Nurses’ legal literacy related to informed consent in the Chinese cultural context:a cross-sectional study

Nurses’ legal literacy related to informed consent in the Chinese cultural context:a cross-sectional study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Nurses’ legal literacy related to informed consent in the Chinese cultural context:a cross-sectional study Lingli Cai, Siyun Wang, Yuxin Zhang, Shuxian Zhang, Weiju Chen, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9212541/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Background Informed consent is a communication process between health care providers and patients, which culminates in the authorisation or refusal of a specific intervention. For clinical nurses to appropriately follow the requisite practices for informed consent, it is crucial for them to have sufficient ethical and legal knowledge, as well as sensitivity. The present study aimed to investigate the current status of nurses’ legal literacy toward informed consent and analyze its factors. Methods A descriptive cross-sectional study using a researcher-generated questionnaire for data collection was employed. Data were collected from 6199 nurses in different clinical departments, and analysed using descriptive statistics and a non-parametric Mann-Whitney U test. Results The average score of informed consent was 3.80 ± 1.45. 40.6% nurses answered all the questions correctly. Only 62.2% believed that medical staff could be exempted from legal liability, when the patient refused or insisted on staff performing a treatment, after having signed an informed consent form. Nurses’ age, work experience, and professional titles revealed a significant positive correlation with their awareness of informed consent. However, clinical departments where nurses worked, and whether they had received medico-legal knowledge during school, presented an irrelevant result. Conclusions Nurses’ awareness of the accurate implementation of informed consent was not adequate because of the disconnect between theory and practice in nursing education, moral cognitive bias of Chinese laws and ethics, and family-oriented medical and family ethics. It is necessary to carry out medical law-related continuing education considering Chinese culture, and combine theoretical knowledge with clinical practice. Health sciences/Health care Health sciences/Health occupations Health sciences/Medical research informed consent nursing ethics legal education Chinese culture Background Informed consent is the basis for respecting and guaranteeing patients’ self-determination during medical treatment. It is an important personal right concerning patients’ health, physical wellness, and privacy, with ethical and legal connotations.While implied, oral, and written consent are acceptable forms of informed consent.In the West informed consent has been applied since the early 1960s.China changed the concept of consent from ‘simple consent’ to ‘informed consent’ in 1999 , when the Law of the People's Republic of China on Medical Practitioners was promulgated. Until 2020, in the Civil Code of the People’s Republic of China, informed consent has been changed from the original ‘obtaining written consent’ to ‘obtaining explicit consent’ (Article 1219 of the Civil Code of the People’s Republic of China, Number 1260, enacted on 28 May 2020) [1]. The right of informed consent in China has been further developed and improved. Nurses Regulation issued by The State Council of the People’s Republic of China, which stipulates nurses’ notification and guidance obligations. Nurses who fail to perform their notified duties or improperly cause harm to patients, face corresponding legal liabilities. But Nurses Regulation is just an administrative regulation with limited legal rights and responsibilities. All in all, there is no a law on nurse practitioners promulgated by the People's Republic of China, which clearly distinguishes between individual responsibilities and the scope of informed consent. Informed consent is a process of communication and negotiation between the healthcare provider or investigator, and the patient or research participant. Informed consent is important from both legal and ethical perspectives. It involves the autonomy of patients, and implies that they possess independent clinical judgement to fully accept and understand medical information related to their disease. It also involves the necessary information including potential risks and alternatives that patients need to understand before a procedure. Hence, they have the right to decide on their own choice of treatment plans, rather than those formulated by the medical staff [2]. This process should be conducted rationally and voluntarily, according to the patients' expressed wishes. Although written consent’s frequency often makes it a clerical need [3], the implied and oral consent forms of expressing patients' wishes mandated by law are often ignored in clinical practice. While this may overemphasise written documentation in an effort to protect providers and institutions from liability [4], it does not necessarily reflect autonomous decisions regarding authentic informed consent. The International Council of Nurses’ Code of Ethics prescribe that ‘Practitioners and managers need to provide sufficient information to permit informed consent for nursing and/or medical care, and the right to choose or refuse treatment’ [5]. Informed consent is more than a signature on a legal document; it is a process of communication required to provide and achieve informed consent [6]. Hence, the role that nurses need to play in the process of informed consent is pivotal. Nurses play a unique role in clinical practice. Besides fulfilling their own duties, they are required to coordinate various relationships, such as those with doctors, other nurses or departments, patients and their families. Such coordination promotes the smooth progress of clinical diagnoses and treatment plans, providing patients with comprehensive medical services [7]. Based on these characteristics of nursing work and clinical nursing practice, nurses are often regarded as medical staff, with the closest contact with patients, during the nursing process. Therefore, it is important for them to respect patients’ rights to informed consent, as they also have a legal obligation in this regard. Although Chinese law stipulates that the statutory subject to implement informed consent are medical personnel, the law does not clearly distinguish between the responsibilities of each responsible subject and the scope of informed consent, especially in the case of nurses. Similarly, in Korean [8] and Indonesian [9], there is a lack of definitive nurse roles and responsibilities in the informed consent process. It places the nurse in a dilemma regarding obtaining informed consent. Nurses still have a blind spot on patients' right to informed consent. Nurses have difficulties in performing patients' right to informed consent. Since the early 2000s, the number of medical disputes in China have risen by approximately 23% [10]. In 2018, 42% of the lawsuits were lost due to failure to obtain informed consent, which was the biggest factor in medical losses [11]. Awareness among medical staff of the informed consent obligation has increased in recent years. According to the latest 2021 statistics, the proportion of lawsuits lost by medical parties due to failure to obtain informed consent have dropped to 22%, but further improvement is still needed [12]. Most people, including nurses, believe that physicians, rather than nurses, comprise the main body having legal obligations in the informed consent process. Such recognition is already reflected in the legislation of countries, such as the United States [3,13] and Canadian [6], whose laws stipulate that doctors bear the legal responsibility of obtaining their patients’ informed consent. In China, the Civil Code of the People’s Republic of China stipulates that medical personnel are statutorily liable for implementing informed consent. This means that nurses, as one of medical personnel, also have the same legal responsibilities as doctors. However, there is no a law which can clarify the legal rights and obligations on nurse practitioners promulgated by the People's Republic of China. The professional identity of nurses is insufficient in China, which is different from Western countries. Nursing work may be continuously underestimated or not given due respect, affecting nurses' identification with the profession, especially young nurses. Those may separate nurses becoming affiliated to doctors rather than independent professionals. Gradually, it leads to insufficient legal literacy among nurses regarding consciously performing the obligatory obtaining of informed consent. In addition, Chinese nurses currently do not enjoy the legal right to prescribe prescriptions, which seems to represent decision-making and authority. Nurses may feel that they do not have “decision-making and authority”, and thus lack of confidence in the implementation of informed consent. In China, Performing various invasive procedures become the routine work for nurses, which may be different from the work content of Western nurses, such as arteriovenous puncture technique, peripherally inserted central catheter, insertion of gastric tube, insertion of urinary catheter, etc. Doctors may believe that nurses should perform the duty of informed information, because these invasive procedures are not their job scope. On the contrary, nurses believe that doctors should inform patients about medical information related to these invasive procedures because of the prescriptions for those procedures given by doctors. These may cause the blind area of informed consent right, thus violating the legitimate rights and interests of patients. It is essential for clinical nurses to have sufficient ethical and legal knowledge related to informed consent. Nurses should be sensitive to the topic and understand their roles and responsibilities, so that the practices required for consent can be appropriately followed [14] At present, there are few domestic studies on nurses’ legal literacy related to informed consent. The purpose of this study was to describe the current status of nurses’ legal literacy related to informed consent within the Chinese context, that will lead to the design of interventions. In addition, China is one of the countries with Civil Law System. This study also aimed to explore the ethical and legal role of nurses in informed consent, in order to provide inspiration for other civil law countries, especially those with less developed economies or nursing manpower shortage. Methods Design and sample This was a descriptive and cross-sectional study, which recruited 6280 nurses from different regions and provinces in China—Northeast, North, East, Northwest, South, Southwest, the Central region of China, and Hong Kong, Macao, and Taiwan. Participants were recruited between June and October 2020,and the inclusion criteria were: (1) registered nurses, and (2) have at least 1 year of clinical nursing experience. Manager level nurses who do not deliver bedside care were excluded. Of the 6280 nurses, 6199 returned the duly filled questionnaires, and the response rate was 98.6%. Questionnaire and data collection Demographic, work-related information, and medical law education information Participants' demographic (age, gender, marital status, educational level) and work-related information(hospital classification, professional titles, regions of the hospital, operating post, clinical sections, working experience) were collected. In addition, medical law education information received during school and after work were collected. Clinical nurses’ l egal literacy questionnaire The Clinical nurses' legal literacy questionnaire was adopted to evaluate behaviors toward among Chinese nurses. The scale was designed by Wang [15] and contained 18 items and 8 nursing legal topics (implementation of medical orders, informed consent, right to privacy, emergency care, scope of legal liability, nursing record standard, duty of care, and constraint protection). The questionnaire used in this study was developed by researchers based on a review of the literature and nurses’ work experience. Thereafter, its first version was developed and presented to five experts in clinical nursing and nursing management, and one expert in medical legality, for advice regarding content validity. Some semantic ambiguities and linguistic errors were identified, and more appropriate words were chosen. The questionnaire were revised accordingly. After re-evaluating, the scale was submitted to the expert committee to evaluate the content validity, and the item-content validity index (I-CVI) was 0.96. In a pilot study with a sample of 30 nurses, Cronbach’s α showed an acceptable reliability of about 0.876. Each question was answered as “Yes” or “No”; correct answers received 1 point while wrong answers earned 0 points. The score was converted to a percentile correct answer rate (%), with higher scores indicating greater the legal literacy. Only the patient informed consent section (PIC) was used in this study, which included five items. Data analysis All analyses were performed using IBM SPSS Statistics version 27.0. Descriptive statistics (frequency, mean, standard deviation), and a non-parametric Mann-Whitney U test were used for data analysis. For all statistical analyses, the significance level was set at P < 0.05. Results The questionnaire’s response rate was 98.6%, as 6199 of the 6280 nurse respondents returned the duly filled questionnaires. The respondents included 5973 (95.8%) female and 262 (4.2%) male nurses, whose mean age was 32.20±7.87, with a range of 19–61 years, and mean working experience was 11.51±8.32 years, with a range of 1–41 years ( Table 1 ) . Table 1 Demographic characteristics of the sample Features n(%) Means±SD t/F P Age 19–30 31–40 41–50 51–61 3138(50.6) 2095(33.8) 822(13.3) 144(2.3) 3.72±1.496 3.84±1.440 3.97±1.306 4.06±1.012 9.346 .000 Gender Male Female 262(4.2) 5937(95.8) 2.97±1.811 3.84±1.418 - 7.658 .000 Hospital classification Municipal tertiary hospital Municipal secondary hospital Provincial hospital Teaching hospital directly under the university Township or community and other grassroots medical institutions County-level hospital Others 3798(61.3) 357(5.8) 670(10.8) 515(8.3) 177(2.9) 549(8.9) 133(2.1) Highest education Technical secondary school Diploma Bachelor of nursing science Master's degree or PhD degree 356(5.7) 1922(31.0) 3817(61.6) 104(1.7) 3.64±1.554 3.69±1.518 3.87±1.393 3.65±1.486 8.608 .000 First academic Technical secondary school Diploma Bachelor of Nursing Science 3055(49.3) 2048(33.0) 1096(17.7) 3.81±1.423 3.77±1.488 3.84±1.436 0.893 .410 Professional titles Primary title Middle title Senior title 4082(65.8) 1732(27.9) 385(6.2) 3.72±1.483 3.92±1.397 4.07±1.179 18.757 .000 Regions of the hospital Northeast North East Northwest South Southwest The central region Others 6(0.1) 95(1.5) 316(5.1) 266(4.3) 4886(78.8) 347(5.6) 127(2.0) 156(2.5) Operating post Clinical nurse (not head nurse) Clinical nurse (head nurse or chief nurse) Community nurse/ Township hospital nurse Administrative post Others 5310(85.7) 648(10.5) 26(0.4) 82(1.3) 133(2.1) Clinical sections Internal Medicine Surgical Department Obstetrics and Gynaecology Department Paediatrics E.N.T. Department Intensive Care Unit Emergency Room Outpatient Related Departments Non-clinical First-line Department Operating Room, Disinfection Supply Room 1637(26.4) 1317(21.2) 539(8.7) 488(7.9) 166(2.7) 394(6.4) 510(8.2) 389(6.3) 316(5.1) 443(7.1) 3.84±1.431 3.81±1.448 3.89±1.368 3.64±1.457 3.94±1.329 3.70±1.564 3.75±1.553 3.95±1.315 3.79±1.378 3.66±1.524 0.009 2.442 Working experience 1–10 11–20 21–30 31–41 3501(56.5) 1716(27.7) 810(13.1) 171(2.8) 3.73±1.493 3.85±1.421 3.97±1.332 4.00±1.111 7.842 .000 Whether received medical law education during school Yes No 4307(69.5) 1892(30.5) 3.79±1.475 3.83±1.381 - 1.049 0.294 Whether received medical law education after working Yes No 5002(80.7) 1197(19.3) 3.83±1.438 3.68±1.476 3.193 0.001 Five items were designed to evaluate nurses’ legal literacy of patients’ informed consent. 40.6% nurses answered all the questions correctly. More specifically, the percentage of nurses who answered the first, second, third, and fourth questions correctly were 61.2%, 74.90%, 85.3%, 85.9%, and 72.7%, respectively (Table 2) . Table 2 The item answer rate of the patient informed consent section (PIC) English item Correct number answer rate (%), Q1. When a patient either refuses or insists on having a treatment performed and has signed an informed consent form, can the medical staff be exempted from legal liability while the safety of the patient cannot be guaranteed by your professional judgment? 3795 61.2 Q2. Do you think that no matter how serious the patient's condition is, that medical staff should truthfully explain the condition and medical measures to the patient, even if the patient's immediate family asks you to hide it? 4643 74.9 Q3. Do you think that medical staff cannot rescue the patient without the consent of the patient or his close relatives, even if in critical condition? 5287 85.3 Q4. Do you think that as a medical staff mastering cutting-edge technology, you do not need to be responsible for the medical consequences arising from operating against a nursing routine with the consent of the patient? 5328 85.9 Q5. There is a medical technology under development, the safety and treatment effect are not clear, and there is a high risk. Do you think that if the patient has informed consent and has signed the relevant informed consent form, that the patient can join the group to conduct the medical trial? 4509 72.7 Additionally, the nurses’ mean PIC score was 3.80±1.45. Female and male nurses’ scores differed in PIC (p = .000). Female nurses’ scored higher than male nurses (3.84±1.42 versus 2.97±1.81). And nurses’ age, work experience, and professional titles showed a significant positive correlation with their PIC scores ( p < .05). Nurses who were older, had more work experience, and had greater seniority in terms of job title obtained higher PIC scores compared to their younger, less experienced counterparts, which implied better awareness regarding patients’ informed consent. Similarly, the nurses’ unit/department (e.g. intensive care unit, outpatient departments, etc.) also showed a significant correlation with PIC scores ( p < .05). While respondents’ highest educational level and their having received medical-related legal knowledge after work showed a significant correlation with PIC scores ( p .05). The clinical departments where the nurses worked also presented an irrelevant result ( p > .05) ( Table 1 ) . There were extremely uneven ratios in hospital classifications, regions of the hospital, and operating posts. Therefore, these three variables were not statistically analysed in this study. In terms of nurses’ medical law education, 69.5% confirmed receiving it at their academic education stage, and 80.7% after commencing work. Experienced registered nurses and those with medical ethics and law education had higher PIC scores. Discussion Nurses’ legal literacy in informed consent and its relationship with nursing education This study attempts to expose nurses’ actual level of legal literacy regarding patients’ informed consent in nursing clinical practice in China. The fact, that less than half of this study’s respondents were considerably familiar with patients’ informed consent implies that nurses’ role awareness in the informed consent process is unclear. Similarly, Axson et al. [ 3 ] found that 45% of the nurses, who indicated that they were involved with informed consent, disagreed with the following statement: ‘I, as a nurse, have a defined role in the informed consent process’. In addition, a significant correlation was observed between nurses’ highest education level and their questionnaire score in the process of obtaining informed consent. It seemed that higher the nurses’ educational levels, higher were their PIC scores. However, those with Bachelor of Nursing Science had the highest PIC score, and having Master’s or PhD degrees did not correlate to PIC scores.Yinli [ 16 ] also reported that nursing staff with a diploma maintained significantly higher legal knowledge and awareness. This is related to the lack of nursing education in China, especially when it comes to ethical and legal in the medical field. The teaching content is too academic and framed, and does not have clinical practice value, which are the reasons for the insufficient performance in the aspects of "care" and "nursing", and just outstanding performance of Chinese nursing students in the technical field. Nurses generally do not come into contact with most ethical and legal issues until they are formally engaged in clinical work. Nurses with low education have longer clinical working hours and higher ethical and legal sensitivity to informed consent. Nurses with less education have more work experience and have higher ethical and legal sensitivity to informed consent. This is because of the need for clinical practice or has been sued. Nurses with a master's degree or above mainly focus on scientific research and primary clinical practice. They tended to neglect clinical communication, and hence, were less likely to receive medico-legal education and subsequently cultivate legal consciousness in their clinical work. Compared with low-educated nurses, these highly educated nurses not only have no further improvement in relevant legal theories, but also lack clinical work experience. As a result, their sensitivity and practical ability of performing informed consent are weaker than low-educated nurses. This is further verified in the findings that higher professional titles are associated with better PIC practice ability. Nurses’ professional titles are related to clinical work experience in China. The higher professional title, the richer work experience. Moreover, nurses who had received relevant medico-legal education since commencing work showed higher PIC scores than those who did not receive such education. Simultaneously, relevant education during their academic education did not correlate with PIC scores. This study’s findings support the qualitative work of Axson et al. [ 3 ] who reported that 30% of the respondents disagreed with the statement that their undergraduate education prepared them to actively engage in the informed consent process. Clearly, if the theoretical knowledge learnt in nursing school is not combined with clinical practice, there will not be a satisfactory result. Currently, the teaching mode dominated by theoretical knowledge is largely prevalent in nursing academic education and continuing education in China. This exposes the shortcomings of the current educational approach and reminds nursing educators and administrators, that reforms and innovations in nursing academic education and continuing education are urgently needed to improve legal knowledge training, by focusing on informed consent in practice. Therefore, this study contributes to the development of practical suggestions for an alternative educational approach. Nurses’ informed consent influenced by the moral cognitive bias of Chinese law and ethics In this study, older nurses, those seniority in terms of professional titles, and greater work experience had higher PIC scores. Inferentially, nurses who had rich working experience enjoyed a clearer awareness of patients’ informed consent in clinical work. The clinical environment in which nurses work is complex. In China, as nurses have no prescription rights, they are more likely to cooperate with doctors’ instructions to complete patients’ informed consent. Moreover, there are no laws for nurses regarding protection of patients' rights and interests. Although there are relevant laws on the responsibility and obligation of medical staff to implement patients' informed consent rights, the role of nurses remains ambiguous. Huang et al. [ 17 ] found that nurses primarily rely on intuition for making decisions in day-to-day clinical practice. Although their actions may often align with what is ethically acceptable, they appear to lack awareness of the ethical aspects involved or conscious reference to the ethical frameworks. Therefore, relying on ‘intuition’, experienced nurses have an advantage in the correct implementation of patients' right to informed consent. Staff nurses who lack experience may rely on the opinions of senior nurses [ 18 ]. It is noteworthy that this complex, unregulated work situation could temper nurses’ awareness and authority to implement informed consent rights. Hence, the laws need to be improved upon. For example, nurses’ rights and obligations relating to informed consent should be further clarified, and the scope of some legal concepts involved in informed consent should be defined more clearly. These could help nurses better define their roles in the process of informed consent, and better protect patients’ legal rights and interests. Nurses’ informed consent influenced by medical and family ethics One-fourth of the nurse respondents thought they should truthfully explain the condition and medical measures to patients, even if the patients’ immediate family asked them to hide the truth. The medical ethical spirit of informed consent is based on respect for patient autonomy. To maintain the medical purpose of charity which is to achieve the greatest happiness and health for the patient, China respects the decisions of patients’ families, which is different from respect for patients’ individual rights in western countries [ 19 ]. Therefore, in China, especially for serious illnesses, informed consent is often the right of patients' families, not patients themselves. Furthermore, as per Chinese family ethics, family decision-making is considered higher than individual decision-making (i.e. individual health decisions are made under the consideration of the entire family) [ 19 ]. This is different from the individualism advocated in the West. Therefore, in the face of patients' right to informed consent and their family members’ request for concealment, both legal and ethical grounds would urge medical staff to give careful consideration to the families’ needs. During complex medical relationships, nurses often experience ethical dilemmas between honouring the family’s preference for protective nondisclosure, and patients’ ‘right to know’ about their condition. Hence, by virtue of being medical workers, who are most closely related to patients, nurses should focus on clinical or community work, and attach importance to the health popularization and knowledge guidance of patients and their families, by assisting them in making more reasonable health-related decisions. Study limitations This study had some limitations. First, a cross-sectional design was used, making causal inferences impossible to determine. Second, although an effective sample size was used for the analysis, there were insufficient samples for psychiatric clinical nurses and forensic nurses, who may maintain a higher legal literacy level in informed consent. It may have affected Chinese clinical nurses’ legal literacy level in informed consent. Conclusion This study’s findings suggest that nurses’ awareness of the accurate implementation of informed consent is not adequate, despite its importance in clinical practice. Fortunately, this study reminds us that factors, such as experience, higher educational levels, and medical law education, play an important role in legal literacy of informed consent among nurses. Therefore, combining theoretical knowledge with clinical practice, and continuing education on medical legalities could be included as a standard practice in the curriculum of both medical and nursing schools. Meanwhile, Chinese culture should be valued in medico-legal education. A study of the law combined with clinical experience and the professional practice environment will reduce the legal confusion among nurses, and better promote the implementation of the right to informed consent. Thus, medico-legal education, should be provided as part of continuing professional education, which meeting the aim of improving the level of Chinese nurses’ legal literacy of patients’ informed consent. Declarations Ethics approval and consent to participate This study was approved by the Ethics Review Committee of The First Affiliated Hospital, Jinan University(No. KY-2021-089). All methods were carried out in accordance with relevant guidelines and regulation. Informed consent was obtained from all subjects. Competing interests The authors declare no competing interests. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Author Contribution All authors contributed to the conception and design of the study. Study design, questionnaire collection, data acquisition were performed by CLL,WSY and ZYX. Data analysis and the first draft of the manuscript was written by CLL and ZSX. LQR and CWJ commented on the manuscript and revised it critically for important intellectual content.All authors read and approved the final manuscript. Acknowledgement We thank the five nursing experts and one legal expert for their valuable advice on the compilation of the questionnaire. We also thank all clinical nurses who participated in this study as well as the reviewers and editors. Data Availability The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. References National People’s Congress of the People’s Republic of China. The Civil Code of the People’s Republic of China. (Civil Law.) (Law no. 1260) May 2020 (in China). Xue Q. 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Nurs Ethics. 2005;12:595–605. https://doi.org/ 10.1191/0969733005ne829oa Wang YL. Informed consent—patients’ right and dilemma. Medicine and Philosophy. 2001;3:1–3. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 13 May, 2026 Reviewers agreed at journal 03 May, 2026 Reviewers invited by journal 02 Apr, 2026 Editor assigned by journal 02 Apr, 2026 Editor invited by journal 31 Mar, 2026 Submission checks completed at journal 28 Mar, 2026 First submitted to journal 28 Mar, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9212541","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":617688317,"identity":"7d44d8c7-f87e-45cc-8723-630bff607f5d","order_by":0,"name":"Lingli Cai","email":"","orcid":"","institution":"The First Affiliated Hospital of Jinan University","correspondingAuthor":false,"prefix":"","firstName":"Lingli","middleName":"","lastName":"Cai","suffix":""},{"id":617688318,"identity":"ba812b27-c8bd-4a6f-820e-7a7f6d0867bd","order_by":1,"name":"Siyun Wang","email":"","orcid":"","institution":"Sichuan college of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Siyun","middleName":"","lastName":"Wang","suffix":""},{"id":617688319,"identity":"4772db89-1ca9-4c1a-850e-ce47052d22a1","order_by":2,"name":"Yuxin Zhang","email":"","orcid":"","institution":"Ili Kazakh Autonomous Prefecture Branch of the High People's Court of Xinjiang Uygur Autonomous Region","correspondingAuthor":false,"prefix":"","firstName":"Yuxin","middleName":"","lastName":"Zhang","suffix":""},{"id":617688320,"identity":"c0876e5e-ea1c-4bea-9073-1bc08c417ce5","order_by":3,"name":"Shuxian Zhang","email":"","orcid":"","institution":"Wenzhou Medical University Affiliated Eye Hospital","correspondingAuthor":false,"prefix":"","firstName":"Shuxian","middleName":"","lastName":"Zhang","suffix":""},{"id":617688321,"identity":"b713706d-2a85-4b1b-8167-7dc96a12a3e5","order_by":4,"name":"Weiju Chen","email":"","orcid":"","institution":"University of Jinan","correspondingAuthor":false,"prefix":"","firstName":"Weiju","middleName":"","lastName":"Chen","suffix":""},{"id":617688322,"identity":"7e92a2b6-44d6-423a-9b04-572192f6213f","order_by":5,"name":"Qingran Lin","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0UlEQVRIiWNgGAWjYDACZgglw8bAfODAhwoStPCwMbAlHpxxhgTLeIDI+DBvCxFK+Y7zHn5dUXOHh0+658MB3gYGeX6xA/i1SB7mS7M8c+wZD5vM2Q0HJHcwGM6cnYBfi8FhHjPDBrbDPGwSuRsOGJ5hSDC4TZSWfyAtOQ8OJLYRp8X4YWMbWAvDgYPEaJEE2sLY2AfSkmZwsOGMBGG/8J0/Y/yx4dthOfkZyY8//6mwkeeXJqCF4QADmwQSVwKnQmQtzB+IUDYKRsEoGAUjGQAAr1dFuBib2awAAAAASUVORK5CYII=","orcid":"","institution":"The First Affiliated Hospital of Jinan University","correspondingAuthor":true,"prefix":"","firstName":"Qingran","middleName":"","lastName":"Lin","suffix":""}],"badges":[],"createdAt":"2026-03-24 13:25:47","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9212541/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9212541/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":106960125,"identity":"364015ad-1d26-48e8-80ef-cefb79c668aa","added_by":"auto","created_at":"2026-04-15 09:19:01","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":746769,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9212541/v1/6e053a61-25fb-4fab-a455-c31f3fd04f5e.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Nurses’ legal literacy related to informed consent in the Chinese cultural context:a cross-sectional study","fulltext":[{"header":"Background","content":"\u003cp\u003eInformed consent is the basis for respecting and guaranteeing patients\u0026rsquo; self-determination during medical treatment. It is an important personal right concerning patients\u0026rsquo; health, physical wellness, and privacy, with ethical and legal connotations.While implied, oral, and written consent are acceptable forms of informed consent.In the West informed consent has been applied since the early 1960s.China changed the concept of consent from \u0026lsquo;simple consent\u0026rsquo; to \u0026lsquo;informed consent\u0026rsquo; in 1999\u003cstrong\u003e,\u003c/strong\u003e when the\u0026nbsp;Law of the People\u0026apos;s Republic of China on Medical Practitioners\u0026nbsp;was promulgated. Until 2020, in\u0026nbsp;the Civil Code of the People\u0026rsquo;s Republic of China, informed consent has\u0026nbsp;been\u0026nbsp;changed from the original \u0026lsquo;obtaining written consent\u0026rsquo; to \u0026lsquo;obtaining explicit consent\u0026rsquo; (Article 1219 of the Civil Code of the People\u0026rsquo;s Republic of China, Number 1260, enacted on 28 May 2020)\u0026nbsp;[1]. The right of informed consent in China has been further developed and improved.\u0026nbsp;Nurses Regulation issued by The State Council of the People\u0026rsquo;s Republic of China, which stipulates nurses\u0026rsquo; notification and guidance obligations. Nurses who fail to perform their notified duties or improperly cause harm to patients, face corresponding legal liabilities. But Nurses Regulation is just an administrative regulation with limited legal rights and responsibilities. All in all, there is no a law on nurse practitioners promulgated by the People\u0026apos;s Republic of China, which clearly distinguishes between individual responsibilities and the scope of informed consent.\u003c/p\u003e\n\u003cp\u003eInformed consent is a process of communication and negotiation between the healthcare provider or investigator, and the patient or research participant. Informed consent is important from both legal and ethical perspectives. It involves the autonomy of patients, and implies that they possess independent clinical judgement to fully accept and understand medical information related to their disease. It also involves the necessary information including potential risks and alternatives that patients need to understand before a procedure. Hence, they have the right to decide on their own choice of treatment plans, rather than those formulated by the medical staff [2]. This process should be conducted rationally and voluntarily, according to the patients\u0026apos; expressed wishes. Although written consent\u0026rsquo;s frequency often makes it a clerical need [3], the implied and oral consent forms of expressing patients\u0026apos; wishes mandated by law are often ignored in clinical practice. While this may overemphasise written documentation in an effort to protect providers and institutions from liability [4], it does not necessarily reflect autonomous decisions regarding authentic informed consent. The International Council of Nurses\u0026rsquo; Code of Ethics prescribe that \u0026lsquo;Practitioners and managers need to provide sufficient information to permit informed consent for nursing and/or medical care, and the right to choose or refuse treatment\u0026rsquo; [5].\u003csup\u003e\u0026nbsp;\u003c/sup\u003eInformed consent is more than a signature on a legal document; it is a process of communication required to provide and achieve informed consent [6]. Hence,\u0026nbsp;the role that nurses need to play in the process of informed consent is pivotal.\u003c/p\u003e\n\u003cp\u003eNurses play a unique role in clinical practice. Besides fulfilling their own duties, they are required to coordinate various relationships, such as those with doctors, other nurses or departments, patients and their families. Such coordination promotes the smooth progress of clinical diagnoses and treatment plans, providing patients with comprehensive medical services [7]. Based on these characteristics of nursing work and clinical nursing practice, nurses are often regarded as medical staff, with the closest contact with patients, during the nursing process. Therefore, it is important for them to respect patients\u0026rsquo; rights to informed consent, as they also have a legal obligation in this regard. Although Chinese law stipulates that the statutory subject to implement informed consent are medical personnel, the law does not clearly distinguish between the responsibilities of each responsible subject and the scope of informed consent, especially in the case of nurses. Similarly, in Korean [8]\u0026nbsp;and Indonesian\u0026nbsp;[9], there is a lack of definitive nurse roles and responsibilities in the informed consent process. It places the nurse in a dilemma regarding obtaining informed consent.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNurses still have a blind spot on patients\u0026apos; right to informed consent. Nurses have difficulties in performing patients\u0026apos; right to informed consent. Since the early 2000s, the number of medical disputes in China have risen by approximately 23% [10]. In 2018, 42% of the lawsuits were lost due to failure to obtain informed consent, which was the biggest factor in medical losses [11]. Awareness among medical staff of the informed consent obligation has increased in recent years. According to the latest 2021 statistics, the proportion of lawsuits lost by medical parties due to failure to obtain informed consent have dropped to 22%, but further improvement is still needed [12]. Most people, including nurses, believe that physicians, rather than nurses, comprise the main body having legal obligations in the informed consent process. Such recognition is already reflected in the legislation of countries, such as the United States [3,13] and Canadian [6], whose laws stipulate that doctors bear the legal responsibility of obtaining their patients\u0026rsquo; informed consent. In China,\u0026nbsp;the Civil Code of the People\u0026rsquo;s Republic of China stipulates that medical personnel are statutorily liable for implementing informed consent. This means that nurses, as one of medical personnel, also have the same legal responsibilities as doctors. However, there is no a law which can clarify the legal rights and obligations\u0026nbsp;on nurse practitioners promulgated by the People\u0026apos;s Republic of China.\u0026nbsp;The professional identity of nurses is insufficient in China, which is different from Western countries. Nursing work may be continuously underestimated or not given due respect, affecting nurses\u0026apos; identification with the profession, especially young nurses. Those may separate nurses becoming affiliated to doctors rather than independent professionals. Gradually, it leads to insufficient\u0026nbsp;legal literacy\u0026nbsp;among nurses regarding consciously performing the obligatory obtaining of informed consent.\u0026nbsp;In addition, Chinese nurses currently do not enjoy the legal right to prescribe prescriptions, which seems to represent decision-making and authority.\u0026nbsp;Nurses may\u0026nbsp;feel\u0026nbsp;that they do not have\u0026nbsp;\u0026ldquo;decision-making and authority\u0026rdquo;, and thus\u0026nbsp;lack of confidence in the implementation of informed consent. In China,\u0026nbsp;Performing various\u0026nbsp;invasive procedures\u0026nbsp;become the routine work for nurses, which may be different from the work content of Western nurses,\u0026nbsp;such as arteriovenous puncture technique, peripherally inserted central catheter, insertion of gastric tube, insertion of urinary catheter, etc. Doctors may believe that nurses should perform the duty of informed information, because these invasive procedures are not their job scope. On the contrary, nurses believe that doctors should inform patients about\u0026nbsp;medical information related to\u0026nbsp;these invasive procedures because of the prescriptions for those procedures given by doctors. These may cause the blind area of informed consent right, thus violating the legitimate rights and interests of patients.\u0026nbsp;It is essential for clinical nurses to have sufficient ethical and legal knowledge related to informed consent.\u0026nbsp;Nurses should be sensitive to the topic and understand their roles and responsibilities, so that the practices required for consent can be appropriately\u0026nbsp;followed\u0026nbsp;[14]\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt present, there are few domestic studies on nurses\u0026rsquo; legal literacy related to informed consent. The purpose of this study was to describe the current status of nurses\u0026rsquo; legal literacy related to informed consent within the Chinese context, that will lead to the design of interventions. In addition, China is one of the countries with Civil Law System. This study also aimed to explore the ethical and legal role of nurses in informed consent, in order to provide inspiration for other civil law countries, especially those with less developed economies or nursing manpower shortage.\u003c/p\u003e"},{"header":"Methods","content":"\u003ch2\u003eDesign and sample\u003c/h2\u003e\n\u003cp\u003eThis was a descriptive and cross-sectional study, which recruited 6280 nurses from different regions and provinces in China\u0026mdash;Northeast, North, East, Northwest, South, Southwest, the Central region of China, and Hong Kong, Macao, and Taiwan. Participants were recruited between June and October 2020,and the inclusion criteria were: (1) registered nurses, and (2) have at least 1 year of clinical nursing experience. Manager level nurses who do not deliver bedside care were excluded. Of the 6280 nurses, 6199 returned the duly filled questionnaires, and the response rate was 98.6%.\u003c/p\u003e\n\u003ch2\u003eQuestionnaire and data collection\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDemographic, work-related information, and medical law\u0026nbsp;education information\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants\u0026apos; demographic (age, gender, marital status, educational level) and work-related information(hospital classification, professional titles, regions of the hospital, operating post, clinical sections, working experience) were collected. In addition, medical law education information received during school and after work were collected.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eClinical\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;nurses\u0026rsquo; l\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003eegal literacy\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;questionnaire\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Clinical nurses\u0026apos; legal literacy questionnaire was adopted to evaluate behaviors toward among Chinese nurses. The scale was designed by Wang [15] and contained 18 items and 8 nursing legal topics (implementation of medical orders, informed consent, right to privacy, emergency care, scope of legal liability, nursing record standard, duty of care, and constraint protection).\u0026nbsp;The questionnaire used in this study was developed by researchers based on a review of the literature and nurses\u0026rsquo; work experience. Thereafter, its first version was developed and presented to five experts in clinical nursing and nursing management, and one expert in medical legality, for advice regarding content validity. Some semantic ambiguities and linguistic errors were identified, and more appropriate words were chosen.\u0026nbsp;The questionnaire were revised accordingly. After re-evaluating, the scale was submitted to the expert committee to\u0026nbsp;evaluate the content validity, and the item-content validity index\u0026nbsp;(I-CVI) was 0.96.\u0026nbsp;In a pilot study with a sample of 30 nurses, Cronbach\u0026rsquo;s \u0026alpha; showed an acceptable reliability of about 0.876.\u0026nbsp;Each question was answered as\u0026nbsp;\u0026ldquo;Yes\u0026rdquo;\u0026nbsp;or\u0026nbsp;\u0026ldquo;No\u0026rdquo;;\u0026nbsp;correct answers received 1 point while wrong answers earned 0 points. The score was\u0026nbsp;converted to a percentile correct answer rate (%), with higher scores\u0026nbsp;indicating greater the legal literacy. Only the\u0026nbsp;patient\u0026nbsp;informed consent\u0026nbsp;section\u0026nbsp;(PIC)\u0026nbsp;was used in this study, which included five items.\u003c/p\u003e\n\u003ch2\u003eData analysis\u003c/h2\u003e\n\u003cp\u003eAll analyses were performed using IBM SPSS Statistics version 27.0. Descriptive statistics (frequency, mean, standard deviation), and a non-parametric Mann-Whitney U test were used for data analysis. For all statistical analyses, the significance level was set at\u003cem\u003e\u0026nbsp;P\u003c/em\u003e \u0026lt; 0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThe questionnaire\u0026rsquo;s response rate was 98.6%, as 6199 of the 6280 nurse respondents returned the duly filled questionnaires. The respondents included 5973 (95.8%) female and 262 (4.2%) male nurses, whose mean age was 32.20\u0026plusmn;7.87, with a range of 19\u0026ndash;61 years, and mean working experience was 11.51\u0026plusmn;8.32 years, with a range of 1\u0026ndash;41 years \u003cstrong\u003e(\u003c/strong\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003cstrong\u003e)\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;Demographic characteristics of the sample\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"879\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 38.9522%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFeatures\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u003cstrong\u003en(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 17.1982%;\"\u003e\n \u003cp\u003eMeans\u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 17.1982%;\"\u003e\n \u003cp\u003et/F\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;19\u0026ndash;30\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;31\u0026ndash;40\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;41\u0026ndash;50\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;51\u0026ndash;61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3138(50.6)\u003c/p\u003e\n \u003cp\u003e2095(33.8)\u003c/p\u003e\n \u003cp\u003e822(13.3)\u003c/p\u003e\n \u003cp\u003e144(2.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.72\u0026plusmn;1.496\u003c/p\u003e\n \u003cp\u003e3.84\u0026plusmn;1.440\u003c/p\u003e\n \u003cp\u003e3.97\u0026plusmn;1.306\u003c/p\u003e\n \u003cp\u003e4.06\u0026plusmn;1.012\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e9.346\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e262(4.2)\u003c/p\u003e\n \u003cp\u003e5937(95.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2.97\u0026plusmn;1.811\u003c/p\u003e\n \u003cp\u003e3.84\u0026plusmn;1.418\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e- 7.658\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eHospital classification\u003c/p\u003e\n \u003cp\u003eMunicipal tertiary hospital\u003c/p\u003e\n \u003cp\u003eMunicipal secondary hospital\u003c/p\u003e\n \u003cp\u003eProvincial hospital\u003c/p\u003e\n \u003cp\u003eTeaching hospital directly under the university\u003c/p\u003e\n \u003cp\u003eTownship or community and other grassroots medical institutions\u003c/p\u003e\n \u003cp\u003eCounty-level hospital\u003c/p\u003e\n \u003cp\u003eOthers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3798(61.3)\u003c/p\u003e\n \u003cp\u003e357(5.8)\u003c/p\u003e\n \u003cp\u003e670(10.8)\u003c/p\u003e\n \u003cp\u003e515(8.3)\u003c/p\u003e\n \u003cp\u003e177(2.9)\u003c/p\u003e\n \u003cp\u003e549(8.9)\u003c/p\u003e\n \u003cp\u003e133(2.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eHighest education\u003c/p\u003e\n \u003cp\u003eTechnical secondary school\u003c/p\u003e\n \u003cp\u003eDiploma\u003c/p\u003e\n \u003cp\u003eBachelor of nursing science\u003c/p\u003e\n \u003cp\u003eMaster\u0026apos;s degree or PhD degree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e356(5.7)\u003c/p\u003e\n \u003cp\u003e1922(31.0)\u003c/p\u003e\n \u003cp\u003e3817(61.6)\u003c/p\u003e\n \u003cp\u003e104(1.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.64\u0026plusmn;1.554\u003c/p\u003e\n \u003cp\u003e3.69\u0026plusmn;1.518\u003c/p\u003e\n \u003cp\u003e3.87\u0026plusmn;1.393\u003c/p\u003e\n \u003cp\u003e3.65\u0026plusmn;1.486\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e8.608\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eFirst academic\u003c/p\u003e\n \u003cp\u003eTechnical secondary school\u003c/p\u003e\n \u003cp\u003eDiploma\u003c/p\u003e\n \u003cp\u003eBachelor of Nursing Science\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3055(49.3)\u003c/p\u003e\n \u003cp\u003e2048(33.0)\u003c/p\u003e\n \u003cp\u003e1096(17.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.81\u0026plusmn;1.423\u003c/p\u003e\n \u003cp\u003e3.77\u0026plusmn;1.488\u003c/p\u003e\n \u003cp\u003e3.84\u0026plusmn;1.436\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e0.893\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e.410\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eProfessional titles\u003c/p\u003e\n \u003cp\u003ePrimary title\u003c/p\u003e\n \u003cp\u003eMiddle title\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eSenior title\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4082(65.8)\u003c/p\u003e\n \u003cp\u003e1732(27.9)\u003c/p\u003e\n \u003cp\u003e385(6.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.72\u0026plusmn;1.483\u003c/p\u003e\n \u003cp\u003e3.92\u0026plusmn;1.397\u003c/p\u003e\n \u003cp\u003e4.07\u0026plusmn;1.179\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e18.757\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eRegions of the hospital\u003c/p\u003e\n \u003cp\u003eNortheast\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eNorth\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eEast\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eNorthwest\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eSouth \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eSouthwest\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eThe central region\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eOthers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e6(0.1)\u003c/p\u003e\n \u003cp\u003e95(1.5)\u003c/p\u003e\n \u003cp\u003e316(5.1)\u003c/p\u003e\n \u003cp\u003e266(4.3)\u003c/p\u003e\n \u003cp\u003e4886(78.8)\u003c/p\u003e\n \u003cp\u003e347(5.6)\u003c/p\u003e\n \u003cp\u003e127(2.0)\u003c/p\u003e\n \u003cp\u003e156(2.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eOperating post\u003c/p\u003e\n \u003cp\u003eClinical nurse (not head nurse)\u003c/p\u003e\n \u003cp\u003eClinical nurse (head nurse or chief nurse)\u003c/p\u003e\n \u003cp\u003eCommunity nurse/ Township hospital nurse\u003c/p\u003e\n \u003cp\u003eAdministrative post\u003c/p\u003e\n \u003cp\u003eOthers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5310(85.7)\u003c/p\u003e\n \u003cp\u003e648(10.5)\u003c/p\u003e\n \u003cp\u003e26(0.4)\u003c/p\u003e\n \u003cp\u003e82(1.3)\u003c/p\u003e\n \u003cp\u003e133(2.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eClinical sections\u003c/p\u003e\n \u003cp\u003eInternal Medicine\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eSurgical Department\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eObstetrics and\u0026nbsp;Gynaecology\u0026nbsp;Department\u003c/p\u003e\n \u003cp\u003ePaediatrics \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eE.N.T. Department\u003c/p\u003e\n \u003cp\u003eIntensive Care Unit\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eEmergency Room \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eOutpatient Related Departments \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eNon-clinical First-line Department \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eOperating Room, Disinfection Supply Room \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1637(26.4)\u003c/p\u003e\n \u003cp\u003e1317(21.2)\u003c/p\u003e\n \u003cp\u003e539(8.7)\u003c/p\u003e\n \u003cp\u003e488(7.9)\u003c/p\u003e\n \u003cp\u003e166(2.7)\u003c/p\u003e\n \u003cp\u003e394(6.4)\u003c/p\u003e\n \u003cp\u003e510(8.2)\u003c/p\u003e\n \u003cp\u003e389(6.3)\u003c/p\u003e\n \u003cp\u003e316(5.1)\u003c/p\u003e\n \u003cp\u003e443(7.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.84\u0026plusmn;1.431\u003c/p\u003e\n \u003cp\u003e3.81\u0026plusmn;1.448\u003c/p\u003e\n \u003cp\u003e3.89\u0026plusmn;1.368\u003c/p\u003e\n \u003cp\u003e3.64\u0026plusmn;1.457\u003c/p\u003e\n \u003cp\u003e3.94\u0026plusmn;1.329\u003c/p\u003e\n \u003cp\u003e3.70\u0026plusmn;1.564\u003c/p\u003e\n \u003cp\u003e3.75\u0026plusmn;1.553\u003c/p\u003e\n \u003cp\u003e3.95\u0026plusmn;1.315\u003c/p\u003e\n \u003cp\u003e3.79\u0026plusmn;1.378\u003c/p\u003e\n \u003cp\u003e3.66\u0026plusmn;1.524\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e0.009\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e2.442\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eWorking experience\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;1\u0026ndash;10\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;11\u0026ndash;20\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;21\u0026ndash;30\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;31\u0026ndash;41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3501(56.5)\u003c/p\u003e\n \u003cp\u003e1716(27.7)\u003c/p\u003e\n \u003cp\u003e810(13.1)\u003c/p\u003e\n \u003cp\u003e171(2.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.73\u0026plusmn;1.493\u003c/p\u003e\n \u003cp\u003e3.85\u0026plusmn;1.421\u003c/p\u003e\n \u003cp\u003e3.97\u0026plusmn;1.332\u003c/p\u003e\n \u003cp\u003e4.00\u0026plusmn;1.111\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e7.842\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e.000\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eWhether received medical law education during school\u003c/p\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4307(69.5)\u003c/p\u003e\n \u003cp\u003e1892(30.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.79\u0026plusmn;1.475\u003c/p\u003e\n \u003cp\u003e3.83\u0026plusmn;1.381\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e- 1.049\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e0.294\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38.9522%;\"\u003e\n \u003cp\u003eWhether received medical law education after working\u003c/p\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9.4533%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5002(80.7)\u003c/p\u003e\n \u003cp\u003e1197(19.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3.83\u0026plusmn;1.438\u003c/p\u003e\n \u003cp\u003e3.68\u0026plusmn;1.476\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e3.193\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.1982%;\"\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eFive items were designed to evaluate nurses\u0026rsquo; legal literacy of patients\u0026rsquo; informed consent. 40.6% nurses answered all the questions correctly. More specifically, the percentage of nurses who answered the first, second, third, and fourth questions correctly were 61.2%, 74.90%, 85.3%, 85.9%, and 72.7%, respectively \u003cstrong\u003e(Table 2)\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eThe\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eitem\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;answer rate\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;of the patient informed consent section\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;(PIC)\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 75.3086%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnglish item\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003eCorrect number\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003eanswer rate (%),\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75.3086%;\"\u003e\n \u003cp\u003eQ1. When a patient either refuses or insists on having a treatment\u0026nbsp;performed and has signed an\u0026nbsp;informed consent form,\u0026nbsp;can\u0026nbsp;the medical staff be exempted from legal liability while the safety of the patient\u0026nbsp;cannot\u0026nbsp;be guaranteed by your professional judgment?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e3795\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e61.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75.3086%;\"\u003e\n \u003cp\u003eQ2. Do you think that no matter how serious the patient\u0026apos;s condition is, that medical staff should truthfully explain the condition and medical measures to the patient, even if the patient\u0026apos;s immediate family asks you to hide it?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e4643\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e74.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75.3086%;\"\u003e\n \u003cp\u003eQ3. Do you think that\u0026nbsp;medical staff cannot rescue the patient without the consent of the patient or his close relatives, even if in critical condition?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e5287\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e85.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75.3086%;\"\u003e\n \u003cp\u003eQ4. Do you think that as a medical staff mastering cutting-edge technology, you do not need to be responsible for the medical consequences arising from operating against a nursing routine with the consent of the patient?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e5328\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e85.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75.3086%;\"\u003e\n \u003cp\u003eQ5. There is a medical technology under development, the safety and treatment effect are not clear, and there is a high risk. Do you think that if the patient has informed consent and has signed the relevant informed consent form, that the patient can join the group to conduct the medical trial?\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e4509\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 12.3457%;\"\u003e\n \u003cp\u003e72.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAdditionally, the nurses\u0026rsquo; mean PIC score was 3.80\u0026plusmn;1.45. Female and male\u0026nbsp;nurses\u0026rsquo; scores differed in PIC (p = .000). Female nurses\u0026rsquo; scored higher than male\u0026nbsp;nurses (3.84\u0026plusmn;1.42 versus 2.97\u0026plusmn;1.81). And nurses\u0026rsquo; age, work experience, and professional titles showed a significant positive correlation with their PIC scores (\u003cem\u003ep\u003c/em\u003e \u0026lt; .05). Nurses who were older, had more work experience, and had greater seniority in terms of job title obtained higher PIC scores compared to their younger, less experienced counterparts, which implied better awareness regarding patients\u0026rsquo; informed consent. Similarly, the nurses\u0026rsquo; unit/department (e.g. intensive care unit, outpatient departments, etc.) also showed a significant correlation with PIC scores (\u003cem\u003ep\u003c/em\u003e \u0026lt; .05). While respondents\u0026rsquo; highest educational level and their having received medical-related legal knowledge after work showed a significant correlation with PIC scores (\u003cem\u003ep\u003c/em\u003e \u0026lt; .05), their first educational level and their having received medical legal knowledge during school were not significantly correlated with PIC scores (\u003cem\u003ep\u003c/em\u003e \u0026gt; .05). The clinical departments where the nurses worked also presented an irrelevant result (\u003cem\u003ep\u003c/em\u003e \u0026gt; .05) \u003cstrong\u003e(\u003c/strong\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003cstrong\u003e)\u003c/strong\u003e.\u0026nbsp;There were extremely uneven ratios in hospital classifications, regions of the hospital, and operating posts. Therefore, these three variables were not statistically analysed in this study.\u003c/p\u003e\n\u003cp\u003eIn terms of nurses\u0026rsquo; medical law education, 69.5% confirmed receiving it at their academic education stage, and 80.7% after commencing work. Experienced registered nurses and those with medical ethics and law education had higher PIC scores.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eNurses\u0026rsquo; legal literacy in informed consent and its relationship with nursing education\u003c/h2\u003e \u003cp\u003eThis study attempts to expose nurses\u0026rsquo; actual level of legal literacy regarding patients\u0026rsquo; informed consent in nursing clinical practice in China. The fact, that less than half of this study\u0026rsquo;s respondents were considerably familiar with patients\u0026rsquo; informed consent implies that nurses\u0026rsquo; role awareness in the informed consent process is unclear. Similarly, Axson et al. [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] found that 45% of the nurses, who indicated that they were involved with informed consent, disagreed with the following statement: \u0026lsquo;I, as a nurse, have a defined role in the informed consent process\u0026rsquo;. In addition, a significant correlation was observed between nurses\u0026rsquo; highest education level and their questionnaire score in the process of obtaining informed consent. It seemed that higher the nurses\u0026rsquo; educational levels, higher were their PIC scores. However, those with Bachelor of Nursing Science had the highest PIC score, and having Master\u0026rsquo;s or PhD degrees did not correlate to PIC scores.Yinli [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] also reported that nursing staff with a diploma maintained significantly higher legal knowledge and awareness. This is related to the lack of nursing education in China, especially when it comes to ethical and legal in the medical field. The teaching content is too academic and framed, and does not have clinical practice value, which are the reasons for the insufficient performance in the aspects of \"care\" and \"nursing\", and just outstanding performance of Chinese nursing students in the technical field. Nurses generally do not come into contact with most ethical and legal issues until they are formally engaged in clinical work. Nurses with low education have longer clinical working hours and higher ethical and legal sensitivity to informed consent. Nurses with less education have more work experience and have higher ethical and legal sensitivity to informed consent. This is because of the need for clinical practice or has been sued. Nurses with a master's degree or above mainly focus on scientific research and primary clinical practice. They tended to neglect clinical communication, and hence, were less likely to receive medico-legal education and subsequently cultivate legal consciousness in their clinical work. Compared with low-educated nurses, these highly educated nurses not only have no further improvement in relevant legal theories, but also lack clinical work experience. As a result, their sensitivity and practical ability of performing informed consent are weaker than low-educated nurses. This is further verified in the findings that higher professional titles are associated with better PIC practice ability. Nurses\u0026rsquo; professional titles are related to clinical work experience in China. The higher professional title, the richer work experience.\u003c/p\u003e \u003cp\u003eMoreover, nurses who had received relevant medico-legal education since commencing work showed higher PIC scores than those who did not receive such education. Simultaneously, relevant education during their academic education did not correlate with PIC scores. This study\u0026rsquo;s findings support the qualitative work of Axson et al. [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] who reported that 30% of the respondents disagreed with the statement that their undergraduate education prepared them to actively engage in the informed consent process. Clearly, if the theoretical knowledge learnt in nursing school is not combined with clinical practice, there will not be a satisfactory result. Currently, the teaching mode dominated by theoretical knowledge is largely prevalent in nursing academic education and continuing education in China. This exposes the shortcomings of the current educational approach and reminds nursing educators and administrators, that reforms and innovations in nursing academic education and continuing education are urgently needed to improve legal knowledge training, by focusing on informed consent in practice. Therefore, this study contributes to the development of practical suggestions for an alternative educational approach.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eNurses\u0026rsquo; informed consent influenced by the moral cognitive bias of Chinese law and ethics\u003c/h2\u003e \u003cp\u003eIn this study, older nurses, those seniority in terms of professional titles, and greater work experience had higher PIC scores. Inferentially, nurses who had rich working experience enjoyed a clearer awareness of patients\u0026rsquo; informed consent in clinical work. The clinical environment in which nurses work is complex. In China, as nurses have no prescription rights, they are more likely to cooperate with doctors\u0026rsquo; instructions to complete patients\u0026rsquo; informed consent. Moreover, there are no laws for nurses regarding protection of patients' rights and interests. Although there are relevant laws on the responsibility and obligation of medical staff to implement patients' informed consent rights, the role of nurses remains ambiguous. Huang et al. [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] found that nurses primarily rely on intuition for making decisions in day-to-day clinical practice. Although their actions may often align with what is ethically acceptable, they appear to lack awareness of the ethical aspects involved or conscious reference to the ethical frameworks. Therefore, relying on \u0026lsquo;intuition\u0026rsquo;, experienced nurses have an advantage in the correct implementation of patients' right to informed consent. Staff nurses who lack experience may rely on the opinions of senior nurses [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. It is noteworthy that this complex, unregulated work situation could temper nurses\u0026rsquo; awareness and authority to implement informed consent rights. Hence, the laws need to be improved upon. For example, nurses\u0026rsquo; rights and obligations relating to informed consent should be further clarified, and the scope of some legal concepts involved in informed consent should be defined more clearly. These could help nurses better define their roles in the process of informed consent, and better protect patients\u0026rsquo; legal rights and interests.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eNurses\u0026rsquo; informed consent influenced by medical and family ethics\u003c/h2\u003e \u003cp\u003eOne-fourth of the nurse respondents thought they should truthfully explain the condition and medical measures to patients, even if the patients\u0026rsquo; immediate family asked them to hide the truth. The medical ethical spirit of informed consent is based on respect for patient autonomy. To maintain the medical purpose of charity which is to achieve the greatest happiness and health for the patient, China respects the decisions of patients\u0026rsquo; families, which is different from respect for patients\u0026rsquo; individual rights in western countries [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Therefore, in China, especially for serious illnesses, informed consent is often the right of patients' families, not patients themselves.\u003c/p\u003e \u003cp\u003eFurthermore, as per Chinese family ethics, family decision-making is considered higher than individual decision-making (i.e. individual health decisions are made under the consideration of the entire family) [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. This is different from the individualism advocated in the West. Therefore, in the face of patients' right to informed consent and their family members\u0026rsquo; request for concealment, both legal and ethical grounds would urge medical staff to give careful consideration to the families\u0026rsquo; needs. During complex medical relationships, nurses often experience ethical dilemmas between honouring the family\u0026rsquo;s preference for protective nondisclosure, and patients\u0026rsquo; \u0026lsquo;right to know\u0026rsquo; about their condition. Hence, by virtue of being medical workers, who are most closely related to patients, nurses should focus on clinical or community work, and attach importance to the health popularization and knowledge guidance of patients and their families, by assisting them in making more reasonable health-related decisions.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eStudy limitations\u003c/h2\u003e \u003cp\u003eThis study had some limitations. First, a cross-sectional design was used, making causal inferences impossible to determine. Second, although an effective sample size was used for the analysis, there were insufficient samples for psychiatric clinical nurses and forensic nurses, who may maintain a higher legal literacy level in informed consent. It may have affected Chinese clinical nurses\u0026rsquo; legal literacy level in informed consent.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study\u0026rsquo;s findings suggest that nurses\u0026rsquo; awareness of the accurate implementation of informed consent is not adequate, despite its importance in clinical practice. Fortunately, this study reminds us that factors, such as experience, higher educational levels, and medical law education, play an important role in legal literacy of informed consent among nurses. Therefore, combining theoretical knowledge with clinical practice, and continuing education on medical legalities could be included as a standard practice in the curriculum of both medical and nursing schools. Meanwhile, Chinese culture should be valued in medico-legal education. A study of the law combined with clinical experience and the professional practice environment will reduce the legal confusion among nurses, and better promote the implementation of the right to informed consent. Thus, medico-legal education, should be provided as part of continuing professional education, which meeting the aim of improving the level of Chinese nurses\u0026rsquo; legal literacy of patients\u0026rsquo; informed consent.\u003c/p\u003e "},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThis study was approved by the Ethics Review Committee of The First Affiliated Hospital, Jinan University(No. KY-2021-089). All methods were carried out in accordance with relevant guidelines and regulation. Informed consent was obtained from all subjects.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eAll authors contributed to the conception and design of the study. Study design, questionnaire collection, data acquisition were performed by CLL,WSY and ZYX. Data analysis and the first draft of the manuscript was written by CLL and ZSX. LQR and CWJ commented on the manuscript and revised it critically for important intellectual content.All authors read and approved the final manuscript.\u003c/p\u003e\n\u003ch2\u003eAcknowledgement\u003c/h2\u003e\n\u003cp\u003eWe thank the five nursing experts and one legal expert for their valuable advice on the compilation of the questionnaire. We also thank all clinical nurses who participated in this study as well as the reviewers and editors.\u003c/p\u003e\n\u003ch2\u003eData Availability\u003c/h2\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eNational People\u0026rsquo;s Congress of the People\u0026rsquo;s Republic of China. The Civil Code of the People\u0026rsquo;s Republic of China. (Civil Law.) (Law no. 1260) May 2020 (in China).\u003c/li\u003e\n\u003cli\u003eXue Q. An analysis of the right of informed consent of patients in my country [PhD Thesis]. China: Qingdao University 2017.\u003c/li\u003e\n\u003cli\u003eAxson SA, Giordano NA, Hermann RM, Ulrich CM. Evaluating nurse understanding and participation in the informed consent process. Nurs Ethics. 2019;26(4):1050-1061. https://doi.org/10.1177/0969733017740175\u003c/li\u003e\n\u003cli\u003eGrady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015;372(9):855-62. https://doi.org/10.1056/NEJMra1411250\u003c/li\u003e\n\u003cli\u003eInternational Council of Nurses. The ICN code of ethics. Available from:https://www.icn.ch/sites/default/files/inline-files/2012_ICN_Codeofethicsfornurses_%20eng.pdf\u003c/li\u003e\n\u003cli\u003eCantini F, Ells C. The role of the clinical trial nurse in the informed consent process. Can J Nurs Res 2007;39:126\u0026ndash;44. \u003c/li\u003e\n\u003cli\u003eLiu JY ,Wang W, Jiang SH, Chen H, Li X. Problems and countermeasures of informed consent in nursing work. Chine J trauma and disability Med. 2013;21:377\u0026ndash;378.https://doi.org/10.3969/j.issn.1673-6567.2013.04.347\u003c/li\u003e\n\u003cli\u003eLee S, Lee WH, Kong BH, Kim IS, Kim S. Nurses\u0026rsquo; perceptions of informed consent and their related roles in Korea: an exploratory study. Int J Nurs Stud 2009;46:1580\u0026ndash;4. https://doi.org/10.1016/j.ijnurstu.2009.05.011\u003c/li\u003e\n\u003cli\u003eSusilo AP, van Dalen J, Chenault MN, Scherpbier A. Informed consent and nurses\u0026rsquo; roles: a survey of Indonesian practitioners. Nurs Ethics 2014;21:684\u0026ndash;94. https://doi.org/10.1177/0969733014531524\u003c/li\u003e\n\u003cli\u003eFeng JM, Li YM, Han CG, Xu L, Duan LS. A retrospective analysis on 418 medical disputes. Chin Hosp Manag 2013;33:77\u0026ndash;9. https://doi.org/ CNKI:SUN:YYGL.0.2013-09-046\u003c/li\u003e\n\u003cli\u003eMedical method to remit. Big data report on national medical damage liability disputes in 2018. Available from:https://mp.weixin.qq.com/s/A4bnqRRnxCw8RDK-x2E71Q\u003c/li\u003e\n\u003cli\u003eMedical method to remit. Big data report on national medical damage liability disputes in 2021. Available from:https://mp.weixin.qq.com/s/kOJo2p4eYWO-QwBRzprbBg\u003c/li\u003e\n\u003cli\u003eRock MJ, Hoebeke R. Informed consent: Whose duty to inform? Medsurg Nurs 2014;23:189\u0026ndash;191, 194. \u003c/li\u003e\n\u003cli\u003eAveyard H. The requirement for informed consent prior to nursing care procedures. J Adv Nurs 2002;37:243\u0026ndash;9. https://doi.org/10.1046/j.1365-2648.2002.02084.x\u003c/li\u003e\n\u003cli\u003eWang SY, Cai LL, Zhang YX, Zhang SX, Lin QR, Chen WJ. Current status of nursing related legal education and legal literacy of clinical nurses.J Nurses Training. 2023;38 (07): 642-648. https://link.cnki.net/doi/10.16821/j.cnki.hsjx.2023.07.012\u003c/li\u003e\n\u003cli\u003eYinli S. Investigation and analysis on cognition and attitude and the effecting factors about patient\u0026rsquo;s right of informed consent among patients, their relatives and medical staffs [PhD Thesis]. China: Zhongnan University 2008. \u003c/li\u003e\n\u003cli\u003eHuang FF, Yang Q, Zhang J, Khoshnood K, Zhang JP. Chinese nurses\u0026rsquo; perceived barriers and facilitators of ethical sensitivity. Nurs Ethics. 2016;23:507\u0026ndash;22. https://doi.org/10.1177/0969733015574925\u003c/li\u003e\n\u003cli\u003eKim YS, Park JW, You MA, Seo YS, Han SS. Sensitivity to ethical issues confronted by Korean hospital staff nurses. Nurs Ethics. 2005;12:595\u0026ndash;605. https://doi.org/ 10.1191/0969733005ne829oa\u003c/li\u003e\n\u003cli\u003eWang YL. Informed consent\u0026mdash;patients\u0026rsquo; right and dilemma. Medicine and Philosophy. 2001;3:1\u0026ndash;3. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"informed consent, nursing, ethics, legal education, Chinese culture","lastPublishedDoi":"10.21203/rs.3.rs-9212541/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9212541/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eInformed consent is a communication process between health care providers and patients, which culminates in the authorisation or refusal of a specific intervention. For clinical nurses to appropriately follow the requisite practices for informed consent, it is crucial for them to have sufficient ethical and legal knowledge, as well as sensitivity. The present study aimed to investigate the current status of nurses\u0026rsquo; legal literacy toward informed consent and analyze its factors.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA descriptive cross-sectional study using a researcher-generated questionnaire for data collection was employed. Data were collected from 6199 nurses in different clinical departments, and analysed using descriptive statistics and a non-parametric Mann-Whitney U test.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe average score of informed consent was 3.80\u0026thinsp;\u0026plusmn;\u0026thinsp;1.45. 40.6% nurses answered all the questions correctly. Only 62.2% believed that medical staff could be exempted from legal liability, when the patient refused or insisted on staff performing a treatment, after having signed an informed consent form. Nurses\u0026rsquo; age, work experience, and professional titles revealed a significant positive correlation with their awareness of informed consent. However, clinical departments where nurses worked, and whether they had received medico-legal knowledge during school, presented an irrelevant result.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eNurses\u0026rsquo; awareness of the accurate implementation of informed consent was not adequate because of the disconnect between theory and practice in nursing education, moral cognitive bias of Chinese laws and ethics, and family-oriented medical and family ethics. It is necessary to carry out medical law-related continuing education considering Chinese culture, and combine theoretical knowledge with clinical practice.\u003c/p\u003e","manuscriptTitle":"Nurses’ legal literacy related to informed consent in the Chinese cultural context:a cross-sectional study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-09 13:52:57","doi":"10.21203/rs.3.rs-9212541/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-05-13T10:14:54+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"132675515149672468296485921488915913221","date":"2026-05-03T11:20:03+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-03T02:11:55+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-03T00:37:38+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-03-31T05:33:18+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-03-28T13:35:36+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2026-03-28T13:30:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ad1860e3-76e3-4503-a739-6b99987828d1","owner":[],"postedDate":"April 9th, 2026","published":true,"recentEditorialEvents":[{"type":"editorInvitedReview","content":"","date":"2026-05-13T10:14:54+00:00","index":62,"fulltext":""},{"type":"reviewerAgreed","content":"132675515149672468296485921488915913221","date":"2026-05-03T11:20:03+00:00","index":60,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":65736845,"name":"Health sciences/Health care"},{"id":65736846,"name":"Health sciences/Health occupations"},{"id":65736847,"name":"Health sciences/Medical research"}],"tags":[],"updatedAt":"2026-04-09T13:52:57+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-09 13:52:57","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9212541","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9212541","identity":"rs-9212541","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}