THE INTERIM RULE AND ITS ALTERNATIVES
In this chapter, we deal analytically with the issues associated with the Interim Rule, focusing mainly on the "external" policy issues on which DoD requires the concurrence of FDA. However, we also consider those "internal" issues under the control of DoD, such as provision of information to military personnel about investigational drugs, whose implementation reflects on the merit of the general policy. In the first section, we consider the regulatory issues associated with the Interim Rule, as defined by the FDA's Request for Comments of July 31, 1997. Then, in the second section, we address three alternatives to the Interim Rule: revocation, "anticipatory consent," and other arrangements.
Many, but not all, of the regulatory issues associated with the Interim Rule were raised in FDA's July 31, 1997, Request for Comments (62 FR 40966, July 31, 1997). Since the request constitutes the focus of rule making, and thus policy, the following discussion is organized in relation to the questions it asks. The request is organized by Questions A, B, and C: Question A asks eight numbered questions, of which the eighth has parts (a) through (g); Questions B and C ask about standards of approval. Most of these questions are discussed in this section. However, we consider the question about revocation of the rule (A-1) and the two questions about "anticipatory consent (A-4 and A-5) under "Alternatives to the Interim Rule" below. In addition, several questions are addressed in Chapter Five, "Broader Issues." Table 2 provides a guide to how the questions asked by FDA in its Request for Comments are considered in the text.
Question A-2 asks, "Are there circumstances under which the use of the Interim Rule would be justified? If so, what are those circumstances?" Several bioethicists, as noted above, answer this question with an absolutist position: The Nuremberg Code provides no basis for exceptions to informed consent on human subjects of research, and thus the Interim Rule is not justified. An abso