At a time when social justice movements are coming to the fore, what if research subjects boycotted trials until they were guaranteed medical care if injured? Similar questions have been raised about research subjects involved in testing drugs that they will not be able to afford when they eventually come to market.
Many in the public may assume subjects would be provided medical care as part of agreeing to participate in a trial, but in most cases, it is proceed at your own risk, says Carl Elliott, MD, PhD, a professor in the Center for Bioethics at the University of Minnesota.
“At the heart of the United States medical research enterprise is a tremendous injustice,” Elliott wrote in a recent commentary.1 “Unlike virtually every other country in the developed world, the United States does not guarantee payment for the medical care of subjects injured in research studies.”
Despite ethical recommendations from various prestigious groups over the years, the status quo holds. “The situation is unlikely to change unless research subjects exercise the only real power they have: boycotting research studies that do not offer paid medical care for subjects who are injured,” he wrote. He agreed to field a few questions on this controversial topic in the following interview with IRB Advisor.
IRB Advisor: Is your commentary primarily provocative for the purpose of raising awareness, or do you think a research subject boycott could actually be organized to demand action?
Elliott: I would like to think it could happen and it could make a difference, but in the past things have been stacked heavily against this sort of thing. The odds are pretty long. The only events I can think of when there has been a large public backlash against the research establishment are incidents like Tuskegee. It is just very difficult to find a way for research subjects to develop the kind of solidarity with one another that is required for any kind of group action.
IRB Advisor: You cite the case of a patient finding out, to her dismay, in reading a 22-page informed consent form that she would receive no long-term medical care if injured in the trial.
Elliott: You are just told that. Most people are told that. It’s like, “This is the deal you are being offered, and if you don’t like it don’t enroll in the trial.” I think a lot of people like to think that nothing bad is going to happen to them and they skip right over that part.
IRB Advisor: Can an individual IRB decide it would not approve research unless medical coverage was provided?
Elliott: I was on two IRBs in Canada at McGill University. We usually reviewed pharmaceutical research proposals. If they had that provision in them — essentially telling subjects they are responsible for their own medical care if they are injured in the trial — we would strike it out. We told them “Either you get rid of that, or we are not approving the study.” That was standard. When I moved to the University of Minnesota, I just assumed that would be the case here as well. I was simply told, “No, of course we don’t include that. It’s standard.” It was shocking. It’s really only shocking to the rest of the world. In America, it’s the norm.
IRB Advisor: You cite a 2011 presidential commission and other prestigious academic bodies over the years that have recommended that injured research subjects should not have to bear the cost of their medical care. Why has this not happened?
Elliott: It is simply a matter of power. Somebody will have to pay for it, and nobody is interested in that. The only people who have interest in changing the system are research subjects. Institutions that do research are not interested in something that is going to cost them more money.
IRB Advisor: Perhaps your stance will raise awareness and start a conversation about change.
Elliott: I think if there were a high-profile scandal in which subjects were injured and were forced to pay for their own medical expenses, that could raise awareness. But my sense is that, with most of these cases, it becomes a legal issue and nobody talks to the press about what actually happened. The legal settlement is sealed. Finding out about the cases is very difficult.
1. Elliott, C. Power Concedes Nothing without a Demand: The Case for a Patient Boycott of U.S. Clinical Trials. IRB Ethics Human Research 2018;40:2:15-18.