Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -142

Accepted - Volume 3

Comment Record
Commentor Mrs. Pat Martin Date/Time 2002-11-04 13:48:55
Organization Grant Medical Center (IRB member)
Category Health Professional

Comments for FDA General
Questions
1. General Comments At this time it appears that the risks to the child participants outweigh the benefits especially since it seems that the same information could be obtained from adult participants. In addition to risks of adverse events, keeping children basically isolated for 30 days is not reasonable. In my opinion, this does not constitute minimal risk to children. Although I identified myself as a health professional, my comments can also be attributed to me as a parent and grandparent. I would not consent for my children to participate in this study.




EC -142