Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -406

Accepted - Volume 4

Comment Record
Commentor Dr. Larry Scott Date/Time 2002-11-27 10:52:20
Organization University of Texas HSC-Houston
Category Health Professional

Comments for FDA General
1. General Comments It must be kept in mind that this study is being proposed only for the POSSIBILITY of a bioterroist attack that MIGHT include smallpox. Hence, the consent process and document must reflect this perspective. Parents will be motivated to enroll their children because of fear that such an event in fact will become a reality; this is a powerful coercive variable which should be minimized. The current consent document fails in this regard. The issue of more concern, however, is the failure to adequately address research-related injury. At present, medical care at no cost is not assured. For a study of this type which is designed to address a potential public health issue and in which no individual benefit may accrue, this is unacceptable and should be addressed if this study is to go forward. What are the options? It is unlikely that the National Vaccine Injury Compensation Program would apply, as this vaccine is not likely on the list of covered agents; perhaps, however, the Advisory Commission on Childhood Vaccines could address this issue. It would be worth exploring. The other option would be to budget as a direct cost, funds for liability insurance or a self-funded plan, to cover at least medical expenses, and as required, other funds for long term care, if required. While insurance costs are generally viewed as covered under indirect funds, the unique features of this study may justify direct budgeting. The investigators, in my view, have a moral obligation to provide at the very least free medical care; there are existing mechanisms to do this. This is probably beyond any obligation that a 3rd party payor might assume, in this particular situation, although at the very least a participant's coverage for this possibility (unlikely) could be determined prior to entry into the study. Parents should not assume this responsibility. On the balance, this study can be approved but only with satisfactory attention to these issues.

EC -406