Table 1 Summary of Rankings
From: Development of a consensus operational definition of child assent for research
Assessment of child capacity | |
Assessment | Ranking Mean ± SD (Median) |
Discussion with both the parent(s) and child to gauge maturity/cognitive ability | 20.33 ± 15.8 (30.0) |
Employ “teach back” (feedback) to assess understanding | 18.67 ± 20.00 (20.0) |
Discussion with the child only to gauge maturity/cognitive ability | 12.33 ± 11.3 (10.0) |
Based on general developmental level e.g., child versus adolescent | 11.67 ± 11.4 (10.0) |
Based on age cut-offs: (please specify) | 9.00 ± 10.2 (5.0) |
Employ a short quiz to determine level of understanding | 7.67 ± 10.3 (0.00) |
Assessment based on a formal standardized tool e.g., MacCAT-CR | 6.00 ± 9.3 (0.0) |
Discussion with the parent(s) only to gauge maturity/cognitive ability | 3.00 ± 4.6 (0.0) |
Disclosure: Non-therapeutic trial-younger children (7-11 yrs) | |
Elements | Ranking Mean ± SD (Median) |
What will be done (the procedures) | 22.56 ± 4.6 (20.0) |
That the study is voluntary | 16.79 ± 7.2 (20.0) |
That they can withdraw at any time | 14.49 ± 7.7 (15.0) |
Purpose of the study | 11.77 ± 7.7 (10.0) |
Benefits to the child | 6.92 ± 5.9 (10.0) |
Risks | 6.92 ± 6.9 (5.0) |
Benefits to others | 5.00 ± 5.0 (5.0) |
That the research is different from clinical care | 4.00 ± 5.9 (0.0) |
Alternatives | 3.31 ± 3.7 (3.0) |
They do not need to understand, parental permission is sufficient | 1.92 ± 3.8 (0.0) |
That their information will remain confidential | 0.92 ± 1.9 (0.0) |
Level of discomfort or effort required | 20.0 ± 0.0 (20.0) n = 1 |
Disclosure: Non-Therapeutic trial-older children (12-17 yrs) | |
Elements | Ranking Mean ± SD (Median) |
What will be done (the procedures) | 17.46 ± 6.8 (15.0) |
That the study is voluntary | 13.07 ± 4.3 (10.0) |
Purpose of the study | 13.06 ± 5.9 (10.0) |
That they can withdraw at any time | 11.15 ± 5.1 (10.0) |
Risks | 10.9 ± 4.9 (10.0) |
That the research is different from clinical care | 7.69 ± 5.6 (10.0) |
Benefits to the child | 7.61 ± 3.8 (10.0) |
Benefits to others | 7.07 ± 4.5 (10.0) |
That their information will remain confidential | 6.15 ± 5.8 (5.0) |
Alternatives | 5.00 ± 3.5 (5.0) |
They do not need to understand, parental permission is sufficient | 0.00 ± 0.00 (0.00) |
Level of discomfort or effort required | 10.0 ± 0.00 (10.0) n = 1 |
Disclosure: Therapeutic trial-younger children (7-11 yrs) | |
Elements | Ranking Mean ± SD (Median) |
What will be done (the procedures) | 21.25 ± 8.3 (20.0) |
Purpose of the study | 13.31 ± 8.4 (15.0) |
That the study is voluntary | 12.41 ± 9.2 (10.0) |
That they can withdraw at any time | 12.18 ± 10.0 (10.0) |
They do not need to understand, parental permission is sufficient | 8.08 ± 20.7 (0.0) |
Risks | 7.46 ± 6.1 (5.0) |
Benefits to the child | 7.08 ± 5.7 (5.0) |
Alternatives | 5.00 ± 4.0 (5.0) |
That the research is different from clinical care | 5.00 ± 6.5 (0.0) |
Benefits to others | 3.08 ± 3.8 (0.0) |
That their information will remain confidential | 1.69 ± 3.1 (0.0) |
Disclosure: Therapeutic trial-older children (12-17 yrs) | |
Elements | Ranking Mean ± SD (Median) |
What will be done (the procedures) | 17.46 ± 7.6 (17.0) |
Purpose of the study | 13.84 ± 5.8 (10.0) |
That they can withdraw at any time | 12.08 ± 5.9 (10.0) |
That the study is voluntary | 11.38 ± 5.6 (10.0) |
Risks | 11.2 ± 4.6 (10.0) |
That the research is different from clinical care | 8.84 ± 5.8 (10.0) |
Benefits to the child | 7.69 ± 3.9 (10.0) |
Alternatives | 6.38 ± 3.6 (5.0) |
Benefits to others | 5.38 ± 4.8 (5.0) |
That their information will remain confidential | 3.85 ± 3.6 (5.0) |
They do not need to understand, parental permission is sufficient | 0.00 ± 0.0 (0.0) |
Level of discomfort or effort required | 10.0 ± 0.00 (10.0) n = 1 |
Requirements for meaningful assent: younger children (7-11 yrs) | |
Ranking Mean ± SD (Median) | |
Child should understand the basic information | 24.23 ± 10.4 (25.0) |
Child should have a developmentally appropriate awareness of their condition | 18.84 ± 8.9 (20.0) |
Child should be able to appreciate the information (i.e., apply the information to their own situation) | 13.84 ± 8.2 (15.0) |
Decisions should be free of any external pressure or expectations | 13.84 ± 13.6 (10.0) |
Child should be able to articulate an unambiguous choice | 10.77 ± 6.1(10.0) |
Child should be able to reason (i.e., able to incorporate information with personal priorities and potential consequences) | 6.54 ± 6.6 (5.0) |
Decisions must be reasonable and rational | 3.08 ± 4.8 (0.0) |
Child should understand the concept of altruism | 1.92 ± 3.3 (0.0) |
Requirements for meaningful assent: older children (12-17 yrs) | |
Ranking Mean ± SD (Median) | |
Child should understand the basic information | 22.23 ± 10.6 (20.0) |
Child should be able to appreciate the information (i.e., apply the information to their own situation) | 15.88 ± 4.5 (17.5) |
Child should have a developmentally appropriate awareness of their condition | 14.53 ± 5.6 (10.0) |
Child should be able to articulate an unambiguous choice | 13.84 ± 5.5 (10.0) |
Decisions should be free of any external pressure or expectations | 11.92 ± 8.3 (10.0) |
Child should be able to reason (i.e., able to incorporate information with personal priorities and potential consequences) | 9.62 ± 6.91 (10.0) |
Decisions must be reasonable and rational | 5.11 ± 6.0 (5.0) |
Child should understand the concept of altruism | 3.00 ± 4.6 (3.0) |