The protection of clinical trial subjects, directive shall apply without prejudice to the national provisions on the protection of clinical trial subjects if they are more comprehensive than the provisions of this Directive and consistent with the procedures and time-scales specified therein. Member states shall, insofar as they have not already done so, adopt detailed rules to protect from abuse individuals who are not capable of giving their informed consent.
A clinical trial on minors may be accepted only if:
- The informed consent of the parents or legal representative has been obtained; consent must represent the minor’s presumed will and may be revoked at any time, without harm to the minor.
- The minor must be informed according to its capacity of understanding, from staff with experience with minors, regarding the trial, the risks and the benefits.
- The explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator or where appropriate the principal investigator.
- No incentives or financial inducements are given except compensation.
- Some direct benefit for the group of patients is obtained from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods; additionally, such research should either relate directly to a clinical condition from which the minor concerned suffers or be of such a nature that it can only be carried out on minors.
- The corresponding scientific guidelines of the Agency have been followed.
- Clinical Trials have been designed to minimize pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress have to be specially defined and constantly monitored;
- The Ethics committee, with pediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of pediatrics, has endorsed the protocol, and;
- The interests of the patient always prevail over those of science and society.
If we are not careful, it can be easy to overlook the patients at the other end, who give their time and effort - the clinical trials volunteers. Volunteers put their well-being in the hands of researchers to help us move medicine forward for everybody. That is why it is so important that clinical trial protocols always centre patient experience and welfare.
