Trial Participants: Informed Consent, GCP, Patient Involvement

8. Informed Consent in Studies With Participation of Minors

In studies requiring participation of minors, two types of informed consent can be used:

Signed informed consent from the parent or legal guardians or legally acceptable representatives (LAR).
Signed informed consent from the minor.

The language of these two documents should be different and appropriate to the level of understanding of the person signing.

Sample text for parent/legal guardian

Malaria is one of the most common and dangerous diseases in this region. The vaccine that is currently being used is not as good as we would like it to be but there is a new vaccine which may work better. The purpose of this research is to test the new vaccine to see if it protects young children better than the current vaccine.

Example text for minors (12–16 years)

We want to find better ways to prevent malaria before it makes children sick. We have a new vaccine to prevent malaria which we are hoping might be better than the one that is currently being used. In order to find out if it is better we have to test it.