cost problems reported by many state and local public health agencies, the lack of an adverse event compensation plan and the many delays in developing and implementing it with needed clarification on liability issues, unfinalized informed consent materials, and the lack of an appropriate and complete data system in the first 3 weeks of the program.

Although rapid program implementation would have been warranted in the face of an impending crisis, government’s assurances that there was no imminent threat made the call for rapid implementation perplexing.

The Informed Consent Process

Like other aspects of smallpox vaccination program implementation, the informed consent process suffered from the program’s rapid start and ambitious timeline. The early weeks of the program appeared to be caught up in a whirlwind of enormous effort on the part of CDC (GAO, 2003). CDC staff developed dozens of educational training materials, provided technical assistance and held regular conference calls with state public health agency leadership, and worked on communication plans. The crucial importance of the informed consent information and forms was recognized from the beginning, but additional time was needed to make corrections and improvements in the materials. That meant that some of the items were not final at the time vaccination began. The committee’s concerns about the informed consent form were related to larger issues, such as the lack of adequate compensation provisions and the program’s unique nature as a public health program established for national security reasons, that at a practical level implied a public health intervention with known risk and unknown benefits. For those reasons, the committee expressed concern in its first report to CDC that the informed consent form did not include an explanation of the state of compensation mechanisms for volunteers who would be injured by the vaccine (IOM, 2003a, or refer to Appendix B). The committee believed that there were ethical reasons for including clear language about compensation on the informed consent form, and it noted that there was a tension between the desire to maximize participation of appropriate candidates in the program and the imperative to minimize participation of those with contraindications and to create conditions that would allow those unwilling to receive the vaccine to feel comfortable in declining. CDC delayed for several weeks updating the informed consent and vaccination information materials with information about injury compensation to avoid deluging jurisdictions with yet another in a series of changes that seemed to cause dismay and logistical difficulties.

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