Amid Rising Concern, Pay-to-Play Clinical Trials Are Drawing Federal Scrutiny

August 6, 2019

(STAT News) – In each case, there were “serious concerns about how ethical it was to charge people to participate in the research — and whether it was absolutely necessary,” said Russell-Einhorn, chief compliance officer for Advarra, the second-largest commercial IRB. These studies have caught the attention of federal regulators. The Food and Drug Administration recently asked a federal advisory committee to consider how the research community should think about such trials, an agency spokesperson confirmed. Members of that panel are now drafting recommendations on the issue. And the National Institutes of Health asked the committee to consider whether its existing resources to guide patients considering a clinical trial are adequate for scenarios in which they are being asked to pay, a spokesperson for that agency confirmed.