Dataset Information

Children's Understanding of Informed Assents in Research Studies.

ABSTRACT: 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.

SUBMITTER: Cotrim H

PROVIDER: S-EPMC8307200 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background/aimsMany investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).MethodsIn collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process.ResultsA total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process (p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process.ConclusionThis randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

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