Developing an ethical framework for informed consent using human fetal and embryological collections: An Australian perspective
Research Report
Joyce El-Haddad, Nalini Pather
Anatomical Sciences Education, 8 January 2025
Abstract
The term “human fetal and embryological collections” refers to repositories or archives that house remains of human fetuses and embryos. Most of these remains have been obtained without informed consent from the next of kin, thus reflecting a time in history where this may have been acceptable. Previous quantitative studies seeking stakeholder perceptions toward these collections suggest that there is misalignment with the values of society today, and the current guiding frameworks pertaining to these collections. The aim of this study was to qualitatively explore and analyze the perceptions of key stakeholders regarding human fetal and embryological collections. Twenty-seven individuals signed up and completed the demographic survey. However, 25 attended the focus group interviews. The study sought to provide an in-depth exploration of how stakeholders perceive the value of fetal and embryological collections, and the importance of informed consent. The mean age of participants was 29.1 years of age with a gender distribution of 40.7% (n = 11 out of 27) men and 50.3% (n = 16 out of 27) of women. Thematic analysis identified four themes: (1) consent; (2) preparation for clinical practice; (3) equity and fairness; and (4) educational value, with several subthemes identified at macro, meso, and micro ethical levels. Macro subthemes included importance of informed consent, equity and fairness, and genetic composition. Meso subthemes included respect and privacy, and legal and institutional considerations. Micro subthemes included emotional considerations, preparation for clinical practice, and educational value. The results of this study indicate that ethical issues surrounding human fetal and embryological collections need careful consideration based on macro, meso, and micro ethical frameworks.
Month: January 2025
Documentation of informed consent for anaesthesia: A single-site retrospective audit at a rural Australian hospital
Documentation of informed consent for anaesthesia: A single-site retrospective audit at a rural Australian hospital
Research Article
Yannick J De Silva, Luke Anderson
Anaesthesia and Intensive Care, 6 January 2025
Excerpt
Respecting patient autonomy and providing relevant information are the foundations of informed consent, especially in anaesthesia due to the complexity of procedures, the impact on consciousness and autonomic function, and the specific risks and complications associated with delivering anaesthesia. It is important to note that a statement indicating the need for anaesthesia for an operation does not constitute informed consent for anaesthesia. The Australian and New Zealand College of Anaesthetists (ANZCA) recommends recording significant details of the discussion in the patient’s notes, including the material risks and the agreement of the patient to undergo the anaesthesia. This aligns with the recommendation from the Royal College of Anaesthetists (RCoA), based in the United Kingdom (UK), which suggests documenting the risks, benefits, alternatives and concerns raised by the patient.
We conducted a retrospective clinical audit on the anaesthetic records of patients undergoing emergency and elective procedures over a 3-week period at a rural hospital in Australia, starting from 1 January 2024. Data were collected with reference to the recommendations by ANZCA and RCoA for documenting informed consent for anaesthesia. Since informed consent for anaesthesia is not included in the procedure consent form at our hospital, our audit focused solely on anaesthetic records. Ethical approval was not deemed required as per our local health district’s checklist for ‘Ethical Considerations in Quality Improvement, Service Evaluation and Audit Activities’…
The quality of informed consent from nurses’ and hospitalized patients’ points of view in Iran: A cross-sectional study
The quality of informed consent from nurses’ and hospitalized patients’ points of view in Iran: A cross-sectional study
Naser Mozaffari, Mohammad Ali Mohammadi, Behrouz Jafari, Sirous Jafari
Journal of Nursing Reports in Clinical Practice, 6 January 2025
Open Access
Abstract
Informed consent constitutes a fundamental aspect of patient rights. How informed consent is procured significantly influences patient satisfaction during the treatment and care continuum and contributes to decreased mortality associated with high-risk medical interventions. The primary objective of this study is to assess the quality of informed consent from the perspectives of both nurses and hospitalized patients within the educational medical centers of Ardabil, Iran. This research employs a cross-sectional design involving a sample of 420 individuals drawn from the target population, comprising 210 patients and 210 nurses. Stratified random sampling was utilized for participant selection, with data collection occurring between February and July 2024. The instrument for data gathering consisted of a two-part questionnaire; the first section captured demographic information of both patients and nurses, while the second section focused on evaluating the quality of informed consent as perceived by nurses and patients. Data analysis was performed using inferential statistical methods, including independent t-test, one-sample t-test, the Chi-square test, and analysis of variance (ANOVA) test. The mean informed consent quality score was higher in nurses compared to patients (107.44 [standard deviation [SD]=14.85] vs. 103.84 [SD=17.53], P<0.05). Results of the one-sample t-test indicated that the quality of obtained informed consent from patients and nurses’ viewpoints was lower than the expected amount in information provision, understanding the information, voluntary participation, signing the consent form, and the interaction between the patient and the doctor. At the same time, the score assigned to decision-making competence was higher than the expected amount. The general quality of obtaining informed consent was unfavorable from nurses’ and patients’ points of view. It is recommended that the process of obtaining informed consent be modified and that transparency and capacity in all the stages of obtaining informed consent be improved.
Position of Informed Consent in Emergency Handling of Patients in Hospital
Position of Informed Consent in Emergency Handling of Patients in Hospital
Hadi Zulkarnain, Zainal Arifin Hoesein
Journal Indonesia Law and Policy Review (JILPR), October 2024
Abstract
The Indonesian Constitution mandates that health must be the main thing in continuous sustainable development. Therefore, in order to create a good health law system, doctors must respect whatever the patient’s choice is, because if informed consent has occurred, then the rights and obligations between the doctor and the patient arise. However, the position of informed consent becomes unclear when there is emergency treatment of patients in hospitals. The problem studied is how is the position of informed consent in emergency treatment of patients in hospitals in law in Indonesia and the United States? The research method used is normative. The results of the study show that the position of informed consent in emergency treatment of patients in hospitals in law in Indonesia and the United States is different. In the health law system in Indonesia, the position of informed consent in emergency treatment of patients in hospitals is considered given, so that doctors who perform medical actions in order to save lives or prevent disability of a person in an Emergency and/or disaster are exempt from claims for compensation. A different thing happens in the health legal system in the United States, where the position of informed consent in emergency patient care in hospitals remains very important in law, because the legal consequences if informed consent is not given, are that the medical action is considered an act of abuse (intentionally) against the patient which causes the doctor and hospital to become parties who can be held legally responsible if the patient feels disadvantaged.
The legal requirements for patient consent in Poland: A survey of doctors’ level of knowledge
The legal requirements for patient consent in Poland: A survey of doctors’ level of knowledge
Kamila Kocańda, Zbigniew Siudak, Michał Chrobot
Journal of Forensic and Legal Medicine, January 2025
Abstract
The legality of providing any medical intervention needs to be guarded by the requirement of a conscious and informed consent given by the patient. The legal requirements of granting such a consent in practice should apply not only to typical situations, when the patient is able to manifest his medical decision consciously, but also to more complicated cases where a patient cannot provide such a consent himself by the time the provision of service is given. This implies the need for the doctor to take actions specified by law, such as, but not limited to obtaining the consent of the guardianship court or intervene without the consent. The purpose of this study was to determine the level of knowledge of the currently in force Polish statutory requirements for legitimizing medical decisions in the relationships between physicians and patients. The study used anonymous surveys designed by the authors for the purpose of this study to test the level of knowledge of legal requirements regarding the principles under which patients provide consent to healthcare services and was conducted in two hospitals in Poland and Polish medical university. The survey results indicated that respondents do not possess sufficient understanding of the legal requirements for legitimizing acts or omissions of the physicians in the diagnostic and therapeutic process.
Towards Equitable Healthcare: Redesigning Informed Consent Regulations
Towards Equitable Healthcare: Redesigning Informed Consent Regulations
Rohmad Imam Masyuri, Didiet Setioboedi, Anis Mashdurohatun, Dhiwangkoro Aji Kadarmo, Nur Fareha
Journal of Ecohumanism, 22 December 2024; 3(8)
Abstract
Informed consent is a fundamental element of ethical and legal healthcare practices, serving as a cornerstone for patient autonomy and equitable care. In Indonesia, informed consent is regulated under frameworks such as Law No. 17 of 2023 on Health, Government Regulation No. 28 of 2024, and Ministerial Regulation No. 290 of 2008. While these regulations establish foundational guidelines, they are limited in addressing contemporary challenges, particularly in the communication of medical information tailored to diverse patient needs. This article examines the gaps in the current regulatory framework, particularly regarding the inadequacies in ensuring patient understanding and participation in medical decision-making. The analysis highlights key shortcomings, including the lack of detailed technical provisions for adapting information delivery to various patient conditions, such as those with disabilities, language barriers, or limited literacy. It argues that these gaps undermine the principles of equity and justice, potentially resulting in consent that does not reflect informed patient choice. To address these challenges, the article proposes regulatory reconstructions emphasizing justice, transparency, and inclusivity. Suggested reforms include the mandatory use of digital documentation, enhanced communication technologies, and support systems such as translators or visual aids for vulnerable populations. By integrating these reforms into the legal framework, the healthcare system can foster a more inclusive informed consent process, enhancing patient trust, autonomy, and equity in medical decision-making. These changes are crucial for bridging the gap between ethical theory and practical application in Indonesia’s evolving healthcare landscape.
Ethical Issues in Vaccination: Balancing Public Health and Individual Autonomy
Ethical Issues in Vaccination: Balancing Public Health and Individual Autonomy
Ledia Qatipi, Albana Fico, Gentian Vyshka
Current Research in Medical Sciences, December 2024; 3(4)
Abstract
Vaccination has been one of the most successful public health interventions, contributing significantly to the prevention of numerous infectious diseases and saving countless lives. However, its implementation has not been without ethical challenges. This paper examines key ethical issues related to vaccination, considering the tension between public health goals and individual autonomy. Through an exploration of informed consent, distribution equity, vaccine mandates, and misinformation, this paper aims to provide a comprehensive analysis of the complex ethical landscape in the realm of vaccination.
Vulnerability in research ethics: A call for assessing vulnerability and implementing protections
Vulnerability in research ethics: A call for assessing vulnerability and implementing protections
Michael G Findley, Faten Ghosn, Sara J Lowe
Proceedings of the National Academy of Sciences of the United States of America, 20 August 2024
Abstract
Ethics standards reference the need for special consideration of vulnerable populations, such as pregnant women, incarcerated individuals, and minors. The concept of vulnerability is poorly conceptualized in the medical sciences where it originated, and its application to the social sciences is even more challenging. Social science researchers may unwittingly fail to appreciate preexisting vulnerabilities and indeed may be responsible for inducing new research-related vulnerability. In this paper, we present the first comprehensive coding of country-level vulnerability designations. Specifically, we coded all 355 official documents governing social/behavioral human subjects research for the 107 countries with such regulations and identified 68 distinct vulnerability categories. The data reveal substantial regional variation, overemphasis of categories derived from medical sciences, neglect of critical categories such as displacement, and likely heterogeneity within and across groups. The article provides a conceptual framework that shifts the problem away from static, enumerated categories toward emphasis on research-induced vulnerability. Based on our conceptualization and coding, we present a framework for assessing vulnerability and implementing appropriate protections.
Does silence imply consent? Organ Donation and the Presumption of Informed Consent
Does silence imply consent? Organ Donation and the Presumption of Informed Consent
Cárdenas Krenz, Arturo Ronald, Córdova Pérez, Edwin Francisco
Medical Research Archives, 2024
Abstract
In response to the global shortage of organ donation, each country has been applying different public policies to reduce the donor deficit. One of them has been to propose regulatory modifications to the presumed consent system, in order to establish a system in which a favorable will is presumed for post-mortem organ donation, unless the person has declared otherwise while alive. Recently, the Peruvian law has established the presumed consent system for the donation of organs; it means that, in the absence of express will, the donor’s willingness to donate his or her organs at the time of death is now presumed. This regulatory modification follows a tendency established in other countries; however, others remain and respect the free and inform consent regards the willing of donating organs. This article presents a critical vision of this legal presumption. Under analyzing others health legal systems, we deveal the risks of violation of people’s rights when applying a regulation in this sense, which establishes a kind of compelled solidarity, highlighting policies that promote organ donation without compromising fundamental rights.
Is Specific Consent for Educational Sensitive Exams on Anesthetized Patients Necessary? Arguments for and Against From Canadian Medical Students
Is Specific Consent for Educational Sensitive Exams on Anesthetized Patients Necessary? Arguments for and Against From Canadian Medical Students
Original Article
Phoebe Friesen, Wan-Li Sun, Sarah Towle, Zoe Hyman-Levy
Journal of Surgical Education, March 2025; 82(3)
Abstract
Objective
Discussions related to the importance of seeking specific consent for sensitive (e.g., pelvic, rectal) exams performed on anesthetized patients by medical students have been growing. The perspectives of Canadian medical students on this topic have never been sought.
Design
An anonymous questionnaire related to experiences and beliefs regarding consent and sensitive exams under anesthesia (EUAs) within medical training was distributed to medical students across Canada.
Setting
Of 17 medical schools in Canada, 6 confirmed distribution, 8 schools expressed an intention to distribute but did not confirm whether distribution had occurred, and 3 did not share the questionnaire.
Participants
134 respondents answered at least 1 question. Canadian medical students who had begun clerkship or previous students enrolled within the last 5 years were eligible.
Results
Our data indicates that, of Canadian medical students surveyed, the majority (72%) believe that specific consent for educational sensitive EUAs is a moral requirement, while 20% are unsure, and 8% do not share this belief. Respondents offered a variety of reasons why specific consent is necessary, including patient rights, autonomy, respect, and integrity, as well as concerns related to nonconsensual exams being abusive or constituting assault. Some respondents noted that consent is already implied, is unnecessary because of clinical benefit, or requiring it could lead to missed educational opportunities, especially for male and/or racialized medical students.
Conclusion
These results indicate that while most respondents support specific consent for educational EUAs, confusion regarding the purpose of these exams and the moral basis of specific consent exists in training.