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
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
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
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

Consent Mechanisms and Default Effects in Health Information Exchange in Japan
Original Research
Atsushi Ito, Fumihiko Nakamura
Frontiers in Digital Health, 3 February 2025
Background
Health information exchange (HIE) is an information system that efficiently shares patient information across medical institutions. However, traditional consent methods, represented by opt-in and opt-out, face a trade-off between efficiency and ethical, making it difficult to fundamentally improve consent rates. To address this issue, we focused on default settings and proposed an innovative approach called the “two-step consent model,” which leverages the advantages of existing models using utility theory. We evaluated the acceptability of this method.
Methods
An online survey was conducted with 2,000 participants registered with Japan’s largest internet survey company. We compared and analyzed the consent rates of the opt-in, opt-out, and two-step consent models. Results: The opt-in model had a 29.5% consent rate, maximizing patient autonomy but increasing the burden and reducing efficiency. The opt-out model had a 95.0% consent rate but raised concerns among half of the respondents. The two-step consent model had a 68.5% consent rate, demonstrating its cost-effectiveness compared with traditional models
Discussion
The two-step consent model, involving implicit and explicit consent when needed, ensures efficient consent acquisition while respecting patient autonomy. It is a cost-effective policy option that can overcome the ethical issues associated with the opt-out model. Introducing methods that leverage both opt-in and opt-out advantages is expected to address HIE stagnation.
Conclusion
The two-step consent model is expected to improve consent rates by balancing the efficiency and quality of consent acquisition. To achieve this, patient education is crucial for raising awareness and understanding of HIE and its consent methods.

Surgical informed consent practice and associated factors among adult postoperative patients in public hospitals of Mekelle, Tigray, Ethiopia 2023/2024
Research Article
Fiseha Abadi Gebreanenia, Hailemarim Berhe Kahsay, Desta Siyoum Belay, Binyam Gebrehiwet Tesfay, Fissha Brhane Mesele, Mamush Gidey Abirha
PLOS One, 3 February 2025
Open Access
Abstract
Background
Substantial weaknesses and omissions of surgical informed consent are evident and the current elements of the surgical informed consent process are largely neglected in daily practice. This study aimed to assess surgical informed consent practice and associated factors among adult postoperative patients in public hospitals of Mekelle, Tigray, Ethiopia.
Methods
Institution based cross-sectional study was conducted among 314 adult postoperative patients in public hospitals of Mekelle, Tigray, Ethiopia. Participants were selected using systematic random sampling. A pretested interviewer-administered questionnaire was used to collect data. Descriptive, Descriptive, bivariate and multivariable logistic regression analyses were performed using statistical package for social science version 27.
Result
Only 35.8% (CI 95%, 30.6, 41) of the respondents were identified to have received the recommended (6 or more) components of surgical informed consent. Educational level [AOR 5.76 (1.02, 32.6)], timing of surgical informed consent delivery [AOR 3.27 (1.5, 7.11)], qualification of counselor who took surgical informed consent them [AOR3.185 (1.21, 8.38)], hospital type [AOR 2.85 (1.26, 6.46)], and duration of counseling [AOR 6.9 (3.33, 14.3)] were statistically significant at P<0.05.
Conclusion
Majority of participants did not receive comprehensive information during the surgical informed consent process in the study hospitals. To improve the delivery it is suggested that health professionals; create rapport with patient, spend more time during counseling.

Practice and factors affecting informed consent among healthcare workers for major surgical procedures at Gurage zone hospitals, South Ethiopia, 2022: a facility-based cross-sectional study
Bitew Tefera Zewudie, Shegaw Geze Tenaw, Yibeltal Mesfin, Haimanot Abebe, Zebene Mekonnen, Shegaw Tesfa Mengist, Bogale Chekole, Agere Aynalem, Tadele Lankrew, Yihenew Sewale, Muche Argaw, Tadesse Sahle, Daniel Tsega
BMJ Open, 20 January 2025
Open Access
Abstract
Objective
This study aimed to assess the informed consent practice process and associated factors among healthcare workers for major surgical procedures at Gurage zone hospitals, in 2022.
Methods and materials
Institution-based cross-sectional study was employed.
Settings
This study was conducted in Gurage zone hospitals.
Participants
All healthcare workers who have been working in Gurage zone hospitals of surgical, operation rooms and obstetrics/gynaecology wards had exposure to patients who had undergone surgery during the study period
Outcome
The primary outcome of the study was the practice of informed consent practice among healthcare workers in Gurage zone hospitals.
Result
A total of 448 study participants were involved in this study giving a response rate of 98%. The mean (±SD) age of the study participants was 29.16 (±4.06) years. The mean score of study participants towards the surgical informed consent was 19.5, and 260 (58%, 95% CI: 53.7, 62.5) of them had good practice in the surgical informed consent. In multivariable logistic analysis model, factors like favourable attitude towards informed consent 2.4 (1.556, 3.596), work experience participants 4.9 (2.8, 8.7), adequate knowledge of informed consent 2.5 (1.6, 3.9) and communication challenge 1.6 (1.07, 2.50) were independently associated with the practice of informed consent at a p value of <0.05.
Conclusion
More than half of healthcare providers had good practice towards the surgical informed consent process. The practice of informed consent is low, and it is better to work on healthcare providers’ in-service training, knowledge and attitude towards informed consent.

Evaluation of the readability of informed consent forms commonly used in dermatology and cosmetology in Türkiye
Mine Mujde Kus
Medicine Science, 12 January 2025
Abstract
Informed consent forms (ICFs) must contain all the necessary information related to medical interventions and be comprehensible to the patient. This study aims to determine the readability levels of the ICFs listed on the official website of the Turkish Dermatology Association. A total of 23 consent forms, accessible on the website (https://turkdermatoloji.org.tr/icerik/detay/289) of the Turkish Dermatology Association, were incorporated into the study and classified into seven distinct categories. Twenty-three consent forms available on the Turkish Dermatology Association’s website were included in the study and categorized into seven groups. The texts of these forms were loaded into readability software. To ascertain the readability levels of the included texts, the mean number of words per sentence, the mean word count, the mean number of words with four syllables or more, and the mean number of syllables were calculated using the Bezirci-Yılmaz and Ateşman formulas. These data were then statistically compared. The mean readability of all ICFs was at the high school level according to the Bezirci-Yılmaz formula and at a medium difficulty level according to the Ateşman formula. According to the Bezirci-Yılmaz formula, the Methotrexate ICF was at an academic level, while the ICFs for Cosmetic Procedures with Energy-Based Devices and Superficial Skin Renewal Methods were at the undergraduate level. When comparing the readability values of Bezirci-Yılmaz and Ateşman, a significant difference was found between five groups with multiple consent forms (p=0.006 for both). Pairwise comparisons revealed that the low readability of the ICFs for Cosmetic Procedures with Energy-Based Devices was responsible for this significant difference. The readability of these forms was at the undergraduate level, according to Bezirci-Yılmaz, and at a challenging level, according to Ateşman. The readability levels of the ICFs available on the official website of the Turkish Dermatology Association are low. These consent forms should be revised to guarantee that patients are sufficiently informed about the medical procedures they will undergo. Otherwise, patients and physicians may face legal challenges due to potential complications.

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.

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’…