Three senators have requested that the Government Accountability Office (GAO) look into the operations of commercial IRBs to determine whether conflicts of interest or profit motives affect their ability to protect the health and safety of clinical trial participants.
Sens. Elizabeth Warren (D-Mass.), Bernie Sanders (D-Vermont) and Sherrod Brown (D-Ohio) began a preliminary investigation in November 2019, and the COVID-19 pandemic makes the issue more pressing, they say.
The letter notes that commercial IRBs oversee approximately 70 percent of all drug and medical device trials and asks the GAO to investigate the extent to which the use of commercial IRBs has increased over academic or other nonprofit IRBs, and how procedures and outcomes differ between for-profit and nonprofit boards.
In particular, the lawmakers say they want to know if commercial IRBs have appropriate procedures to protect patients and ensure the scientific integrity of trials that charge patients for participation.