ing purposes, but it made no pretense of being able to resolve all of the nettlesome issues, especially the potentially wide range of study-specific risk-benefit comparisons that might be raised in this context. These ultimately must be resolved through publicly transparent policy deliberations and through the case-by-case decisions made by duly constituted review bodies.

POTENTIAL BENEFITS FROM INTENTIONAL HUMAN DOSING STUDIES

The Common Rule under which EPA conducts and sponsors studies requires that “risks to subjects” must be “reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result” (40 CFR §26.111(a)(2)). NBAC interpreted the basic ethical framework guiding human research as requiring independent review to “ensure that risks are reasonable in relation to potential personal and societal benefits” (NBAC, 2001, 3).

As indicated by these formulations of the risk-benefit requirement, potential or anticipated benefits from studies involving humans can be divided into two broad types—personal and societal. Potential personal benefits are those that may accrue to an individual by virtue of participating in the experiment. Potential societal benefits are those that accrue to the society as a whole or to groups within a society by virtue of the application of the scientific results of the study.

For example, placebo-controlled Phase 3 drug trials are designed to test the effectiveness of a drug. If the drug proves effective, at least some of the participants have the prospect of receiving direct medical benefit from the new treatment. Both intervention and control participants also may have the prospect of gaining other personal benefits, although such benefits would not result from receiving the drug being studied. For example, participants may benefit from increased knowledge about their condition from the medical evaluation that is included in the study.

There are many clinical trials, however, that are not intended to offer direct clinical benefits to participants. Phase 1 drug trials, for example, are designed to test for side effects of a drug and to establish dosing regimens. These trials often enroll healthy individuals who do not suffer from the condition the drug is intended to treat. These participants will receive no direct medical benefits from receiving the drugs during the trial. Nonetheless, carefully designed and conducted Phase 1 trials with healthy volunteers have been considered ethically acceptable. When risks are minimized, some risks to informed and consenting participants can be and are considered reasonable in light of the potential societal benefits that may result from the study.



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