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.

Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania
Renatha Kato, Renatha Joseph, Lazaro Haule, Mwanaidi Kafuye
BMC Medical Ethics, 22 April 2025
Open Access
Abstract
Background
Obtaining informed consent is the practice of respect for persons that gives the right to participants to make autonomous decisions about research participation. The difficult-to-read research informed consent forms (RICFs) hinder comprehension and can expose participants to harm. This study aims to assess the readability of health RICFs for studies approved by the National Health Research Ethics Committee (NatHREC) in Tanzania.
Methods
We used a retrospective cross-sectional study design. A total of 266 RICFs were sampled from the NatHREC database using stratified and systematic random sampling strategies. The readability of RICFs was assessed using the Flesch Reading Ease (FRE) and Flesch-Kincaid Readability Grade Level (FKRGL) formulas available in Microsoft Word Office and by manual check. Data were collected using the assessment checklist, analyzed, and presented with SPSS and MS Excel software.
Results
Out of 266 RICFs assessed, 65.4% had the recommended page numbers, 81.6% had longer sentences, and 80.5% were difficult to read, necessitating a person to acquire a US grade 10 (Form Four educational level in Tanzania) to understand the presented information. Pearson’s correlation coefficient with p-values of < 0.001 and 95% confidence level disclosed that sentence lengths in the RICFs had a statistical association with the difficult reading levels obtained.
Conclusion
Findings from this study showed that most of the RICFs were concise in terms of page numbers and word count but had long and difficult sentences. Researchers should assess the readability of RICFs before submitting them for ethical approval. Research Ethics Committees (RECs) should consider inclusion of RICFs readability measurements in the Ethics Guidelines for Health Research. The study recommends further studies to assess the Kiswahili versions of RICFs to determine if the results obtained in this study apply to Kiswahili texts.

Informed Consent in Tertiary Care Hospitals of Pakistan; The Moral Magic of Consent
Nargis Khan, Gul Hassan Sethar, Zia Ullah Khan, Lubna Meraj, Nadia Shams, Farhat Bashir
Journal of Rawalpindi Medical College, 29 March 2025
Abstract
Objective
This study aimed to assess whether standard international guidelines obtain informed consent and to identify potential contributing factors.
Methodology
This Questionnaire descriptive cross-sectional study was conducted at public sector hospitals of Karachi (October 2021-Aug. 2022) after ethical approval.  A 12-point questionnaire was developed based on three categories, first to assess awareness & significance of IC, second regarding elements of IC & third for administrative part of IC.  Indoor adult patients ≥18 years of age, who have undergone any surgical or medical procedures were included. The critically ill, unconscious and those unable to give consent were excluded. Data was analyzed by SPSS version 23.
Results
A total of 587 subjects were included, with a mean age of 43. There were 340(57.9%) males & 247(42.1%) females. 51.7% of respondents had an education level of <10 years. 51.1% & 48.9 % of subjects underwent medical related & surgical related procedures respectively. 426(72.6%) patients were aware of IC and 318(54.2%) responded affirmative to significance of IC. 407(69.3%) subjects were informed about treatment options prior to procedure, 349(59.5%) were informed about complications, while risks & benefits of procedure were discussed with 294(50.1%). 281(47.9%) of the patients were satisfied with the information about the procedure, and 288(49.1%) subjects understood the information. Of the respondents, 356(60.6%) stated that the language used wasn’t appropriate for comprehension, 200(34.1%) identified language as a barrier, 185(31.5%) pointed to cultural factors, and 202(34.4%) believed that both language and culture were barriers to IC. 368(62.7%) of the subjects signed the IC, while the IC was signed by a family member in 219(37.3%). Only a minority of patients, 199(33.9%), felt that the consent process was free and fair, while 388(66.1%) believed their decision was influenced. Among them, 233(39.7%) felt influenced by the doctor, and 155(26.4%) attributed the influence to a family member.
Conclusion
There is significant room for improvement in achieving legally and ethically valid informed consent (IC). Literacy, language barriers, and cultural beliefs are major factors influencing patient’s understanding of IC. Higher levels of education were associated with better comprehension of IC.  The majority of patients reported that the consent process was neither free nor fair, with language and cultural barriers being significant obstacles. Enhancing the communication skills of healthcare professionals and incorporating formal training on obtaining IC at all levels, from undergraduate education to consultant training, is suggested.

Informed Consent as a Fundamental Principle of Medical Ethics: An Examination of its Application in Nigerian Healthcare Settings
Onyegbule Kelechi Goodluck
Journal of Commercial and Property Law, 23 March 2025
Abstract
The patient’s right of consent to any medical treatment recommended by a medical practitioner is now internationally recognised. This consent is required by the premise of the individual’s inviolable right to choose and control his own health-care situations. Consent must be free, prior, and informed. Free indicates that permission is invalid if obtained through manipulation or coercion. Consent gained unwillingly, under duress or coercion, may result in a battery lawsuit. The consent must be granted voluntarily by a patient who has capacity to so do. Prior means that consent must be obtained adequately in advance of any authorisation granted by medical or hospital authorities, or the initiation of hospital activities that influence the patient’s health. Informed means that the patient’s agreement must be obtained only after complete and legally accurate disclosure of information about the proposed medical operation. The disclosure must be in a form that is both accessible and clear to the patient, including the nature, scope, duration, potential hazards, and foreseeable consequences of the medical operation. There must be complete disclosure of information about the treatment, benefit, danger, complications, and repercussions of such a procedure. Regarding a procedure or therapy that needs to be administered to the patient, the doctor gives all the information that is required. In Nigeria, the idea of informed, prior, and free consent is not widely recognized in the medical field. This is caused by multiple variables. First, there is the issue of Nigeria’s low literacy rate. Patients with limited literacy typically depend solely on the doctor’s judgement. The second factor is the lack of enforcement of the right to informed consent. Under Nigerian law, patients whose rights to informed consent have been violated have little recourse options. Bureaucracy also hinders the processes that are in place to enforce the right to informed consent. This article makes the case that the legal and institutional regimes for Nigeria’s informed consent laws are insufficient.

Challenges to gaining informed consent in a low-income urban community in Ghana: a case study of Tetegu, Weija Gbawe
Case Study
Darrold Cordes, Paul Sefah, Dora Marinova
Discover Sustainability, 20 March 2025
Open Access
Abstract
There is a lack of data describing the physical, social, economic, and environmental conditions of low-income communities in Sub-Saharan African cities. Research to obtain this data requires informed consent from business owners and heads of households. This case study focuses on a small enclave of approximately 150 households and associated businesses and community services in Tetegu, Accra, Ghana. Low-altitude aerial and terrestrial surveys were conducted to identify all structures, business types, and occupancy levels of households. A sample of businesses and households were purposively chosen as potential participants in the study. Interviews were conducted and informed consent procedures were followed in accordance with the ethics approval. Data was collected online using a computer tablet and informed consent was recorded electronically. Language and literacy barriers required considerable patience when presenting the scope of the research and participants’ roles and rights. Distrust of researchers, resentment, indifference, and aggressive behavior towards researchers were encountered. Other challenges included health and safety concerns and the quality of telecommunication services. Informed consent was obtained from more than 30% of households and 10% of businesses. The research outcomes may not represent other urban low-income communities in Accra or other cities in Ghana, West Africa, or Sub-Saharan Africa.