Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -310

Accepted - Volume 3

Comment Record
Commentor Ms. Elizabeth Tierney Date/Time 2002-11-18 14:00:26
Organization SAVVI Crisis Center
Category Other

Comments for FDA General
1. General Comments Who would sign up thier child for a test that could result in serious side effects or death, and why? I would question the motives of the guardian. I'm sure there is always someone who will sign up their child, but perhaps we should question whether participating in this test could be in any child's best interest, even if it is for the greater good of the community. Only the participant should have the right to choose such risk and potential sacrifice, and a child can't make that choice. I can't see a selfless reason why any responsible parent would include their child in this test.

EC -310