San Francisco’s ‘Care Not Cash’ and the Role of Payments in Clinical Trials
In 2002, San Francisco voters approved the ‘Care Not Cash’ initiative, focusing on reducing cash payments to homeless individuals. This measure was based on the belief that cash might be spent on drugs or alcohol. At this time, however, another approach was being used in research: providing financial incentives to people who use drugs to participate in studies. Critics argued these payments might lead to relapse, but research showed most funds went to basic needs like rent, food, and bills.
Participants in clinical trials for new treatments, such as the buprenorphine and naloxone combination (now known as Suboxone), were often active drug users. The success of these studies hinged on participants’ ability to engage, which financial incentives helped facilitate.
Now, the federal government is revisiting this issue. The Health and Human Services (HHS) Office of Inspector General is seeking public comment on the protection of payments to clinical trial participants. Comments are due by August 24. This inquiry is part of broader efforts to bolster American clinical research. For years, payments have been in a legal gray area due to complex statutes that could penalize paying beneficiaries of Medicare and Medicaid for participation, even when payments cover routine expenses.
Bioethics concerns focus on whether such payments might influence the choices of vulnerable individuals. Research shows, however, that providing cash incentives to drug users did not increase their drug use. Instead, it improved follow-up rates and engagement.
In 2021, an important study embedded randomized cash incentives into two clinical trials. Results showed that one trial saw increased enrollment, while the other was unaffected. Neither trial showed bias in participants’ risk assessment or in attracting economically disadvantaged individuals.
Justice and scientific integrity require that trials include diverse groups, fully capturing the treatment needs of all people, including drug users and Medicaid recipients. Suboxone was developed because trials included active opioid users, contradicting assumptions of their unreliability.
Fair remuneration for clinical trial participants ensures studies cover all necessary costs and reflect the real impact of proposed treatments.
Recommendations urge policymakers to codify reimbursement for actual out-of-pocket costs, which should be uncontroversial. In 2018, the FDA clarified such reimbursements do not pose ethical concerns, and the inspector general should affirm this approach.
Compensating participants for time is complex and should be guided by institutional review boards. Fixed limits on compensation could stifle research or exclude essential participants, as appropriate payment should reflect the demands of the study.
Beyond government-sponsored trials, these principles should extend to academic and industry-sponsored research. Institutional review boards currently evaluate participant compensation fairness and should continue doing so.
‘Care Not Cash’ stemmed from distrust in people’s ability to manage money, yet clinical trials evidenced the contrary. These trials confirmed that buprenorphine-naloxone functioned effectively for its target users, with Suboxone now saving numerous lives. This progress relied on participants who were actively using opioids taking part under fair compensation, recognizing trial participation as work requiring oversight, punctuality, and risk-taking.
Today’s Medicaid imposes work requirements. Participation in trials that address disease-related poverty should qualify, as it contributes significantly to public health. The inspector general’s rules can acknowledge these findings or fall back on outdated fears. Evidence and not apprehension should guide future regulations.
Matthew Baggott, PhD, is a neuroscientist and CEO of Tactogen Inc. John Mendelson, MD, is a board-certified internist specializing in addiction treatment, and Chief Medical Officer and Founder of Ria Health.