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儿童对研究中知情同意的理解。

Children's Understanding of Informed Assents in Research Studies.

作者信息

Cotrim Hortense, Granja Cristina, Carvalho Ana Sofia, Cotrim Carlos, Martins Rui

机构信息

Nursing Department, Universidade Atlântica, Fábrica da Pólvora de Barcarena, 2730-036 Barcarena, Portugal.

Anaesthesiology Department, Centro Hospitalar Universitário São João, 4200-319 Porto, Portugal.

出版信息

Healthcare (Basel). 2021 Jul 10;9(7):871. doi: 10.3390/healthcare9070871.

Abstract

UNLABELLED

The assent procedure reflects an effort to enable the minor to understand, to the degree they are capable of, what their participation in the decision making process would involve.

AIMS

To evaluate the minors' ability to understand the information provided to them when obtaining assent and to evaluate the opinion of the parents regarding the importance of asking the child's assent.

METHODS

The sample included a total of 52 minors aged between 10 and 17 years who underwent exercise echocardiogram. The Quality of Informed Consent is divided into two parts: Part A was used to measure objective understanding and part B to measure subjective understanding.

RESULTS

The results show that the minors have a high capacity to understand the information given to them when asking for assent. A positive relationship was found between the two parts of the questionnaire. No statistically significant relationship was found between age and sex and part A and part B or between both age groups (<14 years old and ≥14 years old) and the measure. In the case of the parents, 96.6% of parents consider assent as an advantage for the child's acceptance of health care. The opinion of the parents is not related to the age, sex or level of schooling.

CONCLUSION

Minors showed a substantial level of understanding regarding the information provided to them. The parents considered the implementation of assent fundamental to the child's acceptance of health care.

摘要

未标注

同意程序反映了一种努力,即让未成年人在其能力范围内理解参与决策过程会涉及哪些方面。

目的

评估未成年人在获得同意时理解所提供信息的能力,并评估父母对于征求孩子同意的重要性的看法。

方法

样本包括总共52名年龄在10至17岁之间接受运动超声心动图检查的未成年人。知情同意质量分为两部分:A部分用于衡量客观理解,B部分用于衡量主观理解。

结果

结果表明,未成年人在征求同意时对所提供的信息有很高的理解能力。问卷的两部分之间发现了正相关关系。年龄、性别与A部分、B部分之间,或两个年龄组(<14岁和≥14岁)与该测量之间均未发现统计学上的显著关系。就父母而言,96.6%的父母认为同意对孩子接受医疗保健有好处。父母的看法与年龄、性别或受教育程度无关。

结论

未成年人对提供给他们的信息表现出了相当程度的理解。父母认为实施同意对孩子接受医疗保健至关重要。

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本文引用的文献

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Assessing an Adolescent's Capacity for Autonomous Decision-Making in Clinical Care.评估青少年在临床护理中自主决策的能力。
J Adolesc Health. 2015 Oct;57(4):361-6. doi: 10.1016/j.jadohealth.2015.06.012. Epub 2015 Aug 15.
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Informed consent in pediatric research.儿科研究中的知情同意
Paediatr Drugs. 2015 Feb;17(1):5-11. doi: 10.1007/s40272-014-0108-y.
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Assent in research: the voices of adolescents.研究中的同意:青少年的声音。
J Adolesc Health. 2014 May;54(5):515-20. doi: 10.1016/j.jadohealth.2014.02.005. Epub 2014 Mar 14.

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