We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Estratégias para favorecer a compreensão do termo de consentimento pelos participantes de ensaios clínicos: revisão integrativa.
- Authors
Fernandes Marques Vieira, Valquíria; Giarola Cecílio, Sumaya; Ferreira de Sousa, Lorenza; Gazzinelli Bethony, Maria Flávia
- Abstract
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.
- Subjects
PATIENT selection; CLINICAL trials; HUMAN research subjects; LEARNING; DECISION making; SYSTEMATIC reviews; BIBLIOGRAPHICAL citations; INFORMED consent (Medical law); BIBLIOGRAPHY; COGNITION
- Publication
Revista Eletrônica de Enfermagem, 2023, Vol 25, p1
- ISSN
1518-1944
- Publication type
Article
- DOI
10.5216/ree.v25.70441