Comprehension of a simplified assent form in a vaccine trial for adolescents: Table 1

Lee, Sonia; Kapogiannis, Bill G.; Flynn, Patricia M.; Rudy, Bret J.; Bethel, James; Ahmad, Sushma; Tucker, Diane; Abdalian, Sue Ellen; Hoffman, Dannie; Wilson, Craig M.; Cunningham, Coleen K.; Interventions, Aids

doi:10.1136/medethics-2012-101286

Cited by 13 publications

(8 citation statements)

References 11 publications

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“…Studies show that this process has been insufficient to achieve its ethical goal, since children and adolescents do not understand a great deal of the information about the research in which they are involved 4,[12][13][14][15] . In this sense, obtaining the FPIC from these participants may represent failure of the principle of respect for people 16 , because it only formally fulfills the ethical determination to provide participants with information and clarification about the study.…”

Section: Children's Knowledge Of the Terms Of Informed Assentmentioning

confidence: 99%

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Lobato

Gazzinelli²,

Pedroso³

et al. 2016

Rev. Bioét.

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The objective of this study is to describe the knowledge of children and adolescents regarding the information disclosed by the terms of assent used in pediatric clinical research, and report the attitudes of the participants. It is an experimental study with a quantitative approach, conducted in cities in the Northeast of Minas Gerais, Brazil, with 142 participants from 7 to 15 years old, chosen for a clinical study of schistosomiasis. These children and adolescents participated in the assent process using the corresponding term. We evaluated the participants through a semi-structured questionnaire. The average knowledge of participants regarding the survey information was 41.22%, with only 1.4% having a high level of knowledge. This study concluded that most children are unaware of the information regarding the research and were unaware of their rights as research participants. Keywords: Informed consent. Research, ethics. Child-Adolescent-Comprehension. Bioethics. Resumo Conhecimento de crianças sobre o termo de assentimento livre e esclarecidoEste estudo tem como objetivo descrever o conhecimento de crianças e adolescentes sobre as informações divulgadas pelo termo de assentimento em pesquisa clínica pediátrica, além de relatar as atitudes dos participantes. Trata-se de estudo experimental com abordagem quantitativa, realizado em municípios do Nordeste de Minas Gerais com 142 participantes de 7 a 15 anos, escolhidos para estudo clínico sobre esquistossomose. Essas crianças e adolescentes participaram do processo de assentimento, com a utilização do termo correspondente. Avaliaram-se os participantes com questionário semiestruturado. O conhecimento médio dos participantes sobre as informações da pesquisa foi 41,22%, com apenas 1,4% apresentando alto grau de conhecimento. Concluiu-se que a maioria das crianças desconhece as informações sobre a investigação e seus direitos enquanto participantes de pesquisa. Palavras-chave: Consentimento livre e esclarecido. Ética em pesquisa. Criança-Adolescente-Compreensão. Bioética. Resumen Conocimientos de los niños sobre el documento de consentimiento libre e informadoEste estudio tiene como objetivo describir los conocimientos de los niños y adolescentes sobre la información divulgada por el documento de consentimiento en la investigación clínica pediátrica, además de describir las actitudes de los participantes. Se trata de un estudio experimental con un enfoque cuantitativo, llevado a cabo en ciudades del noreste de Minas Gerais, Brasil, con 142 participantes, de 7 a 15 años de edad, seleccionados para un estudio clínico sobre esquistosomiasis. Estos niños y adolescentes participaron en el proceso de consentimiento mediante el documento de consentimiento correspondiente. Se evaluó a los participantes con un cuestionario semiestructurado. El conocimiento promedio de los participantes sobre la información de la encuesta fue del 41,22%, siendo que solo un 1,4% presentó un alto grado de conocimiento. Se concluye que la mayoría de los niños desconoce las informacione...

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Section: Children's Knowledge Of the Terms Of Informed Assentmentioning

confidence: 99%

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Lobato

Gazzinelli²,

Pedroso³

et al. 2016

Rev. Bioét.

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show abstract

“…Instead, they only stated that the highest portion of participants that answered all questions correctly was in the story group [11]. Three additional studies found that using everyday language with graphs and Q&A format, an illustrated booklet, and a comic strip in the assent process generally led to good understanding of the research details, but the interventions were not tested against a standard or control format [16,18,20].…”

Section: Study Characteristicsmentioning

confidence: 99%

Improving assent in health research: a rapid systematic review

Soll

Guraiib

Rollins

et al. 2020

BMC Med Res Methodol

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Background: Enrolment in a research study requires the participant's informed consent. In the case of minors, informed consent of the respective legal guardian is obtained in conjunction with informed assent of the underage p articipant. Since comprehension of the information provided may be limited, effective interventions to improve understanding should be identified. Thus, it is the objective of this study to review quantitative studies that tested interventions to improve the understanding of information provided during assent processes in health research. The studied population consisted of minors that participated or were willing to participate in research. The primary outcome was the level of comprehension after intervention. Methods: A systematic search was conducted in eleven databases including regional databases: PubMed, Web of Science, ERIC, PsycINFO, CINAHL, POPLINE, AIM, LILACS, WPRIM, IMSEAR, and IMEMR and included references from inception of the database until July 2018 except PubMed which spanned the period from May 2013 to July 2018. Search terms focused on Informed Consent/Assent, Minors, and Comprehension. To complement the search, reference lists of retrieved publications were additionally searched. We included all quantitative studies that were conducted in minors, tested an intervention, covered assent processes in health research, and assessed comprehension. One reviewer screened titles, abstracts, and full-texts to determine eligibility and collected data on study design, population, intervention, methods, outcome, and for critical appraisal. Interventions comprised enhanced paper forms, interspersed questions, multimedia format, and others. Results: Out of 7089 studies initially identified, 19 studies comprising 2805 participants and conducted in seven countries were included in the review. Fourteen studies (74 %) tested an intervention against control and ten (53 %) were randomized controlled trials. Heterogeneous methodology as well as incomplete outcome and statistical reporting impaired the reliability of the collected data. Positive effects were suggested for use of enhanced paper forms, interspersed questions, use of pie charts, and organizational factors. Conclusions: Improving assent in health research is an under-researched area with little reliable evidence. While some interventions are proposed to improve understanding in assent processes, further investigation is necessary to be able to give evidence-based recommendations.

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“…Lee et al [7] investigated how youths comprehend an assent form in the setting of a Hepatitis B vaccine trial. One hundred and twenty three adolescents 12-17 years of age (average age was 15 years) read a consent form and completed a comprehension test.…”

Section: Measuring Children's Capacity To Consent To Researchmentioning

confidence: 99%

“…The percentage of subjects who demonstrated absolute comprehension (100 % correct answers) was 56 %. This may imply that had they been asked to make a decision, almost half would have based their decision on information they did not fully understand [7].…”

Section: Measuring Children's Capacity To Consent To Researchmentioning

confidence: 99%

Informed Consent in Pediatric Research

Leibson

Koren

2014

Pediatr Drugs

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Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in. Key PointsThe appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician.There is compelling evidence that most children younger than 9 years of age lack the capacity to consent for participation in clinical trials.In some jurisdictions, institutional review boards approve the participation in drug research of healthy volunteering children during early adolescence.

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Comprehension of a simplified assent form in a vaccine trial for adolescents: Table 1

Cited by 13 publications

References 11 publications

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Improving assent in health research: a rapid systematic review

Informed Consent in Pediatric Research

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