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HHS should protect payments to clinical trial participants

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HHS should protect payments to clinical trial participants
Opinion>Opinions - Healthcare The views expressed by contributors are their own and not the view of The Hill HHS should protect payments to clinical trial participants Comments: by Matthew Baggott and John Mendelson, opinion contributors - 08/07/26 9:00 AM ET Comments: Link copied by Matthew Baggott and John Mendelson, opinion contributors - 08/07/26 9:00 AM ET Comments: Link copied Getty Images

In 2002, San Francisco voters passed the “Care Not Cash” measure, built on a simple intuition: Stop handing cash to homeless people, because they will only waste it on drugs and alcohol.

By then, we were a decade into doing the opposite — paying people who used drugs, often hundreds of dollars at a time, to take part in research. The conventional wisdom said we were funding relapse, but it was wrong. When researchers have looked, the bulk of the money goes to rent, food, and bills, not drugs.

New treatments get developed only when the people who need them can afford the time, travel, and support to take part. The studies we were working to complete tested the buprenorphine and naloxone combination now sold as Suboxone, in people actively using heroin.

The federal government is now asking the same question we spent years answering. As part of a broader effort to support American clinical research, the HHS Office of Inspector General has opened a formal request for comment on whether to protect payments to clinical trial participants, with comments due Aug. 24.

For decades, those payments have sat in a legal gray zone, created by an anti-kickback statute and a related rule that penalizes offering inducements to Medicare and Medicaid patients. The worry is that reimbursing a federal beneficiary’s costs can look like an inducement to use reimbursable services, even when those costs would have been incurred in routine care anyway. The bioethics worry is that money could corrupt the choices of vulnerable people.

That bioethics concern has been tested in people who use drugs, where the fear that cash buys drugs and addiction clouds consent is sharpest. In randomized studies, paying people who use drugs, even substantial amounts in cash, did not raise their drug use or make them feel coerced, and improved follow-up.

Asked whether research money pulls them into studies they would otherwise refuse, participants tend to reject the premise. They can get drugs without it. There is even evidence that payment helps: In experimental studies, higher payments make participants more attentive to risk disclosures, not less, treating a larger offer as a signal of higher stakes.

A rigorous test came in 2021, when a study embedded randomized cash incentives inside two clinical trials. Incentives raised enrollment in one and made no difference in the other. In neither did they distort how people weighed the risks or skew the sample toward poorer participants.

Justice and scientific validity point the same way. The treatments that will work for people who use drugs, who are poor, or who are on Medicaid are the ones whose trials included them. Suboxone exists because we and other researchers were willing to study people who were actively using opioids instead of deciding they were too compromised to include. Refusing to pay the participants who can least afford to take part shifts the cost of research onto the people it is meant to serve, and builds the evidence base on people unlike them. The rules try to prevent exploitation from overpaying participants. They produce an exploitation in the other direction, underpaying or excluding the people who most need the answers.

The inspector general should codify two things. One is reimbursement for real out-of-pocket costs, which restores participants financially and should be uncontroversial. In 2018, FDA clarified that reimbursing travel and lodging does not raise undue-influence concerns; the inspector general should follow suit.

The other is compensation for time, which is more complex and should be left to the institutional review board. Hard dollar caps would be a mistake: the right compensation depends on what a study asks of people. A cap low enough to feel safe to regulators will either constrain protocols or shut out the people research needs. Protections should also reach beyond government-sponsored trials to the academic and industry trials where most research happens. Review boards already weigh whether participants are fairly paid and protected, and should keep doing so.

Care Not Cash drew on the conviction that some people cannot be trusted with money. The clinical trials showed the opposite. They also showed that the buprenorphine-naloxone combination behaved as hoped in the people who would actually need it. Suboxone has since saved many lives. None of that would have happened without people who were actively using opioids taking part in those trials.

And Care Not Cash governed welfare, not work. Clinical trial participation is work. It means showing up on time, following protocol, and sometimes accepting real physical risk. Medicaid now has work requirements of its own, and the work that helps cure the diseases that trap people in poverty should count. The inspector general can write that lesson into the rules, or write in the old fear instead. It should choose the evidence.

Matthew Baggott, PhD, is a neuroscientist and CEO of Tactogen Inc. John Mendelson, MD, is a board-certified internist with over 30 years in the field of addiction treatment, and is Chief Medical Officer and Founder of Ria Health.

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