Nova Scotia’s Deemed Consent for Deceased Organ Donation: Family Member Perspectives and Experiences in the ICU Setting

Nova Scotia’s Deemed Consent for Deceased Organ Donation: Family Member Perspectives and Experiences in the ICU Setting
Aimee J. Sarti,  Stephanie Sutherland, Matthew J. Weiss, Alain Landry, Heather Hemming, Jade Dirk, Ken Lotherington, Stephen Beed
Transplantation Direct, November 2024
Abstract
Background
The purpose of this study was to explore the experience of family members of potential organ donors in the intensive care unit following the change to deemed consent legislation in Nova Scotia.
Methods
This was a qualitative study with semistructured, in-depth interviews with 17 family members who were asked to make an organ donation decision on behalf of patients admitted to the intensive care unit in Nova Scotia. We analyzed themes using a descriptive approach. Participants were recruited from the organ donation organization in Nova Scotia, Canada.
Results
Participant awareness and knowledge of the Human Organ and Tissue Donation Act legislation varied from individuals having no awareness and knowledge of the bill to those who had awareness and optimism that the legislation would be beneficial for increasing organ donation rates in the province. Other themes emerging from the interviews included (1) COVID context, (2) quality of healthcare professional care, (3) family support, and (4) barriers to donation (waiting, consent questionnaire, and patient transfers).
Conclusions
The Human Organ and Tissue Donation Act legislation included enhanced support, which was viewed positively by family members. There is a need for continued evaluation as most participants felt it was too early to see the tangible impacts of the newly implemented legislation.

Rethinking with Onora O’Neill the Kantian Concept of Autonomy in Biolaw

Rethinking with Onora O’Neill the Kantian Concept of Autonomy in Biolaw
Book Chapter
María Jesús Vázquez Lobeiras
The Discourse of Biorights, 1 October 2024; Chapter 6 [Springer]
Abstract
The concept of autonomy plays a significant role in Bioethics as well as in Biolaw, the Kantian conception of autonomy being an unavoidable element in the debate. Some of the most relevant contributions in this discussion stem from Onora O’Neill’s work. Prof. O’Neill promotes an anti-individualist interpretation of autonomy and, in order to increase its ethical efficiency, suggests reconsidering the meaning of autonomy as closely linked to trust. This chapter tries to show how intertwined information, autonomy and trust are at a time when medical technologies and care need to be interpreted and disclosed in order to be properly understood.
Introduction
…Informed consent and the ethical and legal principle of autonomy are closely linked, since the former is usually considered a genuine expression of the latter…Considering informed consent to be one of the main expressions of autonomy, although not the only one, in what follows we will analyse it from the perspective of Onora O’Neill. Kant’s texts will be consulted once again in order to clarify what the eminent thinker of Königsberg understands by autonomy and to what extent his concept of application can be applied in the field of biolaw.

Unraveling a Political Technology: Free, Prior, and Informed Consent in Peruvian Oil and Mining Sectors

Unraveling a Political Technology: Free, Prior, and Informed Consent in Peruvian Oil and Mining Sectors
Research Article
Roger Merino
Journal of Politics in Latin America, 27 September 2024
Open Access
Abstract
The worldwide dissemination of the right to free, prior, and informed consent (FPIC) has fostered discussions about its significance for removing the social exclusion of indigenous peoples. Most studies address problems in the regulation and implementation of FPIC, but less attention is paid to how the strengths and weaknesses of indigenous organizations and their different political engagements influence FPIC processes and outcomes. Based on the analysis of consultation agreements in the mining and oil sectors in Peru (2011–2022) and the evaluation of two case studies, this article explains how FPIC might be a tool for indigenous politics and state governance.

Ethical, Psychological and Social Un/certainties in the Face of Deemed Consent for Organ Donation in England

Ethical, Psychological and Social Un/certainties in the Face of Deemed Consent for Organ Donation in England
Original Article
Laura L. Machin, Elizabeth Wrench, Jessie Cooper, Heather Dixon, Mark Wilkinson
Health Care Analysis, 24 September 2024
Open access
Abstract
Deemed consent legislation for deceased organ donation was introduced in England in 2020, and is considered a vital part of the new UK NHS Blood and Transplant’s 10-year strategy to increase consent for organ donation. Despite the legislation containing safeguards to protect the public, the introduction of deemed consent creates ethical, psychological and social un/certainties for healthcare professionals in their practice. In this paper, we offer insights into healthcare professionals’ perspectives on deemed consent, drawn from interview data with 24 healthcare professionals in an NHS Trust in England, prior to the introduction of the legislation. Whilst participants supported deemed consent in principle, they were concerned that it would present a threat to the nature of donation as a ‘gift’; the notion of informed consent (or non-consent); and the autonomy of donors, their relatives, and their own roles as health professionals, posing dilemmas for practice. We argue that healthcare professionals present themselves as guardians of potential (non)donors and thus as having ethics and integrity in their own practice. We draw conclusions around the values and principles that matter to healthcare professionals when contemplating consent in deceased donation which will be useful for organ donation committees and ethics forums.

The requirement to obtain the consent of a legal guardian for the provision of reproductive health pharmacist services to minors under the pilot program

The requirement to obtain the consent of a legal guardian for the provision of reproductive health pharmacist services to minors under the pilot program
Marek Tomków, Radosław Balwierz, Opole University, Adam Majewski,Aleksandra Szopa
Polish Journal of Public Health, September 2024
Abstract
Emergency contraception in Poland is often referred to as the “morning-after pill”. Its legal status has changed many times. In Poland, it has only been available on prescription since 2017. Attempts have been made to change the legal status in 2024. A draft amendment to the Pharmaceutical Act was then submitted to Parliament. However, the bill was vetoed by the President of the Republic of Poland. In response to the veto, the Minister of Health issued a decree on a pilot programme in the field of pharmacists’ services related to reproductive health. In connection with this regulation, a question arose for pharmacists: whether it is necessary to obtain the consent of the legal guardian of minors who want to use the programme. Therefore, the aim of the work was a legal-comparative and dogmatic-legal analysis of legal acts in the field of reproductive health. A review of the data shows that while the pharmacist carries out the activities indicated in the pilot programme for pharmacist services about reproductive health, health services are provided to patients. Therefore, in the case of minor patients under 16 years of age, or who are over 16 but under 18 years of age, the consent of their legal representatives is required. It should also be noted that the term “pharmacist service” used in the title is not defined in any way in the law (unlike the term “pharmaceutical service”) and does not constitute a definition that would allow the statement to be made that it is another unlisted activity that exempts the pharmacist from the obligation to obtain the consent of the legal guardian. It should therefore be assumed that this consent is necessary to provide the service.

The Civil Law Aspects of Informed Consent to Medical Procedures

The Civil Law Aspects of Informed Consent to Medical Procedures
Gede Agus Kurniawan, Ade Chandra
SASI, September 2024
Abstract
Introduction
Informed consent is a communication process between healthcare providers and patients regarding the medical procedures to be performed. Its aim is to provide sufficient information so that patients can make informed decisions, and it is regulated by various laws and regulations in Indonesia.
Purpose of the Research
The purpose of this research is to analyze the legal position of informed consent from the perspective of Indonesian civil law and to examine the civil law implications that arise if there is a violation of the informed consent principle in medical procedures.
Method of Research
This research uses normative legal methods with legislative and conceptual approaches, analyzing primary, secondary, and tertiary legal materials through literature study, and applying descriptive qualitative analysis.
Results of Research
Research findings indicate that informed consent holds a strong legal position within the perspective of Indonesian civil law, being viewed as a manifestation of a therapeutic agreement that must meet the valid agreement requirements according to the Civil Code (KUHPerdata) and be supported by various regulations. Violations of the principles of informed consent can lead to significant civil legal implications, including claims for damages on the grounds of breach of contract or unlawful acts, cancellation of the therapeutic agreement, liability for breach of professional standards, and claims based on consumer protection law. These implications can involve healthcare professionals and healthcare institutions, with consequences that include payment of material and immaterial damages, the burden of proof in court, and impacts on reputation and medical practice.

Editor’s note: SASI is a peer-reviewed journal published by the Faculty of Law, Universitas Pattimura, Indonesia.

Prevalence of pelvic examinations on anesthetized patients without informed consent

Prevalence of pelvic examinations on anesthetized patients without informed consent
Rachel Cutting, Varsha Reddy, Sneha Polam, Nicole Neiman, David Manna
Journal of Osteopathic Medicine, 7 October 2024
Open Access
Abstract
Context
The pelvic examination is a fundamental tool for the evaluation and diagnosis of women’s health conditions and an important skill for all medical students to learn as future physicians for the early detection of treatable conditions such as infection or cancer. Although the American College of Obstetricians and Gynecologists (ACOG) asserts that performing pelvic examinations under anesthesia for educational purposes should only occur if the patient provides explicit and informed consent, there still have been reports of medical students performing pelvic examinations on anesthetized patients across the country, and many states are now starting to pass bills requiring informed patient consents to conduct pelvic examinations under anesthesia.
Objectives
The objectives of this study are to evaluate the prevalence of pelvic examinations performed by osteopathic medical students on anesthetized patients without consent while fulfilling their third-year OB-GYN clerkship requirements.
Methods
The survey was administered and distributed to all osteopathic medical schools in the country via the Student Osteopathic Medical Association’s (SOMA’s) chapter emails, outreach emails, and SOMA’s social media accounts to collect data. Inclusion criteria included third- or fourth-year osteopathic medical students who completed their OB-GYN clerkship rotations when taking the survey. The exclusion criteria included any osteopathic medical student who had not completed their OB-GYN clerkship rotation. We utilized descriptive analysis to summarize the final data.
Results
We received 310 responses. The final number of responses was 291 after meeting the exclusion criteria. Most osteopathic medical students (94.2 %, n=274) considered the practice of performing pelvic examinations on anesthetized patients without their explicit consent unethical. Among the participants, 40.9 % (n=119) admitted to performing pelvic examinations on patients under anesthesia while on OB-GYN rotations, but most of them (57.1 %, n=68) did so without obtaining prior consent from the patients. Notably, the number of pelvic examinations performed by medical students on patients under anesthesia ranged widely from 1 to 25 with a median number of 10. Moreover, 58.9 % (n=70) indicated that they had not been properly educated to obtain specific consent before performing pelvic examinations under anesthesia. Many participants cited efficiency of practice, lack of policy awareness and personal education by medical students, and failure to refuse to perform pelvic examinations on anesthetized patients as trainees when asked by their seniors or preceptors.
Conclusions
This study demonstrates that although most osteopathic medical students consider performing pelvic examinations on anesthetized patients unethical, many still admit to practicing pelvic examinations on patients under anesthesia, while on OB-GYN rotations for efficiency of practice, lack of policy awareness and personal education, and being in unique positions in which grades are determined by seniors and preceptors for their willingness to do what is asked even if the practice does not align with their conviction. This study highlights the importance of ongoing research and implementation of policies at institutional and state levels that will procure the value of pelvic examinations while protecting and upholding the ethics of patients’ rights and autonomy of medical students.

The Impact of Obtaining Explicit Informed Consent for Medical Student Participation in the Pelvic Exam Under Anesthesia: A Qualitative Interview Study

The Impact of Obtaining Explicit Informed Consent for Medical Student Participation in the Pelvic Exam Under Anesthesia: A Qualitative Interview Study
Research Article
Hannah C Milad, Katie Watson, Patrick F Eucalitto, Ricky Hill, Alithia Zamantakis, Marlise Jeanne Pierre Wright, Adaeze A Emeka, Susan Tsai, Susan Goldsmit, Magdy P Milad
International Journal on Obstetrics and Gynecology, 26 September 2024
Open Access
Abstract
The pelvic exam under anesthesia (EUA) is an essential step in gynecologic surgery. Attending, fellow, and/or resident physicians utilize exam findings for surgical planning. Afterwards, medical students often perform this exam for their own learning; the student exam provides no direct clinical benefit to patients. Historically, consent for trainee EUAs was embedded within the surgical consent form. At one urban academic medical center, a written consent form specifically for medical student participation in the pelvic EUA was introduced. Our study examines patient, physician, and operating room (OR) staff perceptions of this new, explicit consent process between May 2021 and May 2023. Thirty-one (31) subjects including patients, OR staff, and physicians were interviewed and Northwestern University IRB approval was obtained. Our data suggest patients appreciated being asked to explicitly consent to or refuse the student pelvic EUA and having a dedicated consent form left them with a positive feeling about the hospital and their healthcare providers. OR staff and physicians agreed that the student pelvic EUA is necessary and almost all supported an explicit consent form. Physicians did not find the additional consent form burdensome and noted only a modest decline in learning opportunities. Patients and healthcare providers agreed that requiring explicit written consent for the student pelvic EUA respected patient autonomy, improved healthcare quality, and caused minimal disruption to medical education. Our data support the use of an explicit written consent form for student participation in the pelvic exam under anesthesia as standard practice.

Reevaluating Informed Consent: Integrating Shared Decision-Making into Spinal Surgery for Better Patient Outcomes

Reevaluating Informed Consent: Integrating Shared Decision-Making into Spinal Surgery for Better Patient Outcomes
Jeffrey N. Wang, Mohamed A. Elhakeem, Matthew J. Mesimer, Paul G. Mastrokostas, Salman Ahmad, Tim Reed, Brandon Klein, Lucas E. Bartlett, Adam D. Bitterman, Andrew Megas
Global Spine Journal, 26 October 2024
Abstract
Study Design
Narrative review.
Objectives
The objectives of this study were to answer the following questions: (1) What is the quality of informed consent in spine surgery, including both neurosurgery and orthopaedic spine surgery? (2) What limitations impede the ability of surgeons to engage in effective shared decision-making (SDM) and obtain adequate informed consent? (3) What strategies and solutions may improve the quality of informed consent and SDM? (4) What factors decrease the incidence of litigation in spine surgery?
Methods
N/A.
Results
SDM is a collaborative process where patients are involved in their treatment choices through open communication about risks, alternatives, and postoperative expectations. Informed consent is a vital component of this process, ensuring that patients are fully informed and empowered to make decisions based on their values and preferences. This review highlights the current state of informed consent within the context of SDM in spine surgery and explores how enhancing this process can improve patient outcomes, reduce dissatisfaction, and decrease litigation. By emphasizing patient autonomy and improving the quality of risk communication, SDM fosters better physician-patient relationships and more positive clinical outcomes.
Conclusions
Orthopaedic surgery and neurosurgery are highly litigated specialties, with failure to obtain informed consent frequently cited in lawsuits. These legal challenges are costly and time-consuming for both physicians and patients. Integrating SDM into the informed consent process can help mitigate these issues, leading to improved patient satisfaction and fewer legal disputes.

Development and early Evaluation of a novel tool for assessment of individualised risk tolerance during surgical consent

Development and early Evaluation of a novel tool for assessment of individualised risk tolerance during surgical consent
Research Article
James Booker, Jack Penn, Nicola Newall, David Rowland, Siddharth Sinha, Hani J Marcus
British Journal of Neurosurgery, 17 October 2024
Abstract
Purpose
The legal interpretation of consent has transitioned over the last decade. Surgeons must identify what patients value to individualise surgical consent. This presents a considerable challenge during busy ward rounds or outpatient clinics. We aimed to develop and evaluate a novel risk tolerance tool to aid surgical consent.
Methods
This prospective, longitudinal cohort study evaluated the views of adult, elective surgical patients from a single centre. Attitudes to the existing surgical consent process were assessed (n = 48) and responses underwent thematic analysis. From these responses and a stakeholder focus group, a novel risk tolerance tool was developed. The risk tool was evaluated using questionnaires in 25 pre-operative patients. Post-operatively, the same cohort were followed-up with a telephone clinic 6–8 weeks after discharge.
Results
Overall patients were satisfied with the current consent process, but negative themes emerged including that it is generalised, impersonal, and time pressured. The developed risk tool contained six domains: death, pain, loss of physical function, loss of cognitive function, need for repeat medical interventions, and social disability. Loss of physical function (mean = 34.0, SD = 12.8) and loss of cognitive function (mean = 34.0, SD = 6.1) had lowest risk tolerance, and need for repeat medical interventions (mean = 18.8, SD = 10.9) had the highest risk tolerance. Thirteen (93%) patients had a positive experience of the consent process vs 85% of patients in pre-consent tool cohort.
Conclusions
The tool demonstrated good patient acceptability and patient reported experience. The tool gathered data that may enhance understanding of patient risk tolerance and personalise the surgical consent process.