ently in Subpart C should be replaced by a slightly modified version of the definition, as follows:

The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons living outside the correctional setting.

This definition reflects the fact that prisoners are faced with a high baseline level of daily risk, thus making prison life an inappropriate reference point for determining whether a research protocol presents more than minimal risk.

Guidance on biomedical research The following guidance suggests how the risk-benefit framework should be applied to biomedical research. Specific direction is being supplied for this area because of the history and controversy surrounding medical and pharmacological studies in prisons. For other types of research (i.e., epidemiological, behavioral, and so on), these very specific limitations are not relevant.

There are two narrow circumstances in which biomedical research might be ethically acceptable:

  1. In normal circumstances, a biomedical research study may be ethically acceptable if:

  • for research on new therapies or preventive measures, there is already some evidence of safety and efficacy, as in phase 3 testing for new drugs, as defined by the Food and Drug Administration (FDA); and

  • the ratio of prisoner to nonprisoner-subjects does not exceed 50 percent.

  1. In exceptional circumstances, a biomedical research study may be ethically acceptable even if the benefit of an intervention has not been completely established, or if the research population is disproportionately composed of prisoners. This requires a federal-level review, for example, if the research addresses a condition that is solely or almost solely found in incarcerated populations. For studies of this nature to proceed, the protocol must be submitted to a national, specially convened panel of experts, who, in a public process, consider the ethical acceptability of the protocol (as is the process for Subpart D [45 C.F.R. § 46.407]), and make recommendations to the responsible government authority (the OHRP) regarding the special circumstances that do or do not provide a basis for research and the safeguards that must apply.

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