Year: 2024

On the exercise of the right to withdraw consent by human genetic resources providers

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On the exercise of the right to withdraw consent by human genetic resources providers
Qi Su, Jing Zhang, Ping Wang`
Chinese Medical Ethics, 2024; 37(8) pp 896-902
Abstract
To fully respect the true meaning and self-determination of human genetic resources providers, the Regulation on the Administration of Human Genetic Resources gives the providers the right to withdraw unconditionally at any time, that is, the right to withdraw consent. “Withdraw unconditionally at any time” means that the providers have the right to withdraw their consent at any stage without any adverse consequences. To ensure that the right to withdraw the consent of human genetic resources providers can be realized under the rule of law, adequate information should be provided to ensure the provider’s right to know, institutional management systems and withdrawal mechanisms should be established, and ethical reviews should be strengthened, which will ultimately produce legal effects, such as providers’ termination of participation, the destruction or deletion of genetic resources and no further use.

Editor’s note: This is a Chinese language publication from Xi’an Jiaotong University.

Comparing comprehension of consent document between adolescent girls and caregivers of adolescents in Siaya County, Kenya: implications for research with adolescents

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Comparing comprehension of consent document between adolescent girls and caregivers of adolescents in Siaya County, Kenya: implications for research with adolescents
Research article
Jacob Onyango, Gift-Noelle Wango, Nicky Okeyo, Lennah Oluoch, Harsha Thirumurthy, Millicent Omoya, Nancy Ounda, Dickens Omondi, Kawango Agot
Research Ethics, 16 October 2024
Open access
Abstract
Despite their vulnerability, adolescents are often excluded from health research due to ethical concerns about research with minors, especially in low-income regions like Sub-Saharan Africa. We enrolled adolescent girls aged 15–17 years and caregivers of girls of the same age. Using a 25-question Comprehension Score Sheet, we applied a quantitative approach to compare the comprehension of informed consent of 33 adolescent girls and 41 caregivers of adolescent girls aged 15–17 years. The assessments were audio-recorded and reviewed for quality check. The results showed that adolescent girls were significantly better than caregivers in comprehending informed consent information overall and specifically on study procedures, voluntarism and study purpose. This suggests that adolescents can understand informed consent information at the same level as or better than caregivers who are entrusted with providing permission for adolescents to participate in research.

Developing best practice guidance for educational psychologists gaining consent across the 0-25 age range

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Developing best practice guidance for educational psychologists gaining consent across the 0-25 age range
Althea Lyons, George Thomas, Sean Octigan, Joe Orme
Educational Psychology in Practice, 26 September 2024
Open access
Abstract
Consent is essential for legal and ethical psychological practice. EPs in the UK work with children and young people from ages 0 to 25, meaning that consent gaining practices must take account of the complexities of different professional guidelines, legislation, and case law depending on the age and competence of individual service users. This study used participatory action research to develop consent gaining guidance specific to EPs, considering issues related to children’s rights, parental responsibility, Gillick competence, mental capacity, and data protection. Findings from a preliminary study were used by a stakeholder group of EPs to create draft guidance. The project was guided by a working party comprising a trainee educational psychologist, a main grade EP, a professional body representative and a solicitor specialising in education law. Implications for professional practice and future research are discussed.

The Ethical Importance of Assent in Adults with Decisional Incapacity

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The Ethical Importance of Assent in Adults with Decisional Incapacity
Videocast
David Wendler
NIH Webinar, 17 October 2024
Description
Our speaker for this session is Dr. David Wendler, senior investigator, and head of the section on research ethics in the NIH Clinical Center Department of Bioethics.

Topics addressed:

  • Ethical background about why it is important to consider whether obtaining assent/respecting dissent in adults who are unable to provide consent for research is appropriate
  • When is obtaining assent appropriate vs. not?
  • How would they conduct such an assent process
  • The difference between assent and dissent

Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care

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Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care
Systematic Review
Loren G. Marino, Katherine E. Boguszewski, Haley F. Stephens, Julia F. Taylor
BMC Medical Ethics, 8 October 2024
Open Access
Abstract
Background
Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments.
Methods
Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed.
Results
Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning).
Conclusions
For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns.

Editor’s Note: After assessing the observations and arguments made in this paper, we are reaching out to the corresponding author for clarification.

Capacity, autonomy, and risk: reflecting on asymmetries in capacity to consent and capacity to refuse

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Capacity, autonomy, and risk: reflecting on asymmetries in capacity to consent and capacity to refuse
Jonathan Pugh
Ethical Theory and Moral Practice, 2024
Abstract
There has been renewed interest in whether we should understand standards of decision-making capacity (DMC) to be risk relative. Critics of risk-relative standards often highlight a puzzling asymmetry that they imply; a patient may have the requisite DMC to consent to a treatment that is in their best interests, whilst lacking the requisite DMC to refuse that same treatment, given the much higher risk that this would entail. Whilst some have argued that this asymmetry suggests that risk-relative standards are nonsensical, in this paper I defend a ‘quality of evidence’ view of such standards. I begin by outlining DMC’s purported gate-keeping role in medical ethics, and identifying three key normative claims that undergird this role. I then explain how two competing theories of risk-relative standards are incompatible with at least one of these claims. Drawing on Douglas’ distinction between standards of ‘true capacity’ and standards invoked in the ‘test’ for capacity, I then outline my ‘quality of evidence’ view. I explain how the view is compatible with the aforementioned normative claims and outline the nature of the asymmetry it implies. I conclude by responding to the objection that there is no meaningful distinction between ‘true capacity’ and the ‘test’ for capacity.

Editor’s note: The distinction between the standards of ‘true capacity’ referenced in this abstract refer to arguments made by Thomas Douglas in his article Pragmatic argument for an acceptance-refusal asymmetry in competence requirements.

Analysis of Attitudes Towards Opt-Out Organ Donation Consent: A Cross-Sectional Study Among Saudi Arabian Residents

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Analysis of Attitudes Towards Opt-Out Organ Donation Consent: A Cross-Sectional Study Among Saudi Arabian Residents
Sami Alobaidi
Transplantation Proceedings, 24 October 2024
Abstract
Objective
The study aims to investigate public opinion on opt-out organ donation registration in Saudi Arabia, addressing a gap identified in existing research that reveals varied attitudes and intentions among the population, as indicated by studies in Qatar and Saudi Arabia.
Methods
This study employed a secondary analysis approach, utilizing data from a cross-sectional survey conducted online among 1397 residents of Saudi Arabia. The survey utilized a GoogleTM form questionnaire adapted from a previous study in Qatar. The questionnaire comprised three sections, gathering socio-demographic information, assessing general awareness about organ donation, and exploring participants’ agreement with opt-out consent and beliefs related to organ donation using the Theory of Planned Behaviour (TPB) model.
Results
Among the participants, 44.4% supported opt-out consent, with 25.7% females and 39.1% Saudi citizens. Females and diploma/graduation-level education were significantly associated with opt-out support (P < .001, P = .012, respectively). 98.06% of opt-out supporters were familiar with organ donation. 93.05% agreed to promote organ donation, 98.38% believed registration saves lives, and 81.91% were willing if family had no objections. 86.75% were ready with more information, and 85.78% if informed about their religion’s perspective. 92.25% believed living and posthumous donation positively impact life after death. Concerns included inadequate care (33.44%) and bodily disfigurement (28.43%) postmortem. Majority felt healthy (45.56%) and appropriate in age for donation (57.67%). Among opt-out supporters, 20.84% expressed interest, 8.4% conveyed disinterest, while 36.34% remained undecided regarding organ donation registration.
Conclusion
The study reveals a considerable openness among Saudis toward adopting an opt-out organ donation system, suggesting a potential avenue for increased organ donation rates. While acknowledging cultural nuances, particularly familial influences, targeted interventions are vital to overcome specific barriers and ensure the successful implementation of an opt-out policy.

Implementation of Respect for Autonomy in Hospital Services Within the Indonesia National Health Insurance System

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Implementation of Respect for Autonomy in Hospital Services Within the Indonesia National Health Insurance System
Desdiani Desdiani, Sri Mulatsih, Diah Ayu Puspandari
National Journey of Community Medicine, 1 October 2024
Abstract
The principle of patient autonomy forms the foundation of medical ethics. However, its exploration within the context of national health insurance systems in developing countries remains under-researched. This study aimed to evaluate respect for patient autonomy within Indonesia’s National Health Insurance (NHI/JKN) system. The study using a qualitative research interview analyzed thematically. Conducted in Depok, West Java, the study involved in-depth semi-structured interviews with 18 participants, encompassing patients from first-level health facilities (FLHF), general practitioners at FLHF, specialist doctors, and management of referral hospital (RH) officers, and staff members of the JKN. The data were transcribed and analyzed using a thematic approach. The study revealed substantial underutilization of respecting patient autonomy within medical contexts under the JKN. Five themes emerged: challenges in the referral system, knowledge and information dissemination, decision-making and autonomy, quality of healthcare services, and systemic constraints and impact. These themes highlight the lack of patient awareness, restricted medical choices, the dominant role of paternalism (a system in which the government or a person in a position of authority makes decisions for other people) in healthcare decisions, and improper informed consent process. The findings suggest that the principles of beneficence and paternalism often overshadow respect for patient autonomy in the JKN system. This raises concerns about the ethical aspect of patient treatment, particularly the need for greater focus on patient autonomy and shared decision-making to align more closely with global medical ethics practices. This study contributes to understanding autonomy in national health insurance systems in developing countries. It highlights the need for systemic reforms to enhance healthcare efficiency and effectiveness while respecting patient autonomy.

Consent: The practice of the Nigerian Orthodontist

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Consent: The practice of the Nigerian Orthodontist
Sylvia Etim, Onyinye Dorothy Ume
International Dental Journal, October 2024
Open Access
Abstract
Aim or Purpose
The aim of the study was to survey the knowledge and practices of Nigerian Orthodontists regarding the obtainment of consent before administering procedures capable of modifying the facial profiles of patients.
Materials and Method
This was a 6-months cross-sectional study design involving Orthodontic practitioners in Nigeria. A 14-item questionnaire was administered to participants via google form, consisting of 2 sections. Section A elicited information on socio-demographic data, professional status, and institution of practice. Section B elicited information on the knowledge and practice of consent taking before Orthodontic procedures. Data collected was analyzed using both descriptive and inferential statistics with significance set at P value > 0.05. Ethical approval was duly obtained from the Research and Ethics committee of University of Port Harcourt Teaching Hospital.
Results
There were 66 participants (Male-46; Female-20) with mean age 43.7 +/- 9.26 years. Those who had knowledge of informed consent (64, 97%), verbal consent (57, 86.4%), and implied consent (49, 74.2%), but in terms of practices, most obtained informed (52, 78.8%), next was expressed consent (27,40.9%) and least was surrogate consent (6,9.1%). Informed consent was obtained more for fixed appliance therapy and aligners (62, 94% ) than removable appliances (49,74%).
Conclusion
Most Nigerian Orthodontic practitioners are aware of the importance of obtaining consent from their patients and they do obtain appropriate consent before carrying out Orthodontic procedures.

Enhancing Professional Awareness of Informed Consent : Safeguarding the Rights of Patients and Practitioners

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Enhancing Professional Awareness of Informed Consent : Safeguarding the Rights of Patients and Practitioners
Min Ji Kim
Journal of Korean Neurosurgical Society, 30 September 2024
Abstract
Informed consent is a crucial communication process between doctors and patients for obtaining patients’ approval before initiating medical treatment. It is derived from the legal principles of medical contracts and requires doctors to explain the treatment process to patients. Surgeons should be aware of informed consent not only to avoid unnecessary litigation risks but also to provide patients with the right to self-determination. The aim of the study is to help surgeons in Korea understand the legal doctrine on informed consent for practical application. This article reviews the legal doctrine of IC according to 4W1H-why, who, what, when, and how-with judicial cases to communicate effectively with patients in clinical settings. Regardless of seniority or rank, doctors may provide competent patients with information to protect their rights to self-determination. Informed consent should be advanced for patients to consider, discuss with significant others, and determine whether or not to undergo medical treatment. At that stage, patients need to be informed of the necessity, risks, and so on. The most common method of informed consent is an oral explanation utilizing certain forms for documentation. However, the informed consent of patients can be exempted on certain occasions. Optimal informed consent, when implemented, leads to patient-centered care, which significantly improves patient satisfaction and outcomes. Ultimately, it not only protects doctors from litigation risks but also upholds patients’ autonomy.