Evaluation of the surgical informed consent for elective and emergency surgeries in obstetrics and gynaecology in Saudi Arabia
Research
Maryam Al-Meshkhas, Zahraa Alakrawi, Sumaiah Alrawiai
BMC Medical Ethics, 12 March 2025
Open Access
Abstract
Background
Informed consent (IC) represents one of the fundamental rights of patients in healthcare. An essential aspect of the IC process is providing patients with equal access to information to enable them to make the right decisions. However, failure to obtain IC undermines patient autonomy, lowers patient satisfaction, increases risks, and negatively affects the patient’s trust in healthcare providers. This study aims to evaluate the surgical informed consent (SIC) process from the patient’s perspective both for emergency and elective surgeries in obstetrics/genecology in Saudi Arabia.
Methods
This is a quantitative cross-sectional study. The study population included all hospitalized female patients who had undergone obstetric or gynaecological surgeries, from February 2021 to March 2021. The total sample size was 156 female patients.
Results
Most of the participants were married (96.2%) and unemployed (80.1%). The most performed surgery was caesarean Sect. (84%). Most of the patients were satisfied with their SIC experience which represents over 85%. No significant difference has been found between the elective and emergency surgeries. However, person-in-charge of SIC administration and the time provided to sign the IC were deemed to be significant predictors.
Conclusion
Based on the findings, it is recommended that physician take responsibility for the SIC administration rather than an unknown provider. It is also recommended to provide the patients with adequate time to understand the SIC. Furthermore, ensuring the availability of emotional support is critical for enhancing the patient experience.
Barriers and willingness to express consent to organ donation among the Kazakhstani population
Barriers and willingness to express consent to organ donation among the Kazakhstani population
Research
Aidos Bolatov, Aruzhan Asanova, Gulnur Daniyarova, Vitaliy Sazonov, Yuliya Semenova, Aigerim Abdiorazova, Yuriy Pya
BMC Public Health, 3 March 2025
Open Access
Abstract
Background
Organ donation is a critical component of healthcare, yet donation rates in Kazakhstan remain low. Understanding the socio-demographic factors, knowledge levels, and perceived barriers influencing individuals’ willingness to consent to organ donation is essential for developing effective interventions.
Methods
This cross-sectional study surveyed 1,294 participants across Kazakhstan. The sample was predominantly female (78.3%), urban (79.4%), and well-educated, with a significant proportion having medical backgrounds. Data were collected on socio-demographic characteristics, knowledge about organ donation, and perceived barriers. Comparison methods and binomial logistic regression analysis was used to identify significant predictors of willingness to express consent for organ donation.
Results
Age, ethnicity, family status, and knowledge about organ donation were significant predictors of willingness to donate. Older participants and Russian ethnic group members were less likely to consent, while widowed individuals and those with higher knowledge levels were more likely to express consent. Although several factors did not have significant prediction with willingness to donate in the regression analysis, chi-square and U-tests revealed significant associations for residence, occupation, educational level, and religious affiliation. Key barriers to donation included distrust in the medical system, fears of organ trafficking, and insufficient awareness, particularly among non-medical participants. These barriers were significant deterrents and correlated with lower willingness to donate. However, due to the overrepresentation of urban, educated, and medical-affiliated participants in the sample, findings may not fully reflect the general population of Kazakhstan.
Conclusion
The findings highlight the need for targeted educational campaigns to increase public awareness and address misconceptions about organ donation. Building trust in the medical system and dispelling fears of unethical practices are essential for improving donation rates. The study underscores the complex interplay of socio-demographic factors, knowledge, and perceived barriers in shaping organ donation decisions in Kazakhstan, while also emphasizing the need for future research with a more representative sample.
Community engagement approaches and lessons learned: A case study of the PRECISE pregnancy cohort study in Kenya
Community engagement approaches and lessons learned: A case study of the PRECISE pregnancy cohort study in Kenya
Onesmus Wanje, Angela Koech, Maggie Woo Kinshella, Grace Mwashigadi, Alice Kombo, Grace Maitha, Nathan Barreh, Hiten D Mistry, Rachel Craik, Marianne Vidler, Marie-Laure Volvert, Peter von Dadelszen, Marleen Temmerman, The Precise Network
Fronteirs of Public Health, 24 February 2025
Abstract
Community engagement (CE) has been recommended as an important ethical consideration for health research to enhance informed consent and exchange knowledge between researchers and community members. The purpose of this paper is to describe how CE was developed and delivered for the PRECISE prospective pregnancy cohort study in Kenya. PRECISE enrolled pregnant women in antenatal care, followed them up to the postpartum period, and collected data and biological samples to enable the study of placental disorders in sub-Saharan Africa. Initially CE was aimed at informing the community about the study, establishing community-wide acceptance of the research and addressing concerns about biological sample collection to facilitate participation in the study. CE later evolved to be a platform for mutual learning aiming to deepen the community’s understanding of research principles and informed consent and providing a feedback loop to researchers. We engaged diverse stakeholders including health workers and managers, local administrators, religious and traditional leaders, older women, pregnant women, non-pregnant women and men. We utilized a variety of CE approaches and tools adapting to the specific contextual factors at the study sites. Achievements included widespread understanding of informed consent and research principles, clarification of misconceptions, and dispelling of fears regarding biological sample collection. The relationship with the community was strengthened evidenced by frequent inquiries and active participation in CE activities and the research study. For effective CE, we recommend involvement of community members in the CE team and continuous and adaptive CE throughout the study period.
Informed Consent for Breast Cancer: The Perspective of Physicians in Japan
Informed Consent for Breast Cancer: The Perspective of Physicians in Japan
Review
Erika Suzuki, Hiroyuki Takei
Journal of Nippon Medical School, 2025
Abstract
Informed consent (IC) is closely related to shared decision making (SDM), and SDM can lead to IC. IC is fundamental to medical ethics as described in the Geneva, Helsinki, and Lisbon declarations and is essential for clinical practice, as it provides legal protection for healthcare professionals. IC should be achieved through SDM based on both narrative-based medicine and evidence-based medicine. SDM should also involve healthcare professionals other than physicians (e.g., nurses, pharmacists, social workers). Communication skills for IC are important and are encapsulated in the SPIKES protocol. IC for breast cancer treatment requires explanation of the roles of local and systemic therapy. A documented “do not attempt resuscitation” order should be obtained for end-of-life IC.
Editor’s Note:
The referenced declarations in the abstract are further identified in this article excerpt:
…Medical Ethics and Informed Consent
Three declarations are relevant to medical ethics: the Declaration of Geneva on the physician’s pledge[6], the Declaration of Helsinki on ethical principles for medical research involving human subjects[7], and the Declaration of Lisbon on the rights of the patient[8]. These documents confirm that IC is essential to the provision of medical care. In particular, the content of the explanations given to patients in medical research must be based on the principles of the Declaration of Helsinki and approved by the ethical review committee of each institution[9].
6.World Medical Association. WMA Declaration of Geneva [Internet]. Ferney-Voltaire; World Medical Association: 2024. Available from: https://www.wma.net/policies-post/wma-declaration-of-geneva
7.World Medical Association. WMA Declaration of Helsinki- Ethical Principles for Medical Research Involving Human Participants [Internet]. Ferney-Voltaire; World Medical Association: 2024. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects
8.World Medical Association. WMA Declaration of Lisbon on the Rights of the Patient [Internet]. Ferney-Voltaire; World Medical Association: 2024. Available from: https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient
Updating Winterwerp with Rooman to add a requirement for ‘Real therapeutic measures’ to legal criteria for admission without consent in psychiatry
Updating Winterwerp with Rooman to add a requirement for ‘Real therapeutic measures’ to legal criteria for admission without consent in psychiatry
Brendan D. Kelly
International Journal of Law and Psychiatry, July–August 2025
Open Access
Abstract
Admission without consent and treatment without consent are topics of prolonged discussion throughout the history of psychiatry. These practices raise significant issues pertaining to human rights to liberty, bodily integrity, and treatment. Balancing rights is always challenging, especially when people lack decision-making capacity owing to the impact of mental illness. In 1979, the European Court of Human Rights outlined criteria required to justify lawful admission without consent owing to mental disorder in Winterwerp v. the Netherlands. These criteria were: (a) a competent national authority needs to demonstrate the existence of a true mental disorder based on objective medical expertise; (b) the extent of the mental disorder needs to warrant compulsory confinement, and (c) continued detention needs to be validated by the persistence of the disorder. Since then, the Court has delivered multiple judgements relating to psychiatric committal and detention in various facilities, but the most significant potential addition to the Winterwerp criteria occurred in 2019, in Rooman v. Belgium. In this case, the Court stated, “that there exists a close link between the ‘lawfulness’ of the detention of persons suffering from mental disorders and the appropriateness of the treatment provided for their mental condition”. The Court stressed ‘that, irrespective of the facility in which those persons are placed, they are entitled to be provided with a suitable medical environment accompanied by real therapeutic measures’. On this basis, this paper proposes adding a fourth requirement to the Winterwerp criteria to justify lawful admission without consent owing to mental disorder: ‘(d) real therapeutic measures must be provided’. The absence of ‘real therapeutic measures’ should undermine the legal basis of admission without consent on the basis of mental disorder. This would mean that there could be no involuntary admission owing to mental disorder without treatment being appropriate and available. Such an addition to criteria for involuntary admission in national mental health legislation would protect, rather than erode, human rights, and would more accurately reflect the core purpose of psychiatry: the treatment of mental illness and the consequent alleviation of suffering.
Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers
Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers
Amanda Siriwardana, Brendan Smyth, Meg Jardine
BMJ Open, 18 March 2025
Abstract
Objective
Low-risk pragmatic clinical research such as learning health system research, quality assurance activities and comparative effectiveness studies are approaches to embedding clinical research within routine practice to generate generalisable evidence. Individual written informed consent may present a barrier to the feasibility and inclusiveness of such low-risk clinical research. Within an overarching moral and ethical framework, the form and requirements of consent vary in both clinical practice and research settings according to the context and level of risk. Within some low-risk research settings, waiver of consent may be appropriate.
Analysis
We sought to describe contemporary national and international English-language guidelines pertaining to the use and oversight of waiver of consent in clinical research. We identify 14 guidelines including 1 international, 1 regional and 12 national statements, and summarise the principles in each for circumstances in which a waiver of consent is appropriate.
Conclusion
While complete international harmonisation of policy may be neither realistic nor necessary, there are numerous unifying concordances suggesting a broad consensus on the approach to waiver of consent research.
Unconsented Educational Pelvic Exams on Anesthetized Patients: The Collapse of Legal and Ethical Safeguards for Patient Consent
Unconsented Educational Pelvic Exams on Anesthetized Patients: The Collapse of Legal and Ethical Safeguards for Patient Consent
Rachel Beth Cohen
Maine Law Review, 10 March 2025
Abstract
It is a troubling reality that medical students in some U.S. teaching hospitals perform pelvic examinations on anesthetized surgical patients without their explicit knowledge or consent. These unconsented educational pelvic examinations raise serious ethical and legal concerns. Although professional medical societies agree that specific and voluntary consent is a fundamental ethical prerequisite for conducting such examinations, this standard has been frequently disregarded in practice. The law offers little practical deterrence to this violation of patient autonomy. Tort law provisions on battery and informed consent are ineffective in addressing the issue, while state legislatures have largely failed, or outright refused, to pass enforceable prohibitions on the practice. Criminal prosecution is problematic for multiple reasons. Even the United States Department of Health and Human Services, which has the authority to regulate procedures performed on anesthetized patients, has issued guidance that stops short of providing an enforceable solution. Given the inability to reliably ensure patient consent, this Article argues that educational pelvic examinations on anesthetized patients must be categorically prohibited. Ethical and legally sound alternatives exist to train medical students in pelvic examination techniques without compromising patients’ autonomy.
Changes to Parental Consent Requirements for Abortion in Massachusetts and Impact on Timeliness of Care for Adolescents Aged 16 to 17 Years
Changes to Parental Consent Requirements for Abortion in Massachusetts and Impact on Timeliness of Care for Adolescents Aged 16 to 17 Years
Isabel Fulcher, Kara Kimball, Zarah Rosen, Jennifer Fortin, Namita Arunkumar, Danielle Gelfand, Elizabeth Janiak, Luu Ireland
American Journal of Public Health, March 2025
Abstract
Objectives
To measure the effect of the ROE Act, which eliminated parental consent requirements for abortion for individuals ages 16 to 17 years, on abortion timing for adolescents in this age group in Massachusetts.
Methods
The primary outcome was gestational duration at abortion for individuals aged 16 to 19 years at Planned Parenthood League of Massachusetts from 2017 to 2022. Our control group included abortions among those aged 18 to 19 years. In our primary analysis, we used a comparative interrupted time series with a linear model to capture temporal trends, seasonality, whether an abortion was undergone during the acute phase of the COVID-19 pandemic, previous abortion, and race/ethnicity categories.
Results
Minors aged 16 to 17 years underwent 749 abortions during the study. Individuals aged 18 to 19 years underwent 2773 abortions. The ROE Act resulted in a 5.46-day decrease in gestational duration at abortion among minors (95% confidence interval = −11.82, 0.91).
Conclusions
Removal of the parental involvement requirement for adolescents aged 16 to 17 years in Massachusetts led to minors undergoing abortions at earlier gestational durations, highlighting the importance of potential impacts of similar legislation to decrease barriers to abortion access for minors.
Evaluation of a Retrieval-Augmented Generation-Powered Chatbot for Pre-CT Informed Consent: a Prospective Comparative Study
Evaluation of a Retrieval-Augmented Generation-Powered Chatbot for Pre-CT Informed Consent: a Prospective Comparative Study
Original Paper
Felix Busch, Lukas Kaibel, Hai Nguyen, Tristan Lemke, Sebastian Ziegelmayer, Markus Graf, Alexander W. Marka, Lukas Endrös, Philipp Prucker, Daniel Spitzl, Markus Mergen, Marcus R. Makowski, Keno K. Bressem, Sebastian Petzoldt, Lisa C. Adams, Tim Landgraf
Journal of Imaging Informatics in Medicine, 21 March 2025
Open Access
Abstract
This study aims to investigate the feasibility, usability, and effectiveness of a Retrieval-Augmented Generation (RAG)-powered Patient Information Assistant (PIA) chatbot for pre-CT information counseling compared to the standard physician consultation and informed consent process. This prospective comparative study included 86 patients scheduled for CT imaging between November and December 2024. Patients were randomly assigned to either the PIA group (n = 43), who received pre-CT information via the PIA chat app, or the control group (n = 43), with standard doctor-led consultation. Patient satisfaction, information clarity and comprehension, and concerns were assessed using six ten-point Likert-scale questions after information counseling with PIA or the doctor’s consultation. Additionally, consultation duration was measured, and PIA group patients were asked about their preference for pre-CT consultation, while two radiologists rated each PIA chat in five categories. Both groups reported similarly high ratings for information clarity (PIA: 8.64 ± 1.69; control: 8.86 ± 1.28; p = 0.82) and overall comprehension (PIA: 8.81 ± 1.40; control: 8.93 ± 1.61; p = 0.35). However, the doctor consultation group showed greater effectiveness in alleviating patient concerns (8.30 ± 2.63 versus 6.46 ± 3.29; p = 0.003). The PIA group demonstrated significantly shorter subsequent consultation times (median: 120 s [interquartile range (IQR): 100–140] versus 195 s [IQR: 170–220]; p = 0.04). Both radiologists rated overall quality, scientific and clinical evidence, clinical usefulness and relevance, consistency, and up-to-dateness of PIA high. The RAG-powered PIA effectively provided pre-CT information while significantly reducing physician consultation time. While both methods achieved comparable patient satisfaction and comprehension, physicians were more effective at addressing worries or concerns regarding the examination.
Demographic disparities in blood-borne-virus screening in two London Emergency Departments: a case for implied consent
Demographic disparities in blood-borne-virus screening in two London Emergency Departments: a case for implied consent
Research Article
Cassandra Fairhead, Tristan J. Barber, Hajra Okhai, Russell Durkin, Jennifer Hart, Jessica Pinto, Alan Hunter, Douglas Macdonald, Fiona Burns
AIDS Care, 17 March 2025
Abstract
“Opt-out” Emergency Department (ED) blood-borne-virus screening enables early diagnosis, improving outcomes. Whereas some EDs encourage verbal reminders at blood draw, others emphasise “implied consent”. Associations between these approaches and screening equity have not been explored. This retrospective cohort evaluation quantified demographic disparities in screening in two EDs following “reminder model” screening rollout. Staff attitudes were explored, identifying screening barriers. ED attendees from July-October 2022 were identified electronically. Associations between age, sex, self-identified ethnicity, attendance time and admission status on screening were analysed using odds ratios (ORs). Twenty ED staff underwent semi-structured interviews. There were 33,388 eligible ED attendances (54.8% female; median age 53y). 58.9% of attendees received screening. In unadjusted analysis, the screening rate was higher in men (OR 1.05; 95%CI 1.00–1.10) and in non-admitted attendees. People of Black, Asian or Other ethnic backgrounds had lower rates compared to White ethnicity. Attendees between 5pm–11pm had lower rates and 11pm–9am higher rates compared to 9am–5pm. All associations persisted in multivariable models. Interviews revealed low confidence in follow-up discussion in attendees who opted out and a high workload precluding screening. Demographic disparities were seen in this “reminder model” context. Simplifying processes and emphasising implied consent may improve equitable screening.