Children’s informed signified and voluntary consent to heart surgery: Professionals’ practical perspectives
Empirical Paper
Priscilla Alderson, Hannah Bellsham-Revell, Joe Brierley, Nathalie Dedieu, Joanna Heath, Mae Johnson, Samantha Johnson, Alexia Katsatis, Romana Kazmi, Liz King, Rosa Mendizabal, Katy Sutcliffe, Judith Trowell
Nursing Ethics, 25 February 2022
Open Access
Abstract
Background
The law and literature about children’s consent generally assume that patients aged under-18 cannot consent until around 12 years, and cannot refuse recommended surgery. Children deemed pre-competent do not have automatic rights to information or to protection from unwanted interventions. However, the observed practitioners tend to inform young children, respect their consent or refusal, and help them to “want” to have the surgery. Refusal of heart transplantation by 6-year-olds is accepted.
Research question
What are possible reasons to explain the differences between theories and practices about the ages when children begin to be informed about elective heart surgery, and when their consent or refusal begins to be respected?
Research design, participants and context
Research methods included reviews of related healthcare, law and ethics literature; observations and conversations with staff and families in two London hospitals; audio-recorded semi-structured interviews with a purposive sample of 45 healthcare professionals and related experts; interviews and a survey with parents and children aged 6- to 15-years having elective surgery (not reported in this paper); meetings with an interdisciplinary advisory group; thematic analysis of qualitative data and co-authorship of papers with participants.
Ethical considerations
Approval was granted by four research ethics committees/authorities. All interviewees gave their informed written consent.
Findings
Interviewees explained their views and experiences about children’s ages of competence to understand and consent or refuse, analysed by their differing emphases on informed, signified or voluntary consent.
Discussion
Differing views about children’s competence to understand and consent are associated with emphases on consent as an intellectual, practical and/or emotional process.
Conclusion
“Greater respect for children’s practical signified, emotional voluntary and intellectual informed consent can increase respectful understanding of children’s consent. Nurses play a vital part in children’s practitioner-patient relationships and physical care and therefore in all three elements of consent.”
Tele-consent using mixed reality glasses (NREAL) in pediatric inguinal herniorrhaphy: a preliminary study
Tele-consent using mixed reality glasses (NREAL) in pediatric inguinal herniorrhaphy: a preliminary study
Article
Won-Gun Yun, Joong Kee Youn, Dayoung Ko, Inhwa Yeom, Hyun-Jin Joo, Hyoun-Joong Kong, Hyun-Young Kim
Nature – Scientific Reports, 24 February 2022; 12(3105)
Open Access
Abstract
There is an increasing demand and need for patients and caregivers to actively participate in the treatment process. However, when there are unexpected findings during pediatrics surgery, access restrictions in the operating room may lead to a lack of understanding of the medical condition, as the caregivers are forced to indirectly hear about it. To overcome this, we designed a tele-consent system that operates through a specially constructed mixed reality (MR) environment during surgery. We enrolled 11 patients with unilateral inguinal hernia and their caregivers among the patients undergoing laparoscopic inguinal herniorrhaphy between January through February 2021. The caregivers were informed of the intraoperative findings in real-time through MR glasses outside the operating room. After surgery, we conducted questionnaire surveys to evaluate the satisfaction and usefulness of tele-consent. We identified contralateral patent processus vaginalis in seven out of 11 patients, and then additionally performed surgery on the contralateral side with tele-consent from their caregivers. Most caregivers and surgeons answered positively about the satisfaction and usefulness of tele-consent. This study found that tele-consent with caregivers using MR glasses not only increased the satisfaction of caregivers and surgeons, but also helped to accommodate real-time findings by adapting surgical plan through the tele-consent.
Ages of Consent and Majority [BOOK CHAPTER]
Ages of Consent and Majority [BOOK CHAPTER]
Dana Lee Baker, Raquel Lisette Baker
Neuroethical Policy Design, 1 January 2022; pp 89-100 [Springer]
Abstract
Most contemporary humans distinguish adulthood from childhood. Historical conceptions of these two states have varied across time and place. Understanding past approaches to majority takes in the reality that for much of human history, a large proportion of children did not survive until adulthood. Cultures around the world once created definite transitions into adulthood for children fortunate enough to survive childhood. Once the fragility of children weighed less heavily on the collective human consciousness, consideration of the distinction between child and adult became more nuanced. Many cultural traditions surrounding transition to adulthood remain in contemporary practice. However, as adult life became more complicated, access to adult privileges and assumption of adult responsibilities became more staggered. Furthermore, determining whether or not a particular individual has transitioned to adulthood became less clear and absolute in most contemporary societies.
Consent to Treatment for Transgender Youth: The Next Chapter – Bell & Anor v The Tavistock and Portman NHS Foundation Trust & Ors
Consent to Treatment for Transgender Youth: The Next Chapter – Bell & Anor v The Tavistock and Portman NHS Foundation Trust & Ors
Hillary Chua
Modern Law Review, 25 February 2022
Abstract
In September 2021, the Court of Appeal reversed the controversial decision of Quincy Bell v Tavistock and Portman NHS Trust in a victory for transgender rights. At first instance, the Divisional Court had set a high legal threshold for transgender children to attain Gillick competence to consent to treatment with puberty blockers – effectively restricting access to treatment for many. On appeal, the Court of Appeal held that children are capable in law of giving valid consent to treatment for gender dysphoria, and court authorisation would not be routinely required before children could access such treatment. This note considers the implications of the Court of Appeal decision for the law on minors and consent to medical treatment in the transgender health context.
Our data? An examination of the possible role of individual consent in the regulation of posthumous medical data donation (PMDD)
Our data? An examination of the possible role of individual consent in the regulation of posthumous medical data donation (PMDD)
Henry Pearce
Computer Law & Security Review, 17 February 2022
Abstract
This article considers the regulation of posthumous medical data donation (PMDD) and examines the extent to which the law should require the opt-in ante-mortem consent of deceased persons for their medical data to be retained and used as part of PMDD initiatives. The article considers arguments on either side of this debate (i.e., pro-consent vs. anti- consent) before tentatively suggesting that, as a general matter, opt-in consent should not be required for medical data of deceased persons to be used for PMDD purposes. It is also proposed, however, that whilst opt-in consent should not be required by law, individuals should be provided with a qualified right through which they can object or “opt out” of their medical data being used in this way.
Free, Prior and Informed Consent in Kenyan Law and Policy After Endorois and Ogiek
Free, Prior and Informed Consent in Kenyan Law and Policy After Endorois and Ogiek
Nqobizitha Ndlovu, Enyinna S Nwauche
Journal of African Law, 14 March 2022
Abstract
This article examines the Kenyan legal and policy framework as well as jurisprudence on the principle of free, prior and informed consent (FPIC) occasioned by the decision of the African Commission on Human and Peoples’ Rights (African Commission) in Centre for Minority Rights Development (Kenya) and Minority Rights Group (on behalf of Endorois Welfare Council) v Republic of Kenya (Endorois) and the judgment of the African Court on Human and Peoples’ Rights (African Court) in the case of African Commission on Human and Peoples’ Rights v Republic of Kenya (Ogiek). The main objective of this article is to examine the development and level of operationalization of the principle of FPIC in Kenyan domestic law and policy using the Endorois and Ogiek standard. It examines how the Kenyan domestic legal system has responded to these regional and international developments on FPIC and its operationalization.
Health care users’ acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda
Health care users’ acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda
Research Article [awaiting peer review]
Hellen Nansumba, Mugalula Flaviano, Semanda Patrick, Ssewanyana Isaac, Douglas Wassenaar
Wellcome Open Research, 1 March 2022
Abstract
Background
Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Bio-repository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a short informed consent statement (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda.
Methods
A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental draft ICF for this study was developed and attached to the Laboratory investigation form.
Results
Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. HCUs who did not understand the draft ICF were 90% less likely to accept broad consent compared to those who understood (OR=0.10, CI [0.03-0.32] while those who partly understood the ICF were 73% less likely to accept broad consent compared to those who understood (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health.
Conclusion
Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.
Informed consent in a patient with aortic dissection and mild intellectual impairment
Informed consent in a patient with aortic dissection and mild intellectual impairment
Wafa Abdelghaffar, Elyes Lagha, Fares Azaiez, Nadia Haloui, Rym Rafrafi
QScience, 19 January 2022
Open Access
Abstract
Informed consent is an ethical and legal requirement in modern medicine. A valid consent implies that the patient can decide on treatment after receiving adequate information from his doctor. In case of incapacity and specific conditions, doctors can administer treatments without patient consent. Nonetheless, some cases are borderline, such as the patient presented in this paper who had a mild intellectual impairment and refused to undergo urgent intervention for aortic dissection. In this case, psychiatrists and cardiologists collaborated to check whether the patient could consent and decided to respect his choice. He was not operated, and the local ethical committee agreed with this decision. In Tunisia and developing countries, the paternalistic approach is still prevalent in the doctor-patient relationship. This paper highlights that ethical considerations should be universal and applied to all patients in all cultures and discusses ethical and legal aspects.
Editor’s note: QScience is the online publishing platform from Hamad bin Khalifa University Press, Qatar.
Meaningful Digital Consent in Canada: Recommendations from Pan-Canadian Consent Management Workshops
Meaningful Digital Consent in Canada: Recommendations from Pan-Canadian Consent Management Workshops
Nelson Shen, Iman Kassam, Daria Ilkina, Sarah Wickham, Abigail Carter-Langford
Healthcare Quarterly, January 2022; 24(4) pp 40-47
Abstract
The digital health landscape is rapidly evolving with regard to how society accesses and interacts with digital information and technologies. With a largely commercial marketplace, there are growing concerns that users are not fully informed about how their data are used. Canadian privacy legislation is currently undergoing modernization to improve the transparency of commercial information handling practices through the introduction of meaningful consent. This paper reports on workshops held across Canada, exploring the implications of meaningful consent in a digital health context. Recommendations focus on measures to promote transparency, improve digital literacy and foster public trust in digital health innovations.
Consent to Research in Madagascar: Challenges, Strategies, and Priorities for Future Research
Consent to Research in Madagascar: Challenges, Strategies, and Priorities for Future Research
Elysée Nouvet, Simon Grandjean Lapierre, Astrid Knoblauch, Laurence Baril, Andry Andriamiadanarivo, Mihaja Raberahona, Chiarella Mattern, LorieDonelle, Jean Rubis Andriantsoa
Canadian Journal of Bioethics, 2022; 5(1) pp 33-44
Open Access
Abstract
The ethical conduct of research in any setting hinges on the voluntary and informed consent of research participants. Working towards consent that is truly voluntary and informed, however, is far from straightforward, and requires attention to contextual factors that may complicate achievement of this ideal in specific research settings. This paper is based on Madagascar’s first “Consent complexities in health research in Madagascar” workshop, held in Antananarivo, Madagascar, in October 2018. It identifies a number of challenges encountered by individuals responsible for the conduct or oversight of health research in Madagascar related to informed and voluntary consent. Key challenges identified included: adaptation of consent tools into local dialects and for limited literacy populations; perceived acquiescence of potential participants regardless of actual preference based on cultural norms; perceived time pressures within tight project timelines to collect data as quickly as possible, limited time for consent processes; fears and taboos related to specific research procedures or topics; and, uncertainty about how best to approach and verify the validity of individual consent in contexts where traditional leaders’ influence is conventionally sought out and respected. Potential strategies for responding to each of these challenges are proposed, as are key questions meriting further study.
Center for Informed Consent Integrity 