Understanding Therapeutic Misconceptions Associated With Clinical Trial Enrollment
Therapeutic misconception is an important type of false belief in medical research and medical practice.
Therapeutic misconception is an important type of false belief in medical research and medical practice and there are many conflicting opinions regarding the role of therapeutic misconception in informed consent, according to a paper published in the AMA Journal of Ethics.
One effective strategy to overcome ethical issues in research, as reported by the paper's author Jennifer B. McCormick, PhD, MPP, member of the Penn State Clinical and Translational Science Institute in Hershey, Pennsylvania, and the American Society of Human Genetics' Social Issues Committee, is to connect researchers with practicing physicians and to regularly assess risks and benefits.
Therapeutic misconception is a trial participant's erroneous belief that that the medical care received during a clinical trial is made for their personal benefit — confusing their role as a patient and a research participant. Research ethics required that both physicians and patients understand the benefits as well as the risks of medical care, regardless of whether that care is approved or investigational in nature. Informed consent should be a continuous discussion, according to Dr McCormick, in which “a participant is reminded of the voluntary nature of her participation, the potential risks and benefits to her, and the purpose of her participation.”
Many patients may be desperate for a cure and will seek any route necessary, including clinical trial participation. Therapeutic misconception may be equated with false hope for a cure, due to the patient's physical, mental, or emotional vulnerabilities. Researchers may require self-assessment prior to conducting a trial in an effort to check their biases regarding their studied treatment. Medical ethics research may be helpful in developing a scale or self-assessment tool for reducing the likelihood of therapeutic misconceptions.
“While some have argued that worrying about therapeutic misconception can undermine rather than promote participants' understanding and informed consent,” Dr McCormick wrote, “others argue that being concerned about therapeutic misconception and its clinical and ethical relevance is more important than ever because the assumptions of and relationships between researchers and participants (and clinicians and patients) can be rather muddled in translational research, learning health systems, and research-intensive academic medical centers, where clinicians are also investigators, patients are also participants, and research results can have clinical usefulness to participants.”
McCormick JB. How should a research ethicist combat false beliefs and therapeutic misconception risk in biomedical research? AMA J Ethics. 2018;20(11):E1100-E1106.