evidence that the conduct of those studies was fundamentally unethical (e.g., the studies were intended to seriously harm participants or failed to obtain informed consent) or that the conduct was deficient relative to then-prevailing ethical standards. Exceptional cases in which the Human Studies Review Board determines that unethically conducted studies may provide valid information to support a regulatory standard that would provide greater protection for public health should be presented to a special outside panel, described in Recommendation 5-6, for consideration.

This special panel should consider recommending the use of such data only with the additional requirement that the ethical concerns raised by the study are documented and made publicly available. The committee’s recommendations apply to both third-party and government-sponsored studies, and they apply to the cholinesterase inhibition studies that were central to the considerations of this committee.

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