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
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.

What Is Truly Informed Consent in Medical Practice and What Has the Perception of Risk Got to Do with It?
Catherine Jane Calderwood, Geir Sverre Braut, Siri Wiig
Healthcare, 24 December 2024
Abstract
Making decisions about risk, describing and appropriately explaining risk in medical practice is complex for patients and professionals. In this paper, we investigate how the concept of consent is practiced differently in the UK and Norway and discuss pros and cons of the chosen approaches from a patient safety culture perspective. We argue that consent is a fundamental part of the safety culture and influence on health system functioning and patient and staff safety. Examples from the UK and Norway are used and discussed in terms of how risk perception influences consent processes and practices.

‘Some parts of the consent form are written using complex scientific language’: community perspectives on informed consent for research with pregnant and lactating mothers in Uganda
Research
Adelline Twimukye, Sylvia Nabukenya, Aida N. Kawuma, Josephine Bayigga, Ritah Nakijoba, Simon Peter Asiimwe, Fredrick Byenume, Francis Williams Ojara, Catriona Waitt
BMC Medical Ethics, 21 December 2024
Open Access
Abstract
Background
Appropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent process and propose interventions to improve clarity and understanding of pregnant and breastfeeding women participating in research.
Methods
A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August 2023 to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board members. 19 FGD comprised adult participants representing at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, Lugbara and English). An inductive thematic approach was utilized for data analysis using NVivo version 12 software to identify language factors that influence informed consent. A series of community validation workshops ensured concurrence.
Results
At the individual level, language barriers, and low levels of literacy contributed to poor comprehension, thus hindering ability to achieve genuine informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, with poor and complicated grammar in some consent forms. Participants reported that complex medical terminologies are difficult to translate to local languages. Community members highlighted that social/cultural norms in language use affected cultural perceptions of informed consent. To enhance understanding for individuals without education in science, participants suggested simplification of terminologies and avoidance of complex medical jargon. Researchers should identify participants’ preferred languages and communicate in those languages whenever possible. If researchers are not fluent, trained interpreters should be identified. Informed consent documents must be translated into local languages to ensure participants comprehend the study’s purpose, procedures, risks, and benefits. Involving community members during development and translation of these documents can provide valuable insights into local dialects and culturally specific concepts, ensuring that study tools like surveys and consent forms are accurate and respectful.
Conclusion
Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Consideration of locally understandable terms in community-facing study documentation is likely to enhance understanding and could improve research participation, although further studies are needed to assess these. The use of appropriate language ensures that informed consent is genuine in keeping with principles of Good Clinical Practice, and developing a research communication strategy should be part of inclusive research design.

Patients’ satisfaction with the preoperative informed consent in elective gynecological surgery in a tertiary hospital, BMA
Thossaporn Chuaysatit, Apichaya Pradyachaipimol, Jiraporn Luengmettakul
Thai Journal of Obstetrics and Gynaecology, 18 December 2024
Abstract
Objectives
This study aimed to evaluate patients’ satisfaction with the preoperative informed consent process in elective gynecological surgery.
Materials and Methods
This cross-sectional study was conducted at Charoenkrung Pracharak Hospital, Bangkok, Thailand, from October 2023 to May 2024. Personal data and satisfaction with the preoperative informed consent process were collected on the second postoperative day. The Thai version of the Decisional Satisfaction Scale (DSS) was used to measure the satisfaction and the Informed Consent Process Questionnaire was used to assess knowledge of surgery and perception of informed consent process. Bivariate associations between highly satisfied and not highly satisfied groups were tested using Fisher’s exact test.
Results
A total of 178 participants were enrolled, with mean age of 42.48 years. Most participants agreed or strongly agreed with the statements on the DSS, a mean total score was 27.87, indicating high overall satisfaction. 135 patients (75.8%) were highly satisfied with the informed consent process. There were several factors with significant differences between the highly satisfied group and not highly satisfied group. These included being informed about the consequences of not undergoing the procedure, knowing enough about the procedure to explain it, being informed about the reasons for prolonged urine catheterization and being given the opportunity to refuse the procedure.
Conclusion
This study highlights the critical role of an effective informed consent process in elective gynecological surgery. High   patient satisfaction is achieved when communication and patient participation are prioritized. Future research should explore these dynamics in different settings and diverse populations.

Assessing informed consent in surgical patients at Queen Elizabeth Central Hospital in Blantyre, Malawi: a cross-sectional study
Lucy Kaomba, Wakisa Mulwafu
Malawi Medical Journal, December 2024; 36(4) pp 249-254
Abstract
Introduction
Informed consent is critical to medical practice, and a clearly outlined process that results in signing the consent form may improve the validity of the given consent. There is a paucity of studies in Malawi that have assessed the informed consent process in surgical patients.
Aim
To assess the informed consent process for patients undergoing surgery at QECH in Malawi.
Methods
A cross-sectional quantitative descriptive study was conducted among postoperative patients in the adult surgical wards at QECH through face-to-face interviews. The calculated sample size was 235. A consecutive sampling technique was used. Those below 18 years and those who didn’t or couldn’t consent were excluded. Data was entered and analyzed in Microsoft Excel 2016 and IBM SPSS 25.0. The level of significance was considered as P<0.05.
Results
A total of 222 patients were interviewed. The age range was 21 to 75 years, with a median of 38.5. Two hundred and twelve (95%) patients signed a consent form before surgery, and 21 (9%) knew the content of the form. Most patients, 100 (47%) had a primary school education, and 156 (70%) could read and write. Those with secondary or tertiary education were more likely to want to ask a question given the opportunity (OR 2.82, p= 0.0012), but there was no significant difference in the likelihood of being given time to ask questions between the two groups who had primary and no formal education vs those who had secondary and tertiary education (OR 1.4, p=0.3367)
Conclusion
This study highlights the necessity of employing effective communication strategies during the consent process for surgical procedures and the need to tailor the consent form to the patient’s education level.

Awareness of consent among Nigerian orthodontic patients; a study of perceptions and practices
Sylvia Simon Etim, Onyinye Dorathy Umeh
Acta Stomatologica Marisiensis, December 2024
Abstract
Introduction
Orthodontic treatment is elective but not without risks. Prospective patients need to be fully informed of their treatment options and understand the associated risks and benefits.
Aim of the study
To assess the perception of Nigerian orthodontic patients regarding the consent and assent-giving process before orthodontic treatment.
Material and Methods
A total of 349 patients from the University of Port Harcourt Teaching Hospital and Lagos University Teaching Hospital, who received orthodontic treatment between December 2023 and May 2024, participated in this study. A 21-item questionnaire was administered via Google Forms. The questionnaire contained demographic questions and items assessing knowledge, perception, and practice of consent in orthodontics. Data were analyzed using IBM SPSS Version 26, employing descriptive statistics (frequencies and percentages).
Results
Of the 349 participants, 99 (28.4%) were male, and 250 (71.6%) were female, with a mean age of 23.43 ± 10.49 years. Of the study population, 88% of female and 91.9% of male participants had heard of consent before treatment. A total of 93.1% of participants gave consent, with 78.5% of these being verbal. Pain (45.6%) was the most commonly explained complication, while infection (6.9%) was the least. In terms of satisfaction, 92% of participants were satisfied with the consent process.
Conclusion
Most Nigerian orthodontic patients are aware of the consent process and are generally satisfied with it. Orthodontists in Nigeria should prioritize obtaining written informed consent to ensure patient protection and avoid potential legal issues.

Editor’s note: Acta Stomatologica Marisiensis is the Journal of George Emil Palade University of Medicine, Pharmacy, Science, and Technology in Romania.

The Role of Informed Consent in Medical Disputes at State University Hospitals
Putu Agus Prawira Eka Putra, Gusti Ayu Putri Kartika, R.A. Tuty Kuswardhani
Unram Law Review, 11 November 2024
Abstract
The research aims to understand how informed consent functions in the context of medical disputes at state university hospitals in Indonesia. The main benefit of the study is to provide an overview of how informed consent offers legal protection to the medical profession, particularly in resolving disputes that may arise in the hospital setting. The research utilizes a normative legal research method, focusing on the examination of written laws, regulations, and legal materials applicable in Indonesia. The research concludes that the thoroughness of informed consent documentation is crucial, especially for medical procedures that carry high risks. This thoroughness serves as a legal safeguard for medical professionals, ensuring their protection in case of disputes. Enhanced attention to the completeness of informed consent is necessary to mitigate the risks for doctors and provide legal security within the medical field at state university hospitals.

Barriers to Familial Consent in Deceased Organ Donation among Racialized and Indigenous Communities in Canada: A Qualitative Study
Simran Sandhu, Jagbir Gill, Reetinder Kaur
Journal of the American Society of Nephrology, October 2024
Poster
Metrics
Background
In Canada, over 3700 people are on the organ transplant list, with deceased donor kidney transplants making the majority of transplants completed annually. Despite the increasing numbers of transplants, populations marginalized by race and ethnicity have lower rates of organ donation registration and are less likely to consent to donation. Gaining insight into barriers to providing consent is critical in developing strategies to address disparities. This study aimed to identify barriers to familial consent among members of racialized and Indigenous communities.
Methods
48 participants were recruited through community-based organizations in British Columbia (BC) and included BC residents, aged over 19, who spoke English. 31 participants completed interviews and 17 completed focus groups. Participants were oversampled for members of racialized and Indigenous communities. A case vignette was used to collect data with data analyzed using summative content analysis.
Results
Four overarching barriers were identified: 1) system-level; 2) community-based; 3) related to decision-making; and 4) informational. System-level barriers highlighted mistrust of Canadian healthcare institutions, perceived coercion, and the role of language in consent. Community-based barriers involved ideas around the deceased body, funeral, afterlife, and general perceptions of organ donation. Decision-making was affected by family dynamics and donor and recipient identity. Informational barriers such as age eligibility also influenced consent. Facilitators to address barriers include culturally diverse resources, increasing community knowledge, and providing language, cultural, and religious support to build trust and facilitate discussions.
Conclusion
This study highlights barriers and modifiable determinants to familial consent in deceased organ donation among members of racialized and Indigenous communities. Although it examines barriers to familial consent for all organ donation, findings are of significant relevance to kidney care, as patients waiting for kidney transplants constitute the majority of patients on transplant waitlists. Education and engagement initiatives must be targeted at the health system and community levels to fully address barriers to consent and reduce racial and ethnic disparities in organ transplantation.

Evaluating the Informed Consent Process: Insights from Post-Operative Experiences in Pharmaceutical Care
Research Article
Muhammad Ajmal, Arslan Wajid, Zahra Rafique, Ahsan Sikandar Khan, Abdul Rehman Saddiq, Muhammad Sulaiman, Muhammad Aqeel Sultan, Usman Wajid
History of Medicine, 30 September 2024
Abstract
Background
An informed consent must be obtained legally and ethically before invasive or high-risk therapeutic procedures are performed. It is defined as the “process of communication between a patients and healthcare professionals that leads in the patient’s permission or agreement to undergo any specific medical procedure.
Aim
To investigate informed consent’s practices and determine whether the persons who have signed for surgical treatments have a sufficient understanding about the process of informed consent.
Methodology
It was a descriptive cross-sectional study that was conducted at the Rehman Medical Institute (RMI) Peshawar. Using Simple Random Probability Sampling Technique; a sample of 108 surgical patients was recruited. Data was collected using closed ended interview schedule. The validity of the redesigned instrument was evaluated by a panel of specialists, including a research supervisor and surgical practitioners. To analyze data a descriptive statistic will be used. The computer’s software, Statistical Package for Social Science (SPSS version 20) will be used for data analysis and interpretation.
Result
The sample size was 108 patients, with a 100% response rate. A total of 108 patients (89 male and 19 female) were randomly selected for post-operative interviews. Out of 108 patients, all the patients gave and signed the pre-operative informed consent process form on their own. Only 21 (19.44%) patients already knew about the informed consent process because they had almost a bachelor’s degree education. Only 31 patients (28.70%) read and fully understood the surgical informed consent process form. And 106 (98.14%) had their consent taken by a young doctor rather than the surgeon who would be doing the surgery.
Conclusion
Our study revealed that quality of informed consent process is limited at RMI Hayatabad Peshawar, due to surgeons making little or no attempt to educate their patients on this subject and the informed consent form is only available in English, with no verified translation into the patient’s mother tongue.