studies. Although EPA has in place procedures for ethical and patient protection review of agency-sponsored human studies (EPA, 1999), a more uniform and scientifically rigorous system should be considered for them and for third-party studies (discussed further in Chapter 6). The principal criteria for the scientific review of human dosing studies are briefly described in this chapter.

SCIENTIFIC ELEMENTS

As with all types of research, proposals to conduct intentional human dosing studies should begin with a discussion of the purpose and value of the study—the study justification. Assuming a study is justified, questions arise regarding study design and conduct and the reporting and evaluation of study results, matters that should be detailed in a study protocol. The protocol also includes information regarding protection of research participants. These two critical elements—study justification and study protocol—are the focus of this chapter.

It is important to recognize some of the critical distinctions between the types of research that are of interest to EPA as it carries out its legislative mandate and research that has a broader purpose. EPA is a regulatory agency that seeks information to fulfill its mission, such as that needed to improve the scientific basis of the risk assessments that are used to set regulatory standards or to fashion other types of health protection goals. Much of the committee’s thinking regarding study justification and study protocols has been developed in recognition of the unique needs of regulatory agencies such as EPA. The committee also recognizes that all human research, whatever the purpose, must be conducted in adherence to the highest scientific standards, and it sought to incorporate such standards, along with those uniquely related to the regulatory process, into its recommendations. In addition, the committee proposes careful, independent review of study justifications and protocols for all intentional human dosing studies within the scope of EPA’s mandate.

Before examining the issues involved in providing scientific justifications of and study protocols for intentional human dosing studies, a brief discussion is presented of the types of scientific investigations involving intentional dosing that are typically considered for possible conduct in human populations.

TYPES OF INTENTIONAL HUMAN DOSING STUDIES

There are three principal types of studies involving intentional dosing of research participants with chemicals that have been conducted for EPA regulatory purposes. The three types of studies seek to elicit (1) phar-



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