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Table 1 sections and subparts of MacCAT-CR

From: "...because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials – assessment of understanding, appreciation and reasoning

Understanding

Disclosure: nature of project

Disclosure: primary purpose is research

Disclosure: effect of research on individualized care (e.g. placebo, randomized design)

Disclosure: risk/discomfort (side-effects)

Disclosure: ability to withdraw

Appreciation

primary purpose is not individualized care

An explanation was e.g.:

"The doctors can explore whether the new medication works well in patients with an ADHD."

Reasonable possibility of less personal benefit (e.g. placebo)

Questions were e.g.:

"Are all the children in this study given the new medication?"

"Do you think you will receive a sugar-pill, a tablet without any agent?"

believes that the decision to withdraw will be honoured

Reasoning

consequential and comparing reasoning

"Well, what is your decision now?"

Generation consequences (e.g. on every day life)

In case of assent: "why have you made this decision, what are the reasons for your decision?" "OK. You say you want to take part. Why did you decide to take part? What were your reasons?"

logical consistency

Expressing a choice

Expressing a choice