Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis.

We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as 'sponsor' or 'collaborator' could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as 'sponsor' or 'collaborator' was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as 'completed' (n = 408) or 'terminated' (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as 'collaborator' were significantly more likely to post ICFs when trials were in the 'active, not recruiting' phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as 'sponsors' were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as 'collaborators'. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.

Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study.

(1) Background: The wording of informed consent forms could hinder their comprehension and hinder patients' autonomous choice. The objective of this study was to analyze the readability and comprehension of anesthesia informed consent forms in a Spanish county hospital. (2) Methods: Descriptive and cross-sectional study carried out on patients who were going to undergo anesthetic techniques. The readability of the forms was analyzed using the INFLESZ tool and their subjective comprehension using an ad hoc questionnaire. (3) Results: The analyzed forms presented a "somewhat difficult" legibility. A total of 44.2% of the patients decided not to read the form, mainly because they had previously undergone surgery with the same anesthetic technique. The language used in the forms was considered inadequate by 49.5% of the patients and 53.3% did not comprehend it in its entirety. A statistically significant negative correlation of age and INFLESZ readability score with the overall questionnaire score was found. A statistically significant association was observed as a function of age and educational level with the different criteria of the questionnaire. (4) Conclusions: The anesthesia informed consent forms presented low readability with limited comprehension. It would be necessary to improve their wording to favor comprehension and to guarantee patients' freedom of choice.

Ethical regulation of biomedical research in Brazil: a quality improvement initiative.

BACKGROUND: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil's national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world's largest research ethics evaluation systems.

Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties.

INTRODUCTION: To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties. METHODS: We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included. RESULTS: The main outcomes were language complexity (measured using Flesch-Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch-Kincaid Grade Level and Flesch Reading Ease indices. CONCLUSIONS: Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making.

Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital.

(1) Background: Because of their direct and continuous contact with the patient, nurses play a relevant role in ensuring that informed consent forms are complete and easy to read and comprehend. The objective of this study was to analyze the legibility and formal quality of informed consent forms for non-surgical procedures in a county hospital. (2) Methods: The readability of these forms was analyzed using the INFLESZ scale and the information they provided according to the formal quality criteria established for these forms. (3) Results: Readability was difficult in 78.08% of the forms analyzed. No form fulfilled all the criteria, the most non-compliant being the non-appearance of the verification of delivery of a copy to the patient (100%), the contraindications (94.59%), and the alternatives (83.78%) of the procedure. Statistically significant differences were observed between disciplines with respect to the INFLESZ readability score and the formal quality score, but no statistically significant correlation was found between the two scores. (4) Conclusions: The informed consent forms for non-surgical procedures analyzed presented mostly difficult readability and poor formal quality, making it difficult for patients to have understandable and complete information. Nursing professionals should be actively involved in their improvement to facilitate patient decision making.

Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms.

Introduction: The purpose of the informed consent form (ICF) is to outline the risks and benefits of an interventional clinical trial to potential participants. The aim of this study was to explore the feasibility of a short addendum to the ICF, summarizing key points most relevant to potential participants. Methods: A sample of 20 ICFs was reviewed against the requirements of the U.S. federal regulation documents and assessed for readability. Alongside the ICF review, we conducted focus groups and one-on-one interviews with people with lung cancer (n = 9) to learn what information was most important when considering participation in a clinical trial using a hypothetical phase 3 ICF. Results: The 20 ICFs reviewed were from phases 1 to 3, expanded-access, and single-patient trials covering predominantly NSCLC; 60% were global. The mean length of the ICFs was 21 (range: 15-34) pages. The average reading level was tenth grade whereas the average U.S. reading level was eighth grade. Readability varied by section, the "purpose of the study" section had the highest reading level. In the qualitative research component, participants were "overwhelmed" by the hypothetical ICF. Participants were also asked to list information for the addendum; their suggestions broadly map to federal regulations. An addendum with reference to sections in the ICF for additional details was well received. Conclusions: The variations in ICF architecture and readability make it difficult for patients to make an informed decision to participate in a clinical trial. Implications extend beyond lung cancer, highlighting key areas for ICF improvements and providing a roadmap for developing a patient-centric addendum.

Posting of clinical trial results and other critical information from completed medicines trials on ClinicalTrials.gov.

PURPOSE: Clinical trials transparency requires trial registration and the posting of results on a public register. US regulations also require the posting of protocols and statistical analysis plans (SAPs). For US Federal agency funded trials to be started on or after 21 January 2019, informed consent forms (ICFs) must also be posted. Posting these documents is not mandatory in other countries. We aimed to assess compliance with US regulations of trials conducted in the US or in other countries with respect to ICFs, protocols, SAPs, and results. METHODS: This cross-sectional analysis (27 April 2023) comprised completed medicines trials to be started on or after 21 January 2019 registered on ClinicalTrials.gov. Trial data were registered by funder type (i.e., 'US federal agencies', industry, and 'all others') and development phase. RESULTS: Of 5,584 trials, 40% were conducted solely in the US. 47% and 12% of US and non-US trials had posted results. Some 40% of US trials had posted protocols and SAPs as did 9% of trials conducted in other countries. Only 10% (US) and 2% (other countries) of trials had posted ICFs. When the margin of the last 2 and 12 months after primary completion date were considered in the analysis, ICF posting rate did not change, but posting results increased to 64% for US trials. 'US Federal agencies' funded trials were significantly more likely to post ICFs than industry [OR 23.9 (12.5-45.7; <.001)] or 'all others' [OR 3.16 (1.79-5.56; <.001)]. CONCLUSION: Future interventions should be considered to encourage timely posting of trial results and information.

A cross-sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines.

Background: Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time. Aim: This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the Indian Council of Medical Research [ICMR]) of informed consent coupled with online surveys. Methods: We collected the informed consent text from online survey links obtained from a network of colleagues who got a request to participate in a survey. Data were collected from July 2020 to June 2022. The text was anonymized for further analysis. The word count, sentences, and Flesch reading ease score were calculated. The adherence to ICMR guidelines where checked by two authors individually and a consensus was reached to prepare the final result. Results: A total of 44 online surveys in English were audited and among them, 10 did not have informed consent. The informed consent in 34 surveys had a median of 6 sentences and 84 words. The median reading ease score was 45.7 (college level). The majority of the consent states the purpose of the research (91.18%), the voluntary nature of the participation (85.29%), and mentioned that it is research (64.71%). However, the rest of the components are ignored by the majority of the survey consent form. Conclusion: Informed consent form with online surveys lacks adherence to the components suggested by ICMR. Hence, the forms should be made carefully by the researchers so that the vigor of informed consent is maintained in the online surveys.

The mediating effect of shared decision-making in enhancing patient satisfaction with participation in cancer clinical trials.

Objective: The participation of patients with advanced cancer(s) in clinical trials is vital for new drug development. We aimed to investigate patients' decision-making processes and satisfaction with their decision (SWD) to participate; the study's purpose was to provide results that can help support high-quality research in clinical trials. In addition, we explored how shared decision-making (SDM) mediates the relationship between understanding informed consent forms and SWD to participate in a clinical trial. Methods: A cross-sectional study was conducted. A purposive sample of 111 cancer patients was recruited, and they completed a questionnaire on demographic characteristics, SDM, and decision-making satisfaction to participate in a clinical trial. Correlation and mediation analyses were used. Results: Participants aged under 65 years and with higher education reported high SWDs, and SDM significantly mediated the relationship between self-assessed understanding of informed consent forms and SWDs related to clinical trials. Conclusions: SDM in patients with lung or liver cancer was a significant mediator between understanding the informed consent form and the patient's SWD. The higher the SWD level of participating in clinical trials, the better study team members' SDM involvement and the better the comprehension of informed consent forms. In addition, patients' age and education level should also be considered as influencing factors in SWD. This survey is the first in Taiwan to examine SDM in drug-related clinical trials. The study results provide evidence to support SDM in a clinical trial model and develop informed consent process policies in research facilities.

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials.

BACKGROUND/AIMS: An informed consent form is essential in drug development clinical trials. This study aimed to evaluate regulatory compliance and readability of informed consent forms currently being used in industry-sponsored drug development clinical trials. METHODS: This descriptive, cross-sectional study evaluated the informed consent forms of industry-sponsored drug development clinical trials conducted at the Faculty of Medicine, Chiang Mai University, between 2019 and 2020. The informed consent form's compliance with the three major ethical guidelines and regulations (i.e. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6(R2) Good Clinical Practice; Declaration of Helsinki; and the revised Common Rule) were analyzed. The document length and the readability scores (using Flesch Reading Ease and Flesch-Kincaid Reading Grade) were assessed. RESULTS: Of 64 reviewed informed consent forms, the average page length was 22.0 ± 7.4 pages. More than half of their length was mainly devoted to three elements: trial procedures (22.9%), risks and discomforts (19.1%), and confidentiality and the limit of confidentiality (10.1%). Although most of the required elements of the informed consent form content were included in most informed consent forms, we identified four elements with often missing information in the form: aspects of research that are experimental (n = 43, 67.2%), involvement of whole-genome sequencing (n = 35, 54.7%), commercial profit sharing (n = 31, 48.4%), and posttrial provisions (n = 28, 43.8%). CONCLUSION: The informed consent forms in industry-sponsored drug development clinical trials were long but incomplete. Our findings draw attention to ongoing challenges in industry-sponsored drug development clinical trials, where deficient informed consent form quality continues to exist.

Determination of the Readability Level of Consent Forms Used in the Gynecology and Obstetrics Clinic at Suleyman Demirel University.

Background This study aimed to evaluate the readability level of consent forms used for interventional procedures in the obstetrics and gynecology clinic and to determine the readability of the texts according to the education level of the patient. Methodology This study determined the readability of patient consent forms used before interventional procedures in the gynecology and obstetrics clinic at the Suleyman Demirel University Hospital, Isparta. The consent forms were divided into two main groups according to their use in obstetrics and gynecology procedures. The readability level of consent forms was assessed using two readability formulas developed by Atesman and Bezirci-Yilmaz, which determine the readability level of Turkish texts in the literature. Results When the consent forms were analyzed according to Atesman's readability formula, they were found to be readable with more than 15 years of education at the undergraduate level, while according to Bezirci-Yilmaz's readability formula, they were found to be readable with 17 years of education at the postgraduate level. Conclusions Easy-to-read consent forms will ensure that patients are more informed about interventional procedures and participate more effectively in the treatment process. There is a need to develop readable consent forms suitable for the general education level.

Social control, transparency, accountability, and scientific integrity in medical research / Control social, transparencia, responsabilidad y integridad de la investigación médica / CONTROLE SOCIAL, TRANSPARÊNCIA, INTEIREZA CIENTÍFICA E RESPONSABILIDADE EM PESQUISAS MÉDICAS

The CEP/CONEP System, submitted to social control, is responsible for the ethical approval of research in Brazil to protect research participants. The Informed Consent Form (ICF) is the public document that implements the protection of participants. The paper presents two cases of medical research in the Amazon region on malaria and the use of chloroquine for treating COVID-19. The participants were uninformed in the ICF on relevant aspects of the two studies, with serious health risks. For the sake of increasing transparency and social control, it is proposed the mandatory publication of the ICF in studies supported by public funds, presentation of an objective summary of the study at the beginning of the ICF, publication of central elements of the protocol of clinical trials in open access Brazilian virtual platforms, and promulgation of a dedicated law to improve scientific and ethical integrity in Brazilian medical research.

El Sistema CEP/CONEP es responsable del análisis ético de la investigación en Brasil, sometida al control social, con la misión de proteger a los participantes en la investigación.  El Formulario de Consentimiento Libre e Informado es el documento público que implementa la protección de los participantes. El artículo presenta dos casos de investigación médica en la región amazónica sobre malaria y tratamiento con cloroquina para COVID-19, en que los participantes no fueron informados, en el documento de consentimiento informado, aprobado por el sistema CEP/CONEP, sobre aspectos relevantes de los estudios, con graves riesgos para la salud.  Para aumentar la transparencia y el control social, el artículo propone la divulgación obligatoria del modelo de consentimiento informado en estudios financiados con recursos públicos, la presentación de un resumen objetivo del estudio al inicio del documento de consentimiento, la publicación de elementos centrales del protocolo de ensayos clínicos en plataformas virtuales brasileñas de acceso abierto, y la promulgación de una ley para perfeccionar la integridad científica y ética en la investigación médica brasileña.

O Sistema CEP/CONEP é responsável pela regulação ética de pesquisas no Brasil, comprometido com o controle social, para proteger os direitos dos participantes em pesquisas. O Termo de Consentimento Livre e Esclarecido (TCLE) é o documento público que concretiza a proteção dos participantes. O artigo aborda dois casos de pesquisas médicas na região amazônica, sobre malária e tratamento com cloroquina para COVID-19, em que os participantes foram desinformados no TCLE, aprovado pelo sistema CEP/CONEP, sobre aspectos relevantes dos estudos, com sérios riscos à saúde.  Para ampliar a transparência e  controle social, propõe-se a divulgação obrigatória do modelo de TCLE em pesquisas que usem recursos públicos, apresentação de resumo itemizado no início do TCLE, publicação de elementos centrais do protocolo de ensaios clínicos em plataformas virtuais brasileiras de acesso aberto e promulgação de lei para aprimorar a inteireza científica e ética nas pesquisas médicas brasileiras.

The effects of modifying elements of written informed consent forms for elective surgical or invasive procedures: A systematic review.

OBJECTIVE: To study the effect of modifying content and design elements within written informed-consent-forms (ICF) for patients undergoing elective surgical or invasive procedures. METHODS: We included (quasi-)randomized trials in which a modified written ICF (e.g. visual aids) was compared to a standard written ICF. We searched PubMed, Web-of-Science and PsycINFO until 08/2021. Risk of Bias was assessed. The complexity of intervention was assessed using the Intervention Complexity Assessment Tool for Systematic Reviews. RESULTS: Eleven trials with 1091 participants were eligible. Effect sizes and levels of evidence varied from trivial to moderate andthere were contradictory findings for some outcomes. Providing patients with more informationin general or specific information on risks and complications mostly increased anxiety. The use of verbal risk presentation decreased anxiety and increased satisfaction.A lower readability level decreased anxiety and improved comprehension and knowledge. CONCLUSION: Our results suggest that providing more information and addressing certain types of risks have differential effects. While more information improved knowledge, it also increased anxiety. We did not find any or only insufficient evidence for many other possible ICF modifications. PRACTICE IMPLICATIONS: When developing ICFs the differential impact of different elements on patient important outcomes should be carefully considered.

Evaluation of consent forms for clinical practice in Spanish Public Hospitals.

OBJECTIVE: To evaluate the access, development, and quality of consents forms for clinical practice within the Spanish Public Hospitals. METHOD: A cross-sectional study was conducted in a two-stage process (January 2018-September 2021). In stage 1, A nationwide survey was undertaken across all public general hospitals (n=223) in the Spanish Healthcare System. In stage 2, Data was taken from the regional health services websites and Spanish regulations. Health Regional Departments were contacted to verify the accuracy of the findings. Data was analyzed using a descriptive and inferential statistics (frequencies, percentages, Chi-square & Fisher's exact tests). RESULTS: The response rate was 123 (55.16%) of Spanish Public Hospitals. The results revealed a range of hospital departments involved in the development of consent documents and the absence of a standardized approach to consent forms nationally. Consent audits are undertaken in 43.09% hospitals and translation of written consents into other languages is limited to a minority of hospitals (35.77%). The validation process of consent documentation is not in evidence in 13% of Spanish Hospitals. Regional Informed Consent Committees are not place in the majority (70.7%) of hospitals. Citizens can freely access to consent documents through the regional websites of Andalusia and Valencia only. CONCLUSION: Variability is found on access, development and quality of written consent across the Spanish Public Hospitals. This points to the need for a national informed consent strategy to establish policy, standards and an effective quality control system. National audits at regular intervals are necessary to improve the consistency and compliance of consent practice.

Shared decision-making and specific informed consent in patients with aortic aneurysms

ABSTRACT Objective To analyze the refusal rate of elective aortic aneurysm surgery in asymptomatic patients after the presentation of a detailed informed consent form followed by a meeting where patient and their families can analyze each item. Methods We conducted a retrospective analysis of 49 patients who had aneurysms and were offered surgical treatment between June 2017 and February 2019. The patients were divided into two groups: the Rejected Surgery Group, which was composed of patients who refused the proposed surgical treatment, and the Accepted Surgery Group, comprising patients who accepted the proposed surgeries and subsequently underwent them. Results Of the 49 patients, 13 (26.5%) refused surgery after reading the informed consent and attending the comprehensive meeting. We observed that patients who refused surgery had statistically smaller aneurysms than those who accepted surgery (9% versus 26%). These smaller aneurysms were above the indication size, according to the literature. Conclusion One-quarter of patients who were indicated for elective surgical repair of aortic aneurysms rejected surgery after shared decision-making, which involved presenting patients with an informed consent form followed by a clarification meeting for them and their families to analyze each item. The only factor that significantly influenced a rejection of the procedure was the size of the aneurysm; patients who rejected surgery had smaller aneurysms than those who accepted surgery.

Acessibilidade do termo de consentimento na pesquisa clínica no Brasil / Accessibility of the consent form in Brazilian clinical research / Accesibilidad al formulario de consentimiento en la investigación clínica en Brasil

Resumo O termo de consentimento livre e esclarecido tem a função de informar o participante de pesquisas clínicas sobre a natureza da pesquisa e seus direitos, formalizando sua decisão de participar. Estudos indicam que esse documento é redigido de modo complexo, comprometendo a autonomia do participante. Para este trabalho, foram redigidos dois termos de consentimento da mesma pesquisa hipotética, com estilos de redação diferentes. Ambos os termos foram analisados pela ferramenta Coh-Metrix Port, que avalia métricas linguísticas e acessibilidade textual. A análise indicou que os textos são complexos e exigem alta escolaridade para serem entendidos. Esses achados reforçam a percepção de que, no Brasil, os termos de consentimento podem ter sua real função comprometida e apontam a importância de modificar sua forma de elaboração.

Abstract The informed consent form informs clinical research patients about the nature of the research and their rights, formalizing their decision to participate; however, studies show that this document is written in a complex manner, compromising patient autonomy. Two consent forms from the same hypothetical research were developed with different writing styles and analyzed by the Coh-Metrix Port tool, which evaluates linguistic metrics and textual accessibility. Results showed that both texts were complex and required high schooling level to be understood. These findings reinforce the perception that consent forms may have their real function compromised and point to the importance of changing its elaboration.

Resumen El formulario de consentimiento informado tiene la finalidad de mostrar la naturaleza de la investigación y sus derechos al participante de la investigación clínica para formalizar su decisión de participar en el estudio. Los estudios indican que la redacción de este documento es compleja, lo que compromete la autonomía del participante. Para este estudio se redactaron dos formularios de consentimiento de una misma investigación hipotética, con diferentes estilos de escritura. Para el análisis de ambos formularios se utilizó la herramienta Coh-Metrix Port, que evalúa las métricas lingüísticas y la accesibilidad textual. Los resultados apuntaron a que los textos son complejos, lo que requiere un alto nivel de educación para su comprensión. Estos hallazgos coinciden que, en Brasil, los formularios de consentimiento pueden tener su finalidad comprometida y señalan la necesidad de modificar su forma de elaboración.

Dever de informação em medicina: análise de processos judiciais / Disclosure of information in medicine: analysis of judicial cases / El deber de informar en medicina: análisis de las demandas

Resumo Termo de consentimento é a expressão de uma decisão voluntária, tomada após processo informativo, no sentido de aceitar um tratamento considerando riscos, benefícios e possíveis consequências. Este estudo analisou o papel do termo de consentimento em decisões do Tribunal de Justiça do Estado de São Paulo. No período de um ano, realizou-se busca com as palavras-chave "termo de consentimento" e "erro médico", e os dados dos 65 acórdãos estudados foram expostos mediante recursos do programa Excel. Em 15 casos não se utilizou o documento, dos quais 12 demostraram falta do dever de informar. Em 31% dos processos houve condenação do réu e a maioria dos autores que receberam compensação financeira fez jus a indenização por danos morais. As áreas de atuação na medicina que mais figuraram como rés foram cirurgia plástica e ginecologia e obstetrícia. Ficou demonstrada a relevância da aplicação do termo de consentimento e da atuação do perito médico.

Abstract Consent expresses a voluntary decision, taken after disclosure of information, to accept treatment considering risks, benefits, and possible consequences. This study analyzed the role of consent forms in decisions by the São Paulo State Court of Justice. Bibliographic search was conducted using the keywords "consent form" and "medical error." The 65 rulings identified were analyzed using Excel. Of the 15 cases in which patients were not presented with a consent form, 12 showed lack of information disclosure. In 31% of the cases, the defendant was found guilty, and most of the plaintiffs who received financial compensation were awarded moral damages. Plastic surgery, gynecology and obstetrics were the branches that most often featured as defendants. The findings attest the relevant role played by the consent form and the medical expert.

Resumen El formulario de consentimiento expresa una toma de decisión voluntaria al aceptar el tratamiento después de informados los riesgos, beneficios y posibles consecuencias. Este estudio analizó el papel del formulario de consentimiento en las decisiones del Tribunal de Justicia del Estado de São Paulo. Durante un año se realizó una búsqueda con las palabras clave "formulario de consentimiento" y "error médico", y los datos de las 65 demandas se expusieron en el programa Excel. En 15 casos no se utilizó el documento, de los cuales 12 demostraron haber una falla del deber de informar. El 31% de los casos lo condenó al acusado, y la mayoría de los autores que recibieron una compensación económica tenían derecho a indemnización por daño moral. Las áreas de la Medicina que recibieron más demandas fueron la cirugía plástica y la ginecología y obstetricia. Son fundamentales aplicar el formulario y la actuación del perito médico.

Processo de obtenção de consentimento livre e esclarecido para pessoas analfabetas em procedimentos de saúde / Process for obtaining informed consent for illiterate people in healthcare procedures

O Termo de Consentimento Livre e Esclarecido (TCLE) é um documento que faz parte do processo de obtenção da anuência de pacientes ou de participantes de pesquisa, para garantir seus direitos e atribuir seus deveres. Caso o TCLE contenha um texto complexo, ele restringirá, de certa forma, a liberdade de decisão de indivíduos analfabetos. Objetivo: avaliar a percepção de analfabetos sobre o conhecimento do TCLE e suas formas de manifestação de anuência para procedimentos de saúde. Material e método: trata-se de uma pesquisa transversal quali-quantitativa, cuja coleta de dados foi realizada com alunos da Educação de Jovens e Adultos (EJA) por meio de entrevista gravada após leitura de um TCLE modelo. Os resultados qualitativos foram analisados segundo a Técnica de Análise de Conteúdo, proposta por Bardin. Os quantitativos foram analisados pelo teste qui-quadrado e por análise de regressão logística por meio do software JAMOVI. Resultados: participaram da pesquisa 32 alunos. Os dados obtidos mostraram que o conhecimento prévio acerca do TCLE era baixo (34,37%), apenas 46,87% dos participantes compreenderam o documento, sendo 38% da 4ª etapa da EJA. Quase todos os participantes entenderam os benefícios em aplicar o TCLE nas práticas clínicas e 75% informaram que imagens facilitariam a compreensão do documento. Conclusão: concluiu-se que baixas habilidades de alfabetização afetam diretamente a autonomia para anuência em TCLE. A dificuldade na compreensão do TCLE pode estar relacionada aos elementos textuais, como o tamanho da fonte, utilização de termos difíceis e apresentação de um texto extenso contendo muitas informações

The Informed Consent (IC) is a document that is part of the process for obtaining the consent of patients or research participants, to guarantee their rights and assign their duties. The IC, by containing a complex text, restricts, in some way, the freedom of decision of illiterate individuals. Objective: to evaluate the perception of illiterate individuals on the knowledge of the IC and their forms of expression of consent to health procedures. Material and method: this is a quali-quantitative cross-sectional study, whose data collection was carried out with students of Youth and Adult Education (YAE) by means of recorded interview after reading an IC model. The qualitative results were analyzed according to the Content Analysis Technique, proposed by Bardin. Quantitative results were analyzed applying the Chi-square test and logistic regression analysis using the JAMOVI software. Results: 32 students participated in the research. The data obtained showed that the previous knowledge about the ICF is low (34.37%), only 46.87% of the participants understood the document, 38% of them from the 4th stage of YAE. Almost all participants understood the benefits in applying the IC in clinical practices and 75% claimed that images would facilitate understanding of the document. Conclusion: It was concluded that low literacy skills directly affect the autonomy to consent using the IC. The difficulty in understanding the IC may be related to textual elements, such as font size, use of difficult terms, and presentation of an extensive text containing a lot of information

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.

BACKGROUND: This study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form (IAF)/informed consent form (ICF) of a pediatric drug trial. METHODS: A descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in a questionnaire, by giving a rating scale from 1 (not important) to 5 (very important). RESULTS: A total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk-benefit aspects (i.e., direct health benefit [mean: 4.71 for child respondents, 4.89 for parent respondents], indirect/societal benefit [mean: 4.65, 4.85], major foreseeable risk [mean: 4.47, 4.78], post-trial benefit/provision [mean: 4.59, 4.74], and all adverse effects of the drug including uncommon adverse effects [mean: 4.53, 4.74]) were perceived to be of most concerning items from both child participants' and parents' viewpoint. None of the items were considered 'slightly important' or lower by more than 20% of the respondents. CONCLUSIONS: For pediatric drug trials, risk-benefit information (including direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and adverse effects of the drug) should be made a salient feature of an IAF/ICF. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/ICF to better suit child participants' and parents' needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases.

The importance of applying the statement of assent to children and adolescents: a qualitative study.

OBJECTIVES: To describe the importance of the Statement of Assent for children and adolescents invited to participate in a clinical study and their main reactions to its explanation. METHODS: This is an exploratory descriptive qualitative study of 17 children and adolescents, who were invited to participate in a clinical study in the field of oncology in a hospital located in Rio de Janeiro (Brazil). Data were analyzed using thematic analysis. RESULTS: Two thematic units were generated after data interpretation: signing the statement of assent, in which participants felt their main role when faced with the possibility of expressing their agreement or not to take part in the study; and understanding of the study, when they showed that they understood the steps of the study by asking pertinent questions to clarify their doubts. Children and adolescents understood the steps of the study contained in the Statement of Assent, were interested and asked questions to clarify their doubts about the study. CONCLUSIONS: The Statement of Assent was important for participants understanding the study and having autonomy over their participation. As the statement strengthened the main role of children and adolescents in the research process, the conclusion was that its use in studies involving the pediatric population should be encouraged.