On conducting a study among institutionalised adolescents in Kerala, India: legal and ethical challenges

We report the dilemmas faced by the investigators while conducting a study on the social and environmental factors for protection of the mental health of adolescents placed under State protection in Kerala, India. The proposal received counsel and directives from the Integrated Child Protection Scheme authorities, under the Social Justice Department of Kerala state and the Institutional Ethics Committee of the host institution. The investigator faced and had to reconcile conflicting directives and antithetical field realities, with respect to seeking informed consent from the study participants. The physical act of adolescents signing the consent form, rather than the actual process of assent, received disproportionately more scrutiny. The authorities also questioned the privacy and confidentiality requirements raised by the researchers. Of the 248 eligible adolescents, 26 chose to dissent from participating in the study, demonstrating that choices would be made if they are offered. There is a need for more discourse on achieving steadfast adherence to the principles of informed consent, particularly in research on vulnerable groups such as institutionalised children.

Assessment of knowledge and attitude toward informed consent and assent for biomedical research involving children among health-care professionals in Belagavi city A questionnaire study

Background: Most of the nations have proposed research regulations to protect the rights and welfare of the research participants. Among such regulations are the informed consent and assent. In the present world, informed consent and assent is the cornerstone in health practice. Aims and Objectives: To compare and evaluate the knowledge and attitude toward informed consent and assent for biomedical research involving children among health-care professionals in Belagavi city. Materials and Methods: A cross-sectional questionnaire study was conducted among 300 house surgeons divided into four groups of Medical, Dental, Nursing, and Ayurveda faculty of Belagavi city. A self-administered multiple choice questions were used to evaluate the knowledge and a five-point Likert scale was used to asses attitude regarding informed consent and assent for research involving children. Statistical analysis was done using SPSS version 20. Results: There was statistically significant difference in mean knowledge and attitude among all four groups (P < 0.05), and there was no significant correlation between knowledge and attitude as a whole in each group of professionals (P > 0.05). Conclusion: Emphasis on additional training is the need of the hour for all the faculty participants and also incorporation of study material regarding informed consent and assent for research involving children by the policy makers.

Significados de autonomía durante la toma del asentimiento informado al menor con enfermedad autoinmune percibidos por los clínicos e investigadores / Meanings of autonomy during the taking of informed consent to the minor with autoimmune disease perceived by clinicians and researchers / Significados de autonomia durante a obtenção do consentimento informado para o menor com doença autoimune percebida por clinico e pesquisadores

El presente artículo presenta un análisis sobre los significados que tienen los clínicos e investigadores, con respecto a la autonomía del menor maduro con enfermedad autoinmune; los cuales podrían llevar a diferentes prácticas de poder durante el momento de la toma del asentimiento informado. Teniendo presente la doctrina del menor maduro, es deber de los clínicos e investigadores contribuir al desarrollo moral o la autonomía del menor desde la misma reflexión de sus prácticas de poder. El objetivo del presente artículo es describir los significados o percepciones de los clínicos e investigadores, al momento del asentimiento informado, en relación con la autonomía o desarrollo moral del menor con enfermedad autoinmune, que surgen de sus experiencias, conocimientos y concepciones previas sobre el menor. La metodología utilizada fue de naturaleza cualitativa con enfoque subjetivista e interpretativista y alcance transversal. Se aplicaron entrevistas semiestructuradas a 21 personas, investigadores y clínicos, que atienden niños con enfermedades autoinmunes, cuyos datos fueron analizados por medio del programa Atlas Ti. 8.0. Como conclusión, el asentimiento informado es un proceso de modelo ético de comunicación asertiva, que busca la estructuración moral del menor más allá de lo percibido por el clínico o investigador. Además, los clínicos e investigadores consideran que estructurar al menor es percibirlo como un sujeto autónomo, lo cual es posible cuando presenta adherencia al tratamiento y cuidado responsable, independientemente del apoyo del tutor.

This article presents an analysis on the meanings that clinicians and researchers, have regarding the autonomy of the mature minor with autoimmune disease, which could lead to different power practices during the moment of taking the informed consent, keeping in mind the doctrine of the minor mature, it is the duty of the clinicians and researchers to contribute to the moral development or the autonomy of the minor from the same reflection of his practices of power. The objective was to describe the meanings or perceptions of clinicians and researchers, at the time of informed consent, in relation to the autonomy or moral development of the child with autoimmune disease, which arise from their experiences, knowledge and previous conceptions about the child. The methodology used was of a qualitative nature with a subjectivist and interpretative approach and a transversal scope. Semistructured interviews were applied to 21 people, researchers and clinicians, who attend children with autoimmune diseases, whose data were analyzed through the Atlas Ti program. 8.0. In conclusion, the informed consent is a process of assertive communication ethical model that seeks the moral structuring of the child beyond what is perceived by the clinician or researcher, in addition the clinicians and researchers consider that to structure the minor is to perceive him as an autonomous subject; which is possible when it shows adherence to treatment and responsible care independently of the tutor's support.

Este artigo apresenta uma análise sobre os significados que clínicos e pesquisadores têm em relação à autonomia do menor maduro com doença autoimune, o que poderia levar a diferentes práticas de poder durante o momento de obtenção do consentimento informado, tendo em vista a doutrina da menor maturidade, É dever dos clínicos e pesquisadores contribuir para o desenvolvimento moral ou a autonomia do menor a partir do mesmo reflexo de suas práticas de poder. O objetivo foi descrever os significados ou percepções de clínicos e pesquisadores, no momento do consentimento informado, em relação à autonomia ou desenvolvimento moral da criança com doença autoimune, que decorrem de suas experiências, conhecimentos e concepções prévias sobre a criança. A metodologia utilizada foi de natureza qualitativa, com uma abordagem subjetivista e interpretativa e um escopo transversal. Entrevistas semiestruturadas foram aplicadas a 21 pessoas, pesquisadores e clínicos, que atendem crianças com doenças autoimunes, cujos dados foram analisados por meio do programa Atlas Ti. 8,0 Em conclusão, o Termo de Consentimento Livre e Esclarecido é um processo de comunicação assertiva, modelo ético que busca a estruturação moral da criança além do percebido pelo clínico ou pesquisador, além dos clínicos e pesquisadores considerarem que estruturar o menor é percebê-lo como um sujeito autônomo; o que é possível quando mostra aderência ao tratamento e cuidados responsáveis independentemente do suporte do tutor.

A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent

OBJECTIVE: When children participate in research protocols, consent (by a parent or legal guardian) and assent (by the children) must be given. Understanding research protocols can be challenging for an adult and even more difficult for a child. The aim of this study was to describe the development of a comic book created to facilitate children's understanding of informed assent with clear and simple language. METHODS: Five researchers with scores above seven according to the Fehring criteria developed the comic book, avoiding the use of technical terminology. Twenty children between 7 and 12 years old, and enrolled in a larger study, responded using a Likert scale and questions about the clarity of texts and illustrations. The final version met National Health System Resolutions (Resoluções do Conselho Nacional da Saúde - CNS n° 196/1996 and 466/2012). RESULTS: The comic book assent presents a short story containing information about a real study: the invitation to participate, objectives, methods, instruments, procedures, risks, benefits, and the researchers' contact information. Most of the participants answered that they perceived the content of the text to be "Excellent" (40%) and "Very good" (40%), and the illustrations were perceived as "Excellent" (45%) and "Very good" (55%). CONCLUSION: The construction of a simple and clear model of informed assent is possible, and this model should be used in experiments with children.

El consentimiento informado en el campo de la salud mental. De la pauta deontológico-jurídica a la dimensión clínica / Informed consent in the field of mental health. From deontological - legal guideline to clinical dimension

El Consentimiento Informado, entendido en términos de derecho inalienable del paciente, se funda en una concepción de sujeto que atiende, por un lado, a su condición jurídica, y por otro a su dimensión singular. Por lo tanto, se deberían considerar las variables propias de cada uno de estos registros, los cuales se presentan de manera diferenciada en distintos momentos de un proceso terapéutico. Para abordar la compleja cuestión de la subjetividad en juego nos valdremos de los conceptos psicoanalíticos de Avaluación clínica y Asentimiento subjetivo, reflexionando así sobre las diferencias entre cumplimentar el procedimiento reglamentario de aceptar una intervención psicológica y el compromiso subjetivo de transitar esa experiencia. El trabajo analiza estas categorías apoyado en una investigación de campo sobre la implementación del Consentimiento Informado en el marco de la Ley de Salud Mental, ofreciendo así una metodología teórico-empírica de abordaje del problema.

Informed Consent, as an inalienable right of the patient, is based on a conception of the subject serving on the one hand to their legal status, and on the other to its unique dimension. Therefore, we should consider the characteristics of these registers which present differently at different times during a therapeutic process. To address the complex issue of subjectivity into play we will use psychoanalytic concepts of "clinical avaluation" and "subjective assent", in order to emphasis the differences between the normative procedure to accept a psychological intervention and subjective commitment to get involved in that experience. The paper analyzes these theoretical categories supported by field study about the implementation of informed consent under the Mental Health Law, providing a theoretical and empirical methodology to approach to the problem.

Writing a research protocol in pediatric oncology / Como elaborar um protocolo de pesquisa de oncologia pediátrica

Children are considered an especially vulnerable population in a clinical trial.Specific research regulations in pediatrics focus on the protection from potential risks. Clinical trials in oncology have become an important step for the researchers to discover new drugs, new combinations of known drugs and new methods. This manuscript aimed to help novice researchers to elaborate protocols in pediatric oncology for clinical trials. This guide describes relevant aspects before writing a research protocol and brings a template of research protocol. Moreover, it showsthe importance of a well-designed research protocol and its appendices – informed consent and informed assent– in a pediatric oncology study.

As crianças são consideradas uma população vulnerável em ensaios clínicos.Normas regulatórias específicas de pesquisa clínica em pediatria estão focadas na proteção de riscos potenciais. Os ensaios clínicos em oncologia tornaram-se um passo importante para os pesquisadores descobrirem novas drogas, novas combinações de drogas conhecidas e novas metodologias. O objetivo deste artigo é ajudar os pesquisadores novatos a elaborar protocolos de pesquisa em oncologia pediátrica. Este guia descreve os aspectos relevantes antes de escrever um protocolo de pesquisa e traz um modelo de protocolo de pesquisa. Além disso, mostra a importância de um protocolo de pesquisa bem delineado e seus apêndices – termo de consentimento livre e informado e termo de assentimento - em um estudode oncologia pediátrica.

Informed Consent in Pediatric Practice.

Informed consent is a communication process of providing the patient/parents/guardians with relevant information regarding the treatment and the diagnosis, so that they can make informed decisions. The process of informed consent in pediatric patients is not well understood. The amount of information to be disclosed in an informed consent is a matter of debate. There are four basic elements to the content of informed consent form: nature of procedure, risks, benefits and alternatives. The article delineates the essential elements and legal implications of informed consent in pediatric practice.

Deber profesional de obtener el asentimiento del niño para participar como sujeto de investigación / Obtaining informed consent from children to participate in a research study: our professional obligation

Por largo tiempo se ha incluido a niños en investigaciones biomédicas. En un principio, sin considerar sus propios derechos como seres humanos y sujetos a la conciencia del investigador, aun cuando se tratase de ensayos experimentales. Con el paso del tiempo y desde la segunda mitad del siglo XX, se alzaron voces para promover un marco legal jurídico suficiente que brindara protección legal al menor de edad y limitara su inclusión en la investigación o, en su caso, brindarles la mayor protección con los mayores beneficios y los menores riesgos relacionados con ésta. En nuestro país, sabemos que los investigadores y comités de ética en los hospitales solicitan, en general, el consentimiento informado del paciente para aceptar participar en una investigación. Se desconoce cuántos solicitan el asentimiento del menor. El presente artículo pretende recalcar la necesidad de contemplar la figura del asentimiento en todo menor de edad mentalmente capaz de entender y, en su caso, aceptar participar en una investigación.

For a long time, many children have been included in biomedical investigations without first being mindful of their rights as human beings and depending only on the ethics of the investigator, although many were experimental studies. Over time and from the second half of the 20th century, many considerations have been made to promote legal protection for the child, attempting to conduct investigational studies with the maximum benefits and minimum risks to the minor. In Mexico, investigators and ethics committees of hospitals require informed consent to participate in a research study. However, we do not know how many investigators actually request assent for participation from minors. This article focuses on the need to ask mentally capable minors to assent to participate in an investigational study.

Realidade: uma razão que não se explica, mas se crê / x

A partir do estudo dos textos de Freud e Lacan, procura-se demonstrar haver no interior da relação do sujeito com os objetos, constitutivos de sua realidade, um vazio de referência que determina que a realidade psíquica se constitui de uma perda. Para a psicanálise, o acesso à verdade, ou realidade, está ligado à própria divisão do sujeito e ao discurso que o circunda. Pretende-se mostrar que a realidade é uma ordem, ou razão, de estabilidade lógica, à qual o sujeito está assentido, ou seja, crê, sem explicação, e que depende de um princípio de ordenação discursivo, que só pode se exercer se não for questionado pelo sujeito.

Reality: a reasoning that cannot be explained, but believed. The author demonstrates, using Freud’s and Lacan’s theory, the existence of a relation between the subject and the objects, that constitute his reality, an emptiness of references that determines that psychic reality is consisted of a loss. For the psychoanalysis the access to the truth, or reality, is related to subject’s division and discourse in which he is embraced. Reality is an order, or reason, of logical stability, to which the subject is assented, he believes, without explanation. The reality depends on arbitrary election of significant as in maître-mot (master word) to constitute one’s self, and the principle of discursive ordering, that can only exist if the subject does not question.