La enseñanza de la Ley Nacional de Trasplante como camino ético para la construcción del valor de la atención en salud en Colombia / Education in the National Transplant Law as an ethical pathway for the construction of the health care value in Colombia

Resumen La Ley Nacional de Trasplantes en Colombia, Ley 1805 de 2016, modificó la legislación colombiana en cuanto a cómo se accede a un trasplante de órganos, pero, sobre todo, cambió la figura de donatario y dispuso el término derivado del derecho del consentimiento presuntivo. Este define la hipotética voluntad de una persona de ser donante de órganos como manifestación de solidaridad y beneficencia con otra persona en situación de necesidad y vulnerabilidad relacionada con su salud y las dimensiones que la definen. En el siguiente texto se presentan siete momentos que se consideran hechos fundamentales en la construcción de una cultura del valor de la atención en salud en la política nacional de trasplantes de Colombia.

Abstract The national transplant law in Colombia, Law 1805 of 2016, modified the Colombian legislation regarding how a person accesses an organ transplant, but above all, it changed the donor figure, establishing the term derived from the presumptive consent right. This term implies a person's hypothetical willingness to be an organ donor as a manifestation of solidarity and charity towards another person in a situation of need and vulnerability concerning his/her health and the dimensions that define it. In the following text, seven moments are considered fundamental facts when constructing a culture about the value of healthcare in the national transplant policy in Colombia.

Termo de consentimento livre e esclarecido e sua relação com os procedimentos de preenchimento labial / Free and informed consent terms and its relationship with lip filling procedures

Introdução: Na medida em que envelhecemos os lábios estreitam-se, ocasionando perda de volume e contorno e como forma de minimizar este efeito fisiológico o preenchimento labial de escolha utilizado é o ácido hialurônico. É possível perceber efeitos adversos advindos do emprego deste material, e pelo fato da informação ao paciente ser assegurada pelo Código de Defesa do Consumidor e pelo fato da necessidade dos Cirurgiões-Dentistas terem de esclarecer seus pacientes, o Termo de Consentimento Livre e Esclarecido tornase necessário. Objetivo: identificar, por meio de aplicação de questionário, a percepção de profissionais que trabalham com Harmonização Orofacial em relação a necessidade do emprego do Termo de Consentimento Livre e Esclarecido (TCLE). O questionário apresentou 6 perguntas objetivas, que foram disponibilizadas na plataforma Google Forms®. Material e Método: os dados obtidos foram tabulados em uma planilha eletrônica do programa Microsoft Excel e após analisados descritivamente através de tabelas de frequência, porcentagens e gráficos estatísticos. Resultados: dentre os entrevistados foi constatado que a maioria, 87,5% dos especialistas em Harmonização Orofacial realizam o procedimento de preenchimento labial em sua rotina clínica, e 12,5% não. Conclusão: no presente estudo identificamos que os especialistas realizam o emprego do TCLE, em sua maioria, porém, alguns destes ainda negligenciam o seu uso(AU)

Introduction: As we age, the lips become thinner and to minimize this effect, the lip filler used is hyaluronic acid. It is possible to notice adverse effects arising from the use of this material, and it is extremely important that Dental Surgeons have to clarify their patients, the Free and Informed Consent Form becomes necessary. Objective: to identify, through the application of a questionnaire, the perception of professionals who work with Orofacial Harmonization in relation to the need to use the Free and Informed Consent Form (TCLE). The questionnaire presented 6 objective questions, which were made available on the Google Forms® platform. Materials and Methods: the data obtained were tabulated in a Microsoft Excel spreadsheet and then analyzed descriptively using frequency tables, percentages and graphs. Results: among those interviewed, it was found that the majority, 87.5% of specialists in Orofacial Harmonization perform the lip filling procedure in their clinical routine, and 12.5% do not. With the high percentage of 59.4%, it was possible to verify that the majority of professionals perform 1 to 3 procedures per month; 31.3% perform 4 to 9 procedures per month; and 9.4% of 10 or more monthly procedures. Conclusion: in the present study it was possible to identify that the majority of specialists in Orofacial Harmonization use the informed consent form, however, some of them still neglect its use(AU)

Diagnóstico humanizado: El paciente en el centro - la comunicación que cura / Diagnóstico humanizado: O paciente no centro - comunicação que cura / Humanized Diagnosis: The pacient at the center - communication that Heals

Este texto plantea la importancia de confeccionar protocolos de diagnóstico humanizado que permitan a los profesionales de la salud brindar información sobre patologías y/o discapacidades de manera clara y veraz, humana y delicadamente, facilitando su recepción por parte del paciente y su familia. El diagnóstico humanizado no forma parte únicamente de un protocolo de "urbanidad" en el vínculo médico ­ paciente: es parte integrante y relevante del procedimiento o tratamiento. Este abordaje exige una mirada interdisciplinar. En esta temática hay elementos que se vinculan a lo médico ­ científico; lo jurídico ­ legislativo ­ jurisprudencial y lo político.

Ao longo deste texto, discute-se a importância da elaboração de protocolos diagnósticos humanizados que permitam aos profissionais de saúde fornecerem informações sobre patologias e/ou incapacidades de forma clara e verdadeira, ao mesmo tempo em que humanizada e delicada, facilitando seu acolhimento pelo paciente e sua família. O diagnóstico humanizado não é apenas parte de um protocolo de "civilidade" na relação médico-paciente, mas parte integrante e relevante do procedimento para realizar o tratamento de uma doença ou deficiência. Essa abordagem requer uma abordagem interdisciplinar. Nessa disciplina há elementos que se vinculam ao médico-científico; as esferas jurídica, legislativa e política.

Throughout this text, the importance of creating humanized diagnostic protocols is discussed. These should allow healthcare professionals to provide clear and truthful information about pathologies and/or disabilities in a humane and delicate manner, facilitating their understanding by the patient and their family. Humanized diagnosis is not just part of a "politeness" protocol in the doctor-patient relationship, but an integral and relevant part of the procedure for treating a disease or disability. This approach requires an interdisciplinary perspective, as there are elements that are linked to the strictly medical-scientific, legal-legislative-jurisprudential, and political aspects of this topic.

A perspective on research ethics committees in the Brazilian amazon

This study presents the importance of the Research Ethics Committees (CEP) in the context of the Brazilian North Region, formed by the Amazon rainforest, which is occupied by traditional populations and those constituted by migratory currents. This study aims to analyze the bioethical implications arising from the activities of CEPs in the ethical evaluation of research projects and their essential role in protecting vulnerable populations. The authors seek to highlight the importance of ethics committees in the Amazon and their importance face the modern bioethical values that can contribute to the preservation of one of the most valuable and diverse environments on earth.

Este estudio presenta la importancia de los comités de ética en investigación (CEP) en el contexto de la Región Norte de Brasil, formada por la selva amazónica, ocupada por poblaciones tradicionales y constituida por corrientes migratorias. Este estudio tiene como objetivo analizar las implicaciones bioéticas derivadas de las actividades de los CEP en la evaluación ética de los proyectos de investigación y su papel esencial en la protección de las poblaciones vulnerables. Los autores buscan destacar la importancia de los comités de ética en la Amazonia y su importancia frente a los valores bioéticos modernos que pueden contribuir a la preservación de uno de los ambientes más valiosos y diversos del planeta.

Esse estudo apresenta a importância dos Comitês de Ética em Pesquisa (CEPs) no contexto da Região Norte Brasileira, formada pela floresta amazônica e ocupada por populações tradicionais e aquelas constituídas por correntes migratórias. Esse estudo objetiva analisar as implicações bioéticas que surgem das atividades dos CEPs na avaliação ética de projetos de pesquisa e seu papel fundamental em proteger populações vulneráveis. Os autores procuram enfatizar a importância dos comitês de ética na Amazônia e sua importância face a valores bioéticos modernos, que podem contribuir para a preservação de um dos mais valiosos e diversos ambientes na terra.

Randomized Controlled Trial Design Based on Patient Cohorts： Methods and Applications of Trials Within Cohorts / 中国实验方剂学杂志

Trials within cohorts （TwiCs） are design methods derived from randomized controlled trials （RCTS）. They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented， some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions"， while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group， the efficacy of intervention measures was evaluated. Within the cohort， the same process could be repeated to carry out multiple RCTS， so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS， TwiCs make it easier to recruit patients from the cohort and have higher external validity， providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However， TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs， including multi-stage informed consent （patients are informed of consent at three stages： entering the cohort， entering the trial group， and after the trial）， randomization procedures （only random sampling of patients from the cohort to receive "trial interventions"）， sample size calculation， and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples， so as to provide new research ideas and methods for clinical researchers.

The question of death criteria in human organ donation / 器官移植

Donation after death is the most important ethical principle to carry out organ donation after citizens’ death. The newly-revised <i>Regulations on Human Organ Donation and Transplantation</i> does not define death, and avoids the key question of “whether to recognize brain death”. Certain legal risks or damages to the rights and interests of donors may exist in organ donation. Death is an inevitable part of human life. It is necessary to establish specific criteria, which is also the only approach, to define death in any era. Death criteria are established based on the view of death, and restricted by the development level of productive forces and other social factors. The determination of death criteria hugely varies between China and the West. To standardize organ donation and transplantation and promote high-quality development of organ donation, medical staff must adhere to the principle of pure motivation, take informed consents as the premise, respect the donors' and their close relatives' rights to choose their own death criteria, strictly follow the death judgment procedures and operating norms, and ensure the scientificity, accuracy and fairness of death determination.

Requirements for biological samples and challenges to ethical review under the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans / 中国医学伦理学

Regarding biological samples， compared to the Measures of Ethical Review of Biomedical Research Involving Humans， the newly released Measures of Ethical Review of Life Science and Medical Research Involving Humans updated the definitions， clarified the scope， defined the responsibilities of the subject， as well as emphasized the management system， ethical review， and informed consent. By comparing and analyzing the current management status of biological samples at home and abroad， it was found that there were still many problems in the management and ethical review of biological samples in China， such as a chaotic management system of biological samples， unclear responsible entities for management， lack of widely recognized management standards of biological samples in the industry， absence of ethics committee， the non-standard ethical review， the inadequacy or inability to implement informed consent， and the difficulty in providing feedback on research results. Therefore， it is recommended to establish a standardized management system of biological samples， conduct a standardized and effective ethical review， as well as sufficient and necessary informed consent， in order to comply with the requirements of the Measures of Ethical Review of Life Science and Medical Research Involving Humans on biological samples， and enhancing the quality of the management of biological samples in China.

Multiple modes of doctors⁃patients shared decision⁃marking from the ethical perspective / 中国医学伦理学

The shared decision marking between doctors and patients is a moral requirement，which stems from the basic rights of medical staff to accept patients or their families，such as autonomy，informed consent and choice.In order to achieve the shared decision marking between doctors and patients，medical staff and patients play different roles.The task of medical staff is to introduce professional knowledge and specific experience，provide patients with multiple recommendations for diagnosis and treatment choices，and the task of patients is to choose treatment plans recognized in the shared decision marking based on their understanding of medical and ethical knowledge such as treatment goals，health values，and basic rights.From the ethical perspective，based on the shared decision marking between doctors and patients，this study deeply analyzes its ethical significance.Centering on the basic requirements of ethics，this study explores various practical models such as the doctor-patient joint participation model，the doctor-patient-family joint participation model，the doctor-nurse-patient joint participation model，the high-risk case conversation model of medical intervention，and the multidisciplinary team collaboration model from multiple perspectives and depths，to further promote the implementation of the shared decision marking between doctors and patients and to provide some reference basis.

“Therapeutic misconception” in clinical research / 中国医学伦理学

Therapeutic misconception refers to the misunderstanding of the essence， purpose， and potential benefits of clinical research among patients， who fail to recognize that participating in clinical research does not involve individualized treatment， but rather aims to obtain generalizable scientific knowledge. This paper explored the definition， causes， and impact of clinical research of “therapeutic misconception”， and proposed strategies to address them. By gaining a deeper understanding of “therapeutic misconception”， the quality of informed consent of research participants can be improved， their rights can be protected， and the quality of research can be enhanced.

Dilemma and Reflection on Children Exercising the Right of Medical Decision-making / 中国医学伦理学

Whether children can exercise their medical decision-making power has always been a controversial topic in law and ethics, and it is also the focus of attention of people from all walks of life. In this regard, combined with the problems existing in the exercise of children’s medical decision-making power, such as conflict with the right to life and health, insufficient guarantee of the right to informed consent system, and the legal guardian’s exercise of children’s medical decision-making power may not be in the best interests of children. This paper discussed the dilemma and feasibility of children’s exercise of medical decision-making power from three aspects: children’s right to life and health, the evaluation of informed consent and medical decision-making ability, and the thinking of children’s informed consent and medical decision-making ability, and pointed out that children who are able to make self-determination should be fully endowed with legal medical decision-making power, so as to ensure their best interests in medical clinic.

Analysis on the Current Status and Ethics Review Key Points of Electronic Informed Consent / 中国医学伦理学

Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.

Analysis of Ethical Review of Clinical Study on Defecation Function of Patients with Rectal Cancer after sphincter-preserving Surgery / 中国医学伦理学

In order to understand the status quo of ethical review of clinical research on the defecation function of patients with rectal cancer after sphincter-preserving surgery, analyze its causes and put forward corresponding suggestions, to arouse researchers’ attention to ethical review in subsequent relevant clinical studies. The ethical review of literatures related to the defecation function of patients with rectal cancer after sphincter-preserving surgery published on CNKI in recent 10 years was sorted out and summarized. The results showed that the ethical review of clinical research papers on defecation function of patients with rectal cancer after sphincter-preserving surgery was not optimistic. We should strengthen the ethical training of researchers, improve the ethical awareness of researchers, strictly implement the ethical norms of paper publication, strengthen the ethical requirements of manuscript contracts, perfect the ethical review system, and pay attention to the examination and supervision of informed consent, so as to promote the construction of ethical examination and approval norms of clinical research documents.

Ethical Reflections on Conducting Qualitative Research in the Medical and Health Field / 中国医学伦理学

Based on the characteristics of qualitative research, such as openness, flexibility, interaction and subjectivity, this paper discussed the related ethical challenges and responsibilities faced by institutional ethics committees and researchers in ethical review, informed consent, privacy protection and researchers’ influence in the application of medical and health fields. Ethics committees need to adopt review standards suitable for qualitative research characteristics and improve their review ability. Researchers need to consider from the perspective of research participants, improve their scientific ability and ethical awareness in the whole process of design, data collection, analysis and reporting, truly respect and protect the rights and interests of research participants, and finally produce valuable research evidence.

Application status and development trend of virtual clinical trials / 中国胸心血管外科临床杂志

@#Virtual clinical trials are clinical trials conducted through computer simulation technology, which breaks through the limitations of traditional clinical trials and has the advantages of saving time, reducing costs, and reducing the risk of human trials. With the application of new computer technologies such as population pharmacokinetics, physiologically-based pharmacokinetics, quantitative systems pharmacology, and artificial intelligence, the field of virtual clinical trials in healthcare has become an important development direction. This article will give a preliminary review of the connotation, methods and future development trends of virtual clinical trials, aiming to provide reference for the application of new technologies and methods in clinical trials.

Practice of model-informed drug development in pharmaceutical in-dustry in China / 中国临床药理学与治疗学

Guideline of model-informed drug de-velopment was published by National Medical Products Administration in 2020,which provided technical guidance for the application of modeling and simulation in the process of new drug develop-ment.In July 2022,Center of Drug Evaluation con-ducted a questionnaire survey on the practical abili-ty of pharmaceutical industry to apply model-in-formed drug development(MIDD)in the process of new drug development,in order to investigate the practice of MIDD in China.Based on the feedback data collected from enterprises,this paper analyzes the practice of MIDD in domestic pharmaceutical industry,and briefly discusses several problems that still exist at present.

Informed consent in epidemic prevention and control is moving towards a new paradigm / 中国医学伦理学

Informed consent is an important medical ethical principle,which has been widely applied in clinical treatment and medical research.However,it is not fully applicable in epidemic prevention and control.The public characteristics of the technical means and governance measures of epidemic prevention and control have led to the lack of some elements of informed consent or changes in ethical standards.The principle of informed consent plays an important role in safeguarding individual rights and interests,therefore its practical value can't be ignored.One of the solutions is to redefine the connotation and practice path of informed consent,including emphasizing the combination of group-informed and individual-informed in the informed process,as well as grasping the boundaries of autonomy,and clarifying the way and scope of legal consent in the process of consent,so as to construct a paradigm of informed consent principles applicable to epidemic prevention and control work.

Exploration of deferred informed consent in clinical research / 中国医学伦理学

Informed consent is an important ethical symbol in clinical research,and researchers have the responsibility to fully inform participants of the research information before conducting clinical research.However,it is difficult to obtain complete informed consent form participants or their guardians within a narrow treatment time period in clinical research conducted in emergency situations.Currently,in addition to traditional general informed consent,there are also reality-accepted informed consent,including exemption of informed consent,broad informed consent,and deferred informed consent.By introducing the origin and development process of deferred informed consent in clinical research,this paper sorted out the current application status of deferred informed consent,proposed the prerequisites for applying deferred informed consent in emergency situations,and explored the issues that need to be noted during the application process of deferred informed consent.It is hoped to provide an ethical defense and ethical procedure for the application of deferred informed consent in clinical research in emergency situations.

"Therapeutic misconception"in clinical research / 中国医学伦理学

Therapeutic misconception refers to the misunderstanding of the essence,purpose,and potential benefits of clinical research among patients,who fail to recognize that participating in clinical research does not involve individualized treatment,but rather aims to obtain generalizable scientific knowledge.This paper explored the definition,causes,and impact of clinical research of"therapeutic misconception",and proposed strategies to address them.By gaining a deeper understanding of"therapeutic misconception",the quality of informed consent of research participants can be improved,their rights can be protected,and the quality of research can be enhanced.

Analysis and research on implementation status of informed consent in surgery / 中国医学伦理学

Objective:Investigating the content and signing status of the informed consent form for surgery,as well as the signing status of the power of attorney to understand the current implementation of informed consent for surgery in medical institutions.Methods:A stratified random sampling method was used to investigate the signing status of surgical consent and power of attorney on 276 surgical records from a tertiary A hospital in the first half year of 2022.Results:The signatures of both patients and doctors were relatively complete.The medical teams had provided sufficient information to patients regarding the main preoperative diagnosis,surgical name,possible complications during or after the surgery,and surgical risks.However,there was inadequate information on the patient's own high-risk factors,as well as alternative treatment plans and their advantages and disadvantages.The signing of surgical consent and power of attorney signed by non-patients was not standardized.Conclusion:The implementation of informed consent for surgery in medical institutions is relatively good,but there are still some shortcomings.Medical institutions can ensure the implementation of informed consent by strengthening legal and regulatory training,clarifying the scope of authorization,strengthening the surgeon's notification and signing,as well as implementing supervision and inspection,so as to protect the unity of rights and obligations of doctors and patients,effectively avoid medical risks,and promote the construction of a harmonious doctor-patient relationship.

Investigation and analysis of the current situation of case reporting ethical review and patient informed consent reports in comprehensive journals of clinical medicine in China / 中国医学伦理学

ObjectiveTo investigate and analyze case reporting ethical review and patient informed consent reports published in the comprehensive journals of clinical medicine in China in 2022. MethodsAccording to the data from the 2022 Edition of the Chinese Science and Technology Journal of the Citation Reports （Extended Version），the case reports published in comprehensive journals of clinical medicine in 2022 were selected as the research objects.The information on ethics and patient informed consent was extracted from the case reports that met the selection criteria，and Microsoft Excel 2021 and SPSS 21.0 were used to sort out and analyze the data. ResultsA total of 587 case reporting articles were published in the 42 included journals in 2022，of which 36 （6.13%） reported on science and technology ethics and/or informed consent.Case reports reporting on science and technology ethics and/or informed consent mostly came from the key magazine of China technology （88.89% Vs.65.88%），and the proportion of manuscripts involving science and technology ethics on the official website of the journal was relatively high （86.11% Vs.63.88%），and the difference was statistically significant （P<0.01）. ConclusionThe proportion of case reports of science and technology ethics and/or informed consent in journals of comprehensive discipline classification of clinical medicine was relatively low.Currently，most international journals are required to obtain the informed consent of patients or legal guardians before publishing case reports.Compared with this，there are still certain gaps in China，which need to be paid great attention to.