We obtained parental informed consent for a 16-year-old subject to participate in a migraine clinical trial. Does the parent need to accompany the child at each research visit? Based on the parent’s work schedule, the parent may not always be available to accompany the child.
– Director of Research, Primary Care Practice
The IRB would not be involved in this decision so long as the parent has given permission/consent to participate in the study. This kind of medical care decision is best left to the prudent judgement of the PI and the parents, with the child.
From an IRB perspective, the site would have to be careful to alert parents if there are protocol amendments that require reconsent and to communicate to the parents any new information that could possibly change the willingness of the parents to allow their child’s participation in the study.