sions to receive the vaccine (Everett et al., 2002). A further consideration in ensuring truly informed consent is the administration’s responsibility to communicate promptly changes in the threat assessment to all health care workers considering vaccination, as well as the general public.

With regard to the consent documents and all other communications, the committee urges continued attention to the tensions inherent in ensuring appropriate participation in the program. That is, there is a tension between maximizing participation of those appropriate for and consenting to vaccination—those with appropriate medical and public health responsibilities who are at risk for infection (should it appear) and without true contraindications themselves or in close personal contacts—and minimizing participation by those at high risk for adverse reactions (or in contact with those at high risk for adverse reactions), or those who for whatever reasons do not wish to be vaccinated.

The committee has two specific concerns about the informed consent aspects of this program. President Bush stressed in his announcement of December 13, 2002, that this is a voluntary program for public health and health care workers (White House, 2002). The committee is pleased with the emphasis on the voluntary nature of the program but stresses that consent is not a simple matter. It is easy to imagine situations whereby a potential vaccinee will not feel free to decline vaccination. A potential vaccinee might not wish to disclose fears about the risk of the vaccine, particularly in regard to one’s own or a personal contact’s HIV or pregnancy status, or even the fear of treating a smallpox victim. While in large hospitals or public health departments, other vaccinees might be available to volunteer for service, in small hospitals, a potential vaccinee might be the only worker with a specific, essential expertise and to decline could put the hospital or clinic at risk of incomplete coverage in the case of a smallpox outbreak. To decline vaccination could lead to rumors about the health status of decliners or their family members. Thus, a vaccinee who would otherwise decline to volunteer for vaccination might feel coerced into participation.

A second concern is more fundamental. It is standard practice to request consent to an intervention, such as vaccination, but highly unusual for an intervention, other than in clinical trials, to have known risks but unknown benefits. Yet, that is the nature of this program, within the broader context of national security. The committee suggests explicitly stating that the benefit of the vaccination program is to increase the nation’s public health preparedness, but that the benefit of vaccination to any one individual might be very low (given the current threat assessment). Vaccinees must have a clear understanding of the real risks of the vaccine and of the consequences of developing smallpox, tempered by the best estimate of the risk of a smallpox release. The informed consent materials that are given to



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