PART 4
CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR
Conditions
1. Subject to paragraph 6, a parent of the minor or, if by reason of the emergency nature of the treatment provided as part of the clinical trial no such person can be contacted prior to the proposed inclusion of the subject in the trial, a guardian for the minor has had an interview with the investigator, or another member of the investigating team, in which he or she has been given the opportunity to understand the objectives, risks and inconveniences of the clinical trial and the conditions under which it is to be conducted.
2. That parent or guardian has been provided with a contact point where he or she may obtain further information about the clinical trial.
3. That parent or guardian has been informed of the right to withdraw the minor from the clinical trial at any time.
4. That parent or guardian has given his informed consent to the minor taking part in the clinical trial.
5. That parent or guardian may, without the minor being subject to any resulting detriment, withdraw the minor from the clinical trial at any time by revoking his or her informed consent.
6. The minor has received information according to his or her capacity of understanding, from staff with experience with minors, regarding the clinical trial, its risks and its benefits.
7. The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in paragraph 6 to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator.
8. No incentives or financial inducements are given —
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(a) to the minor; or
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(b) to a parent of the minor or the guardian of the minor, except provision for compensation in the event of injury or loss.
9. The clinical trial relates directly to a clinical condition from which the minor suffers or is of such a nature that it can only be carried out on minors.
10. Some direct benefit for the group of patients involved in the clinical trial is to be obtained from that clinical trial.
11. The clinical trial is necessary to validate data obtained —
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(a) in other clinical trials involving persons able to give informed consent; or
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(b) by other research methods.
Principles
12. Informed consent given by a parent or guardian to a minor taking part in a clinical trial shall represent the minor's presumed will.
13. The clinical trial has been designed to minimize pain, discomfort, fear and any other foreseeable risk in relation to the disease and the minor's stage of development.
14. The risk threshold and the degree of distress have to be specially defined and constantly monitored.
15. The interests of the patient always prevail over those of science and society.