MREC Reviewer Comment
Protocol Title
Acceptability of Delaire vs Petite types of facemask appliance
Completely satisfied and informative data
Needs Explanation
Comments to the applicant
- The Study design is not clear whether it is observational (based on what already has been written in certain parts of the application and the attached protocol and it seems very logic) or Interventional (based on what has been mentioned in the consent)
- The consent must be revisited, as it must talk to the parents and other one (assent) for the children
Comment to the Committee
Informed consent form:
Needs Modification
