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The Task Force recognized that for research that is categorized as offering no prospect of direct benefit, it may nevertheless be unclear whether the study has more than a negligible prospect of direct benefit or, if more than negligible, how much more; clarity (or its absence) often depends on the current state of available scientific knowledge. In order to clarify this statement, the Task Force offers the example of deep brain stimulation: Prospectively, the desired (and achieved) benefit in cases where deep brain stimulation has been administered to patients who have experienced traumatic brain injury and are in minimally conscious states is uncertain. Although the surgical procedure involves more than a minor increase over minimal risk, there are no other known clinical or research interventions that may improve the condition of these patients. Because deep brain stimulation is an innovative and risky procedure, with little data available, it would be arguably improper to suggest that the study holds out a prospect of direct benefit. However, in the few instances in which the procedure has been performed, remarkable progress has been shown and such knowledge may be invaluable for future studies.Google Scholar

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45 C.F.R. § 46.111.Google Scholar

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