INTRODUCTION

Documenting a research participant’s awareness of the bill of rights is achieved with an informed consent. In recent years, the informed consent document has increasingly become confounding to research participants in its complexity. As such, the awareness of research participants’ bill of rights has emerged as a lingering issue since studies that test awareness of research participants’ bill of rights are limited. Hence, this study aimed to determine the participants’ awareness of the bill of rights after an educational intervention.

A quasi-experimental study was done where participants’ awareness of clinical trial participants’ bill of rights was determined after an educational intervention.

There was a significant difference (pCONCLUSIONS

Significant difference in the awareness of bill of rights was observed after the educational intervention. Additional intervention could be given to participants who are females, of older age group (middle age and older), did not complete high school, and the unemployed when they participate in clinical trials to ensure their awareness of the bill of rights of clinical trial participants. Varied learning materials must be given to participants to emphasize the clinical research objectives and activities as well.

OBJECTIVES: Obtaining informed consent from research participants is an ethical and legal obligation for medical researchers in clinical studies. Electronic informed consent (eIC) is increasingly being adopted in clinical research worldwide. However, there is limited data on Chinese medical researchers' knowledge and attitudes toward eIC. This study aims to investigate their knowledge, attitudes, and influencing factors regarding eIC use in clinical research. METHODS: This cross-sectional study was conducted using stratified random sampling. From June to August 2022, medical researchers from 8 tertiary hospitals were surveyed via an online platform (Wenjuanxing). A self-developed eIC knowledge questionnaire and attitude scale were used to assess participants' understanding and perceptions of eIC. Univariate analysis was employed to explore factors influencing attitude scores and the correlation between knowledge and attitudes. A generalized linear model was used to analyze associations between demographic characteristics and attitude scores, including the frequency of difficulties in using smartphones or computers, preferred device for using eIC, and their interaction effects. Stratified analysis was further performed for significant interactions. RESULTS: A total of 399 valid questionnaires were collected. The mean accuracy rate on the eIC knowledge questionnaire was (94.88±15.50)%. Of the respondents, 74.9% had heard of eIC, and 84.5% preferred using mobile devices over computers to access eIC. The median attitude score was 3.41 (3.18, 3.76), indicating generally positive attitudes. Specifically, 81.7% found eIC more convenient than paper-based consent, 79.7% considered it more efficient, and 51.1% believed it could fully replace paper forms. However, 60.7% expressed concerns about data security and privacy, and 89.7% believed that relevant laws and regulations need improvement. Spearman correlation analysis showed a weak positive correlation between knowledge and attitude scores (r=0.171, P=0.001). Univariate analysis indicated that the frequency of difficulty using devices and preferred device for eIC were significantly associated with attitude scores (P<0.05). After adjusting for confounding factors, the generalized linear model demonstrated that participants who occasionally experienced had difficulty using devices had significantly lower attitude scores compared to those who never had difficulty (β=-0.040, 95% CI -0.071 to -0.009, P=0.012). Those who preferred using PCs had significantly lower attitude scores than those who preferred mobile devices (β=-0.066, 95% CI -0.108 to -0.023, P=0.002). Interaction analysis showed a significant interaction analysis showed a significant interaction between age and preferred device (P=0.011), particularly among participants aged ≥45-year (P<0.001). No other interactions were found to be significant (all P>0.05). CONCLUSIONS Medical researchers in China generally have a high level of knowledge and positive attitudes toward eIC, though concerns remain regarding data security and privacy. Future promotion of eIC in Chinese clinical research should be grounded in ethical considerations and address the specific needs of older users and mobile device users, while also enhancing researchers' competencies in using digital tools and eIC systems.
Humans ; Cross-Sectional Studies ; Informed Consent ; Surveys and Questionnaires ; Female ; Male ; Health Knowledge, Attitudes, Practice ; Adult ; Biomedical Research ; Research Personnel/psychology* ; Middle Aged ; China

As artificial intelligence technology rapidly advances, its deployment within the medical sector presents substantial ethical challenges. Consequently, it becomes crucial to create a standardized, transparent, and secure framework for processing medical data. This includes setting the ethical boundaries for medical artificial intelligence and safeguarding both patient rights and data integrity. This consensus governs every facet of medical data handling through artificial intelligence, encompassing data gathering, processing, storage, transmission, utilization, and sharing. Its purpose is to ensure the management of medical data adheres to ethical standards and legal requirements, while safeguarding patient privacy and data security. Concurrently, the principles of compliance with the law, patient privacy respect, patient interest protection, and safety and reliability are underscored. Key issues such as informed consent, data usage, intellectual property protection, conflict of interest, and benefit sharing are examined in depth. The enactment of this expert consensus is intended to foster the profound integration and sustainable advancement of artificial intelligence within the medical domain, while simultaneously ensuring that artificial intelligence adheres strictly to the relevant ethical norms and legal frameworks during the processing of medical data.
Artificial Intelligence/legislation & jurisprudence* ; Humans ; Consensus ; Computer Security/standards* ; Confidentiality/ethics* ; Informed Consent/ethics*

Humans ; Informed Consent

At present, medical disputes are still widely-concerned social problems and occasionally evolve into severe social events. In the dispute settlement mechanism, forensic identification opinion is the important technical support. Due to the high professionalism and complexity of medicine, the identification of medical malpractice has become major and difficult problem in the identification. This paper systematically analyze the concept of medical malpractice and five legal theories of malpractice determination, pointing out that China's forensic identification of medical damage should be led by the theory of "medical standards", supplemented by "prudent patient" standard and strengthen "peer review" in form. At the same time, seven main identification principles should be followed in practice: (1) take "obligation of diagnosis and treatment" as the basic principle of medical malpractice identification; (2) take whether to fulfill the obligation of diagnosis and treatment corresponding to current medical level as the specific principle; (3) take diagnosis and treatment routine, norms and guidelines as the main basis; (4) the principle of "peer review"; (5) the principle of "the generality of medical emergency action"; (6) the principle of "notification-informed-consent"; (7) the principle of "review of complications". This paper also puts forward the corresponding identification ideas in view of the above principles, hoping this helps standardize medical damage forensic identification activities.
Dissent and Disputes ; Forensic Medicine ; Humans ; Informed Consent ; Malpractice

The Vaccine Administration Law of the People's Republic of China and other relevant laws require that vaccine recipients or their guardians be educated about vaccines and how they work, and described in general the methods and contents of such vaccination education. With the new law and "Standard Operational Procedures for Immunization" as foundation documents, and in consultation with experts at home and abroad, the Chinese Preventive Medicine Association developed a consensus statement about informed consent for vaccination. This consensus statement is written for disease control and prevention health care personnel in vaccination services and describes the educational content of informed consent, a theoretical framework for immunization and immunization knowledge, the informed consent processes, principles of planning for vaccination, and an informed consent form. Part Two of the consensus includes influenza vaccine, pneumococcal vaccine, haemophilus influenzae type b containing vaccine, enterovirus type 71 inactivated vaccine, rotavirus vaccine, varicella attenuated live vaccine, herpes-zoster vaccine, human papillomavirus vaccine, rabies vaccine, hemorrhagic fever with renal syndrome vaccine, leptospira vaccine, anthrax vaccine, hepatitis E vaccine, cholera vaccine, typhoid vaccine, and tick-borne encephalitis vaccine.
China ; Consensus ; Humans ; Influenza Vaccines ; Informed Consent ; Vaccination

informed consent and establishing realistic outcome expectations are imperative for successful postoperative outcomes.]]>
Congenital Abnormalities ; Contracture ; Erectile Dysfunction ; Humans ; Informed Consent ; Male ; Penile Induration ; Penile Prosthesis ; Penis ; Rehabilitation ; Sensation ; Standard of Care ; Surgeons ; Transplants

OBJECTIVE: Recently, three-dimensional (3D) printed models of the intracranial vascular have served as useful tools in simulation and training for cerebral aneurysm clipping surgery. Precise and realistic 3D printed aneurysm models may improve patients’ understanding of the 3D cerebral aneurysm structure. Therefore, we created patient-specific 3D printed aneurysm models as an educational and clinical tool for patients undergoing aneurysm clipping surgery. Herein, we describe how these 3D models can be created and the effects of applying them for patient education purpose.METHODS: Twenty patients with unruptured intracranial aneurysm were randomly divided into two groups. We explained and received informed consent from patients in whom 3D printed models-(group I) or computed tomography angiography-(group II) was used to explain aneurysm clipping surgery. The 3D printed intracranial aneurysm models were created based on time-of-flight magnetic resonance angiography using a 3D printer with acrylonitrile-butadiene-styrene resin as the model material. After describing the model to the patients, they completed a questionnaire about their understanding and satisfaction with aneurysm clipping surgery.RESULTS: The 3D printed models were successfully made, and they precisely replicated the actual intracranial aneurysm structure of the corresponding patients. The use of the 3D model was associated with a higher understanding and satisfaction of preoperative patient education and consultation. On a 5-point Likert scale, the average level of understanding was scored as 4.7 (range, 3.0–5.0) in group I. In group II, the average response was 2.5 (range, 2.0–3.0).CONCLUSION: The 3D printed models were accurate and useful for understanding the intracranial aneurysm structure. In this study, 3D printed intracranial aneurysm models were proven to be helpful in preoperative patient consultation.
Aneurysm ; Humans ; Informed Consent ; Intracranial Aneurysm ; Magnetic Resonance Angiography ; Patient Education as Topic ; Printing, Three-Dimensional

The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus (HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE's genetic experiments. China's guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE's human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist's self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.
CRISPR-Cas Systems ; China ; Consent Forms/ethics* ; Ethics, Medical ; Female ; Gene Editing/legislation & jurisprudence* ; Gene Knockout Techniques/ethics* ; HIV Infections/prevention & control* ; Human Experimentation/legislation & jurisprudence* ; Humans ; Infant, Newborn ; Pregnancy ; Professional Misconduct/ethics* ; Receptors, CCR5/genetics*

BACKGROUND/AIMS: The abdominal pain-related functional gastrointestinal disorders (AP-FGIDs) affect a significant proportion of the pediatric population and consist 1 of the most frequent causes for seeking medical advice. In this study, we aimed to assess the relation of dietary habits with the likelihood of AP-FGIDs. METHODS: This was a school-based, cross-sectional study approved by the Greek Government authorities, after obtaining informed consent by the legal representatives of the children. Diagnoses of AP-FGIDs were based on the Greek official translation of the Rome III questionnaire. Demographic, socioeconomic and dietary data were collected through self-reporting or parent-reporting questionnaires. Associations between the probability of AP-FGIDs and dietary practices were assessed after adjusting for known confounders through a multiple logistic regression analysis. RESULTS: A total of 1365 children (147 AP-FGIDs and 1218 controls, 52.4% females, mean age: 12.8 ± 2.8 years) were included. Multiple regression analysis identified the following statistically significant confounders: victimization, the presence of a person with a severe health problem at home, female sex, engaging in limited physical exercise, and living in a single adult family. Subsequently, logistic regression, adjusted for the abovementioned confounders, showed that reduced fish and increased junk food consumption were related to a higher likelihood of AP-FGIDs. CONCLUSIONS: Children with AP-FGIDs report excessive junk-food and reduced fish intake compared to controls. Further studies are needed in order to clarify the nature of this observation.
Adolescent ; Adult ; Child ; Crime Victims ; Cross-Sectional Studies ; Diagnosis ; Exercise ; Feeding Behavior ; Female ; Food Habits ; Gastrointestinal Diseases ; Humans ; Informed Consent ; Logistic Models