PHILADELPHIA - Charging people to participate in research studies is likely to undermine the fundamental ethical basis of clinical research, according to a new paper written by bioethicists, including lead author Ezekiel Emanuel, MD, PhD, chair of the department of Medical Ethics and Health Policy at the Perelman School of Medicine at the University of Pennsylvania, and published in Science Translational Medicine. The paper outlines the arguments for and against the concept of "pay-to-play" research, ultimately concluding that this type of approach compromises the overall integrity of clinical research.
The paper was prompted by a call asking Emanuel about the legality and ethics of such "pay-to-play" research by researchers who are frustrated over shrinking budgets. The researchers wanted to charge research participants as a way to fund research that otherwise wouldn't move forward. In the paper, the authors suggest that with current resource constraints in medicine leading to patients bearing more of their medical costs -- through high-deductible plans, for example -- it may seem natural to ask participants to contribute to the price of research that could potentially benefit them.
The two strongest arguments for charging research participants are that "pay-to-play" research would fund studies that otherwise would not be conducted, and the freedom argument that patients should be free to do whatever they want with their money as long as it does not harm others, so buying into research is just one way they should be able to spend their money. But the authors say that "pay-to-play" research might actually be harmful. First, it could exploit desperate patients who will do anything to save their own life or a loved one, and who don't have the ability to properly evaluate the likelihood of receiving benefit from the research. Furthermore, once people pay to be part of research studies, this is likely to skew both the types of studies that are conducted and how they are conducted. Paying research participants are unlikely to accept being randomized, especially if it might get them a placebo or a control intervention, and they might be reluctant to abide by the need to report side effects and other problems with a study.
"Because pay-to-play research has a high likelihood of undermining the research enterprise by skewing the types of studies pursued and the researchers and facilities devoted to particular projects, exploiting people, and compromising the methodological rigor of clinical studies, it is not accurate that no one is harmed by people's exercise of their freedom," write the authors. "We are all harmed with the integrity of clinical research is compromised."
The other authors include Steven Joffe, MD, MPH (Penn), Christine Grady, MSN, PhD, David Wendler, MA, PhD, and Govind Persad.
Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.9 billion enterprise.
The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 17 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $409 million awarded in the 2014 fiscal year.
The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania -- recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report; Penn Presbyterian Medical Center; Chester County Hospital; Penn Wissahickon Hospice; and Pennsylvania Hospital -- the nation's first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Chestnut Hill Hospital and Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine. Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2014, Penn Medicine provided $771 million to benefit our community.