Informed Consent: A Monthly Review

January 2022

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:

Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_January 2022

Consent or Public Reason? Legitimacy of Norms Applied in ASPD and COVID-19 Situations

Consent or Public Reason? Legitimacy of Norms Applied in ASPD and COVID-19 Situations
Original Article
Elvio Baccarini
Philosophy and Society, 30 November 2021; 32(4) pp 674–694
Open Access
This paper extends Alan John Simmons’s conceptual distinction between Lockean (or consent) and Kantian (or justificatory) conceptions of legitimacy that he applied to the question of the legitimacy of states, to the issue of legitimacy of public decisions. I criticise the consent conception of legitimacy defended by Simmons, and I defend the Rawlsian version of the justificatory conception of legitimacy from his objection. The approach of this paper is distinctive because the two conceptions are assessed by investigating, using the method of reflective equilibrium, their respective prescriptions concerning the treatment of antisocial personality disorder (ASPD) and epidemiologic measures. I argue that the method of reflective equilibrium does not support the consent conception. Considering the issues of treatment of ASPD and of epidemiologic measures, I argue that the consent conception of legitimacy is not well-equipped for the evaluation of norms that are not strictly self-regarding. This causes a deficit of prescriptions for relevant social responses. Further, by considering the case of responses to epidemics, I argue that such a conception can avoid harmful consequences only by recurring to additional, and independent, premises. This does not cause incoherence but reduces the coherence of a normative system. Finally, the consent conception is not equipped to support social cooperation in an optimal way, which has proved to be necessary in critical conditions, like a pandemic. On the other hand, I argue that the method of reflective equilibrium supports the Rawlsian version of justificatory conception of legitimacy, because of its advantages in handling the indicated issues. In addition, I maintain that this justificatory conception is respectful of freedom and equality of agents as moral self-legislators, and, thus, it is not vulnerable to Simmons’s main criticism.

Implementing two-stage consent pathway in neonatal trials

Implementing two-stage consent pathway in neonatal trials
Short Report
Eleanor Mitchell, Sam J Oddie, Jon Dorling, Chris Gale, Mark John Johnson, William McGuire, Shalini Ojha
Archives of Disease in Childhood – Fetal and Neonatal Edition, 23 December 2021
Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway…

Informed consent and assent guide for paediatric clinical trials in Europe

Informed consent and assent guide for paediatric clinical trials in Europe
Original Research
Pirkko Lepola, Maxine Kindred, Viviana Giannuzzi, Heidi Glosli, Martine Dehlinger-Kremer, Harris Dalrymple, David Neubauer, Geraldine B Boylan, Jean Conway, Jo Dewhurst, Diane Hoffman
Archives of Disease in Childhood, 1 December 2021
Clinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements, and the lack of detailed guidance. The aim of this study was to design new easy-to-use guide publicly available on European Medicines Agency’s, Enpr-EMA website for all stakeholders.
Current EU legal, ethical and regulatory guidance for paediatric clinical trials were collated, analysed and divided into 30 subject elements in two tables. The European Network of Young Person’s Advisory Group reviewed the data and provided specific comments. A three-level recommendation using ‘traffic light’ symbols was designed for four age groups of children, according to relevance and the requirements.
A single guide document includes two tables: (1) general information and (2) trial-specific information. In the age group of 6–9 years old, 92% of the trial-specific subject elements can be or should be included in the IC discussion. Even in the youngest possible age group (2–5 years old children), the number of elements considered was, on average, 52%.
The EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the IC process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials.

Consent models in Canadian critical care randomized controlled trials: a scoping review

Consent models in Canadian critical care randomized controlled trials: a scoping review
Review Article
Katie O’Hearn, Jess Gibson, Karla Krewulak, Rebecca Porteous, Victoria Saigle, Margaret Sampson, Anne Tsampalieros, Nick Barrowman, Saoirse Cameron, the Canadian Critical Care Trials Group
Canadian Journal of Anesthesia, 8 November 2021
Open Access
Our primary objective was to describe consent models used in Canadian-led adult and pediatric intensive care unit (ICU/PICU) randomized controlled trials (RCTs). Our secondary objectives were to determine the consent rate of ICU/PICU RCTs that did and did not use an alternate consent model to describe consent procedures.
Using scoping review methodology, we searched MEDLINE, Embase, and CENTRAL databases (from 1998 to June 2019) for trials published in English or French. We included Canadian-led RCTs that reported on the effects of an intervention on ICU/PICU patients or their families. Two independent reviewers assessed eligibility, abstracted data, and achieved consensus.
Principal findings
We identified 48 RCTs of 17,558 patients. Included RCTs had ethics approval to use prior informed consent (43/48; 90%), deferred consent (13/48; 27%), waived consent (5/48; 10%), and verbal consent (1/48; 2%) models. Fifteen RCTs (15/48; 31%) had ethics approval to use more than one consent model. Twice as many trials used alternate consent between 2010 and 2019 (13/19) than between 2000 and 2009 (6/19). The consent rate for RCTs using only prior informed consent ranged from 54 to 91% (ICU) and 43 to 94% (PICU) and from 78 to 100% (ICU) and 74 to 87% (PICU) in trials using an alternate/hybrid consent model.
Alternate consent models were used in the minority of Canadian-led ICU/PICU RCTs but have been used more frequently over the last decade. This suggests that Canadian ethics boards and research communities are becoming more accepting of alternate consent models in ICU/PICU trials.

Race, Place, and The Federal Exception from Informed Consent (EFIC): A Semiotic Approach [DISSERTATION]

Race, Place, and The Federal Exception from Informed Consent (EFIC): A Semiotic Approach [DISSERTATION]
Samantha Whitney Stein
UCLA, 2021
The Exception from Informed Consent (EFIC) regulatory mechanism can be used to waive federal informed consent requirements for emergency medical research, pending satisfaction of pre-trial requirements. EFIC’s most notoriously challenging pre-trial requirement is ‘community consultation,’ a process through which EFIC researchers solicit public feedback on their trials. Using a Peircean semiotic framework, this thesis unpacks the presuppositions undergirding the idea that community consultation can reduce friction between emergency clinical trials carried out without informed consent and the values of patients enrolled in them. I introduce a semiotics of prediction, showing how assumptions about race figure prominently in the commensuration-based tasks of selecting community consultation respondents and subsequently generalizing findings from these respondents to broader populations. I suggest that in practice the content and / or generalizability of feedback collected through community consultation has very limited utility for reducing friction. Rather, community consultation’s primary function—as it is currently operationalized—is one of public relations, whereby the discursive processes through which community feedback is solicited have more bearing on EFIC trials’ public acceptability than the content of community feedback and the ability of biomedical research actors to transpose this content across contexts. By examining who participates in / is affected by the discursive processes through which community feedback is solicited, I help explain otherwise untheorized yet nonetheless troubling disparities between the acceptability of EFIC as determined by community consultation respondents and the acceptability of EFIC as determined by EFIC trial participants and their surrogates.

Informed Consent as a Component of Online Research Ethics — The Perspective of the Participants

Informed Consent as a Component of Online Research Ethics — The Perspective of the Participants
Online Research
Nataša B. Matović, Kristinka Č. Ovesni, 1 November 2021
The paper discusses informed consent as a component of online research ethics. It begins from the analysis of understanding, from the preconditions on which the realization depends, and from the difficulties that accompany the application of the informed consent in practice. The aim of the empirical part of the research is to determine the characteristics of the process of obtaining the informed consent in online research and to examine the factors on which they depend. The sample included 153 teachers. Data were collected with the survey-type questionnaires and with the descriptive assessment scales. For data processing, besides the frequencies and percentages, the χ2 test and Kramer ‘s V correlation coefficient were performed. The results indicate that most of the respondents have had experience of giving informed consent in online surveys in which they have participated so far; that the text often contained information about the purpose and the goal of the research, apart from the tasks of the respondents in the research; that the majority of the teachers evaluate the content of the text as understandable and useful; and also that most of the characteristics depend on the environment of the school in which the teachers are employed. The results are discussed in the context of the possibility of improvement of the process of obtaining informed consent from the respondents in the online survey.

Editor’s note: is a global network of teachers and institutions with the vision to embed ethics in higher education. It hosts a publishing house open to all the authors interested in applied ethics.

Defining the Critical Components of Informed Consent for Genetic Testing

Defining the Critical Components of Informed Consent for Genetic Testing
Kelly E. Ormond, Maia J. Borensztein, Miranda L. G. Hallquist, Adam H. Buchanan, William Andrew Faucett, Holly L. Peay, Maureen E. Smith, Eric P. Tricou, Wendy R. Uhlmann, Karen E. Wain, Curtis R. Coughlin, Clinical Genome CADRe Workgroup
Journal of Personalised Medicine, 5 December 2021
Open Access
Informed consent for genetic testing has historically been acquired during pretest genetic counseling, without specific guidance defining which core concepts are required.
The Clinical Genome Resource (ClinGen) Consent and Disclosure Recommendations Workgroup (CADRe) used an expert consensus process to identify the core concepts essential to consent for clinical genetic testing. A literature review identified 77 concepts that are included in informed consent for genetic tests. Twenty-five experts (9 medical geneticists, 8 genetic counselors, and 9 bioethicists) completed two rounds of surveys ranking concepts’ importance to informed consent.
The most highly ranked concepts included: (1) genetic testing is voluntary; (2) why is the test recommended and what does it test for?; (3) what results will be returned and to whom?; (4) are there other types of potential results, and what choices exist?; (5) how will the prognosis and management be impacted by results?; (6) what is the potential family impact?; (7) what are the test limitations and next steps?; and (8) potential risk of genetic discrimination and legal protections.
Defining the core concepts necessary for informed consent for genetic testing provides a foundation for quality patient care across a variety of healthcare providers and clinical indications.

Responding from the Place of Suffering: Informed Consent and Non-invasive Prenatal Genetic Screening [BOOK CHAPTER]

Responding from the Place of Suffering: Informed Consent and Non-invasive Prenatal Genetic Screening [BOOK CHAPTER]
Michael McCarthy
Suffering in Theology and Medical Ethics, 3 December 2021; pp 179–187 [Brill]
…Informed consent after a positive screen for Trisomy 21, Down syndrome, should move from an individualist model of autonomy to a principled autonomy that allows the patient to explore the decision from her reality. This shift would need to incorporate the medical facts, understanding the risks and benefits, and learning from those faced previously with similar decisions. This chapter begins, first, by describing non-invasive prenatal genetic screening. Secondly, it explores what constitutes informed consent through an individual/utilitarian model of autonomy and juxtaposes that with principled autonomy grounded in Ada María Isasi-Díaz’s mujerista hermeneutic, lo cotidiano. The chapter concludes by drawing on both insights from minority participants in clinical research and parents of a child with Trisomy 21 in order to enhance the process for informed consent. Better understanding the reality of the patient and explaining the potential options in a way that prioritizes the patient’s reality allows her to make a responsible and informed decision…

Biobank Participants’ Attitudes toward Requiring Understanding for Biobank Consent

Biobank Participants’ Attitudes toward Requiring Understanding for Biobank Consent
T.J. Kasperbauer, Colin Halverson, Abigail Garcia, Karen K. Schmidt, Peter H. Schwartz
Ethics & Human Research, 22 December 2021
Biobank participants often do not understand the information they are provided during the informed consent process. Ethicists and other stakeholders have disagreed, however, on the appropriate response to these failures in understanding. This paper describes an attempt to address this issue by conducting knowledge tests with 22 recent biobank enrollees, followed by in-depth, semistructured interviews about the goal of understanding in biobank consent. The interviews revealed that while biobank enrollees thought the information on the knowledge test was important, they did not think that performance on the test should affect whether individuals are permitted to enroll in a biobank. Three main themes emerged from the interviews: helping others by contributing to research is more important than understanding consent forms, less understanding is required because biobank-based research is low risk, and only a small amount of information in the consent form is really essential. These perspectives should be considered in discussing the ethics and governance of biobank consent processes.