Imagine that you are a 48-year-old man with a wife and 2 kids, working a full-time job that plays slightly more than minimum wage. Your family’s combined income before taxes is at the median US income of approximately $59,000.1 To maintain that income, you have to put your children in daycare, which costs you approximately $12,000 a year2 and health insurance for your family of 4 is another $12,000 a year.3 Of the $35,000 that remains, $10,400 will go towards groceries4 and approximately $13,372 will go towards taxes (assuming a standard deduction of $12,000).5 The remaining $11,000 is hardly enough to cover your mortgage, car payments, fuel, and utility bills. Something’s got to give.
Up to this point, you’ve had no medical issues, your wife is healthy, and your kids are doing well; you know that if they were in need of health care they would easily qualify for the Children’s Health Insurance Program (CHIP). So you take a calculated risk and decide to forgo health insurance next year, hoping that your finances will improve by the following year.
Halfway into the year, you start having nonspecific back pain. You go to see a physician and pay out of pocket for your care, only to find out that you have been diagnosed with a malignancy. There are good treatments out there, but you can’t afford them because the cost far exceeds what you have in savings and a line of credit. You are facing death and desperate for treatment that you cannot afford. Then one day, your physician says: “There’s a pharmaceutical company that’s doing research on an investigational drug for your type of cancer. Would you be interested in participating? The company will pay for the cost of your treatment.”
In 2000, 38.7 million people in the United States were primed for this exact situation.6 With the passing of the Affordable Care Act (ACA), that number dropped to 28.2 million in 2016, or 8.8% of the population. However, with the recent political attacks on the ACA and the repeal of the insurance mandate, the number of uninsured Americans is back on the rise. To make matters worse, skeleton plans — often poorly understood by consumers — offer patients the illusion of being insured when in reality they are underinsured. The number of underinsured individuals is also on the rise as these second-rate plans become more popular due to their lower cost.7 So it is no wonder that uninsured patients are often enthusiastically willing to participate in research trials as a means to gain access to the healthcare or treatments they so desperately need.
Aside from the ethical faux pas of having a healthcare system that limits access based on finances, enrolling uninsured patients in clinical research trials should prompt several ethical concerns regarding the participation of these patients in a clinical trial.
First, there are issues that are not necessarily ethical, but more practical problems that arise when low-income or uninsured patients serve as clinical trial participants. Many face increased barriers to enrollment and retention in clinical trials.7 For example, many of these patients may not be able to get time off from work to attend follow-up sessions; may not have transportation to and from clinical centers; and if they have children, may not be able to afford daycare services. Socioeconomic issues can lead to problems with retention in clinical trials despite the willingness of uninsured patients to participate in these trials.
The next set of issues arises from ethical concerns about exploitation, deliberate inclusion or exclusion of participants based on their insurance status, and overall fair selection of research participants. For example, patients without insurance who participate in research trials are much less likely to benefit from the findings of those trials than patients who have insurance. Take for instance the patient I described above. Let’s say his ailment was diabetes rather than cancer and he helped bring a new experimental drug to market by participating in a clinical trial. When the trial ends, he still doesn’t have insurance and he no longer has access to the drug free of charge from the pharmaceutical company sponsoring the research trial. After the trial has ended, if he continues to be uninsured, how will he have post-trial access to the very drug he helped make accessible to everyone who can afford it?6
It may be viewed as a form of exploitation to enroll such uninsured patients in clinical trials based on their motivation to access care. The investigators in a 2003 study published in Critical Care Medicine argue that exploitation is distinctly taking unfair advantage of an individual.6 In clinical trials investigators may take advantage of the unfair situation that uninsured patients often find themselves in; however, the scenario is not necessarily exploitive if the investigators make a fair offer that is mutually beneficial to both the research participants and the study goals.6 Researchers make the distinction between taking advantage of an unfair situation (eg, buying up stocks at bargain prices as the stock market is crashing) and unfairly taking advantage of individuals6 (eg, in the stock market world, pumping and dumping a stock.)
The same study investigators go on to argue that the fair selection of research participants should be made irrespective of whether they are insured or uninsured,6 and offer the following 3 criteria for ensuring ethical selection.
First, participants should be selected based on the scientific needs of the study and independently of the participant’s financial status. Next, the study should aim to minimize the risks to study participants while maximizing the benefits. Finally, research participants should be in the position of benefitting from the outcome of the studies to which they contribute.
This last criterion is probably the most challenging to achieve and brings us back to where we started: concern about our 48-year-old father having access to care and post-trial access to the investigational treatment once it becomes widely available. When this last and final criterion is not met investigators run the risk of exploiting uninsured trial participants. The researchers argue that it is not necessary for uninsured patients to be guaranteed post-trial access to investigational drugs as long as the investigators are clear at the onset during the informed consent process that the participants are not guaranteed post-trial treatment.6
Moreover, the investigators argue that researchers should make a reasonable attempt to assist uninsured patients in obtaining post-trial treatment, especially when there is no post-trial access to the investigational therapies.6 Some pharmaceutical companies may choose to offer post-trial access to their drugs, but there is certainly no requirement that they do so. When they do offer access as a benefit, some argue that this may be a form of coercion and thus compromise the informed consent process.
This is a problem that arises from our extraordinarily expensive, unimpressive, and unfair healthcare system that leaves hardworking Americans desperate to find alternative access to care. While participation in clinical research is not a solution to our healthcare system’s inadequacies, it does seem prejudicial to deny uninsured patients participation in a clinical trial based solely on their lack of health insurance. It is equally unfair to include them based solely on their uninsured status. Investigators must take special precautions to offer practical risk/benefit ratios to participants, especially when post-trial access to effective interventions is not guaranteed, and they must remove any unnecessary barriers to the participation of any group of individuals — racial, ethnic, gender, or financial — to guarantee fair and equitable patient selection.6
Until universal access to healthcare is ensured as a human right that does not lead to the economic demise of an individual or their family, researchers must keep these ethical concerns in mind when designing future clinical trials.6
- Loudenback T. Middle-class Americans made more money last year than ever before. Business Insider. September 12, 2017. www.businessinsider.com/us-census-median-income-2017-9. Accessed September 10, 2018.
- Care.com Editorial Staff. This is how much child care costs in 2018. Care.com. July 17, 2018. www.care.com/c/stories/2423/how-much-does-child-care-cost/. Accessed September 10, 2018.
- Paavola A. $28K: The average price a family of 4 will spend on healthcare in 2018. Becker’s Hospital CFO Report. June 4, 2018. www.beckershospitalreview.com/finance/28k-the-average-price-healthcare-will-cost-a-family-of-4-in-2018.html. Accessed September 10, 2018.
- Hellmich N. Cost of feeding a family of four: $146 to $289 a week. USA Today. May 1, 2013. www.usatoday.com/story/news/nation/2013/05/01/grocery-costs-for-family/2104165/. Accessed September 10, 2018.
- Tax Tables. $59,000 tax calculation based on 2018. www.taxformcalculator.com/tax/59000.html. Accessed September 10, 2018.
- Pace C, Miller FG, Danis M. Enrolling the uninsured in clinical trials: an ethical perspective. Crit Care Med. 2003;31(3 Suppl):S121-S125.
- Cho HL, Danis M, Grady C. The ethics of uninsured participants accessing healthcare in biomedical research: a literature review [published online August 2, 2018]. Clin Trials. doi:10.1177/1740774518792277