Perspectives

Distinguishing Therapeutic Misconception from Religious Belief

Authors: Nicholas Covaleski, MTS, MBE

Abstract

In the context of early-phase clinical trials, research subjects often confuse the differences between clinical research and personal treatment. This phenomenon, known as therapeutic misconception, potentially undermines the validity of informed consent. Several interventions have been proposed to help mitigate therapeutic misconception, although few have considered the role of religious belief. This is a notable omission, given that an association between therapeutic misconception and religious belief has been shown to exist. This perspective calls for more research into the nature of the association between therapeutic misconception and religious belief and suggests a framework that may help clinicians and researchers distinguish between the two, thereby bolstering the informed consent process.

 

This content is limited to qualifying members.

Existing members, please login first

If you have an existing account please login now to access this article or view purchase options.

Purchase only this article ($25)

Create a free account, then purchase this article to download or access it online for 24 hours.

Purchase an SMJ online subscription ($75)

Create a free account, then purchase a subscription to get complete access to all articles for a full year.

Purchase a membership plan (fees vary)

Premium members can access all articles plus recieve many more benefits. View all membership plans and benefit packages.

References

1. Lidz CW. The therapeutic misconception and our models of competency and informed consent. Behav Sci Law 2006;24:536–546.
 
2. Miller FG, Joffee S. Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment? Clin Trials 2008;5:617–623.
 
3. Appelbaum PS, Roth LH, Lidz CW, et al. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 1987;17:20–24.
 
4. Weinfurt KP. The correlation between patient characteristics and expectations of benefit from phase I clinical trials. Cancer 2003;98:166–175.
 
5. Heynemann S, Lipworth W, McLachlan S, et al. When research becomes practice: the concept of the therapeutic misconception and challenges to consent in clinical trials. Intern Med J 2023;53:271–274.
 
6. Miller M. Phase I cancer trials: a collusion of misunderstanding. Hastings Cent Rep 2000;30: 34–43.
 
7. Escritt K, Mann M, Nelson A, et al. Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of the qualitative evidence on patient-participation experiences. Trials 2022;23:409.
 
8. Pentz R, White M, Harvey RD, et al. Therapeutic misconception, and optimism in subjects enrolled in phase I trials. Cancer 2012;118:4571–4578.
 
9. Abernathy ER, Campbell GP, Hianik RS, et al. Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting. Cancer 2021;127:3794–3800.
 
10. Daugherty CK, Banik DM, Janish L, et al. Quantitative analysis of ethical issues in phase I trials: a survey interview of 144 advanced cancer patients. IRB 2000;22:6–14.
 
11. Kass NE, Sugarman J, Medley AM, et al. An intervention to improve cancer patients’ understanding of early-phase trials. IRB 2009;31:1–10.
 
12. Horng S, Grady C. Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB 2003;25:11–16.
 
13. Jansen LA, Applebaum PS, Klein WMP, et al. Unrealistic optimism in early-phase oncology trials. IRB 2011;33:1–8.
 
14. Sulmasy DP, Astrow AB, He MK, et al. The culture of faith and hope: patients’ justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer 2010;116: 3702–3711.
 
15. Sulmasy DP. Distinguishing denial from authentic faith in miracles: a clinical-pastoral approach. South Med J 2007;100:1268–1272