Exploring knowledge and attitudes toward electronic informed consent among clinical trial participants in China: a cross-sectional study

Ying Wu, Xing Liu, Xiaoying Ge, Xin Tan, Weiwei Yu, Xiaomin Wang

BMC Medical Ethics, 26 May 2025

Open Access

Abstract

Background

With the extensive integration of digital technology into clinical research, intelligence, virtualization, and decentralization have gradually transformed into emerging clinical research modes, the electronization of informed consent has become indispensable to the development of clinical trial informatization, and the inclination to use electronic informed consent (eIC) has grown. The knowledge and perceptions of research participants, as objects of informed consent acquisition, regarding eIC are crucial. However, few studies have empirically explored such issues.

Methods

This cross-sectional study was conducted at three general hospitals in south-central China from July to September 2022. An online survey questionnaire was adapted and administered via WeChat to investigate the issues of interest.

Results

A total of 388 valid questionnaires were included in the analysis. The results showed that the overall response rate for the knowledge section of the questionnaire exceeded 70%. Of the respondents, 53.1% had heard of the term “electronic informed consent,” but only 43.2% had used eIC. The majority of respondents (68%) expressed a preference for using eIC and demonstrated a positive attitude toward it. However, some participants expressed concerns regarding the security and confidentiality (64.4%), operational complexity (52.3%), and effectiveness of online interaction (59.3%) in eIC. Statistically significant relationships were observed between participants’ attitude scores and their age, gender, type of participation, and frequency of involvement in clinical research. Additionally, a positive and statistically significant correlation was found between participants’ knowledge scores and their attitude scores.

Conclusion

The results of this study indicate that most participants have a good understanding of eIC-related knowledge and hold a positive attitude toward its implementation. However, they also express concerns about data protection and privacy security in eIC. These findings provide a foundation for developing targeted strategies to enhance the adoption and acceptance of eIC among diverse populations.

Family consent to deceased organ donation in China: a participatory qualitative study

Original research

Haiyan He, Chaojie Liu, Ying Huang, Wei Ouyang, Zirui Xin, Hanan Khalil, Aijing Luo, Wenzhao Xie

Journal of Medical Ethics, 22 May 2025

Abstract

Background

Organ donation improves patient survival and quality of life, yet family refusal is a major barrier. This study aimed to explore the role of family discussions in shaping attitudes and decisions about organ donation in China, while also examining the influencing factors at the individual, family, community and societal levels.

Method

Participatory interviews with family members were conducted based on the social-ecological model (SEM). A snowball sampling strategy was adopted to recruit volunteer interviewers. Of 52 interviewers, 25 completed the family group interviews, involving 94 participants in total. Interviews were audio-recorded and transcribed verbatim within 24 hours. Two researchers coded the data in line with SEM. Themes were identified through an inductive process.

Results

Four themes were identified out of family discussions about deceased organ donation: (i) individual perceptions on the value of lives and organ donation (value of organ donation, death attitudes, knowledge about organ donation), (ii) family consensus and conflicts (family structure, family altruism), (iii) collective conformity (conformity, individualism, negativity bias) and (IV) culture and social environment (traditional beliefs, incentive policy, education, media promotion).

Conclusion

This study is the first to systematically examine the factors influencing deceased organ donation in the Chinese family context. Obtaining family consent for organ donation appears to be challenging in Chinese families due to limited knowledge and traditional beliefs. Incentive policies that benefit the family are crucial. While media promotion is effective in increasing awareness of organ donation, education and family discussions are critical in alleviating fears and misunderstandings about deceased organ donation.

Too uncertain to consent, too supportive to refuse: the sociocultural dilemma of hesitant organ donors in Kazakhstan

Original Research

Aidos Bolatov, Aruzhan Asanova, Aigerim Abdiorazova, Yuriy Pya

Frontiers of Public Health: Public Health Education and Promotion, 19 May 2025

Abstract

Background

Understanding the factors influencing posthumous organ donation decisions is essential for developing effective strategies to increase donor registration. While previous studies have explored reasons for consent and refusal, less attention has been given to individuals who defer the decision to their families (Decision Left to Close Relatives, DLCR). This study examines the sociodemographic, institutional, and cultural factors influencing donation preferences, with a focus on the DLCR group as a transitional category between consent (LC) and refusal (LR).

Methods

A cross-sectional survey was conducted among 1,333 participants in Kazakhstan. Donation preferences were categorized into Lifetime Consent (35.3%), Lifetime Refusal (21.4%), and DLCR (43.4%). Participants completed measures assessing knowledge, attitudes, and perceived barriers to organ donation. Principal Component Analysis (PSA) identified two key dimensions of perceived barriers: institutional and cultural barriers. Linear regression and mediation analyses were performed to examine predictors of attitudes toward organ donation.

Results

The DLCR group held intermediate attitudes toward donation, significantly higher than LR but lower than LC (p < 0.001), moreover, 44.4% of the DLCR group had a favorable attitude toward organ donation. A critical finding was the high level of uncertainty about how to declare donation status among DLCR participants, significantly higher than in both LC and LR (p < 0.05). PCA revealed that DLCR individuals were institutionally closer to LC but culturally aligned with LR, suggesting that cultural concerns are the stronger barrier preventing proactive consent. Among DLCR participants, knowledge positively predicted donation attitudes (β = 0.223, p < 0.001), while cultural and religious barriers had the strongest negative effect (β = −0.290, p < 0.001). Language preference also emerged as a factor, with Russian speakers demonstrating significantly more favorable attitudes than Kazakh speakers. Specialization (medical vs. non-medical) had no direct effect on donation attitudes (p = 0.777), but it influenced attitudes indirectly through institutional (β = −0.223, p < 0.001) and cultural barriers (β = 0.194, p = 0.003).

Conclusion

Both procedural uncertainty and cultural-religious factors influence the hesitation of DLCR individuals to commit to donation, with cultural concerns having a stronger effect. Language preference also shapes attitudes, reflecting broader sociocultural framings. Reducing uncertainty and addressing cultural misconceptions, particularly among the DLCR group, may be key to increasing donor registration.

Knowledge and associated factors of patients towards informed consent in obstetric and gynecologic surgical procedures at Debre Markos Comprehensive Specialized Hospital, Ethiopia

Addisu Andualem Ferede, Mamaru Getie Fetene, Endinew Beka, Worku Taye Getahun, Aysheshim Asnake Abneh

Frontiers of Surery: Obstetrics and Gynecological Surgery, 7 May 2025

Abstract

Background

Informed consent is a principle in medical ethics that a patient must have adequate information and understanding before making decisions about their medical care. It is essential for both clinicians and patients in surgery and should be seen as a usual activity. Knowledge is one of the main intervention tools to improve patient comprehension in informed consent of surgical patients. In Ethiopia, little is known about the knowledge level and its determinant towards obstetric and gynecologic surgical informed consent. Due to this reason, this study aimed to assess the level of knowledge and determinants of surgical informed consent among patients undergone obstetric and gynecologic surgery at Debre Markos Comprehensive Specialized Hospital.

Methods

An institutional-based cross-sectional study was conducted from November 28 to December 30, 2023, among 298 post-operative women admitted to Debre Markos Comprehensive Specialized Hospital. Data were collected using a pretested structured interviewer-administered questionnaire using a systematic random sampling technique. The collected data were entered into Epi-Data version 4.6 and then exported to SPSS statistical software version 25 for analysis. A multivariable logistic regression analysis was employed to estimate the effect of independent variables on the outcome variable. An adjusted odds ratio (AOR) with 95% Confidence interval was computed to report the presence of association between the dependent and independent variables. Statistical significance was determined at a P-value of <0.05.

Results

A total of 298 women participated in the study. The overall good knowledge of women regarding obstetrical and gynecologic surgical informed consent was 42.3% (95%CI: 36.7, 47.9). Urban residence (AOR= 2.32, 95%CI: 1.08, 5.03), educational status of women (AOR= 4.85, 95%CI: 1.99, 11.78), elective type of surgery AOR= 1.8, 95%CI: 1.14, 4.07), and having previous history of surgery (AOR= 7.2, 95%CI: 4.02, 15.15) were the identified determinant factors affecting knowledge of women towards obstetric and gynecologic surgical informed consent.

Conclusion

More than half of the study participants lack overall good knowledge regarding obstetrical and gynecologic surgical informed consent. Residence, educational status, schedule of surgery, and previous history of surgery were the identified determinant factors affecting the knowledge of women towards obstetric and gynecologic surgical informed consent.

Surgical consent, perception of the patients who underwent a surgical operation in the Kurdistan region, Iraq

Dawan Jamal Hawezy

BMC Medical Ethics, 2 May 2025

Open Access

Abstract

Introduction

Patient satisfaction is a significant measure of healthcare service quality as the patient is the center of any surgical procedure. Patient satisfaction refers to the extent to which a patient’s expectations of optimal care align with their perception of the care received. Patient satisfaction during informed consent is enhanced when written informed consent is accompanied by verbal consent in the preoperative period. Satisfied patients are more inclined to adhere to therapy, engage actively in their care, utilize healthcare services, willingly partake in decision-making, and remain with a healthcare provider. This research examines the practical and ethical considerations of obtaining informed consent during surgical procedures. To better understand and make informed decisions, this study aims to assess the efficacy of present consent methods and pinpoint obstacles patients encounter.

Methodology

A cross-sectional study was conducted from April to December 2024. Data were gathered by second-year students from Koya University’s Faculty of General Medicine by interviewing postoperative patients who had undergone general surgical procedures. The results were entered into a Google form and analyzed using SPSS27.

Results

In interviews with participants, 430 out of 572 patients (75%) indicated trust in their surgeons performing the surgery, while 525 patients (91%) expressed respect for their surgeons’ opinions. However, 41% (239 patients) reported not reading the informed consent form, and a similar percentage denied that the details of the form were explained by the medical staff responsible for the surgery as there are some medical terms or situations in the form that are challenging to assume if not explained.

Conclusion

Compared to others, participants with a higher educational level sought extensive time from the responsible surgeons to discuss every detail of the surgery before signing the informed consent, with a statistically significant difference observed. A similar difference was noted between private and public hospitals.

Patients’ perceptions and understanding of preoperative informed consent: A qualitative thematic analysis from Tanzania

Research Article

Steven Michael, Willbroad Kyejo, Allyzain Ismail, Sunil Samji, Eric Aghan, Columba Mbekenga, Athar Ali

SAGE Open Medicine, 28 April 2025

Open Access

Abstract

Background

Informed consent, grounded in the ethical principle of autonomy, represents a patient’s agreement to undergo a procedure. Given its critical role in protecting human rights and autonomy, obtaining informed consent before any surgery or procedure is now a mandatory practice. However, many studies question whether informed consent is conducted genuinely, ensuring proper understanding of the information disclosed, or merely serves as a medicolegal formality. This has led to increased malpractice, misunderstanding, anxiety, and overall postoperative dissatisfaction.

Objective

This study aimed to explore patients’ perceptions and experiences regarding the informed consent process for elective surgeries, identifying key challenges and areas for improvement.

Methods

This descriptive qualitative study was conducted at Aga Khan Hospital using individual in-depth interviews. Fourteen patients who had undergone elective surgery were recruited. Baseline data were presented in tables, and inductive thematic analysis was used to interpret the qualitative data.

Results

Seven themes emerged from the data: Consent as a legal formality, autonomy, and decision-making, insufficient information, time constraints and lack of opportunities for questions, use of medical jargon, patients’ desired information, and overall satisfaction with care. Despite patients’ higher levels of education and the hospital’s patient-centered care approach, many felt the information provided was insufficient, superficial, and difficult to understand.

Conclusion

The study found a significant gap between the information patients desired and what was provided. Insufficient information, coupled with the use of medical jargon and time constraints, adversely affected the informed consent process. Enhancing clarity in communication and allowing adequate time for discussions could improve patient understanding and satisfaction.