Consent for the paediatric patient

Consent for the paediatric patient
Andrew Jones, James Hyde, Sharon Lee, Sondos Albadri, Laura Gartshore
Faculty Dental Journal, 1 April 2023; 14(2)
Abstract
Introduction
Obtaining valid consent is a fundamental process in dentistry. Written consent must be obtained where treatment involves conscious sedation or general anaesthesia. For children, consent may be provided by a person with parental responsibility (PR).
Methods
A retrospective evaluation was completed of 160 children over 2 UK hospital sites with paediatric services. Cases involving conscious sedation or general anaesthesia for dental treatment were selected. Data were obtained to establish whether it was documented that the correct person had provided consent for a child and whether all possible individuals with PR for the child were identified at the initial visit. UK national legislation and guidance was reviewed, from which a PR form (to determine PR status for a child) was created and implemented. A second evaluation was subsequently completed, again with 160 children.
Results
Combined data from both sites confirmed documentation of an appropriate person providing consent in 127 cases (79%) in the first evaluation. This improved to 155 cases (97%) following implementation of the PR form. All possible individuals who had PR for the child were identified at the initial visit in 35 cases (22%). This improved to 139 cases (87%) following the introduction of the PR form.
Conclusions
Use of a PR form improved documentation regarding valid consent for children.

Editor’s note: This is a publication from the Royals College of Surgeons England.

Informed Consent: How much information is enough? In a Obstetrics and Gynaecology Department in Tertiary Care Hospital – An Interventional Study

Informed Consent: How much information is enough? In a Obstetrics and Gynaecology Department in Tertiary Care Hospital – An Interventional Study
Indian Journal of Forensic Medicine & Toxicology, 17(2), April-June 2023
Open Access
Abstract
Permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits. A process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This paper was an interventional study it was conducted in the Department of Forensic Medicine and Toxicology, Sri Manakula Vinayaga Medical College and Hospital, Madagadipet, Puducherry to audit and to improve it was conducted in the Department of Obstetrics and Gynaecology. The deficiencies were identified and it was analysed. The results of both pre-interventional and post-interventional were recorded, which showed the significant improvement in the consent form of the major and minor procedures. It is essential that this information be discussed in simple terminology that can be easily readily understood and help the patient to give proper consent for the procedures.

Traditional Health Care Practitioners’ Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study

Traditional Health Care Practitioners’ Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study
Francis Akpa-Inyang, Sylvester C. Chima
Journal of Integrative and Complementary Medicine, 17 April 2023
Abstract
Introduction
This study explored the perspectives of traditional health care practitioners (THPs) practicing in the areas of herbalism, bone setting, and traditional birth attendance, from Akwa Ibom state, Nigeria, on the possibility and implications of applying informed consent (IC) during African traditional medicine (ATM) practice.
Methods
Semistructured interviews were conducted with 11 THPs, consisting of 5 herbalists, 3 traditional bone setters (TBS), and 3 traditional birth attendants (TBAs), who represented the diverse groups that the study intended to cover. In-depth interviews were conducted using a semistructured guide and were recorded, transcribed, and analyzed using thematic analysis with the assistance of NVivo® qualitative analysis software.
Results
Participants were seven males (64%) and four females (36%), 35–67 years of age, with 5–25 years of experience as THPs. Forty-six percent of participants were herbalists (27%), TBS, and TBAs (27%). Most participants (82%) were Annang, and (18%) were Ibibio first-language speakers. Three major themes emerged from the data analysis: (i) Existing ethical framework related to IC, (ii) knowledge of consent, and (iii) application of IC during traditional medical practice. These themes and relevant subthemes were explored. All (100%) THPs agreed that it was essential to communicate risks and benefits while allowing patients to ask questions before treatment. All participants (100%) stated that risk communication is essential in ATM, whereas 36% said they communicated all therapy benefits to their patients. Respondents believed patients could make an informed choice if they had complete information disclosure. However, THPs in this study had limited knowledge of formal IC rules and regulations.
Conclusions
This study revealed that THPs in this setting disclose a diagnosis, risks, some benefits, and treatment options to patients. Consent/agreement was obtained verbally and voluntarily during ATM practice, consistent with IC doctrine. THPs had limited knowledge of the critical elements of IC. However, they suggested that a form of IC that does not conflict with traditional African norms could be applicable in ATM. IC could facilitate documentation and help reduce risks in ATM practice.

Determination of the Readability Level of Consent Forms Used in the Gynecology and Obstetrics Clinic at Suleyman Demirel University

Determination of the Readability Level of Consent Forms Used in the Gynecology and Obstetrics Clinic at Suleyman Demirel University
Cem Dağdelen, Evrim Erdemoğlu
Cureus, 5 April 2023; 15(4)
Open Access
Abstract
Background
This study aimed to evaluate the readability level of consent forms used for interventional procedures in the obstetrics and gynecology clinic and to determine the readability of the texts according to the education level of the patient.
Methodology
This study determined the readability of patient consent forms used before interventional procedures in the gynecology and obstetrics clinic at the Suleyman Demirel University Hospital, Isparta. The consent forms were divided into two main groups according to their use in obstetrics and gynecology procedures. The readability level of consent forms was assessed using two readability formulas developed by Ateşman and Bezirci-Yılmaz, which determine the readability level of Turkish texts in the literature.
Results
When the consent forms were analyzed according to Atesman’s readability formula, they were found to be readable with more than 15 years of education at the undergraduate level, while according to Bezirci-Yılmaz’s readability formula, they were found to be readable with 17 years of education at the postgraduate level.
Conclusions
Easy-to-read consent forms will ensure that patients are more informed about interventional procedures and participate more effectively in the treatment process. There is a need to develop readable consent forms suitable for the general education level.

Editor’s note: Suleyman Demirel University is located in the Karasay region of Kazakhstan.

Cardiac Transplant in Southeast Asia: Challenges and Opportunities

Cardiac Transplant in Southeast Asia: Challenges and Opportunities
Sulague, N. Cruz, R. Ricardo, P. Alfonso, D. Vervoort
The Journal of Heart and Lung Transplantation, April 2023; 42(4)
Abstract
Purpose
Among the 18.6 million cardiovascular deaths worldwide, 33.5% occurred in Southeast Asia, where cardiovascular diseases constitute 40.2% of all causes of mortality and injury. There is higher prevalence of symptomatic heart failure in Southeast Asian countries compared with the rest of the world. While advances improved cardiac transplantation, challenges remain to make it widely available. The study aims to discuss its challenges and opportunities in Southeast Asia.
Methods
A review of related literature was conducted on PubMed using combinations of variations of key terms such as cardiac transplant, heart transplant, Southeast Asia, and countries within the region. Ministries of health websites in the region were reviewed for cardiac transplant-related policies. The global burden of disease of heart failure-associated conditions from 2000 to 2019 in disability-adjusted life-years were assessed in the Southeast Asian region and other select geographical region using the Institute for Health Metrics and Evaluation Global Burden of Disease Results Tool.
Results
Southeast Asia’s burden of disease is comparable to Western Europe but does not have the same high volume of cardiac centers, health workforce, and robust network of organ donors. Substantial financial risk protection remains limited for most of the countries. Main barriers to organ donation include knowledge gaps, sociocultural and religious restrictions, and lack of infrastructure. At present, all countries follow an opting-in system based on informed consent, except Singapore which follows an opting-out system based on presumed consent. Association of Southeast Asian Nations may be optimized to promote cooperation, physician mobility, improved training, and policymaking.
Conclusion
Southeast Asian countries may benefit from considering opting-out scheme for donation, implementing a national system for organ donation, forming a centralized body directing all transplant activities, and improving public health education on transplantation.

Understanding of informed consent by patients at the Faculty of Dentistry of the University of Costa Rica

Understanding of informed consent by patients at the Faculty of Dentistry of the University of Costa Rica
José Manuel Fernández Chaves
Medicina Legal de Costa Rica, March 2023
Abstract
Introduction
Informed consent is the result of the evolution of the relationship between health professionals and their patients or users where the principle of autonomy is above anything else. There are many articles on informed consent but none of the studies found assessed whether patients really understand it. The objective of this research was to determine the level of understanding of informed consent by the patients of the Clinic of Oral Surgery of the Faculty of Dentistry of the University of Costa Rica, in the period August to September 2022, by means of a questionnaire that would allow correlating the understanding with the level of schooling.
Materials and methods
A questionnaire was administered to 100 people divided into two parts, one on sociodemographic data and the other to establish the understanding of informed consent and to determine whether the level of schooling was related to the understanding of the same.
Results
The group between 20 and 30 years of age was the largest, of these 51% had university studies, and although the majority (98%) referred to knowing the concept of informed consent, only 33% obtained the correct answers to the clinical questions asked.
Conclusions
Even though patients refer to knowing what informed consent is the results suggest an unclear understanding of important concepts such as complications or immediate or late adverse reactions produced by the effect of dental treatments or surgical procedures.

Adoption without parental consent

Adoption without parental consent
Book Chapter
Julie Doughty
Adoption Law, 25 April 2023 [Elgar]
Abstract
This chapter places controversy about adoption without birth parents’ consent in England and Wales in a wider historical and social context. Although it may appear that legal challenges have become more common in adoption proceedings, it is argued that these rarely succeed and that the relatively few reported cases give only a partial picture of birth parents’ experiences. Three aspects of consent are considered: whether the consent given is valid; withholding consent; and actively contesting court proceedings. Research suggests that, historically, birth parents in the UK, Australia and the USA have been coerced into surrendering their babies, some in circumstances that raise doubts about mothers’ mental capacity to consent. Current debates focus on less direct coercion through a lack of support services for families facing poverty and adverse circumstances. The background to relevant provisions in the Adoption and Children Act 2002 is examined, and case law relating to different stages of the court process is analysed. Although courts give serious consideration to human rights principles and due process, the discussion indicates limited opportunities for birth parents to effectively resist adoption by refusing their formal consent or making court applications. Legal mechanisms designed to allow non-consenting parents to challenge the adoption process, where this was justified, do not appear to offer a realistic prospect of overturning an adoption plan, once this has been approved in care proceedings.

Incapacitous patients, assisted reproductive technology, and the importance of informed consent

Incapacitous patients, assisted reproductive technology, and the importance of informed consent
Lisa Cherkassky
Legal Studies, 20 April 2023
Abstract
The principle of self-determination has gained significant judicial support over the last three decades, and the choice to procreate using assisted reproductive technology is a clear example of our right to choose a treatment that enhances our personal lives. The Human Fertilisation and Embryology Act 1990 (as amended in 2008) stipulates that each party must give written, informed consent to ensure that our reproductive materials are used within strict parameters. However, the growing number of posthumous conception cases in several jurisdictions has raised concerns, particularly in situations where gametes are extracted from incapacitous patients without their consent, leading to posthumous parenthood. The landmark case of Y v A Healthcare NHS Trust [2018] EWCOP 18 caused significant concern when it authorised the retrieval, storage and use of sperm from a suspected brain stem dead man for procreative purposes under the Mental Capacity Act 2005. It has never been known to be in the ‘best interests’ of a patient who lacks capacity to procreate in English law, and the consequences of this decision could be highly significant, raising questions about the exploitation of incapacitous patients and the misuse of genetic material. The decision has since been confirmed as the correct approach by the Court of Protection in Re X (Catastrophic Injury: Collection and Storage of Sperm) [2022] EWCOP 48, and a public consultation has now been opened by the Human Fertilisation and Embryology Authority. This paper examines the rigorous consent regime of the 1990 Act and the ethical complexities of retrieving gametes from incapacitous patients for procreative purposes. It will be determined that the 1990 Act’s preference for a rigorous consent regime for public policy reasons is appropriate, and any alternative forms of consent could open a slippery slope to the unethical use of vulnerable individuals for their reproductive materials.

The Relevance of Consent in the Digital Age: A Consideration of Its Origins and Its Fit for Digital Application

The Relevance of Consent in the Digital Age: A Consideration of Its Origins and Its Fit for Digital Application
Book Chapter
Marietjie Botes
Security and Trust Management, 4 April 2023 [Springer]
Abstract
Consent originated in the 1800s to protect incarcerated prisoners against unwanted medical treatment and was later formalized in the Nuremberg Code in response to harmful medical experiments that was conducted on prisoners of war during World War II. These co-called ethical principles was later reinforced and extended to protect the control and decisional power that individuals need over their bodies in The Belmont Report. Today these ethical consent principles are codified in laws such as the GDPR. Considering that these ethical consent principles were developed around biomedical treatments and experiments, it begs the question whether these same principles are still relevant and can be successfully applied in a digital environment. This paper critically considers the application of the original ethical consent principles in the digital age and highlights certain critical challenges. The aim of the paper is to draw attention to the fact that the concept of consent and whether it can still be applied ethically in a digital environment must be considered first before digital consent models or consent automation tools are developed, because such a consideration will have a critical impact on how these tools must be developed to remain, not only legal, but also ethical and subsequently sustainable.

Bridging the “consent gap”. Mechanisms of legitimization in a cross-border megaproject

Bridging the “consent gap”. Mechanisms of legitimization in a cross-border megaproject
Silvia Lucciarini, Rossana Galdini
Policy & Society, 2023
Abstract
In the recent debate on megaprojects, greater attention is devoted to the functioning of the inter-organisational and multi-actor networks that are one of the most innovative features of recent years. The complexity of these structures brings out governability issues for a megaproject’s management. Mutual recognition and consent become elements capable of inaugurating more collaborative processes and practices to reduce organisational and management criticalities in megaprojects. This paper focuses on a neglected relational dimension, namely legitimacy. We argue that legitimacy is instead the central dimension that attributes effectiveness and capacity for action to the organisations involved. Legitimacy regulates the relationship between various organisations – and especially – between organisations and the public sphere. Institutionalist theory assigns a central role to legitimacy in the construction of social processes, defining it as a generalised form of social acceptance towards an actor, an idea or a project. In this paper, we hypothesise that the legitimacy attributed and “held” by the stakeholders is a crucial element in countering three critical aspects of megaprojects, namely the uncertainty, complexity and conflict acting on the construction of public consensus and the quality of relations between the participating stakeholders. We verify our hypothesis by analysing a cross-border megaproject, the Fehmarnbelt Fixed Link between Germany and Denmark. The paper concentrates on the mechanisms with which stakeholders can acquire legitimacy using the Eriksen discursive legitimation scheme. These mechanisms are different (evidence-based, public participation, and legislators’ command) and produce different outcomes in terms of increasing or containing these three criticalities.

Editor’s note: This is an Italian language publication.