Bioethics Forum Essay
Research Ethics Meets the New Marketplace
As in-person shopping returns, imagine that you enter a clothing store to refresh your wardrobe. You pick out several shirts and two jackets to try on. The helpful salesperson brings you several more, pointing out their special features. After spending a half hour in the store, you don’t purchase anything. When you leave the store, you are handed a $300 bill for the salesperson’s time and the store’s expense in restocking the garments. This is a joke, right?
No Laughing Matter
A similar experience was not a joke for John Mathna, a 58-year-old man from Chattanooga, Tennessee, who contacted a Mayo Clinic doctor to find out about a clinical trial for which he might be eligible. According to an article in Axios, by reporter Bob Herman, Mathna has a brachial plexus avulsion injury (nerve damage at the point of connection to the spinal cord) and suffers severe chronic pain. The Mayo trial is investigating whether electrical stimulation could help ease the pain in injuries like his. He reached a Mayo doc and had a video call that lasted about 20 to 30 minutes. Mathna talked about the study with his wife and decided not to participate.
Imagine his surprise when he got a bill for $476 from the Mayo Clinic. And a further surprise when Cigna, his insurer, reviewed the bill and said that the consultation was out-of-network and not covered at all. Mathna says that he submitted personal and insurance information before the call but was never advised that he would be billed for anything. This was, after all, not a call about treatment or care but about participating in a clinical trial. He was being charged for the investigator’s time in seeking to recruit him to a study.
The Mayo Clinic’s response to the Axios reporter’s inquiries was the standard, “No comment on specific patient circumstances.” But, it added, “participation in studies are [sic] handled differently from clinical appointments or consultations.”
That comment led us to ask: Even if this was a solitary incident (and we have not identified others), what does it say about the difference between asking about participation in clinical trials and asking about treatment? Has research ethics begun to follow the money and charge prospective subjects just for finding out about a trial? Does the “out-of-network” insurance denial mean that only in-network participants are eligible for clinical trials that involve some treatment expenses? Has the effort to reduce disincentives to enroll in trials succumbed to bottom-line considerations?
Ethical Considerations in Research Ethics
Starting with the Nazi abuses, and the revelations about unethical studies in the United States, research ethics has been a major field of study. Among the many articles published in the past 75 years, there are dozens about incentives to prospective subjects–when, how much, and what kind are appropriate. The kinds of costs that patients are expected to pay for the care included in the trial is another topic. Yet to our knowledge, there are no articles that consider the Mayo Clinic case: expecting a prospective subject to pay for learning about the study before deciding whether to participate or not.
This case might (hopefully) be an anomaly. But it is also possible that it is a sign of broader trends in health care. Health care is big business, and big business operates on different moral grounds than service to individuals in distress. Costs must be recovered in some way; the prospective subject has taken the investigator’s time and expertise but has declined to enroll. That cost must be recovered, and the prospective research volunteer, from a business point of view, is the logical person to bill. Since the inquisitive person has insurance, it is not going to be their problem. A billable hour is billable hour no matter what the reason for taking the doctor’s time.
While this way of thinking may not be widespread yet, it could become more common. The federal No Surprises Act of 2020, in effect since January 1, 2022, is a bipartisan effort to protect consumers from just such unjustified costs in out-of-network care. It does not mention research studies.
Considering the research participant as a “partner” rather than a “subject’ is another trend that, while based on admirable goals, may lead to expectations that partners share not only the experience but also the costs. The early HIV/AIDS studies of the 1980s pioneered including prospective subjects, mainly gay men, in trial organization and outreach. So far, the discussion has focused on involving patients in aspects of the study, including compensation. But it’s not a big leap to involving them in bearing the costs of the study. Including recruitment.
Being billed for asking for information about clinical studies can have a negative impact on the person’s financial and credit status. Mr. Mathna’s bill, which he refused to pay, was sent to a collection agency before Mayo Clinic finally withdrew it. Studies of bankruptcy point to health care costs as a leading factor. Adding another problem to the already tenuous financial position of many people with costly chronic conditions is a very bad thing.
Finally, many research studies, particularly those addressing difficult conditions like dementia or chronic pain, appeal to people who believe or become convinced that participating in a study will help them personally. That may happen but it is not the primary goal of studies, which is to gain knowledge that can lead to better care. Believing that a study is the path to cure for themselves and knowing that slots in a study are limited may lead some people to pay an entry fee. Or they may want to please the investigator, who may be someone they know and trust, making it hard to say no to a bill that has nothing to do with their care.
Subjects or partners make a gift of their time and their bodies to allow knowledge to advance. Charging a fee just to find out the basics of a trial is an egregious violation of that partnership.
Carol Levine, MA, is a senior fellow at the United Hospital Fund in New York. Arthur Caplan, PhD, (@ArthurCaplan) is Mitty Professor of Bioethics at the NYU Grossman School of Medicine. Both are Hastings Center fellows.