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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)