Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital / 中国药房

OBJECTIVE To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs， and to protect the legitimate rights and interests of the subjects. METHODS The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st， 2020 to July 1st， 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital. RESULTS Of the 316 clinical trials of registered anti- tumor drugs that were initially reviewed， 257 （81.3%） had problems with the contents of informed consent form， mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer （68.5%）， the incomplete notification of the test content （59.1%）， the insufficient notification of rights and interests and risks （58.4%）， the insufficient notification of personal information protection （56.0%）， and the nonstandard expression of the informed consent form （52.5%）. CONCLUSIONS There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs （GCP）. The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form， and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing， continue to strengthen the examination ability， improve the examination quality， and effectively protect the safety and interests of the subjects.

Agência e poder na pesquisa: algumas reflexões sobre os termos de consentimento livre e esclarecido / Agency and power in research: some thoughts about informed consent forms

Resumo Neste artigo, discutimos algumas premissas do termo de consentimento livre e esclarecido (TCLE), partindo do princípio que elas não são dadas. Argumento que o uso de um termo de consentimento deve ser compreendido dentro de uma relação de pesquisa, que é ao mesmo tempo uma relação intersubjetiva entre duas ou mais pessoas posicionadas socialmente. Desenvolvo esta reflexão a partir de minhas experiências recentes de pesquisa antropológica sobre gestação e parto, nas quais apresentei um TCLE em duas etapas do estudo, mas não em uma intermediária, que se dedicava a explorar mais as relações familiares durante a gravidez do que a experiência corporal em si. Assim, comparando essas três situações, examino suas especificidades na obtenção do consentimento, para discutir as dimensões de agência, poder e ética na pesquisa social.

Abstract This article discusses some premises that constitute informed consent forms, assuming they should not be taken for granted. I argue that the use of informed consent forms should be understood within a research relationship, which is always an intersubjective relation between two or more socially positioned individuals. I develop these reflection based on my recent experiences of anthropological research on pregnancy and birth, during which I used an informed consent form in two stages but not in an intermediary phase, which was dedicated to focus on kinship relations during pregnancy more than the bodily experience itself. Thus, by comparing these three situations, I examine their particularities in obtaining consent, discussing agency, power, and ethics in social research.

Compreensão do consentimento informado em pesquisa clínica de vacina contra o Zika vírus: estudo transversal / Understanding of informed consent in clinical research for a vaccine against Zika virus: a cross-sectional study / Comprensión del consentimiento informado en la investigación clínica de una vacuna contra el virus del Zika: un estudio transversal

OBJETIVO: avaliar a compreensão das informações do Termo de Consentimento Livre e Esclarecido pelos participantes de uma pesquisa clínica de vacina contra o Zika vírus. MÉTODO: estudo transversal com amostra por conveniência e participação de 101 voluntários de uma pesquisa clínica em Belo Horizonte, Minas Gerais. Utilizou-se um questionário estruturado. A análise dos dados foi realizada no programa R, segundo a estatística descritiva e inferencial. RESULTADOS: a média de acertos dos participantes sobre as informações do documento de consentimento foi de 66,9%. A maioria dos participantes assinou o documento sem o conhecimento suficiente das informações da pesquisa. O Índice de compreensão foi maior entre os participantes que tinham se voluntariado em pesquisas prévias (p=0,039). CONCLUSÃO: verificaram-se limitações importantes na compreensão dos participantes sobre informações do termo de consentimento, o que comprometeu a decisão autônoma. São necessárias adaptações e melhorias nos processos de consentimento informado em prol da sua validade.

OBJECTIVE: to assess the understanding of the information contained in the Informed Consent Form by the participants of a clinical trial of a vaccine against the Zika virus. METHOD: cross-sectional study using intentional sampling, including a total of 101 volunteers in clinical research in Belo Horizonte, Minas Gerais. A structured questionnaire was used. Data analysis was performed using R software, according to descriptive and inferential statistics. RESULTS: the mean of correct answers of the participants regarding the information in the consent form was 66.9%. Most participants signed the document without sufficient knowledge of the research information. The comprehension index was higher among participants who had volunteered in previous research (p=0.039). CONCLUSION: there were important limitations in the participants' understanding of information in the consent form, which compromised the autonomous decision. Adaptations and improvements are necessary in the processes of informed consent for its validity.

OBJETIVO: evaluar la comprensión de las informaciones contenidas en el Término de Consentimiento Libre e Informado por los participantes de un ensayo clínico de una vacuna contra el virus del Zika. MÉTODO: estudio transversal con muestra de conveniencia y participación de 101 voluntarios en una investigación clínica en Belo Horizonte, Minas Gerais. Se utilizó un cuestionario estructurado. El análisis de datos se realizó mediante el programa R, según estadística descriptiva e inferencial. RESULTADOS: el promedio de aciertos de los participantes con respecto a las informaciones del documento de consentimiento fue de 66,9%. La mayoría de los participantes firmó el documento sin conocimiento suficiente de las informaciones de la investigación. El índice de comprensión fue mayor entre los participantes que se habían ofrecido como voluntarios en investigaciones anteriores (p=0,039). CONCLUSIÓN: hubo limitaciones importantes en la comprensión de las informaciones del formulario de consentimiento por parte de los participantes, lo que comprometió la decisión autónoma. Son necesarias adecuaciones y mejoras en los procesos de consentimiento informado para su validez.

Termo de consentimento informado: impacto na decisão judicial / Informed consent: impact on court decisions / Formulario de consentimiento informado: impacto en la decisión judicial

Resumo O termo de consentimento informado é fundamental na relação jurídica entre médico e paciente. Visando avaliar seu impacto na sentença judicial, realizou-se estudo retrospectivo de 70 processos de responsabilidade civil envolvendo procedimentos médicos estéticos cirúrgicos e não cirúrgicos com termo de consentimento assinado pelos pacientes. Os casos analisados, julgados entre 2014 e 2016, foram selecionados nos sites dos tribunais brasileiros e classificados em dois grupos: médicos absolvidos (51%) e condenados (49%). No primeiro grupo, 39% das absolvições se embasaram na apresentação adequada do termo de consentimento informado, enquanto, no segundo, 50% dos médicos foram condenados por não o ter incluído. Portanto, o termo de consentimento informado se destaca nos julgamentos de erro médico. O dever de informar é um dos pilares da responsabilidade civil desse profissional e, quando negligenciado, constitui fator substancial para condenação.

Abstract The informed consent form is essential in the physician-patient relationship. To evaluate its impact on court decisions, we conducted a retrospective study of 70 civil suits involving surgical and non-surgical aesthetic medical procedures with an informed consent form signed by patients. The cases, judged between 2014 and 2016, were selected from Brazilian courts websites and classified into two groups: acquitted (51%) and convicted (49%) doctors. In the first group, 39% of acquittals were based on the proper presentation of the informed consent form, whereas in the second 50% of the professionals were convicted for not including the document. The informed consent thus stands out when judging medical errors, and the duty to warn is one of the pillars of the professional liability and, when neglected, becomes a substantial factor for their conviction.

Resumen El formulario de consentimiento informado es fundamental en la relación jurídica entre médico y paciente. Para evaluar su impacto en sentencias judiciales, se realizó un estudio retrospectivo con 70 procesos de responsabilidad civil relacionados con procedimientos médicos estéticos quirúrgicos y no quirúrgicos con el formulario de consentimiento firmado por los pacientes. Los casos analizados, juzgados entre 2014 y 2016, fueron seleccionados en los sitios web de los tribunales brasileños y clasificados en dos grupos: médicos absueltos (51%) y condenados (49%). En el primer grupo, el 39% de las absoluciones se basaron en la presentación adecuada del formulario de consentimiento; en el segundo, en el 50% de los casos se condenaron a los médicos por no incluir este documento. Por tanto, el formulario de consentimiento informado se destaca en los juicios por error médico. El deber de informar es uno de los pilares de la responsabilidad civil del médico, y su incumplimiento constituye un factor sustancial de condena.

A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital

Background: Informed consent is an essential pre-requisite for research on human participants. However, many studies have shown that informed consent documents (ICDs) are incomplete and lack many of the essential elements. The objective of the study was to assess the completeness of ICDs submitted to an institutional ethics committee (IEC) against the Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants.Methods: This is a retrospective cross-sectional study. The ICDs submitted to the IEC during the period from January 2015 to December 2017 were reviewed for completeness, with the help of a checklist which is based ICMR ethical guidelines for biomedical research on human participants 2006.Results: A total of 212 ICDs were reviewed during the study period. More than 50% of the ICDs have clearly explained many of the essential elements like nature and purpose of the study (62.3%), voluntary participation (98.6%), procedures (68.9%), risks (71.2%), benefits (92.9%), alternative treatments (60.7%), maintaining confidentiality (99.1%), no loss of benefits on withdrawal from the study (87.8%) and contact details of principal investigator (99.5%). However, the other essential elements of the ICD are either not mentioned or not clearly explained.Conclusions: This study has shown that although majority of the ICDs submitted for review by the IEC have mentioned many of the essential elements, some of the elements like contact details of Chairman of IEC, future use of sample, compensation for trial related injury and provision of counseling for consent of genetics testing have not been stated.

Study on the Differences of Pregnancy Informs between Chinese and Foreign Informed Consent Form in Drug Clinical Trial / 中国医学伦理学

Objective:To explore and discuss the differences of pregnancy contents and inform formats in in-formed consent form ( ICF) for the drug clinical trial between China and foreign countries. Methods:We collected Chinese and foreign ICFs for drug clinical trial that had been audited by the Ethics Committee of the third Xiangya Hospital for the past five years. Based on the relevant domestic and foreign law, we concluded the element stand-ards and inform formats about pregnancy inform. By analyzing the integrity of the whole elements, the inform rate of every element and the using rate of every inform format, we compared the differences of pregnancy contents and in-form formats between Chinese ICFs and foreign ICFs. Results:The total number of ICFs was 177 in this study, in-cluding 107 Chinese ICFs and 70 foreign ICFs. The integrity rate of pregnancy in Chinese ICFs was statistically lower than them in foreign ICFs (19% vs. 56%, P=0. 000). Compared with foreign ICFs, the low informed ele-ments were the study of the pregnancy risk (32% vs. 73%, P=0. 000), the pregnancy test during the following-up period (33% vs. 56%, P=0. 002) and the measurements for contraception (22% vs. 53%, P=0. 000). Conclusion:The integrity level of pregnancy content in Chinese ICFs was lower than that of the foreign ICFs. And the three elements including pregnancy risk study, pregnancy test during the following-up period and measure-ments for contraception was obviously defected. Pregnancy informing forms of informed consent in China was inferi-or to abroad.

Ethical Analysis on Design and Signature of 2265 Clinical Trial Informed Consent Forms / 中国医学伦理学

Items of design and signature from clinical trial drugs were made , the occurrence ratio of every item in 2265 informed consent form ( ICF) from 63 clinical trial drugs in Beijing Youan Hospital affiliated to Capital U-niversity of Medical Sciences were analyzed , and items with lower occurrence ratio were explored .Generally , the design and signature of ICF met the requirement of GCP .However , there were some defects of ICF and antonym of signature .Based on the analysis on the problems , some measures were put forward:formulate relevant standard op-erating procedures , strengthening the management of informed consent , and strengthen the system construction and education training , promote the hospital ethics construction , to protect the rights and interests of the subjects .

Fatores associados ao conhecimento sobre as informações do Termo de Consentimento Livre e Esclarecido de participantes de um ensaio clínico realizado no Nordeste de Minas Gerais/Brasil / Factors associated with knowledge about the information in the term of informed consent of participants in a clinical trial conducted in the northeast of Minas Gerais / Brazil

Este estudo teve como objetivo analisar a associação entre o conhecimento dasinformações do Termo de Consentimento Livre e Esclarecido (TCLE) de participantes de umensaio clínico e os fatores socioeconômicos, demográficos, o conhecimento sobre termosmédico/metodológicos, autoavaliação do estado de saúde, experiência prévia em pesquisasclínicas e participação em intervenção educativa. Participaram deste estudo 148 indivíduosque consentiram para participar de um ensaio clínico realizado no distrito de Americaninhas,Minas Gerais, cujo objetivo foi o teste de um alimento funcional. Trata-se de um estudodescritivo com delineamento transversal. A coleta de dados foi realizada por meio de um formulárioestruturado que contemplava os temas abordados no TCLE deste ensaio clínico. A aplicaçãodo formulário estruturado ocorreu em outubro de 2011, um mês após os participantesassinarem o Termo de Consentimento Livre e Esclarecido desta investigação clínica. Oconhecimento global médio dos participantes sobre as informações do TCLE foi 57,26%. Aanálise multivariada mostrou que o maior acesso semanal a mídia eletrônica, escolaridadeformal, participação em intervenção educativa e conhecimento de termosmédico/metodológicos estiveram associados positivamente com o conhecimento global dasinformações do TCLE, enquanto a idade esteve associada negativamente. Os exames eprocedimentos do ensaio clínico apresentaram alto percentual de acerto (92,59%), enquanto oconhecimento sobre o patrocinador do ensaio clínico e o seu tempo de duração apresentarambaixo percentual de acerto (18,24%). O conhecimento sobre o objetivo do ensaio clínico(47,30%), o motivo do convite para participação nesta pesquisa (32,43%), os efeitos adversos(44,59%) e os benefícios previsto nesta investigação (73,21%) apresentaram moderadopercentual de acerto. A análise dos direitos do participante retratou alto percentual de acerto oconhecimento sobre: a ausência...

The study aimed to analyze, in a clinical trial, the association between participant´sknowledge relating to information contained in an Informed Consent Form (ICF) andsocioeconomic/demographic factors, knowledge regarding medical and methodological terms,auto evaluation of health status, previous experience in clinical research and previousparticipation in educational interventions. Participated in the study 148 individuals, whoconsented to join in a clinical trial study held in the Americaninhas district, Minas Gerais,which endeavored to test a functional food with anti-helminthic properties. This is adescriptive study with a quantitative approach and cross-section design. A structured form,approaching themes contained in the Clinical Trial ICF, was used as a data collection method.The structure form application occurred in October 2011, one month after the participantssigned the Clinical Trial ICF. The mean global knowledge of participants, regardinginformation contained in the ICF, was 57,26%. A multivariate analysis showed that a higherweekly access to electronic media, formal education, previous participation in educationalinterventions and previous knowledge regarding medical and methodological terms werepositively associated with global knowledge; while age was negatively associated with it..Questions related to exams and procedures of clinical trial presented high percentage ofaccuracy (92,59%), while knowledge about clinical trial sponsor and duration presented lowaccuracy (18,24%). The knowledge regarding the purpose of the trial (47,30%), the reason forthe invitation to participate in this study (32,43%), adverse events (44,59%) and researchintended benefits (73,21%) presented moderate percentage of accuracy. The analysis ofparticipant´s rights showed high percentage of correctness in knowledge concerning: theabsence of financial incentive to join in the clinical investigation (89,02%), the medical...

A brief analysis of problems existing in the composition of informed consent form in scientific research / 中国医学伦理学

Based on the collation and analysis of 178 informed consent forms of clinical research projects related to human accepted by the ethical review committee of one hospital in 2007 and 2008,major problems were summarized as follows:the expression was difficult to be understood and was unsuitable for popular apprehension;lack of basic elements or insufficiently informed;inductive or advertising expressions existed,etc.Accordingly,the discussion was made for some recommendations of improvement.

Establishment and Example of Informed Consent Form for Kidney Transplantation / 中国医学伦理学

Kidney transplantation is a high-cost and high-risk surgery,thus genuine informed consent from the patients and their family members is indispensable both for protecting rights of patients and ensuring medical safety.Guided by related regulations and ethical guidelines,this paper proposes necessary information which should be provided for patients,one example of Informed Consent Form(ICF) composing of information sheet,and consent signature form offered for reference.The proposed ICF applies three accepted requirements for informed consent,i.e.,completely being informed,fully understood and free to make choice.