Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -165

Accepted - Volume 3

Comment Record
Commentor Ms. Lesley Zajac Date/Time 2002-11-05 16:12:09
Organization Jaeb Center for Health Research
Category Individual

Comments for FDA General
Questions
1. General Comments While this study could be approved under 45 CFR 46.407 and the benefits to children and others could be enormous in the event of a biological attack using Smallpox, the consent process needs some serious work. I do not like the exculpatory language. If anyone, particularly a child, suffers harm as a result of a study such as this, they deserve to be compensated. I don't like the idea of not giving the child a gift certificate if they don't complete the study - after all it is not their decision but their parents'. The consent form needs to be edited for grade readability - let's keep it simple and understandable. I don't like the idea of keeping excess tissue stored for some possible future research - way too vague. Parents need to show that they understand how to change the dressings and how to contact someone in the event of an emergency. This is especially important for subjects whose parents are not native speakers of the English language. Parents should also be asked to demonstrate their understanding of the risks and possible adverse events associated with this study.




EC -165