Patients' payment could fund studies that would not otherwise be conducted, said a group of medical ethicists led by Ezekiel J. Emanuel, MD, PhD, the former White House health-policy adviser who now chairs the Department of Medical Ethics and Health Policy at the University of Pennsylvania. Emanuel was asked by a group of academic investigators to review the legality and ethics of charging for enrollment in an early-phase clinical trial; he and his co-authors examine the pros and cons.
No laws or regulations prohibit pay-to-play, said the authors, and it has some upsides. By putting their money where their mouth is, patients could be demonstrating deep engagement with the research protocol, and affirming their informed consent. Their payment could be seen as a direct, Kickstarter-style version of a charitable contribution to medical research, or as an analogue to permissible payment for experimental treatments outside the confines of a clinical trial. Last but not least, there is a liberty argument, that "people should have the freedom to do whatever they want with their own money as long as they are not harming others or diminishing their rights and opportunities," said the authors, whose perspective essay (subscription required) appears today in Science Translational Medicine.
But before going full libertarian, the authors put on the brakes. Let's be honest, they said, this is less about a collaborative partnership than a potentially desperate need to save one's own life; less about a charitable impulse than purchasing a service. It will skew research toward the health needs of the wealthy and could interfere with research integrity: A paying participant may be less willing to accept randomization to a control group or more reluctant to disclose symptoms and side effects. For their part, investigators might feel pressure to bend inclusion or removal criteria, or not to terminate a study. Ultimately, the authors conclude that pay-to-play is generally unethical, and warrants legislative and regulatory attention.
Co-author Govind Persad, JD, a Stanford graduate student in philosophy, told me he's particularly concerned about participants feeling pressure to pay: "There is this real psychological pressure, if you or your kid are sick or in this desperate position, to do something that not only you wouldn't have done, but that you see as having this direct, imminent benefit to yourself out of proportion to the benefit it's likely to have."
Persad hopes the essay will ignite an "educated debate" among researchers, policy makers, potential donors to medical research and people who stand to benefit from interventions to be studied in clinical trials. "An issue for people to think about going forward is: If we need more research into Condition X but pay-to-play is not the way, what would be some other good ways to try to expand the universe of trials?"
Related: A look at crowdfunding clinical trials, Can crowdfunding boost public support and financing for scientific research, Stanford forum on the future of health care in America posted online and When it comes to health-care spending, U.S. is "on a different planet"
Photo by David Goehring