Elements | Abbreviation | Extent of information | |||||||
---|---|---|---|---|---|---|---|---|---|
Child respondents (n = 17) | Parent respondents (n = 27) | ||||||||
Mean | SD | Median | IQR | Mean | SD | Median | IQR | ||
1. General items | |||||||||
 1.1 Title of research | Title | 3.82 | 1.19 | 4 | 3–5 | 4.44 | 0.75 | 5 | 4–5 |
 1.2 Name of researchers (and their affiliation) | Name | 4.00 | 1.17 | 4 | 3–5 | 4.59 | 0.50 | 5 | 4–5 |
 1.3 Source of funds and sponsors | Spons | 4.13 | 1.03 | 4.5 | 3–5 | 4.15 | 0.99 | 4 | 4–5 |
 1.4 Conflict of interest | Coi | 3.59 | 1.12 | 4 | 3–4.5 | 3.67 | 1.21 | 4 | 3–5 |
 1.5 Recognition that this is research | Resea | 4.24 | 0.75 | 4 | 4–5 | 4.27 | 0.72 | 4 | 4–5 |
 1.6 Contact information regarding the trial | cInfo | 4.12 | 1.05 | 4 | 3.5–5 | 4.56 | 0.70 | 5 | 4–5 |
 1.7 Contact information about the participant’s right | cInfoR | 3.82 | 1.13 | 4 | 3–5 | 4.52 | 0.85 | 5 | 4–5 |
2. Study-specific items | |||||||||
 2.1 Background and rationale of research as well as information about investigational new drugs | Backg | 4.41 | 0.71 | 5 | 4–5 | 4.67 | 0.62 | 5 | 4–5 |
 2.2 Purpose of research | Purp | 4.38 | 0.72 | 4.5 | 4–5 | 4.67 | 0.48 | 5 | 4–5 |
 2.3 Eligibility of the participant | Eligib | 3.76 | 0.83 | 4 | 3–4 | 4.22 | 0.75 | 4 | 4–5 |
 2.4 Study design of research | Desig | 4.31 | 0.87 | 5 | 3.25–5 | 4.33 | 0.83 | 5 | 4–5 |
 2.5 Procedure and schedule | Proc | 4.29 | 0.92 | 5 | 4–5 | 4.44 | 0.64 | 5 | 4–5 |
 2.6 Duration of the participant’s participation | Durat | 3.82 | 1.13 | 4 | 3–5 | 4.23 | 0.77 | 4 | 4–5 |
 2.7 Alternative courses of treatment | Altern | 3.59 | 1.46 | 4 | 3–5 | 3.89 | 1.01 | 4 | 3–5 |
 2.8 Criteria for termination | Term | 4.24 | 1.09 | 5 | 4–5 | 4.52 | 0.85 | 5 | 4–5 |
3. Items related to the participant’s right | |||||||||
 3.1 Voluntary participation | Volun | 3.71 | 1.26 | 4 | 3–5 | 4.37 | 0.69 | 4 | 4–5 |
 3.2 Consequence of withdrawal | cWith | 4.06 | 0.97 | 4 | 3–5 | 3.96 | 1.09 | 4 | 3–5 |
 3.3 Right to receive new information | nInfo | 4.00 | 1.12 | 4 | 3–5 | 4.44 | 0.75 | 5 | 4–5 |
4. Items related to risk–benefit | |||||||||
 4.1 Major foreseeable risk | mjRis | 4.47 | 0.80 | 5 | 4–5 | 4.78 | 0.42 | 5 | 5–5 |
 4.2 Minor foreseeable risk | miRis | 3.65 | 1.06 | 3 | 3–5 | 4.07 | 0.92 | 4 | 3–5 |
 4.3 All adverse effects, including uncommon adverse effects | Adv | 4.53 | 0.72 | 5 | 4–5 | 4.74 | 0.45 | 5 | 4–5 |
 4.4 Direct health benefit | dBene | 4.71 | 0.47 | 5 | 4–5 | 4.89 | 0.32 | 5 | 5–5 |
 4.5 Indirect/societal benefit | iBene | 4.65 | 0.61 | 5 | 4–5 | 4.85 | 0.46 | 5 | 5–5 |
 4.6 Post-trial benefit/provision | pBene | 4.59 | 0.62 | 5 | 4–5 | 4.74 | 0.53 | 5 | 5–5 |
5. Items related to data and sample storage | |||||||||
 5.1 Confidentiality and the limit of confidentiality | Confi | 4.35 | 0.86 | 5 | 3–5 | 4.37 | 0.79 | 5 | 4–5 |
 5.2 Storage of biospecimens | Stora | 3.94 | 0.83 | 4 | 3–5 | 4.41 | 0.64 | 4 | 4–5 |
 5.3 Return of research results | Retur | 4.35 | 0.79 | 4 | 4–5 | 4.63 | 0.57 | 5 | 4–5 |
6. Items related to monetary issues | |||||||||
 6.1 Payment and/or remuneration | Paym | 4.06 | 0.97 | 4 | 3–5 | 3.59 | 1.25 | 3 | 3–5 |
 6.2 Anticipated expense | Expen | 4.19 | 0.98 | 4.5 | 3.25–5 | 3.78 | 1.19 | 4 | 3–5 |
 6.3 Compensation for injury | Compe | 4.47 | 0.94 | 5 | 4–5 | 4.37 | 0.74 | 5 | 4–5 |