Informing is an initiative behavior of medical staff in their clinical practice. Besides, informing is a key principle of informed consent. The number of cases of infringing upon patient’s informed consent is increasing because of the underestimate or ignorance of the obligation of informing. This paper discusses the concept, significance, content, and procedure of informing as well as the relationship between informed consent and informing.
Through reviewing the regulations on the right of emergency treatment of hospitals, we analyzed reasons of emergency treatment of hospitals, including uninformed patients and informed patients without consent in emergency situations, as well as the risk of emergency rescue of hospitals. We put forward how to consider the judgment of emergency situations, justification of emergency treatment of hospitals, and risk attribution. We suggested improving the related legislation and regulations, developing compulsory medical insurance and a medical rescue system on emergency treatment.
【摘要】 目的 探讨医院产前超声检查中应用知情同意书的价值。 方法 对2002年1月-2010年1月经产前超声常规筛查并分娩出生缺陷儿（均为基层医院常规超声筛查难以显示或无法诊断的先天性异常）的产妇，按实行知情同意前后分为两组：实施前的有21例（A组），实施后的有19例（B组），比较两组出生缺陷儿产妇对产后结果的反映情况。 结果 B组产妇对产前超声筛查理解13例，可以理解4例，难以理解2例；A组理解3例，可以理解5例，难以理解13例，两组理解程度差异有统计学意义（Z=-3.741，P=0.000）。 结论 知情同意书是产前超声检查过程中孕妇对医方理解及对孕妇负责的必要手段。 【Abstract】 Objective To explore the value of informed consent in prenatal ultrasonographic examination. Methods Between January 2002 and January 2010, the puerperants who underwent routine screening by prenatal ultrasonography in our hospital and delivered the birth of babies with defects (conventional ultrasound screening in basic-level hospitals hard to display or unable to diagnosis of congenital anomaly) were selected. The patients were divided into two groups according to whether had informed consent. The responses after the parturition (having babies with defects) of the puerperants between the two groups were compared. Results The puerperants in informed consent group had more objective understanding of prenatal ultrasonographic examination, and better acceptance level of the results of ultrasonography. Conclusion Informed consent of prenatal ultrasonography process is necessary.
【摘要】目的探讨新型医患沟通范式的临床价值。方法分析新型医患沟通范式的基本文书和临床应用效果。结果自2002年1月2009年12月,新型医患沟通范式应用于9800余例住院患者,无1起医疗事故发生。结论新型医患沟通范式从形式上和内容上对患者知情权进行了充分的保障,对构建和谐医患关系具有重大价值。【Abstract】Objective To explore the clinical value of new doctorpatient communication paradigms. Methods The primary documents and clinical application results of new doctorpatient communication paradigms were analyzed in our study. Results We applied the new doctorpatient communication paradigms to more than 9800 patients of inpatient from January 2001 to December 2009. No medical negligence was observed. Conclusion The new doctorpatient communication paradigms can ensure the patient’s right of informed consent in form and in content. Its value to construct harmony doctorpatient relationship is great.
药物上市前须经过人体试验，参与药物临床试验的受试者将承担不同程度的风险，我国GCP明确规定要充分保障受试者的权益，伦理委员会和知情同意书是保障受试者权益的主要措施，但在实际中仍存在不少问题。为此，如何切实保障受试者的权益，是临床试验所要解决的一个重要问题。
ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.
On the basis of fundamental ethical principles and requirements, combining the practice of ethical management and according to the characteristics and requirements of the prospective cohort study of natural populations, this paper probes into the many key points of ethical design, including the use of existing data, the choice of exposures, the protection of special population subjects and the renewal of informed consent, and the selection of prospective cohort study of natural populations, to provide the beneficial reference to maximize the guarantee of the safety and rights and interests of the subjects.
In order to promote the responsible development of precision medicine in China, the current situation of precision medicine in three major fields (clinical, research and commercial) was briefly introduced, and key ethical issues or disputes in each field (including informed consent, return of incidental findings, and allocation of medical resources in the clinical field; informed consent, return of research results, and data use and sharing in the research field; genetic counseling, clinical utility of genetic testing, and use of data in the field of direct-to-consumer genetic testing) were discussed. It is necessary to actively meet these ethical challenges for the development of precision medicine in China.
Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.