Gestión de la enfermera investigadora en el proceso de consentimiento informado en ensayos clínicos / Management of the research nurse in the informed consent process in clinical trials

El consentimiento informado es un proceso que consiste en un diálogo entre los investigadores y el paciente, acerca de determinado procedimiento relativo a su salud. En los ensayos clínicos, el consentimiento informado tiene una connotación especial por tratarse de una investigación en la cual puede buscarse la eficacia y seguridad de un nuevo producto. Los principios bioéticos de autonomía, justicia y beneficencia tienen su máxima expresión en estos estudios. El profesional sanitario, debe informar al paciente y respetar la decisión que este tome, de acuerdo con sus valores y su proyecto de vida, como clara expresión de su autonomía moral. Históricamente el proceso es liderado por el investigador médico, sin embargo, las enfermeras investigadoras pueden asumir la responsabilidad en el proceso, siempre y cuando estén bien preparadas y entrenadas en el problema que se investiga, en buenas prácticas clínicas y en las leyes y procedimientos vigentes. La enfermera investigadora puede protagonizar el consentimiento informado, tal como lo hace el investigador clínico(AU)

Informed consent is a process that consists of a dialogue between researchers and the patient about a certain procedure related to their health. In clinical trials, informed consent has a special connotation because it is research in which the efficacy and safety of a new product can be sought. The bioethical principles of autonomy, justice and beneficence have their maximum expression in these studies. The health professional must inform the patient and respect the decision she makes, in accordance with her values and her life project, as a clear expression of her moral autonomy. Historically, the process is led by the medical researcher, however, research nurses can assume responsibility in the process, as long as they are well prepared and trained in the problem under investigation, in good clinical practices and in current laws and procedures. The research nurse can lead the informed consent, just as the clinical researcher does(AU)

Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS) 2016. (Parte 1 de 3) / Comparative analysis of the standards of the council of international organizations of medical sciences (CIOMS) 2016. (Part 1 of 3)

Para la realización de investigaciones científicas en seres humanos es fundamental el cumplimiento de la Declaración de Helsinki, cuya última actualización se publicó en el 2013. Para los países de América Latina esta declaración se adaptó como las Pautas CIOMS, por lo que también fue necesario actualizar y su publicación ocurrió en el 2016. Como parte de la evaluación de la asignatura Bioética e Investigación, se solicitó a los estudiantes de la VI Cohorte de la Maestría en Bioética de la Facultad de Medicina, UCV, que realizarán un análisis comparativo de éstas con las pautas contempladas en la edición anterior del 2002 a fin de proporcionar a los investigadores un aporte en su formación y una rápida adaptación a la nueva propuesta. Para el desarrollo de estos trabajos se agruparon las pautas en grandes temas afines y se presentan en tres entregas(AU)

To carry out scientific research on human beings, compliance with the Declaration of Helsinki, whose last update was published in 2013, is essential. For Latin American countries, this statement was adopted as the CIOMS Guidelines, which were last updated and published in 2016. As part of the evaluation of the subject Bioethics and Research, students of the VI Cohort of the Master in Bioethics of the Faculty of Medicine, UCV, were asked to perform a comparative analysis of these with the guidelines contemplated in the previous edition of 2002 to provide researchers with a contribution in their training and a rapid adaptation to the new proposal. For the development of these works, the guidelines were grouped into large related topics and presented in three installments(AU)

Excepciones al uso del consentimiento informado en investigación: ¿cuándo es esto posible en Chile? / Exception to informed consent in research: when is this possible in Chile?

Exceptions or waivers to informed consent in research in Chile are an ethical issue that has not been addressed in all its complexity by the scientific community. The possible waivers to this process could make the difference for the feasibility, success or failure of a study. The purpose of this document is to clarify within the available information, what is the current situation about the exceptions to informed consent in research and what are the ethical-legal guidelines in Chile. Articles were reviewed in both English and Spanish from indexed journals and those documents that meet the inclusion criteria were selected. There is limited information available about waivers to informed consent, which indicates that the ethical guidelines are similar among countries that honor the Declaration of Helsinki, including Chile. However, the current Chilean legislation does not include exceptions. Ethics Committees that authorize research in line with international ethical guidelines could allow possible exceptions. Based on our findings, it is necessary to evaluate possible exceptions for informed consent for research performed in Chile, both from the legal point of view and based on the experience of scientists.

Estudio Descriptivo: Conocimiento de Normativa de Atención Inicial de Víctimas de Violencia en la Unidad de Emergencia del Hospital de Especialidades José Carrasco Arteaga, 2017 / Descriptive Research: Knowledge of Initial Care Standards for Victims of Violence in the Emergency Unit of the José Carrasco Arteaga Specialties Hospital, 2017

INTRODUCCIÓN: Cada año fallecen cinco millones de personas en el mundo por causa de violencia de género, intrafamiliar y sexual. En Ecuador, una de cada tres mujeres, y uno de cada dos niños y adolescentes, refirieron haber sufrido algún tipo de violencia. El objetivo del estudio es determinar y describir el nivel de conocimiento respecto al procedimiento y manejo de víctimas de violencia por parte de los médicos en el área de emergencia. MÉTODOS: Se trata de un estudio descriptivo que incluye 58 médicos que laboran en el servicio de emergencia del Hospital de Especialidades José Carrasco Arteaga en el periodo enero ­ diciembre 2017, excluyendo a quienes no deseen participar, realizándose una encuesta sin validación enfocada a la atención de víctimas de violencia, luego de capacitación por Fiscalía General, se realizó un segundo test. Se utilizó el programa de análisis estadístico IBM SPSS versión 21, para obtención de resultados. RESULTADOS: Inicialmente el conocimiento de atención a víctimas de violencia de género, intrafamiliar y sexual fue de un 55 % en los profesionales, luego de la capacitación se observó un incremento al 11 % con respecto al conocimiento de la Normativa de Atención. CONCLUSIONES: Es importante que el manejo de este fenómeno comprenda una participación multidisciplinaria y articulada con la permanente capacitación a los profesionales médicos especialistas y residentes asistenciales que laboran en el Área de Emergencia del establecimiento por parte de Fiscalía General del Estado.

BACKGROUND: Every year five million people die in the world due to gender, intrafamily and sexual violence. In Ecuador, one in three women and one in two children and adolescents reported having suffered some type of violence. The objective of the study is to determine and describe the knowledge level regarding the procedure and management of violence victims by physicians working in the emergency area. METHODS: This is a descriptive study that includes 58 doctors who work at the emergency service of the José Carrasco Arteaga Specialties Hospital in the period January - December 2017, excluding those who do not wish to participate, performing a survey without validation focused on the care of violence. After training by the Attorney General, a second test was carried out. It was using the statistical analysis software IBM SPSS version 21, for obtaining results. RESULTS: Initially the attention knowledge to victims of gender, intrafamily and sexual violence was of 55 % among the professionals, however after the training it was observed an 11 % increase respect to the knowledge about the Norm of Attention to Victims. CONCLUSIONS: It is important the management with multidisciplinary participation, and the permanent training of medical specialists and care residents who work at Health Unit Emergency Area by the State Attorney General's Office. Additionally.

El consentimiento informado en clínica: inquietudes persistentes / Informed consent in clinical practice: persistent doubts

Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics’ effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics’ insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.

Teoría y práctica del consentimiento informado / Theory and practice of informed consent

En el ámbito asistencial, toda persona que consulta posee el derecho al consentimiento informado y, por tanto, el ejercicio actual de la profesión conlleva el deber de respetarlo. Se espera que el profesional brinde información al paciente antes, durante y al finalizar cualquier procedimiento. Los datos revelados, sean verbalmente o por escrito, no deberán omitir el diagnóstico, el pronóstico, el tratamiento indicado, sus beneficios y posibles alternativas, sin dejar de mencionar la probabilidad de eventuales complicaciones. El lenguaje utilizado debe ser adecuado para que el interesado comprenda acabadamente aquello que se le está trasmitiendo y sea capaz de tomar una determinación. Mediante este proceso de información y toma de decisiones, el paciente estará en condiciones de decidir sobre su propia salud...

Sistema sanitario: capacidad de respuesta limitada detectada en referencias para atención quirúrgica, Hospital escuela Universitario, Tegucigalpa / Health system: limited responsiveness detected in references for surgical care, Hospital Escuela Universitario, Tegucigalpa

Antecedentes: El Hospital Escuela Universitario (HEU) tiene cobertura de atención 24/7 y recibe pacientes referidos a nivel nacional. Objetivo: Identificar los centros asistenciales y características de pacientes referidos a Emergencia de Cirugía General (CG), HEU, mayo-julio 2013. Metodología: Estudio descriptivo transversal sobre pacientes referidos para atención quirúrgica captados en Sala de Emergencia de CG. Previo consentimiento informado verbal, los datos se recolectaron por entrevista, revisión de referencia y expediente clínico. Se registró información sociodemográfica, clínica, condiciones del traslado. Se evaluó características de los centros asistenciales. Resultados: Se registraron 844 pacientes referidos, 20.5% de las 4,114 atenciones del período. El 66.1% (558) fue referido de centros asistenciales de Francisco Morazán; el resto, procedía de El Paraíso10.2%(86), Comayagua6.8% (57) y Olancho 3.8% (32). De las referencias de hospitales regionales (103), 20% (48) correspondió Hospital Santa Teresa, Comayagua, y 18.0% (43) Hospital Gabriela Alvarado, El Paraíso. Las razones de referencia incluyeron falta de médico especialista y de insumos conjuntamente (62.9%),falta de médicos especialistas (27.4%) y de insumos (4.6%), y falta de recursos económicos del paciente (3.1%). Entre condiciones clínicas, 26.7% (225) fue referido por dolor abdominal. El 4.0%(31)se recibió en condiciones inestables y5.2% (44) con deterioro del estado de conciencia. Discusión: El sistema sanitario de Honduras demuestra carencia de personal calificado e insumos para atención quirúrgica. La referencia por razones injustificadas acarrea impacto negativo al paciente, su familia y al centro receptor. Un sistema exitoso requiere organización, integración e interrelación entre los diferentes niveles de atención

Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance.

The office of the Drugs Controller General (India) vide order dated 19th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.

Practical issues in implementation of WMA's draft Declaration of Helsinki.

The working group of the World Medical Association (WMA) has published a revised draft of the Declaration of Helsinki for public consultation till June 15, 2013. There are many positive changes in the document with respect to compensation, education of investigators, informed consent in the case of stored samples, etc. The changes represent a step forward for ethics. However, there may be certain points of concern regarding the implementation of the Declaration.

From informed consent to informed request: strengthening shared decisionmaking.

Obtaining valid consent is regarded as essential before there can be an ethically or legally appropriate medical intervention. The justification is, simply, that patient autonomy should be respected. The patient's body is hers, and she has a right to do with it what she chooses. In order for that choice to be real, it has to be a choice made by a patient who is competent to make it. That competence has two elements. First, the patient must have the cognitive hardware and software necessary to receive, retain and process the information, weighing the benefits and the burdens of the proposed treatment against each other. Second, the inputs must be the relevant ones: the information to be processed must be (i) accurate and (ii) sufficient.

La doctrina del consentimiento informado / The doctrine of informed consent

En las últimas décadas, el paciente ha dejado de aceptar sumisamente las indicaciones del profesional para intervenir de una manera más activa en las decisiones relacionadas con su salud. Es este último quien cuenta con conocimientos que no posee su cliente, situación que da lugar a una brecha informativa entre ambos, de la que se desprenden consecuencias jurídicas, tales como el deber de informar por parte de quien ofrece un servicio. De este modo, se neutraliza la insuficiencia de conocimientos del paciente. Aún son muchos los interrogantes acerca de las formas de poder respetar en la práctica el derecho al consentimiento informado de las personas cuando llegan a los servicios de salud, por lo que resulta esencial considerar los derechos y obligaciones, tanto del facultativo como de quien contrata su asistencia. Mediante la presente reseña, se pretende resaltar algunos aspectos éticos y legales referidos al deber del profesional de informar al paciente y de obtener de él su autorización para llevar a cabo una determinada prestación.

Consentimiento informado / Informed consent

La presente contribución pone énfasis en la importancia del consentimiento informado en la práctica asistencial, sus fundamentos éticos y jurídicos, y al desarrollar la misma remarca aspectos bioéticos y médico-legales conjuntamente con las recientes normas legales que establecen obligaciones a los profesionales y derechos a los pacientes que no deben ignorarse.

In this review we emphasize the importance of the Informed Consent in clinical practice, its ethics and legal fundaments; explaining that we underline bioethic and medico-legal aspects together with the most recent legal regulations establishing obligations of the medical professionals and rights of the patient that can not be ignored.

El consentimiento informado en psicoterapia: revisión conceptual y complejidad en la práctica clínica / [Informed consent in psychotherapy: conceptual and complexity in clinical practice].

The objective of this literature review is to introduce the concept of informed consent. It outlines the definition of informed consent, which are the component parts and technical importance particularly in the field of psychotherapy applied to mental disorders. This review puts special emphasis on the complexity that the informed consent implies in the specific relationship as psychotherapy.

Responsabilidade civil e ética em ortodontia: termo de consentimento livre e esclarecido

Mediante à observação de um aumento no processo de desenvolvimento social, que abrange todas as áreas da ciência em que os cidadãos cada vez mais questionam seus direitos, muitas vezes na Justiça, desenvolveu-se este trabalho com o objetivo de validar a importância do Termo de Consentimento Livre e Esclarecido na prática odontológica com ênfase em Ortodontia...

Sobreexposición de los pacientes en hospitales docentes: la experiencia en un servicio de medicina / Superexposição de pacientes em hospitais de ensino: experiência em um serviço de medicina / Patient overexposure in teaching hospitals: the experience in a medical service facility

Introducción: la enseñanza práctica de la medicina en hospitales ha llevado a la sobrepoblación de estudiantes y muchas veces al agotamiento de los pacientes. Percibimos que a los docentes clínicos se les produce un conflicto de intereses: respeto por la condición del enfermo frente a enseñanza. Planteamos que si estudiantes y docentes conocen la percepción que de ellos tienen los pacientes, es posible crear un clima que permita el aprendizaje y descubrira la persona que hay detrás de cada cuadro clínico. Objetivos: conocer la reacción que provocan los alumnos en los enfermos y precisar si hay un máximo prudente de entrevistas por paciente. Se entrevistó una cohorte de enfermos de un servicio de medicina comprobando que ellos: 1) identifican la relación estudiante-paciente como de beneficio mutuo; 2) piensan que el límite de entrevistaslo establece cada enfermo; 3) saben que pueden negarse a cooperar; 4) que esto último no los predispone negativamente. Conclusiones: 1) la oportunidad de entrevistar o no a un paciente la establece él mismo; 2) es indispensable solicitar el consentimiento informado en docencia; 3) el rol del docente es de observador activo del binomio estudiante paciente fomentando en los alumnos virtudes propias de la convivencia e interviniendo si peligra la confianza o confidencialidad debidas.

Introduction: Practical training in medicine at hospitals has led to an overpopulation of students and, oftentimes, to patient exhaustion. The authors believe professors in a clinical environment face a conflict of interests: respect for the patient's condition versus teaching. It is suggested that a climate conducive to learning and discovery of the person behind each set of clinical symptoms can be created if students and teachers know how they are perceived by patients. Objectives: To understand the reaction students provoke in patients and to indicate whether there is a prudent maximum amount of interviews per patient. A cohort of patients at a medical service facility was interviewed. The results of those interviews indicate: 1) patients identify the student-patient relationship as one of mutual benefit; 2) they believe the limit on interviews should be set by each patient, 3) patients know they can refuse to cooperate; and 4) doing so does not predispose them negatively. Conclusions: 1) The opportunity to interview a patient, or not, is determined by the patient. 2) It is essential to seek informed consent in teaching. 3) The teacher's role is that of an active observer of the studentpatient duo, promoting the virtues of coexistence among students and intervening if due trust or confidentiality are compromised.

Introdução: o ensino prático da medicina nos hospitais conduziu a superlotação de alunos e, muitas vezes, até a exaustão dos pacientes. Os professores clínicos afrontam um conflictode interesses clínicos: o respeito pela condição do paciente versus ensino. Sugerimos que se os estudantes e professores conhecer a percepção que deles têm os pacientes, pode criar-se um clima de aprendizado que permita descobrir a pessoa por trás de cada quadro clínico. Objetivos: conhecer a reação dos doentes à frente dos estudantes e indicar se é máximo da entrevistas-paciente é pertinente. Se entrevistou uma coorte de pacientes de um serviço médico, verificando que: 1) identificam que a relação aluno-paciente é de benefício mútuo, 2) acreditam que o limite de entrevistas o determina cada paciente, 3) sabem que podem se recusar a cooperar, 4) que o último não predispô-los negativamente. Conclusões: 1) a oportunidade de entrevistar um paciente ou não depende deste, 2) é essencial obter o consentimento informado pelo ensino, 3) o papel do professor é um observador ativo do binómio aluno-paciente a fim de promover nos alunos virtudes de convivência, intervindo somente se a confiança ou a confidencialidade estão comprometidas.

Publicações sobre aspectos éticos e consentimento informado na América Latina / Publications about ethical principles and informed consent in Latin America

A aplicação do consentimento informado é uma obrigação ética baseada na Resolução 196/96 do Conselho Nacional de Saúde (BRASIL, 1996) e no respeito aos princípios bioéticos em tratamento eventual ou cirurgia, principalmente quando esta possa resultar em danos irreversíveis, como no caso das cirurgias mutiladoras. Objetivos: Conhecer como está sendo citado o uso do consentimento informado em artigos sobre cirurgias mutiladoras. Assim como, identificar a frequência das publicações sobre cirurgias mutiladoras que citam o uso do consentimento; descrever os princípios bioéticos citados; identificar o profissional responsável pela aplicação do consentimento informado em pacientes submetidos a cirurgias mutiladoras. Material e metódos: Estudo bibliográfico exploratório descritivo buscou obter o estado da arte sobre o uso do consentimento informado em cirurgias mutiladoras, no período de 2000 a 2005, tendo como fonte de informações os resumos e/ou artigos divulgados na base eletrônica de dados LILACS. Resultados: O consentimento informado foi relacionado ao uso em pesquisa e em cirurgia geral e constatouse que em cirurgias mutiladoras não está sendo citado. Foi identificada a associação do consentimento informado com a responsabilidade ética e legal do médico. Conclusões: A aplicabilidade do consentimento informado é evidente, todavia sua importância se mostrou secundária nos resumos analisados, apontando para a necessidade de aprofundamento sobre a temática. Recomenda-se aos profissionais de saúde refletir sobre a utilização da Resolução 196/96 nas práticas de cuidado.

The application of the Informed Consent is an ethical obligation based on the Resolution 196/96 of the National Health Service (BRAZIL, 1996) and with respect to the in any treatment or surgery, especially when this may result in irreversible damage, as in the case of mutilating surgery. Objectives: To know how it is being cited the use of Informed Consent in articles about mutilating surgery, as well as identifying the frequency of publications about mutilating surgery mentioning the use of the Informed Consent; describe bioethical principles cited, identify the professional responsible for the implementation of the Informed Consent in patients undergoing mutilating procedures. Material and methods: A descriptive exploratory study which aimed to obtain the state of the art on the use of Informed Consent in mutilating surgeries in the period of 2000 to 2005, with the source of information summaries and/or articles published in LILACS electronic database. Results: Informed Consent was related to use in research and in general surgery and we found that in mutilating surgery is the consent is not being used. We identified the association of Informed Consent with the legal and ethical responsibility of the physician. Conclusions: The applicability of the Informed Consent is evident, however its importance was shown in secondary way in the abstracts analyzed, pointing the need for further exploration of the subject. ItÆs recommended that health professionals reflect on the use of Resolution 196/96 in their care practices.

Principais falhas na elaboração do TCLE dos projetos tramitados no CEP-FHEMIG nos últimos 24 meses / The most commons flaws on the elaboration of the informed cosent of the projects that were auditioned in CEP-FHEMIG in the last 24 months

INTRODUÇÃO: O Termo de Consentimento Livre e Esclarecido (TCLE) é peça fundamental na elaboração de uma pesquisa envolvendo seres humanos e expressa para o participante todas as garantias éticas e humanas do pesquisador junto ao voluntário. Por sua importância o TCLE é fonte de atenção detalhada dos Comitês de Ética em Pesquisa (CEP) e é determinante para aprovação do início das pesquisas. OBJETIVOS: Levantar as principais falhas detectadas na elaboração do TCLE dos projetos apreciados pelo CEP-FHEMIG, nos últimos 24 meses. MATERIAL: Trata-se de um estudo retrospectivo, no qual foram analisados os projetos de pesquisa que tramitaram no CEP-FHEMIG no período de setembro de 2008 a agosto de 2010. RESULTADOS: Foram analisados 193 projetos de pesquisa, sendo que 39,9% deste receberam o parecer de pendências por diversos motivos, porém a causa mais comum de pendências foram as inadequações do TCLE (38%). As principais falhas na elaboração do TCLE foram: Linguagem inadequada (23%), não disponibilização de contatos telefônicos para esclarecimento de dúvidas (15%), não apresentavam os riscos e benefícios da pesquisa (13,9%), projetos sem envio do TCLE (13,4%), não esclareciam o objetivo do estudo (7,5%), não mencionavam no TCLE os procedimentos a serem realizados (6,4%), falha não relatada no parecer (6,4%), erros de formatação (5,9%), não relatavam no TCLE as garantias do sujeito da pesquisa (5,9%) e sem relato de custo ou remuneração para o voluntário (2,7%). CONCLUSÕES: As principais causas de pendência estão diretamente relacionadas a falhas encontradas no TCLE, em especial as falhas presentes na linguagem do documento.(AU)

The informed consent is a fundamental piece on the elaboration of research with human beings and it contains all the ethics safeties and guaranties for the voluntaries chosen to participate in the project. Because of its importance, the informed consent is given a special attention by the Research Ethics Committee (REC) and is required for the approval of the project. OBJECTIVES: This study aims to assess the aspects of the research projects sent to CEP-FHEMIG, especially the difficulties related to the informed consent. MATERIALS: This is a retrospective study in which the research projects in CEP-FHEMIG were evaluated from November 2008 to August 2010. RESULTS: 193 research projects were analyzed, 39.9% of those were held up for various reasons. However the most common hold up was related to problems on the informed consent (38%). The most common mistakes related to the informed consent were: inappropriate grammar and language (23%) , did not have the phone info necessary to clear possible doubts (15%), did not show the risks and benefits of the research (13.9%), did not send the informed consent (13.4%), did not explain the objectives of the project (7.5%), did not mention the procedures of the research in the informed consent (6.4%), did not have the exact problem identified on their files (6.4%), were not properly formatted (5.9%), did not included the rights of the subject of the research (5.9%) and did not show that there was no costs or payment to the patients (2.7%). CONCLUSIONS: Most hold ups are related to flaws encountered on the informed consent, mainly on the grammar and language of the document.(AU)