Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?

Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?
Adèle Langlois, Stephanie Armstrong, Aloysius Niroshan Siriwardena
Academic Emergency Medicine, 28 November 2020
Open Access
In 2010 Largent, Wendler, and Emanuel proposed the “consent substitute model” for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: 1) the research addresses the patients’ urgent medical needs, 2) the risk–benefit ratio is favorable, 3) there are no known conflicts with patients’ values or interests, 4) cumulative net risk is minimal, and 5) consent is given as soon as possible. We review national and international ethics laws, regulations, and guidelines to determine 1) whether they accord with the consent substitute model’s five conditions and 2) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonization’s Guideline for Good Clinical Practice and the World Medical Association’s Declaration of Helsinki, are revised to include more specific provisions on emergency medical research.

Cultural variation in informed consent for clinical research participation [BOOK]

Cultural variation in informed consent for clinical research participation [BOOK]
David Resnik, Julia Hecking
Routledge; Handbook of Ethnography in Healthcare Research, 2020
Informed consent is one of the cornerstones of ethical research with human subjects. Although most people living in Western countries are familiar with the concept of informed consent, in some parts of the world the idea that an individual has the right to give his or her informed consent for medical care or research participation is a foreign notion. In this chapter, we examine the ethical and legal basis of informed consent and review the published research on cultural variation in informed consent for clinical research participation. Our analysis of this literature identifies four different ways that culture may affect the informed consent process, including: 1) consent of community leaders may be sought prior to obtaining the individual consent of community members; 2) investigators may alter consent documents to better reflect the language and concepts used in the culture; 3) the consent procedure may be modified to reinforce the concept of opt-in participation and give participants more time to discuss their potential enrollment with others; and 4) instead of obtaining informed consent through written documents, researchers may use record consent verbally or through a fingerprint in cultures with an oral history or high rates of illiteracy.

Informed consent for genetic testing in hematology

Informed consent for genetic testing in hematology
Jonathan M. Marron
Hematology, 4 December 2020; 1 pp 213–218
Open Access
Informed consent is a fundamental component of modern health care. All competent adult patients have the legal and ethical authority to accept (consent) or refuse (dissent) recommended health-related interventions. Various models of informed consent have been described, and herein I introduce a model that divides informed consent into 7 distinct elements: competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization. Genetic testing, which is rapidly becoming a common feature of both clinical care and research in hematology, adds additional layers of complexity to each of these consent elements. Using the example case of Mr. Smith, a man with newly diagnosed acute myeloid leukemia whose clinicians offer him genetic testing of the leukemia through a clinical trial, I highlight the challenges and controversies of informed consent for genetic testing, focusing on each consent element as it pertains to genetic testing in such a setting. Ultimately, given the growing importance of genetic testing for hematologic disorders, clinicians, and researchers in hematology should be facile at participating in all aspects of informed consent for genetic testing.

Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding

Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding
Research Article
J. Kasperbauer, Karen K. Schmidt, Ariane Thomas, Susan M. Perkins, Peter H. Schwartz
American Journal of Bioethics, 4 December 2020
Biobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees’ comprehension under an “integrated consent” process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how much patients understand after enrolling under these conditions.
We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants.
Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% “I don’t know.” In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% “I don’t know.” Participants scored particularly poorly on questions about data sharing and accessing medical records.
Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank.

A graphic elicitation technique to represent patient rights

A graphic elicitation technique to represent patient rights
Catherine R. McGowan, Nora Hellman, Louisa Baxter, Sonali Chakma, Samchun Nahar, Ahasan Ud Daula, Kelly Rowe, Josie Gilday, Patricia Kingori, Rachel Pounds, Rachael Cummings
Conflict and Health, 14 December 2020; 14(86)
Open Access
A patient charter is an explicit declaration of the rights of patients within a particular health care setting. In early 2020 the Save the Children Emergency Health Unit deployed to Cox’s Bazar Bangladesh to support the establishment of a severe acute respiratory infection isolation and treatment centre as part of the COVID-19 response. We developed a charter of patient rights and had it translated into Bangla and Burmese; however, the charter remained inaccessible to Rohingya and members of the host community with low literacy.
To both visualise and contextualise the patient charter we undertook a graphic elicitation method involving both the Rohingya and host communities. We carried out two focus group discussions during which we discussed the charter and agreed how best to illustrate the individual rights contained therein.
Logistical constraints and infection prevention and control procedures limited our ability to follow up with the original focus group participants and to engage in back-translation as we had planned; however, we were able to elicit rich descriptions of each right. Reflecting on our method we were able to identify several key learnings relating to: 1) our technique for eliciting feedback on the charter verbatim versus a broader discussion of concepts referenced within each right, 2) our decision to include both men and women in the same focus group, 3) our decision to ask focus group participants to describe specific features of each illustration and how this benefited the inclusivity of our illustrations, and 4) the potential of the focus groups to act as a means to introduce the charter to communities.
Though executing our method was operationally challenging we were able to create culturally appropriate illustrations to accompany our patient charter. In contexts of limited literacy it is possible to enable access to critical clinical governance and accountability tools.

Transparency and Accountability of Pediatric Trials: Should Consent Rate Reporting Be Mandatory?

Transparency and Accountability of Pediatric Trials: Should Consent Rate Reporting Be Mandatory?
Ana Marušić, Ivan Buljan
The Journal of Pediatrics, 1 December 2020; 227 pp 9-10
The study of Lonhart et al in this volume of The Journal sends a warning about reporting consent rates in pediatric trials.1 They analyzed 696 articles from MEDLINE presenting pediatric randomized controlled trials and showed that 60% (n = 418) of them did not report rates of consent for trial participants, or the consent rate was unclear. Among 278 trials that did report the number of consenting subjects, the average consent rate was high (83%), but for 26% of these trials, the average consent rate was less than 70%, which may introduce a bias related to the representativeness of the target population. Overall, the consent rates were greater for trials of vaccination interventions (90%) in comparison with behavioral interventions (79%), and for industry-funded trials (86%) in comparison with government-funded trials (79%). This study raises important questions related to the ethics of pediatric trials and to the quality and validity of evidence from pediatric trials…

Consent Rates Reported in Published Pediatric Randomized Controlled Trials

Consent Rates Reported in Published Pediatric Randomized Controlled Trials
Julia A. Lonhart, Ashley R. Edwards, Swati Agarwal, Brian P. Lucas, Alan R. Schroeder
The Journal of Pediatrics, 1 December 2020; 227 pp 281-287
To determine the average reported consent rate for published pediatric randomized controlled trials (RCTs) and whether this rate varies by trial characteristics.
Study design
A review of pediatric RCTs published in Medline in 2009, 2010, or 2015 was performed. Secondary analyses of prior trials, trials including adults, trials not requiring consent, or trials with missing or unclear consent data were excluded. Consent rate was defined as the number of patients enrolled divided by number of eligible patients where families were approached. Random effects meta-regression was conducted to determine the weighted average consent rate.
Of 2347 trials identified, 1651 were excluded. An additional 418 of 696 (60%) were excluded because the consent rate was missing or unclear. The average consent rate for 278 included RCTs was 82.6% (95% CI, 80.3%-84.8%) and was higher for vaccination compared with behavioral trials and for industry-funded compared with National Institutes of Health-funded or other government-funded trials. The average consent rate was <70% for 26% of included trials. Of these trials, US trials (28/77 [36.4%]) had a higher probability of a consent rate of <70% than non-US studies (35/64 [21.3%]) and multinational (9/37 [24.3%]) studies. There was slight variation by funding category.
Although the average consent rate for published trials was reasonably high, approximately one-quarter of trials had consent rates of <70%. Consent rates reporting has improved over time, but remains suboptimal. Our findings should assist with the planning of future pediatric RCTs, although consent data from unpublished trials are also needed.

[The informed consent in the mature minor: Understanding and decision-making capacity]

[The informed consent in the mature minor: Understanding and decision-making capacity]
R Boceta, O Martínez-Casares, M Albert
Anales de Pediatria, 29 November 2020
The informed consent of the minor is a fundamental requirement of paediatric research. There is a lack of harmonisation as regards the age of the mature minor to consent, and there are no systematic tools available to assess competence in decision-making capacity. The objective of this work is to analyse the ethical and legal situation of consent by minors, as well as studies that use an objective assessment tool in the mature minor.
Material and methods
Systematic review of scientific articles in PubMed, Embase and the Grey Literature, published with keywords “informed consent minors”, without date restriction until March 2019. Abstracts and a selection of complete articles were reviewed following a protocol including identification, screening, eligibility, and inclusion.
Of the 260 records identified, 139 were excluded. After categorising the resulting 121 publications, 13 were finally selected following the eligibility criteria, including 7 articles on international ethical and legal regulations and 6 on understanding and decision- making capacity assessment. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) semi-structured interview was used in 4 studies, including different age ranges (6-21 years) in healthy and sick children.
The semi-structured MacArthur interview adapted to adolescents could be an appropriate tool with robust psychometric measures for assessing competence for the informed consent of minors between 9 and 12 years of age. The regulation of informed consent in paediatric research should consider this evidence.

Editor’s note: This is a Spanish Language Publication.

Implementing Electric Consent Aimed at People Living with Dementia and Their Caregivers: Did We Forget Those Who Forget?

Implementing Electric Consent Aimed at People Living with Dementia and Their Caregivers: Did We Forget Those Who Forget?
Yvonne O’ Connor, Ian Twohig, Leona O’ Brien
Proceedings of the 54th Hawaii International Conference on System Sciences, 2021
Open Access
As policy flows down from law and/or regulation (e.g. GDPR) our individual privacy concerns give rise to demands on improving accessibility, awareness and comprehension, the topic of eConsent is becoming more prevalent. We provide a critical voice by considering, but also challenging, the underlying assumptions that the status quo of eConsent design and implementation is appropriate for all people in society. By answering “what eConsent characteristics are prevalent in the context of dementia applications?”, this paper identifies that the “one size fits all” ethos for eConsent is not applicable in every context. As a result, a taxonomy that depicts the multifaceted concept of eConsent is proposed. It makes us aware of the different ethical, legal, social and technical implications of ICT use and provides an opportunity to create discourse in this area. It argues that future research examining the effectiveness of innovative ICTs must take the eConsent process into account.

How should the ‘privilege’ in therapeutic privilege be conceived when considering the decision-making process for patients with borderline capacity?

How should the ‘privilege’ in therapeutic privilege be conceived when considering the decision-making process for patients with borderline capacity?
Original Research
Sumytra Menon, Vikki Entwistle, Alastair Vincent Campbell, Johannes J M van Delden
BMJ Medical Ethics, 22 December 2020
Open Access
Therapeutic privilege (TP) is a defence that may be available to doctors who fail to disclose to the patient relevant information when seeking informed consent for treatment if they have a reasonable belief that providing that information would likely cause the patient concerned serious physical or mental harm. In a landmark judgement, the Singapore Court of Appeal introduced a novel interpretation of TP, identifying circumstances in which it might be used with patients who did not strictly lack capacity but might be inclined to refuse recommended treatments. In this paper, we explore the conceptual and practical challenges of this novel interpretation of TP. We propose that more emphasis should be placed on forms of shared and supported decision-making that foster the autonomy of patients with compromised mental capacity while being mindful of the need to safeguard their well-being. The kind of privilege that doctors might need to invoke is one of time and supportive expertise to ensure a flexible, responsive approach calibrated to the individual patients’ needs. The provision of such service would extinguish the need for the novel TP proposed by the Singapore Court of Appeal.