Imagine for a moment that you are seriously injured in a medical research study and require expensive medical care. Imagine further that the study in which you are injured is scientifically worthless, deceptive and exploitative – sort of like the Tuskegee syphilis study, for example. Who ought to be responsible for paying for your medical care?
In the United States, the answer is: You are. There is no legal obligation for a research sponsor to pay for your medical care, even if the sponsor is directly responsible for your injury. In the United States, only 16 percent of academic health centers make it a policy to pay for the care of injured subjects, and none of them compensate subjects for lost wages or suffering. As a consequence, the risks of participating in medical research in America do not merely include illness, injury and death. They also include financial ruin.
Last week I published an article about the injustice of this policy in the New England Journal of Medicine. But the best scholarship on the topic comes from Elizabeth Pike, a research analyst with the Presidential Commission for the Study of Bioethical Issues. She graciously consented to an interview.
I think a lot of outsiders are shocked to find out that if research subjects are injured in a clinical trial, they are usually responsible for paying their own medical bills. In this, as in many other things, American medicine stands apart from the rest of the developed world. You make it clear in your article that you believe this is unjust, but I wonder: Can you hazard any guesses as to why the injustice has endured for so long?
I think one reason the injustice has endured for so long is that we lack empirical data about the scope of the problem. We don’t know how many people are injured as a result of their participation in research. We don’t know whether serious research injuries are routine or rare. A number of national commissions have considered the issue of compensating injured research subjects, and have concluded that they cannot take concrete steps forward until the scope of the problem is better understood.
Why is the scope of the problem so important? I’d have thought that even if injuries are rare, it is still unjust to force the injured subject to pay for his or her own medical care.
I agree that forcing injured research subjects to pay out-of-pocket for medical care necessitated by research is unjust. But people are hesitant to implement a solution they fear may be expensive to something they worry may not actually be a problem. Many people also think—incorrectly, as it turns out—that injured research subjects can just bring a lawsuit to receive compensation. As my article “Recovering from Research” points out, this is just not true. Without hard data showing that research subjects do get injured and are forced to pay for the resulting medical care themselves, implementation of a comprehensive solution will likely remain on the back burner.
Every other developed country in the world has taken measures to fix the injustice anyway. We’re the exception. What’s different about us?
One reason may be that in countries with universal health insurance, injured research subjects likely have their medical bills covered; any obligation to provide compensation for research-related injuries may end up being relatively inexpensive. In the United States, some research subjects are uninsured and medical care for serious injuries can be quite expensive. This may mean that, depending on how implemented, requiring no-fault compensation for research injuries could be costlier in the United States. The United States has, however, implemented several successful and cost-effective no-fault compensation systems, including workers’ compensation and car insurance, so fears of an expensive no-fault compensation system may be overblown. We should also recognize that requiring compensation does not add new costs to research; rather, it shifts costs that are already being borne by injured research subjects or their insurers.
You recommend a no-fault compensation system as a solution. Can you say a few words about why you think that’s the best option?
The alternative to a no-fault compensation system is continued reliance on the legal system. My article “Recovering from Research” details the many ways the legal system—and the tort system, in particular—falls short. International research subjects and subjects injured in federally conducted research are essentially unable to receive compensation through the courts. All other research subjects face serious challenges, including difficulty proving causation and the chance that a signed informed consent document may be viewed as assuming the risks of research. Given that the alternative to a no-fault compensation system is continued reliance on a legal system that denies most research subjects access to compensation, no-fault compensation seems like the better choice.
Once you decide to implement no-fault compensation, there are several possibilities for no-fault compensation systems. In the United States, the two leading possibilities are an insurance/self-insurance requirement comparable to our workers’ compensation system and a no-fault compensation court modeled on the Vaccine Court.
An insurance/self-insurance requirement has several advantages that, to my mind, make it the best solution for compensating injured research subjects. First, an insurance/self-insurance requirement could be implemented with minimal centralized bureaucracy. Second, depending on how implemented, an insurance/self-insurance requirement could retain economic incentives for sponsors to minimize risks to subjects. Third, and perhaps most importantly, an insurance/self-insurance requirement would bring our laws into accord with the laws of much of the rest of the world. Many of the countries most involved with research—including 31 European Union countries, Brazil, China, India, and South Africa—have implemented an insurance/self-insurance requirement. Given that so much research is conducted multinationally, bringing U.S. law into closer conformity with the laws of other countries could benefit researchers who conduct multinational research.
Unlike an insurance/self-insurance requirement, the Vaccine Court model is incompatible with no-fault compensation systems around the world, so could cause problems for researchers who conduct multinational research. A Vaccine Court model also requires a centralized bureaucracy, and may implement a risk-pooling system that reduces researchers’ economic incentives to minimize risks to research subjects.
Acknowledgement: This interview was first posted on the Chronicle of Higher Education Brainstorm blog.