Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -5

Accepted - Volume 3

Comment Record
Commentor Dr. Ann Mayo Date/Time 2002-10-31 14:06:27
Organization Kaiser Permanente
Category Health Professional

Comments for FDA General
1. General Comments This research is needed; however the protection of human subjects is critical. I believe informed, signed consent from parents (legal guardians) AND informed assent from the older children should be sought and documented. I believe it would be prudent to include an educational program for the parents and an age appropriate educational program for older children regarding human subjects' rights. Pediatric hospitals with active research programs may be able to assist with the issues related to protection of children in research studies. Many nursing studies use children and this might be an area for the investigators to check out as well. Finally, University of San Diego has a legal program with a concentration in minors' legal rights (or had a few years back). There may be some assistance that the law professors could give to this aspect of the study.

EC -5