Flesch Reading Ease score was 55.8 (48.7 – 59.7) and 18 (25.0%) of the ICFs had easy or standard readability, while the median (IQR) Flesch-Kincaid Grade was 10.2 (8.8 – 11.4), with 23 (30.6%) at least a grade 8 level or lower. The median (IQR) SMOG index  scored below grade 8 level.
Conclusions
Two-thirds of the ICFs from this study fail to meet the SA readability standard, a result matched by using alternative readability formulas. Readability can be improved with simple techniques and by actively monitoring readability metrics.

Legal implications of euthanasia without owner consent
Louise Olley
The Veterinary Nurse, 23 February 2021; 12(1)
Abstract
A veterinary surgeon and registered veterinary nurse must act in accordance with an animal owner’s wishes and should respect their confidentiality. This can cause conflict as animal welfare should also be considered as a priority. Contradictory messages from legislation and the Royal College of Veterinary Surgeons Code of Professional Conduct for Veterinary Nurses are confusing, however, guidance from these suggests that animal welfare overrides all. To practice clinical governance, veterinary teams should discuss ethical scenarios to prepare all staff for prioritising animal welfare while considering the views of the owner.