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
Abstract
Purpose
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.
Source
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.
Conclusion
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
Abstract
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
Globethics.net, 1 November 2021
Abstract
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: Globethics.net 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
Abstract
Purpose
Informed consent for genetic testing has historically been acquired during pretest genetic counseling, without specific guidance defining which core concepts are required.
Methods
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.
Results
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.
Conclusion
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]
Introduction
…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
Abstract
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.
Dynamic Consent for Sensor-Driven Research
Dynamic Consent for Sensor-Driven Research
Hyunsoo Lee
Graduate School of Knowledge Service Engineering [Daejeon, South Korea], 2021
Open Access
Abstract
Dynamic consent is a term initially emerged in biomedical research that involves a large-scale, long-term participant engagement for continuous data collection (e.g., biosamples, health records). Dynamic consent is a wider concept of informed consent that enables granular consent in dealing with personal data. Dynamic consent is typically incorporated into a personalized digital platform that allows participants to tailor and manage their own consent preferences. This feature leads to improved transparency and proactive privacy management. Due to such benefits, dynamic consent offers potential applications in other domains that collect diverse data that require multiple consents over time. One possible testbed is digital health, where there have been several attempts to track symptoms and diagnose mental illnesses (e.g., depression) with data collected from mobile and wearable devices (i.e., digital phenotyping). As these sensors continuously collect personal data, users may feel uncomfortable in certain private contexts. However, the current status of the studies only provides one-off informed consent without consideration of specific user contexts, which calls for context-aware fine-grained control. Thus, this paper explores the feasibility of dynamic consent in sensor-driven research and suggests a future outlook of dynamic consent usage in mobile and ubiquitous computing.
Using Hyperrealistic Simulations to Improve Digital Informed Consent for Endourological Procedures
Using Hyperrealistic Simulations to Improve Digital Informed Consent for Endourological Procedures
Original Article
Víctor Galve Lahoz, David Corbatón Gomollón, Federico Rodríguez-Rubio Cortadellas, Pedro Gil Martínez, Maria Jesús Gil Sanz, Jorge Rioja Zuazu
BJUI International, 25 December 2021
Abstract
Objectives
To show that digital informed consent (DIC) improves the subjective understanding of information and, therefore, informed consent.
Patients and Methods
A nonblinded randomized controlled trial was performed with 84 patients who had undergone a transurethral resection of bladder, transurethral resection of prostate, or ureterorenoscopy between July 2017 to March 2018. The DIC group watched a hyperrealistic simulation on a tablet device before surgery. After surgery and again 30 days later, both groups completed a validated questionnaire that measured subjective understanding, anxiety, and utility of and need for information.
Results
The mean±SD age of participants was 68.7±11.1 years. Nine of 84 patients (10.7%) did not complete the questionnaire. 42 patients were allocated to the DIC group and 42 to the control group. The mean±SD score on immediate subjective understanding in the DIC group was 14.5% higher than in control group (72%±17.5% vs 57.5%±23.5%, respectively; p=0.006). There was no statistical difference among anxiety, utility of and need for information relative to delayed subjective understanding. In subgroup analysis, subjective understanding scores were higher, but not significantly so, among patients with low and higher education levels in the DIC group than in the control group (68%±18.1% vs 54%±22.5%, respectively, p=0.06; and 76%±18.3% vs and 66%±21.9%, respectively, (p=0.89).
Conclusion
Hyperrealistic simulations improved subjective understanding of information and, therefore, informed consent for endourological procedures.
Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives
Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives
Daniel Robins, Rachel Brody, Irena Parvanova, Joseph Finkelstein
Studies in Health Technology and Informatics, 15 December 2021; 284 pp 457-462
Abstract
This study focuses on feedback from domain experts to assess usability and acceptance of the E-Consent electronic consent platform. Quantitative and qualitative data were captured throughout the usability inspection, which was structured around a cognitive walkthrough with heuristics evaluation. Additional surveys measured biobanking knowledge and attitudes and familiarity with informed consent. A semi-structured qualitative interview captured open-ended feedback. 23 researchers of various ages and job titles were included for analysis. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction, and the mean result of 86.7 corresponds with an ‘above average’ usability rating in the >90th percentile. Overall, participants believe that electronic consenting using this platform will be faster than previous workflows while enhancing patient understanding, and human rapport is still a key component of the consent process. Expert review has provided valuable insight and actionable information that will be used to further enhance this maturing platform.
To draw or not to draw: Informed consent dilemma
To draw or not to draw: Informed consent dilemma
Research Article
Santovito D, Cena G, Tattoli L, Di Vella G, Bosco C
Health and Primary Care, 14 May 2021
Open Access
Abstract
Background
Informed consent is a worldwide standard medical practice. The purpose of this study was to determine whether surgical freehand-drawings do facilitate surgeons in the communication process.
Methods
Authors carried out a questionnaire survey aimed at exploring physicians’ perceptions of the usefulness of drawings, in terms of level of understanding in consent acquisition procedures. A total of 90 anonymous questionnaires were distributed for doctors to fill in, in surgical and interventional medicine wards of the University Hospital of Turin.
Results
Out of the 90 questionnaires delivered, 37.8% (n=34) were filled out. 93.8% (n=30) of the physicians interviewed consider freehand-drawings a useful tool, 90% (n=27) of the surgeons, who confirmed to routinely use drawing for informed consent acquisition purposes. 96.3% (n=26) of the physicians who draw themselves illustrative images of proposed treatments asserted to perceive a real benefit in patients’ comprehension of the information when visually provided. Many respondent surgeons stated to consider drawing an effective means of information for consent acquisition. Nonetheless, just in 7.4% of the cases, personally drawn explicative images are then added in patients’ medical records, with possible detrimental effects on a medico legal point of view.
Conclusions
Graphical representation is useful for breaking down comprehension barriers resulting not only from the modality in which the information is conveyed but also from patients’ relational, social, and psychological factors, ensuring bi-directionalness of communication and prove in Italy, a Civil Law Country, the communicative effort of physicians in the best interest of the patients.
Center for Informed Consent Integrity 