Health Affairs November 15, 2024
In clinical research, participants in trials may or may not be considered “vulnerable.” Historically, vulnerable research participants have included children, incarcerated individuals, patients with impaired decision-making capacity, and pregnant people. Federal regulations suggested that these populations were “likely to be vulnerable to coercion or undue influence” by researchers. While such designations may protect against coercion into inappropriate endeavors, they may also serve as administrative barriers against these same populations enrolling in research beneficently. Although a researcher may technically be allowed to enroll members of vulnerable populations, as a practical matter they will often elect to exclude them from studies rather than fulfill the needed regulatory requirements. Thus, the net impact of “vulnerability” may be a diminishment of research benefits for...
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