Evolution of Organ Donation Consent, Retrospective Data on Potential Organ Donors
Petru Cotraua, Marcel Negraub, Viviana Hodosana, Adriana Vladua, Cristian Marius Dainab, Dorel Dulaua, Lucia Georgeta Dainab, Carmen Pantis
Journal of Clinical Medicine, 18 June 2024; 19(2) pp 292-297
Abstract
Introduction and aim
Identifying the best practices to obtain consent for organ donation involves several strategies. This retrospective analysis of the activity in the field of organ donation identifies the most critical impediments, of which the refusal of families to donate is one of the most frequently encountered. Our main aim was to determine the factors that negatively influence the activity of organ and tissue donations from brain dead donors and to summarize the total number of potential and actual deceased donors, their yearly characteristics, and the organ and tissue donation types performed.
Materials and methods
A retrospective descriptive study, covering data from 1 January 2014 to 31 December 2023, was conducted in the intensive care unit of the Emergency Clinical County Hospital of Bihor, a recognized facility engaged in organ donation and transplantation from Romania. All potential and actual deceased donors were included in our research.
Results
During a period of 10 years, between 2014 and 2023, of the 488 potential and actual deceased donors, 355 (72.7%) were potential donors and 133 (27.3%) actual deceased donors.
Conclusions
From 2014 to 2023, a significant percentage [15.28% (133)] of the total number of actual deceased organ donors registered at the national level (870) were identified by us in the Emergency Clinical County Hospital of Bihor.
Year: 2024
Evaluating Egg Donor Recruitment Strategies in Czech ART Clinics: A Critical Analysis of Informed Consent and Ethical Considerations
Evaluating Egg Donor Recruitment Strategies in Czech ART Clinics: A Critical Analysis of Informed Consent and Ethical Considerations
Anna De Bayas Sanchez, Jitka Fialová, Hana Konečná, Francisco Güell
Czech Sociological Review, 2024; 60(3) pp 321-346
Abstract
There is a high demand for egg donors in the Czech Republic, driven by international couples’ interest in assisted reproductive procedures due to affordable treatment, no waiting list, and an extended age limit for recipients up to 49 years. For a population of 10.5 million, the country has 48 reproductive clinics. This study aims to evaluate Czech egg donor recruitment campaigns through the lens of free, informed, and specific consent requirements. A quantitative-qualitative analysis of recruitment strategies from 29 unique clinic websites in Czechia was conducted, with 12 sites specifically designed for marketing purposes. The analysis was based on 14 criteria. Of the 29 clinic websites, only three did not indicate compensation amounts, ranging from 800 to 1400 EUR. Thirteen clinics did not provide information on risks associated with oocyte donation, with one falsely stating no risks exist. Twenty-two websites used emotionally evocative quotes and images. Thirteen clinics did not disclose time commitments, and one provided misleading information. Seventeen clinics omitted conditions for donor refusal and the number of allowable donations. Eighteen clinics did not offer post-donation referrals. Conversely, 15 clinics highlighted psychological benefits, and 23 emphasized health benefits. None fully complied with international guidelines on oocyte donation. Analysed websites lack sufficient information for responsible egg donation decisions. The emphasis on compensation, benefits, and suggestive graphics creates an image of safe, community-oriented donation, potentially leading to inadequate understanding of health risks and commodification of the female body.
A qualitative study on informed consent decision-making at two tertiary hospitals in Uganda: Experiences of patients undergoing emergency surgery and their next of kin
A qualitative study on informed consent decision-making at two tertiary hospitals in Uganda: Experiences of patients undergoing emergency surgery and their next of kin
Research Article
Olivia Kituuka, Erisa Sabakaki Mwaka, Ian Guyton Munabi, Moses Galukande, Nelson Sewankambo
SAGE Open Medicine, 22 June 2024
Open Access
Abstract
Background
In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way.
Objectives
To describe the decision-making process during informed consent for emergency surgery among patients and the next of kin of patients who have undergone emergency surgery.
Methods
Consecutive sampling of 39 participants and in-depth semi-structured interviews were conducted at two tertiary teaching hospitals in Uganda. There were 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24–72 h. Responses about decision-making were coded into themes using the social constructivist theory and phenomenological approach.
Results
There were four emergent themes; decision-makers, people consulted, documentation of the consent and factors influencing decision-making. Most patients and next of kin made decisions on their own and documented the consent for themselves. Other family members and doctors were consulted during the decision-making process. Decision-making was influenced by reassurance of good outcomes of surgery and disclosure by the doctors.
Conclusion
Decisions were made collaboratively with the patient at the center but with input of health personnel, the next of kin
and other family members. A communitarian approach combined with shared decision-making between the doctor and the patient and next of kin with adequate discussion and disclosure of information in simple language would improve decision-making for patients and their next of kin.
Communities and Informed Consent in Medical Research in Africa
Communities and Informed Consent in Medical Research in Africa
Book Chapter
Yaw A. Frimpong-Mansoh
An African Research Ethics Reader, 2024 [Brill]
Abstract
This chapter seeks to clarify the imperative role of community in the complex process of obtaining informed consent in clinical research in African societies. Although the communal character of African ethics and cultures have been much discussed in recent research ethics scholarship, there is still a lack of clarity on the role and justification of community members in the complex process of obtaining informed consent in medical research. The Western liberal individualistic system of ethics is seen as antithetical to the African communal system. The Western system seems concerned that the communal system encourages intrusive paternalism and infringement upon the autonomous rights of the individual. It is argued here however that community involvement in clinical research in Africa is nothing but another justified level of institutional protection comparable to the roles of REC s in efforts to safeguard against exploitative and abusive unethical practices.
Informed consent and the duty to warn: More than the mere provision of information
Informed consent and the duty to warn: More than the mere provision of information
Rajesh Gounder
Journal of Law and Medicine, 1 June 2024
Abstract
Before providing any form of medical treatment, medical practitioners are generally required to discharge their duty to warn. It is argued in this article that the duty to warn, at least as it relates to frail and elderly patients, requires the principles of shared decision-making to be adopted. Doing so will ensure a comprehensive biopsychosocial understanding of the patient and assist in identifying material risks that May not be readily apparent. Such risks include risks that threaten the patient’s values, preferences, treatment aims and long-term outcomes. Once such risks are identified, in discharging the duty to warn, they should be contextualised in a manner that makes clear how that risk will manifest in that particular patient. These risks should then also be synthesised within the context of their other medical issues and longer-term interests. Finally, it is suggested that the traditional consent process may need restructuring.
No recognised ethical standards, no broad consent: navigating the quandary in computational social science research
No recognised ethical standards, no broad consent: navigating the quandary in computational social science research
Research Article
Seliem El-Sayed, Filip Paspalj
Research Ethics, 19 April 2024
Open Access
Abstract
Recital 33 GDPR has often been interpreted as referring to ‘broad consent’. This version of informed consent was intended to allow data subjects to provide their consent for certain areas of research, or parts of research projects, conditional to the research being in line with ‘recognised ethical standards’. In this article, we argue that broad consent is applicable in the emerging field of Computational Social Science (CSS), which lies at the intersection of data science and social science. However, the lack of recognised ethical standards specific to CSS poses a practical barrier to the use of broad consent in this field and other fields that lack recognised ethical standards. Upon examining existing research ethics standards in social science and data science, we argue that they are insufficient for CSS. We further contend that the fragmentation of European Union (EU) law and research ethics sources makes it challenging to establish universally recognised ethical standards for scientific research. As a result, CSS researchers and other researchers in emerging fields that lack recognised ethical standards are left without sufficient guidance on the use of broad consent as provided for in the GDPR. We conclude that responsible EU bodies should provide additional guidance to facilitate the use of broad consent in CSS research.
Presumed Consent To High-Risk Medical Actions In Emergencies: Perspective Of Law Number 17 Of 2023
Presumed Consent To High-Risk Medical Actions In Emergencies: Perspective Of Law Number 17 Of 2023
Irsyam Risdawati
Law Synergy Conference (LSC), 2024
Abstract
Patients must provide informed consent before medical procedures are carried out in ordinary situations, but this does not apply in emergency situations and presumed consent is used instead. Doctors are often faced with situations that require high-risk medical procedures for emergency patients. The concept of presumed consent for this action is not recognized under Law Number 17 of 2023 concerning Health. The aim of the research is to analyze the role of presumed consent in the perspective of this law for high-risk medical procedures in emergency cases emergency. This research uses a normative juridical legal research type, namely library legal research, with a statutory approach and a conceptual approach. The results of the analysis show that presumed consent for high-risk medical procedures in emergency situations is not clearly regulated in Law Number 17 of 2023. However, doctors can still rely on several other articles in this law, including Article 293 paragraph (10) which emphasizes the best interests of patients, Article 275 paragraph (1) which requires doctors to provide assistance in emergency cases, and Article 273 paragraph (1) which provides legal protection to doctors who act according to standards. Apart from that, Article 275 paragraph (1) also exempts doctors from claims for compensation in emergency cases, providing legal security for doctors to act quickly to save the patient’s life without any doubt.
Editor’s note: Law 17 of 2023 is part of the Indonesian Health Transformation Plan.
Do Interns Learn On-The-Job How to Obtain Proper Informed Consent for Surgical Procedures?
Do Interns Learn On-The-Job How to Obtain Proper Informed Consent for Surgical Procedures?
Original Reports
Michael Lamb, John M. Woodward, Brian Quaranto, Bobbie Ann Adair White, Linda M. Harris, James K. Lukan, Jeffrey Brewer, Steven D. Schwaitzberg, Clairice A. Cooper
Journal of Surgical Education, 17 July 2024
Abstract
Objective
Obtaining surgical informed consent (SIC) is a critical skill most residents are expected to learn “on-the-job.” This study sought to quantify the effect of 1 year of clinical experience on performance obtaining SIC in the absence of formal informed consent education.
Design
In this case-control cohort study, PGY1 and PGY2 surgical residents in an academic program were surveyed regarding their experiences and confidence in obtaining SIC; then assessed obtaining informed consent for a right hemicolectomy from a standardized patient.
Setting
Single academic general surgery residency program in Buffalo, NY.
Participants
Ten PGY1 and eight PGY2 general surgery residents were included in the study, after excluding residents with additional years of training.
Results
PGY2 residents had significantly more experience obtaining SIC compared to PGY1 residents (median response: “>50” vs “between 6 and 15,” p = 0.001), however there was no difference in self-reported confidence in ability obtaining SIC (mean 3.2/5 in PGY1 vs 3.4/5 in PGY2, p = 0.61), self-reported knowledge of SIC (mean 3.1/5 in PGY1 vs 3.6/5 in PGY2, p = 0.15), performance on a test regarding SIC (mean score 9.0/20, SD 3.9 for PGY1 vs mean score 9.6/20, SD 3.5, t = 0.387, p = 0.739) or performance during a standardized patient interview (mean 11.2/20, SD 2.78 for PGY1 vs mean 11.4/20, SD 1.51 for PGY2, p = 0.87). In the interviews all residents addressed general risks (bleeding/infection), however both groups performed worse in addressing procedure-specific risks including anastomotic leak as risk for hemicolectomy.
Conclusions
A year of clinical training between PGY1 to PGY2 did not improve performance in obtaining surgical informed consent when lacking formal education, despite self-confidence in their ability. A curriculum covering the content, delivery and assessment of informed consent should be initiated for residents upon arrival to surgical training.
Improving Clinical Communication: a qualitative study on the Informed Consent
Improving Clinical Communication: a qualitative study on the Informed Consent
Isabel García-Izquierdo, Begoña Bellés-Fortuño
Revista De Lingüística Y Lenguas Aplicadas, 8 July 2024
Abstract
In the context of the Patient-Centred Care paradigm (Epstein et al., 2005; Suojanen et al., 2012) and the shift toward the psychobiological model (Dean & Street, 2015; Muñoz & García-Izquierdo, 2020), there is a growing demand for the patient to be an active agent in the management of their health. Clinical communication should be conveyed accurately and empathetically (Bellés Fortuño & García-Izquierdo, forthcoming), especially in complex legal genres such as the Informed Consent (IC). The research carried out by the Gentt research group up-to-date has revealed that there is no specific monitoring with the use of IC protocols in clinical practice. In this paper, we present the results of a qualitative pilot study with a group of practitioners from the Valencian Community (Spain). A focus group was conducted where the articulation of communication with patients was analyzed. The study tries to define the practical insights of using the IC to draw conclusions that can improve clinical communication. Results show that MPs generally consider that the IC process needs improvement, especially when considering closeness with patients to enhance communication.
Reviewing past and present consent practices in unplanned obstetric interventions: an eye towards the future
Reviewing past and present consent practices in unplanned obstetric interventions: an eye towards the future
Original Research
Morganne Wilbourne, Hand, Sophie McAllister, Louise Print-Lyons, Meena Bhatia
Journal of Medical Ethics, 26 June 2024
Abstract
Many first-time mothers (primiparous) within UK National Health Service (NHS) settings require an obstetric intervention to deliver their babies safely. While the antepartum period allows time for conversations about consent for planned interventions, such as elective caesarean section, current practice is that, in emergencies, consent is addressed in the moments before the intervention takes place. This paper explores whether there are limitations on the validity of consent offered in time-pressured and emotionally charged circumstances, specifically concerning emergency obstetric interventions. Using the legal framework of the Mental Capacity Act, Montgomery v. Lanarkshire Health Board (2015) and McCulloch v Forth Valley Health Board (2023), we argue that while women have the capacity to consent during labour, their autonomy is best supported by providing more information about instrumental delivery (ID) during the antepartum period. This conclusion is supported by some national guidelines, including those developed by the Royal College of Obstetricians and Gynaecologists, but not all. Further, we examine the extent to which these principles are upheld in modern-day practice. Data suggest there is relatively little antepartum information provision regarding ID within NHS settings, and that primiparous women do not report a thorough understanding of ID before labour. Based on these results, and bearing in mind the pressures under which NHS obstetric services currently operate, we recommend further research into patient and clinician perceptions of the consent process for ID. Pending these results, we discuss possible modes of information delivery in future practice.
Center for Informed Consent Integrity 