2. Ethical Considerations

2.1. Vulnerable Populations

Compensation is always a special concern in case of vulnerable populations. It is a particularly difficult issue in case of children and the mentally challenged. They do not or cannot make their own decisions but their parents/legal guardians will decide for them, while the risk is not divided the same way: the member of the vulnerable group carries the risk, but the parent or guardian gets the compensation. This is one of the reasons why the EU does not allow compensation to such vulnerable groups beyond the reimbursement of their expenses. ‘For the poor, illiterate and the unaware, monetary inducements can easily be enticing’, state Pandya and Desai (1).

It may happen that the participant does not understand completely what the implications of participation may be. Patient advocates and patient organisations may play a key role in mediating in these situations, and in flagging any irregular practices in this field to the authorities.