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