Estratégias para favorecer a compreensão do termo de consentimento pelos participantes de ensaios clínicos: revisão integrativa / Strategies to favor comprehension of the consent form by clinical trial participants: an integrative review / Estrategias para facilitar la comprensión del formulario de consentimiento por parte de los participantes en ensayos clínicos: una revisión integradora

Objetivo: analisar as estratégias utilizadas para favorecer a compreensão de participantes de pesquisas clínicas sobre o termo de consentimento livre e esclarecido, bem como, as bases teóricas em que se apoiam. Métodos: revisão integrativa da literatura realizada no ano de 2019 e atualizada em 2021 em seis bases de dados eletrônicas, adicionada de busca reversa a partir das referências dos artigos incluídos. Resultados: dos 21 artigos selecionados, foram identificadas estratégias de mudanças no conteúdo, da forma de apresentação do termo de consentimento, bem como estratégias multimodais. As estratégias identificadas relacionam-se, em sua maioria, ao referencial tradicional de aprendizagem e resultaram em melhor compreensão por parte dos indivíduos que estavam em processo de obtenção do consentimento para participar de ensaios clínicos, em comparação com as estratégias usuais, mas, para a maioria o patamar de compreensão manteve-se abaixo de 60,0%. Conclusões: as estratégias resultaram na melhora da compreensão geral, porém, com persistência da incompreensão ou compreensão limitada de conceitos fundamentais inerentes à participação em pesquisas clínicas, reforçando que o processo de obtenção do consentimento é um fenômeno complexo e que requer atenção especial dos pesquisadores, na busca de garantir a compreensão adequada das informações, garantindo, de fato, a tomada de decisão esclarecida.

Objective: to analyze the strategies used to favor the comprehension of clinical trial participants about the informed consent form, as well as the theoretical bases on which these are based. Methods: integrative literature review performed in 2019 and updated in 2021 in six electronic databases, plus a reverse search based on references of the included articles. Results: strategies of changing the content and the form of presentation of the consent form, as well as multimodal strategies were identified in the 21 selected articles. The identified strategies are mostly related to the traditional learning framework and resulted in a better understanding by individuals in the process of obtaining consent to participate in clinical trials, compared to the usual strategies. For the most part, the level of comprehension remained below 60.0%. Conclusions: the strategies resulted in an improvement in general understanding, although with persisting misunderstanding or limited understanding of fundamental concepts inherent to participation in clinical trials, reinforcing that the process of obtaining consent is a complex phenomenon that requires special attention from researchers, in the quest to ensure proper understanding of information, and an actually informed decision-making.

Objetivo: analizar las estrategias utilizadas para favorecer la comprensión de los participantes en la investigación clínica sobre el formulario de consentimiento informado, así como las bases teóricas en las que se fundamentan. Métodos: revisión bibliográfica integradora realizada en 2019 y actualizada en 2021 en seis bases de datos electrónicas, además de búsqueda inversa a partir de las referencias de los artículos incluidos. Resultados:de los 21 artículos seleccionados, se identificaron estrategias para modificar el contenido y la forma de presentación del formulario de consentimiento, así como estrategias multimodales. Las estrategias identificadas estaban relacionadas en su mayoría con el marco de aprendizaje tradicional y dieron lugar a una mejor comprensión por parte de las personas que estaban en proceso de obtener el consentimiento para participar en ensayos clínicos, en comparación con las estrategias habituales, pero para la mayoría de ellas el nivel de comprensión se mantuvo por debajo del 60%. Conclusiones: las estrategias resultaron en una mejora de la comprensión general, sin embargo, con la persistencia de incomprensión o comprensión limitada de conceptos fundamentales inherentes a la participación en la investigación clínica, reforzando que el proceso de obtención del consentimiento es un fenómeno complejo que requiere especial atención por parte de los investigadores, en la búsqueda de garantizar la adecuada comprensión de la información, asegurando, de hecho, la toma de una decisión informada

Human Subjects Protection and Federal Regulations of Clinical Trials.

OBJECTIVES: To explore the federal regulations governing clinical trials and human subject protection, the importance of research participant's informed consent, and the role the oncology clinical research nurse has within the clinical trial setting. DATA SOURCES: Peer-reviewed journal articles, internet, book chapters, white papers. CONCLUSION: Federal regulations mandate the conduct of a clinical research trial, human research participant protection, and the informed consent process. IMPLICATIONS FOR NURSING PRACTICE: The oncology nurse supports the autonomy and safe conduct of the human research participant during a clinical research trial and provides education and support through the informed consent process.

Overcoming the challenges of conducting research with people who have advanced heart failure and palliative care needs.

Research on the palliative care needs of heart failure patients is scant and requires development to provide a sound evidence base for improved care; but there are distinct practical and ethical challenges in conducting research with this population. This paper presents an integrative review of the literature that aims to describe these challenges and discuss potential strategies by which they may be addressed. It is recognised that heart failure is a volatile condition making identification of the end of the life phase difficult. This leads to an array of other issues; firstly clinical teams tend to use this as a rationale for their failure to discuss palliative care issues with patients and families, making identification of the population difficult and research related communication challenging. Symptom volatility also creates methodological problems for researchers in deciding patients' eligibility, securing user involvement and contributes to sample attrition in research. There are also substantial ethical challenges for researchers in terms of gaining access and ensuring patient autonomy in this population. Acknowledgement of these issues and discussion of strategies by which they can be addressed has the potential to augment clinical research, develop practice and ultimately produce the much needed improvements in patient care required for those with advanced heart failure.

Enhancing the quality of hermeneutic research: decision trail.

BACKGROUND: Researchers have ethical and professional obligations to produce research of a high standard. The constituents of quality in research appear to differ between authors, leaving readers unsure about which pathway to follow. This can reflect inadequate consideration of the theoretical framework guiding the study. Many papers fail to consider the theoretical underpinnings of the methodology chosen and the link between these and the methods employed. These need to be accessible to readers in order to assess the trustworthiness of the research. AIM: This paper discusses the development of trustworthiness in hermeneutic phenomenological research. DISCUSSION: Referring to a study on lived experience of Chronic Fatigue Syndrome/myalgic encephalitis, I describe the decision trail and discuss the strengths and limitations of the choices made throughout the study. CONCLUSION: The methodology focused my approach more fully on the importance of recognizing the influences that I brought to the study and the impact of these in generating the data. It highlighted the fact that the process of setting out my horizon can never be complete, the importance of analysing the data at a macro and micro level, acknowledging the evolution of the data over time, and ensuring that analysis does not move beyond the data and out of the hermeneutic circle. In seeking to make the decision trail clear to others, researchers must distill the philosophical principles of the methodology and set these out in a way that is accessible and open to scrutiny.