The Role of Male Consent in Assisted Reproductive Technology Procedures: an Examination of Japanese Court Cases

The Role of Male Consent in Assisted Reproductive Technology Procedures: an Examination of Japanese Court Cases
Original Paper
Yuko Muraoka, Minori Kokado, Kazuto Kato
Asian Bioethics Review, 18 January 2024
Open Access
Abstract
With the development of assisted reproductive technologies, medical, ethical, legal, and social issues have arisen that did not exist when natural conception was the only means of childbirth. In Japan, men tend to believe that assisted reproductive technologies are not directly related to them, with the literature showing that men are often reluctant to be involved in fertility treatment processes. To better understand this situation, this study analyzes the role of male consent during assisted reproductive technology procedures in Japan. First, we examined Japanese court cases that dealt with issues related to male consent during assisted reproductive technology procedures and identified three situations in which problems related to male consent during such procedures may arise. Next, we analyzed the background of such issues and the implications of the lack of consent regarding men’s reproductive rights. Finally, we explored the need for legislation on assisted reproductive technologies. The study concludes that discussions on the scope of male partner rights in assisted reproductive technology procedures are key for minimizing unnecessary conflict between partners, thus ensuring both the rights of women who wish to have children and the welfare of their children.

Culturally appropriate consent processes for community-driven indigenous child health research: a scoping review

Culturally appropriate consent processes for community-driven indigenous child health research: a scoping review
Research
Cindy Peltier, Sarah Dickson, Viviane Grandpierre, Irina Oltean, Lorrilee McGregor, Emilie Hageltorn, Nancy L. Young
BMC Medical Ethics, 3 January 2024; 25(3)
Open Access
Abstract
Background
Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols.
Methods
We followed PRISMA guidelines and Arksey and O’Malley’s approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically.
Results
We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community.
Conclusions
Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children.

Family roles in informed consent from the perspective of young Chinese doctors: a questionnaire study

Family roles in informed consent from the perspective of young Chinese doctors: a questionnaire study
Research
Hanhui Xu, Mengci Yuan
BMC Medical Ethics, 3 January 2024; 25(2)
Open Access
Abstract
Background
Based on the principle of informed consent, doctors are required to fully inform patients and respect their medical
decisions. In China, however, family members usually play a special role in the patient’s informed consent, which creates a unique “doctor-family-patient” model of the physician-patient relationship. Our study targets young doctors to investigate the ethical dilemmas they may encounter in such a model, as well as their attitudes to the family roles in informed consent.
Methods
A questionnaire was developed including general demographic characteristics, the fulfillment of the obligation to fully inform, who will be informed, and the ethical dilemmas in decision-making. We recruited a total of 421 doctors to complete this questionnaire, of which 368 met the age requirements for this study. Cross tabulation and Pearson’s chi-squared test were used to analyze the differences between types of patients for categorical variables, and a p-value < 0.05 was considered statistically significant.
Results
Our data shows that only 20 doctors (5.40%) stated “informing the patient alone is sufficient” when it comes to informing patients of their serious conditions. The rest of the participants would ensure that the family was informed. When facing elderly patients with decision-making capacity, the data was statistically different (3.8%; P < 0.001) The primary reason for ensuring that family members be informed differs among the participants. In addition, when family members asked doctors to conceal the patient’s medical condition for the best interests of patients, 270 doctors (73.4%) would agree and cooperate with the family. A similar proportion (79.6%) would do so when it comes to elderly patients.
Conclusions
(1) Chinese doctors pay extra attention to informing the patient’s family, which may not be in the patient’s best interests. (2) Chinese doctors treat adult (but not elderly) patients and elderly patients differently when it comes to informing family members. (3) When family members request that doctors withhold information from patients “in the best interest of the patient,” the majority choose to comply with the request, although this may cause them distress.

Surgical informed consent practices and influencing factors in sub-Saharan Africa: a scoping review of the literature

Surgical informed consent practices and influencing factors in sub-Saharan Africa: a scoping review of the literature
Systematic Review
Chiara Pittalis, Cherie Sackey, Paul Okeny, Bip Nandi, Jakub Gajewski
BMJ Quality & Safety, 30 December 2023
Open Access
Abstract
Introduction
Current international standards in consent to surgery practices are usually derived from health systems in Western countries, while little attention has been given to other contexts such as sub-Saharan Africa (SSA), despite this region facing the highest burdens of disease amenable to surgery globally. The aim of this study was to examine how the concept of informed consent for surgery is interpreted and applied in the context of SSA, and factors affecting current practices.
Methods
A systematic search of Medline, Embase and African Journal OnLine databases as well as grey sources was executed in May 2023 to retrieve relevant literature published since 2010 in English language against a set of given criteria. The socioecological framework for health was used for organising and summarising the identified evidence.
Results
A total of 27 papers were included in the review. Findings revealed that consent to surgery practices is generally substandard across SSA and the process is not adequate. Patients’ understanding of informed consent is limited, likewise awareness of their rights to decision-making. A range of factors at the individual, interpersonal, institutional and system/societal levels affect the informed consent process.
Conclusion
There is a need to find more culturally acceptable and ethical ways to include the participation of patients in the decision-making process for surgical treatment in the SSA and define standards more closely aligned with the local context.

The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study

The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study
Research
Rachel C Greer, Nipaphan Kanthawang, Jennifer Roest, Carlo Perrone, Tri Wangrangsimakul, Michael Parker, Maureen Kelley, Phaik Yeong Cheah
BMC Medical Ethics, 19 December 2023
Open Access
Abstract
Background
Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research.
Method
We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key informants. A thematic analysis was conducted.
Results
Our analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations.
Conclusions
Participant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors.

Clinical Informed Consent and ABA

Clinical Informed Consent and ABA
Abraham Graber, Allison Maguire
Behavior Analysis in Practice, 8 January 2024
Open Access
Abstract
The practice of clinical informed consent in America is governed by over 100 years of case law. Although predominant ethics resources for behavior analysts offer some guidance regarding the provision of clinical informed consent, such guidance remains limited. The goal of this article is thus to expand the contemporary literature on clinical informed consent in behavior analysis by providing a historical and contemporary guide to relevant case law. The article will highlight seminal moments in the history of case law regarding clinical informed consent, discuss their applicability to the process of clinical informed consent in behavior analysis, and provide an enhanced understanding of the ethical and legal obligations related to informed consent in the therapeutic context.

Editor’s note: ABA stands for applied behavior analysis.

Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians’ knowledge, attitudes and practices in four northern Italian health care facilities

Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians’ knowledge, attitudes and practices in four northern Italian health care facilities
Research
Corinna Porteri, Giulia Ienco, Mariassunta Piccinni, Patrizio Pasqualetti
BMC Medical Ethics, 6 January 2024
Open Access
Abstract
Background
On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person’s autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives. Few years after the approval of the law, we conducted a survey among physicians working in four health care facilities specific for the care of people suffering from psychiatric disorders, cognitive disorders and dementia located in the North of Italy aiming to investigate their perceived knowledge and training need, attitudes regarding law n. 219/2017 provisions, and practices of implementation of the law.
Methods
A semi-structured questionnaire was developed on an online platform. The invitation to participate in the survey was sent by email to the potential participants. Information was collected by means of the online platform (Google Forms) which allows to export data in a spreadsheet (Windows Excel) to perform basic statistical analysis (frequency distributions, bar chart representation).
Results
Twenty-five out of sixty physicians participated in the survey. None of the respondents value their knowledge of the law as very good, 10 good, 13 neither poor nor good, 1 poor and 1 very poor. All the respondents want to learn more about the law (21 yes and 4 absolutely yes). The majority of respondents agrees with the content of the law as a whole (3 absolutely agree, 13 agree), and on each provision. The question on the clarity of the concept of capacity in the law received mixed answers and this impacted on the physicians’ opinion regarding the legitimacy in principle for our groups of patients to realize shared care planning and write advance directives. Thirteen physicians neither introduced the theme of shared care planning nor arranged for shared care planning and the main reason for this was that no patient was in a clinical situation to require it. When shared care planning is realized, a variability in terms of type and number of meetings, mode of tracking and communication is registered.
Conclusions
Our survey results indicate a need for more clarity regarding the interpretation and implementation of the law in the patient groups under study. There are in particular two related areas that deserve further discussion: (1) the question of whether these patient groups are in principle legitimized by the law to realize shared care planning or write advance directives; (2) the notion of capacity required by the law and how this notion can be declined in real-life situations.

Informed consent – Ethical doctrine and a legal mandate

Informed consent – Ethical doctrine and a legal mandate
Review Article
Anjali Gera, Jayashree Sood
Current Medicine Research and Practice, November – December 2023; 13(6) pp 286-291
Open Access
Abstract
Informed consent is not only an ethical doctrine but also a legal mandate in medical practice and clinical research. The concept of consent has changed over the last few decades from doctor-focused to patient-focused. This provides adequate knowledge to the patient about disease and treatment options so that the patient and doctor can make shared decisions. Respecting the patient’s autonomy, disclosure of material risks and solicitation of the patient’s preferences are very important in the process of informed consent. The relationship between doctor and patient should be one of trust and communication. An honest and ethically obtained consent can prevent litigations and medicolegal repercussions.

Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital

Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital
José Manuel García-Álvarez, Alfonso García-Sánchez
Nursing Reports, 4 January 2024; 14(1) pp 89-98
Abstract
Background
Because of their direct and continuous contact with the patient, nurses play a relevant role in ensuring that informed consent forms are complete and easy to read and comprehend. The objective of this study was to analyze the legibility and formal quality of informed consent forms for non-surgical procedures in a county hospital.
Methods
The readability of these forms was analyzed using the INFLESZ scale and the information they provided according to the formal quality criteria established for these forms.
Results
Readability was difficult in 78.08% of the forms analyzed. No form fulfilled all the criteria, the most non-compliant being the non-appearance of the verification of delivery of a copy to the patient (100%), the contraindications (94.59%), and the alternatives (83.78%) of the procedure. Statistically significant differences were observed between disciplines with respect to the INFLESZ readability score and the formal quality score, but no statistically significant correlation was found between the two scores.
Conclusions
The informed consent forms for non-surgical procedures analyzed presented mostly difficult readability and poor formal quality, making it difficult for patients to have understandable and complete information. Nursing professionals should be actively involved in their improvement to facilitate patient decision making.

A Pilot Study On The Global Practice On Informed Consent In Paediatric Dentistry

A Pilot Study On The Global Practice On Informed Consent In Paediatric Dentistry
Original Research
Nicoline Potgieter, Gemma Bridge, Marlies Elfrink, Morenike O. Folayan, Sherry Shiqian Gao,  Sonia Groisman, Ashwin Jawdekar, Arthur M. Kemoli, David Lim, Phuong Ly, Shani Mani, Ray M. Masumo, Joana Monteiro, Majorie K. Muasya, Ambrina Qureshi, Norman Tinanoff
Frontiers in Oral Health, 2024
Abstract
Background
Conducting oral treatment early in the disease course is encouraged for better health outcomes. Obtaining informed consent is an essential part of medical practice, protecting the legal rights of patients and guiding the ethical practice of medicine. In practice, consent means different things in different contexts. Silver Diamine Fluoride (SDF) and Silver Fluoride (SF) are becoming popular and cost-effective methods to manage carious lesions, however, cause black discolouration of lesions treated. Obtaining informed consent and assent is crucial for any dental treatment and has specific relevance with SDF/ SF treatments.
Methods
The aim of this paper is to describe informed consent regulations for dental care in a selection of countries, focusing on children and patients with special healthcare needs. An online survey was shared with a convenience sample of dental professionals from 13 countries. The information was explored and the processes of consent were compared.
Results
Findings suggest that there are variations in terms of informed consent for medical practice. In Tanzania, South Africa, India, Kenya, Malaysia and Brazil age is the determining factor for competence and the ability to give self-consent. In other countries, other factors are considered alongside age. For example, in Singapore, the United Kingdom, and the United States the principle of Gillick Competence is applied. Many countries’ laws and regulations do not specify when a dentist may overrule general consent to act in the “best interest” of the patient.
Conclusion
It is recommended that it is clarified globally when a dentist may act in the “best interest” of the patient, and that guidance is produced to indicate what constitutes a dental emergency. The insights gathered provide insights on international practice of obtaining informed consent and to identify areas for change, to more efficient and ethical treatment for children and patients with special needs. A larger follow up study is recommended to include more or all countries.