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

PURPOSE: The aim of this study is to investigate the clinical performance and safety of Zimmer® natural nail cephalomedullary nail (ZNN CM nail) in the treatment of proximal femur fractures. MATERIALS AND METHODS: The following research was conducted as a prospective, non-comparative, single center outcome study. Upon providing written informed consent, enrolled patients' data were collected and analyzed. Postoperative follow-up visits were scheduled at 6 weeks, 3 months, 6 months, and 1 year. Follow-up evaluation included radiographic assessment, physical examination, and quality of life and adverse events reports. RESULTS: Thirty-nine patients were available for evaluation at one year postoperative. The patients reported the mean EuroQol-5 Dimension score increased after surgery: from 0.4 points at discharge (n=49) to 0.6 points at 1-year post-surgery (n=39). The mean Harris hip score also increased after surgery: from 56.3 points at discharge (n=49) to 72.1 points at 1 year (n=12). Bone union was seen in 64% (n=16) in 6 months and 95% (n=37) in 1 year. CONCLUSION: The results of this 1-year follow-up study affirmed the effectiveness and safety of the ZNN CM nail in the treatment of proximal femur fractures.
Femoral Fractures ; Femur ; Follow-Up Studies ; Fracture Fixation ; Fracture Fixation, Intramedullary ; Hip ; Hip Fractures ; Humans ; Informed Consent ; Outcome Assessment (Health Care) ; Physical Examination ; Prospective Studies ; Quality of Life

OBJECTIVE: To analyze the complications of percutaneous transthoracic needle biopsy using CT-based imaging modalities for needle guidance in comparison with fluoroscopy in a large retrospective cohort. MATERIALS AND METHODS: This study was approved by multiple Institutional Review Boards and the requirement for informed consent was waived. We retrospectively included 10568 biopsies from eight referral hospitals from 2010 through 2014. In univariate and multivariate logistic analyses, 3 CT-based guidance modalities (CT, CT fluoroscopy, and cone-beam CT) were compared with fluoroscopy in terms of the risk of pneumothorax, pneumothorax requiring chest tube insertion, and hemoptysis, with adjustment for other risk factors. RESULTS: Pneumothorax occurred in 2298 of the 10568 biopsies (21.7%). Tube insertion was required after 316 biopsies (3.0%), and hemoptysis occurred in 550 cases (5.2%). In the multivariate analysis, pneumothorax was more frequently detected with CT {odds ratio (OR), 2.752 (95% confidence interval [CI], 2.325–3.258), p < 0.001}, CT fluoroscopy (OR, 1.440 [95% CI, 1.176–1.762], p < 0.001), and cone-beam CT (OR, 2.906 [95% CI, 2.235–3.779], p < 0.001), but no significant relationship was found for pneumothorax requiring chest tube insertion (p = 0.497, p = 0.222, and p = 0.216, respectively). The incidence of hemoptysis was significantly lower under CT (OR, 0.348 [95% CI, 0.247–0.491], p < 0.001), CT fluoroscopy (OR, 0.594 [95% CI, 0.419–0.843], p = 0.004), and cone-beam CT (OR, 0.479 [95% CI, 0.317–0.724], p < 0.001) guidance. CONCLUSION: Hemoptysis occurred less frequently with CT-based guidance modalities in comparison with fluoroscopy. Although pneumothorax requiring chest tube insertion showed a similar incidence, pneumothorax was more frequently detected using CT-based guidance modalities.
Biopsy ; Biopsy, Needle ; Chest Tubes ; Cohort Studies ; Cone-Beam Computed Tomography ; Ethics Committees, Research ; Fluoroscopy ; Hemoptysis ; Image-Guided Biopsy ; Incidence ; Informed Consent ; Lung Neoplasms ; Multivariate Analysis ; Needles ; Pneumothorax ; Referral and Consultation ; Retrospective Studies ; Risk Factors

OBJECTIVE: According to the current guidelines, arterial hyperenhancement for diagnosis of hepatocellular carcinoma (HCC) is determined using the arterial phase only. We investigated the optimal definition of arterial hyperenhancement in patients with HCC using computed tomography (CT) and magnetic resonance imaging (MRI). MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. The requirement for informed consent was waived. Between January 2011 and September 2013, 147 consecutive patients with surgically proven HCCs with both pre-operative CT and MRI were included. Identification rates of arterial hyperenhancement on CT and magnetic resonance (MR) images using arterial phase only, dual phase (unenhanced and arterial phases), and also subtraction MR images were assessed qualitatively. RESULTS: The identification rates for arterial hyperenhancement on CT were significantly different between arterial phase and dual phase (72.8% vs. 90.5%; p < 0.001), whereas the rates were similar on MRI (91.8% vs. 93.9%; p = 0.257). The identification rate of arterial hyperenhancement in MRI increased to 98.6% using subtraction MR images. CONCLUSION: Visual comparison of arterial and unenhanced phases could be recommended instead of conventional qualitative arterial phase alone assessment to determine arterial hyperenhancement of HCCs, especially when using CT.
Carcinoma, Hepatocellular ; Diagnosis ; Ethics Committees, Research ; Humans ; Informed Consent ; Magnetic Resonance Imaging ; Retrospective Studies