Background: Therapeutic misconception occurs when research subjects fail to understand the distinction between the goals of research and those of clinical care. Little attention has been given to the occurrence of therapeutic misconception among provider-researchers. This paper underscores this phenomenon and emphasizes implications for research integrity and the informed consent process.
Methods: A principles-based conceptual analysis approach was used to analyze an illustrative case study, in which a provider-researcher conflates research with care. The illustrative case study was designed based on the author’s reflections of observations in medicine and research and does not represent a single case or a single institution. Conclusion: The illustrative case study highlights how therapeutic misconception might occur when providers conflate their roles as clinicians with their roles as researchers. This can happen, for example, in clinical trials where providers are also researchers. In such cases, providers might blur the lines between providing clinical care and conducting research, for instance by failing to distinguish to themselves and/or the subject that a given procedure is for research versus clinical care. For example, undergoing a CT scan entails inherent risks that an individual might deem acceptable if the scan is being done for clinical care. However, these risks might become unacceptable if the scan is solely for the advancement of generalizable knowledge. Conversely, procedures conducted as part of research are typically covered by the study's sponsor, while the expenses associated with standard of care procedures fall on the patient and/or their health insurance. Clarifying the division of responsibilities regarding costs can be particularly challenging for both provider-researchers and patient-subjects in complex clinical trials. These instances of therapeutic misconception pose a threat to both the autonomy of research subjects and the integrity of the study itself. Respect for persons in research necessitates ensuring that their decision to participate encompasses competence, provision of information, understanding, and voluntariness. When a provider-researcher fails to distinguish research from clinical care, it impedes the patient-subject's ability to fulfill the crucial aspect of "understanding" in informed consent, thereby compromising the validity of consent, and subsequently the integrity of the study.
Limitations: This paper has limitations. The arguments made herein are based on an illustrative case study created by the author based on personal observations in research and medicine. They are therefore subject to bias, and may have limited generalizability. The lack of research studies and related data on this topic is problematic, and presents the need for further development and consideration.
Discussion: Provider-researchers need to be aware of the potential for therapeutic misconception not only among research participants but also within themselves. Recognizing and addressing this misconception is essential for maintaining the ethical conduct of research and ensuring that participants fully understand the nature of their participation and any associated risks. Training and education on research ethics can help providers navigate these complex situations and uphold the principles of beneficence, non-maleficence, and respect for persons in both clinical care and research settings.
