Recent public and professional debate about smallpox vaccine and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. Dryvax is a particularly impure product made of live vaccinia virus harvested from the pustules of calves infected with (it is believed) cowpox. Although the vaccine, which is scratched on the skin, only causes mild infections in most people, in a small but significant number the infection caused serious adverse reactions similar to the complications of the disease they were designed to prevent: painful, disfiguring skin disorders, blindness, neurological impairments and death.

AHRP Recommendations for the protection of children in clinical research

(1) Federal regulations are predicated on our moral responsibility to protect children - who are not volunteers - from being subjected to medical or behavioral experiments that are not in their best interest. Thus, federal regulations - 45 CFR 46 Sub-part D - restrict the use of children in medical experiments involving greater than minimal risk, if there is no potential medical benefit for them or their condition.

Thank you for your considered response to our July 29 letter to the director of the Office of Human Research Protection.

We are astonished to learn that OHRP found that all 12 major research institutions involved in this multi-site trial had violated Federal protections (45 CFR 46.117):

(a) "in all cases OHRP found that the informed consent documents approved by the institutional review boards (IRBs) for the research failed to describe adequately the reasonably foreseeable risks and discomforts of the research."

Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01

The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry and 150 Caucasians. The experiment is not approvable under federal regulations, 45 CFR 46 Subpart D because it involves greater than minimal risk and no potential direct benefit to the children.