Family roles in informed consent from the perspective of young Chinese doctors: a questionnaire study
Research
Hanhui Xu, Mengci Yuan
BMC Medical Ethics, 3 January 2024; 25(2)
Open Access
Abstract
Background
Based on the principle of informed consent, doctors are required to fully inform patients and respect their medical
decisions. In China, however, family members usually play a special role in the patient’s informed consent, which creates a unique “doctor-family-patient” model of the physician-patient relationship. Our study targets young doctors to investigate the ethical dilemmas they may encounter in such a model, as well as their attitudes to the family roles in informed consent.
Methods
A questionnaire was developed including general demographic characteristics, the fulfillment of the obligation to fully inform, who will be informed, and the ethical dilemmas in decision-making. We recruited a total of 421 doctors to complete this questionnaire, of which 368 met the age requirements for this study. Cross tabulation and Pearson’s chi-squared test were used to analyze the differences between types of patients for categorical variables, and a p-value < 0.05 was considered statistically significant.
Results
Our data shows that only 20 doctors (5.40%) stated “informing the patient alone is sufficient” when it comes to informing patients of their serious conditions. The rest of the participants would ensure that the family was informed. When facing elderly patients with decision-making capacity, the data was statistically different (3.8%; P < 0.001) The primary reason for ensuring that family members be informed differs among the participants. In addition, when family members asked doctors to conceal the patient’s medical condition for the best interests of patients, 270 doctors (73.4%) would agree and cooperate with the family. A similar proportion (79.6%) would do so when it comes to elderly patients.
Conclusions
(1) Chinese doctors pay extra attention to informing the patient’s family, which may not be in the patient’s best interests. (2) Chinese doctors treat adult (but not elderly) patients and elderly patients differently when it comes to informing family members. (3) When family members request that doctors withhold information from patients “in the best interest of the patient,” the majority choose to comply with the request, although this may cause them distress.

Surgical informed consent practices and influencing factors in sub-Saharan Africa: a scoping review of the literature
Systematic Review
Chiara Pittalis, Cherie Sackey, Paul Okeny, Bip Nandi, Jakub Gajewski
BMJ Quality & Safety, 30 December 2023
Open Access
Abstract
Introduction
Current international standards in consent to surgery practices are usually derived from health systems in Western countries, while little attention has been given to other contexts such as sub-Saharan Africa (SSA), despite this region facing the highest burdens of disease amenable to surgery globally. The aim of this study was to examine how the concept of informed consent for surgery is interpreted and applied in the context of SSA, and factors affecting current practices.
Methods
A systematic search of Medline, Embase and African Journal OnLine databases as well as grey sources was executed in May 2023 to retrieve relevant literature published since 2010 in English language against a set of given criteria. The socioecological framework for health was used for organising and summarising the identified evidence.
Results
A total of 27 papers were included in the review. Findings revealed that consent to surgery practices is generally substandard across SSA and the process is not adequate. Patients’ understanding of informed consent is limited, likewise awareness of their rights to decision-making. A range of factors at the individual, interpersonal, institutional and system/societal levels affect the informed consent process.
Conclusion
There is a need to find more culturally acceptable and ethical ways to include the participation of patients in the decision-making process for surgical treatment in the SSA and define standards more closely aligned with the local context.

The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study
Research
Rachel C Greer, Nipaphan Kanthawang, Jennifer Roest, Carlo Perrone, Tri Wangrangsimakul, Michael Parker, Maureen Kelley, Phaik Yeong Cheah
BMC Medical Ethics, 19 December 2023
Open Access
Abstract
Background
Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research.
Method
We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key informants. A thematic analysis was conducted.
Results
Our analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations.
Conclusions
Participant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors.

Informed Consent in Human Subjects Research: A Comparison of International and Saudi Arabian Guidelines
May M. Al-Madaney, Roberto Andorno, Margrit Fässler
Journal of Clinical Research & Bioethics, 11 December 2023
Open Access
Abstract
Objective
Informed Consent (IC) is an essential requirement for the conduct of medical research involving human subjects. Since the Nuremberg Code was adopted in the aftermath of the Second World War, various international guidelines have specified the conditions for a valid IC for medical research. Among the most relevant guidelines are the World Medical Association’s Declaration of Helsinki, the guidelines of the Council of International Organization of Medical Sciences (CIOMS), and the Good Clinical Practice Guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP). This paper aims to compare the above-mentioned international guidelines with Saudi Arabia’s Law of Ethics of Research on Living Creatures regarding the requirements for IC. The comparison also includes some relevant regional and domestic laws. The objective of the study is to determine whether the compared regulations coincide regarding the requirements for a valid IC or whether they show significant differences, and to what extent such requirements are also present in Saudi Arabia’s regulations.
Methods
We conducted a content comparative analysis of the above-mentioned guidelines regarding five elements of IC: Disclosure, comprehension, voluntariness, competence, and form of consent. These five topics were subdivided into 44 subtopics. Then we compared and critically analyzed their similarities and differences.
Results
The similarities and differences observed in the seven guidelines are summarized under the five components of IC mentioned above and regarding 44 selected subtopics.
Conclusion
The analysis of the above-mentioned guidelines shows that while the most basic components of IC are present in all the compared documents, there are some differences between them. Specifically, the study found that the Saudi Arabian regulations include 26 of the 44 subtopics considered and that most of the elements that are missing relate to the disclosure of information to participants.

Editor’s note: Figure from p. 4 of article summarizing informed consent elements from various ethical guidelines.

An Audit of Preoperative Informed Consent in Surgical Patients at a Tertiary Care Hospital in Lahore, Pakistan
Muhammad Umer Shafique, Muhammad Salman Saleem, Maryam Saghir, Mohammad Saad Javaid, Mohammad Saad, Ahmad Sadiq, Hafiz U. Shibli, Muhammad Ahmad Khalid, Farhan Saleem
Cureus, 7 December 2023; 15(12)
Open Access
Abstract
    Informed consent plays a crucial role in modern clinical practice, representing a fundamental aspect of patient rights and medical ethics. The purpose of informed consent is to ensure that patients fully comprehend the procedures to which they are providing consent and the recognition that the surgeon is not guilty of battery. Moreover, clinicians safeguard themselves against potential repercussions by documenting the risks adequately conveyed to patients before performing surgery. Therefore, the significance of informed consent cannot be overstated. This survey encompassed patients from various surgical departments who underwent surgery in April 2023 at a tertiary care hospital. For the survey participants above the age of 18 were selected undergoing either emergency or elective surgical procedures. The survey employed a structured questionnaire for interviews, assessing whether patients had given informed consent before surgery. The questionnaire also inquired whether patients received information about the diagnosis, proposed surgical procedure, associated risks, and any available alternative treatment options. Furthermore, patients were asked about the proposed anesthesia type and whether the associated risks were communicated to them before the surgery.
A random selection of 50 patients was done for this study, and the process of block randomization was used with the help of a computer app to reduce bias and allow the representation of the various surgical subspecialties present in the tertiary care hospital. No evidence of consent being taken was present in two patients(4%) or the document on which the consent was signed was not present in the file. Only 48% of the patients acknowledged that they fully understood the provided information. While 60% of the patients were informed about the type of anesthesia proposed, a mere 8% were provided information regarding anesthesia risks. None of the patients in the emergency setting signed the consent form themselves, regardless of their capability to do so. Conversely, only 24% of the patients in the elective setting signed the consent form themselves. The study revealed that the quality of informed consent signing in this tertiary care hospital is below average. Healthcare professionals, including doctors and staff, need education regarding the importance of informed consent and the patient’s right to comprehend any procedure or intervention to which they are subjected. A shift in the paradigm of decision-making about a patient’s health needs to emphasize that the patient is the most critical entity in these decisions.
The main aim of the study is twofold, primarily we want to analyze the existing method of taking informed consent by comparison with the guidelines and check whether the current practice of informed consent achieves its goal of involving the patients in their treatment. Secondarily, we want to discuss the effect that patient-doctor communication might have on the delivery of the above-mentioned information.

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension
Emma Verástegui, Ricardo Páez, Oscar Arrieta
Gaceta Médica de México, 2023; 159(5) pp 426-431
Abstract
Background
The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described.
Objective
To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined.
Results
More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF.
Conclusion
It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

Editor’s note: Gaceta Médica de México is the official scientific dissemination of the National Academy of Medicine of Mexico.

Opinions and practices of midwives working in the delivery rooms on informed consent in vaginal deliveries
Pervin Sahiner, Nevin Utkualp
African Journal of Reproductive Health 2023; 27(11) pp 18-25
Abstract
Obtaining informed consent from women for vaginal birth both safeguards their autonomy and establishes a legal foundation for midwives. This study aimed to determine the opinions and practices of midwives on obtaining valid informed consent for vaginal deliveries. This descriptive study was conducted between November 2021 and December 2022 in two different cities of Turkey, Bursa and Kocaeli. Data were analyzed with Chi-square test. In the study all midwives who had not received ethics training had a common perception that informed consent merely involved obtaining a signature and was a standard practice for vaginal birth (p=0.002). In the study, 92.9% of the midwives reported that they found it necessary to obtain informed consent in vaginal deliveries, 97.6% reported that they provided verbal information. However, information provided by midwives for valid informed consent was mostly not comprehensive (range 44.4%-80.2%). Most midwives (80.2%) focused on highlighting the benefits of vaginal birth for mothers, with comparatively less emphasis on communicating information regarding the potential risks and complications associated with vaginal birth for newborns. The high percentage of midwives who considered it necessary to obtain informed consent in vaginal deliveries in our study suggests that these midwives are well aware of the significance of informed consent.

A Conduit for a Culturally Competent Consent: Medical Interpreters’ Perspectives on Surgical Informed Consent Discussions
Original Study
Benjamin G. Allar, Cristina Ponce, James Wallace, Gezzer Ortega, Amanda J. Reich, Shari Gold-Gomez, Sidhu P. Gangadharan, Tara S. Kent
Annals of Surgery, 22 November 2023
Abstract
Objective
To understand medical interpreter’s perspectives on surgical informed consent discussions and provide feedback for surgeons on improving these conversations.
Summary Background Data
Informed consent is a critical component of patient-centered surgical decision-making. For patients with limited English proficiency (LEP), this conversation may be less thorough, even with a medical interpreter, leaving patients with an inadequate understanding of their diagnosis or treatment options.
Methods
A semi-structured interview guide was developed with input from interpreters and a qualitative research expert. We purposively sampled medical interpreters representing multiple languages until thematic saturation was achieved. Participants discussed their experience with the surgical consent discussion and process. Interview transcripts were analyzed using emergent thematic analysis.
Results
Among 22 interpreters, there were ten languages represented and an average experience of 15 years (range 4-40 y). Four major themes were identified. First, interpreters consistently described their roles as patient advocates and cultural brokers. Second, interpreters reported unique patient attributes that influence the discussion, often based on patients’ cultural values/expectations, anticipated decisional autonomy, and family support. Third, interpreters emphasized the importance of surgeons demonstrating compassion and patience, using simple terminology, conversing around the consent, providing context about the form/process, and initiating a pre-encounter discussion. Finally, interpreters suggested reducing legal terminology on consent forms and translation into other languages.
Conclusions
Experienced interpreters highlighted multiple factors associated with effective and culturally tailored informed consent discussions. Surgeons should recognize interpreters’ critical and complex roles, be cognizant of cultural variations among patients with LEP, and improve interpersonal and communication skills to facilitate effective understanding.

A Survey on Applying Ethics of Informed Consent Among Egyptian Surgeons
Original Article
Omneya Ibrahim Mohamed, Rasha Ismail Khedr, Hend Mostafa Ali, Saffa Abdelaziz Mohamed Abdelaziz
Mansoura Journal of Forensic Medicine & Clinical Toxicology, 21 November 2023
Abstract
Surgical informed consent (SIC) is a fundamental part of safe clinical practice. SIC is an outcome of a proper informative process between surgeons and patients. The current study aimed to assess SIC-related practices among Egyptian surgeons. A self-administered questionnaire was formulated upon review of available literature and surgeons were invited to submit their responses electronically. 97 Egyptian surgeons participated in the study. Participants less than 40 years old represented 85.6% and 91.8% had less than 20 years’ experience. Most surgeons (83.6%) had postgraduate qualifications, 38.1% were consultants. Upon analysis of responses, it was found that 73.2% of the surgeons didn’t consider non-obtaining valid SIC an error. Regarding SIC practices, it was found that 82.5% of surgeons informed patients of all the possible risks, 75.3% of participants emphasized expected surgical outcomes and 70.1% ensured that patients understood the relevant information. 63.9% of surgeons explained the drawbacks of the procedure’s refusal. Also, 63.9% of surgeons documented SIC elements. Alternative treatment strategies were provided by 62.9% of participants. Regarding scoring of these six SIC practices, the median score was 5. Male surgeons had significantly higher median scores compared to females (p=0.003). Higher scores were observed among those less than 40 years old, consultants and those with doctorate degrees. The study concluded that a high percentage of participating surgeons didn’t appreciate the relationship between non-obtaining valid SIC and malpractice. However, the participants’ practices of SIC elements were generally good. Current results highlighted need to raise surgeons’ awareness of ideal SIC practices.

Editor’s note: Mansoura Journal of Forensic Medicine & Clinical Toxicology is published by the Department of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Mansoura University, Egypt.