Challenge Area: Bioethics Challenge Topic: 02-OD(OSP)-105. Ethical Issues Raised by the Blurring between Treatment and Research. Project Title: The Blurring of Treatment and Research in Clinical Trials: Two problems. The blurring of the distinction between treatment and research in the minds of participants in phase 3 clinical trials has been referred to as therapeutic misconception (TM). This has been widely recognized as a major problem for informed consent to research. Subjects often have trouble understanding the distinction between the goals of research and the goals of treatment as well as the implications for their own treatment of participating in research. However, efforts to study TM are greatly hampered by the lack of a valid, reliable, and easily administered measure. Less widely recognized is a related phenomenon that clinical researchers are also caught between the two principles and tend to blur the distinction themselves. This is not so much a failure to understand as it is a moral or normative conflict. In a recent survey we found ample evidence that clinical researchers feel strongly committed to their """"""""patients"""""""" and report breaking protocol in order to provide optimal clinical care. However, the survey data is limited in that we do not know enough about the specifics of the deviations from the protocols and how these deviations were handled by the researchers. The proposed study will make major strides in developing the understanding of both of these important examples of the blurring of treatment and research.
The first aim of the study is to develop a robust, yet usable and easily scored, measure of TM. We will use both a proposed measure and a semi-structured interview to assess TM in 300 subjects in 60 different protocols at 4 different sites. The semi-structured interview with its associated coding rules has been used in prior research by the principal investigator to measure TM and will serve as a criterion for assessing the validity of the structured measure. We will also interview in depth the clinical researchers who provide the day-to-day clinical care in the same 60 protocols about their responses to the same survey that was reported in a recent paper. The goal here is to assess whether these deviations from the protocols would have serious consequences for the validity of the trials and whether they were appropriately reported so that the deviations can be taken into account in the analysis of the results of the study. In the process we will explore the perspective of clinical researchers about clinical care in clinical trials and assess whether they have a form of TM themselves. Public Health Significance: Maintaining the boundary between treatment and research in phase 3 clinical trials is a serious public health matter. Subjects'confusion of the two risks undermine the validity of their informed consent. If they think that research is no different from treatment they will seriously misunderstand to what they are consenting. Equally serious, if clinical researchers fail to maintain that boundary between research and treatment, they may make decisions in the interests of their """"""""patients"""""""" that violate the protocol and thus threaten the validity of the research.
Public Health Significance Maintaining the boundary between treatment and research in phase 3 clinical trials is a serious public health matter. Subjects'confusion of the two risks undermining the validity of their informed consent. If they think that research is no different from treatment they will seriously misunderstand to what they are consenting. Equally seriously, if clinical researchers fail to maintain that boundary between research and treatment, they may make decisions in the interests of their patients that violate the protocol and thus threatening the validity of the research.
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| Appelbaum, Paul S; Anatchkova, Milena; Albert, Karen et al. (2012) Therapeutic misconception in research subjects: development and validation of a measure. Clin Trials 9:748-61 |
| Kim, Scott Y H; Holloway, Robert G (2010) Is it research?: an increasingly common question. Neurology 75:102-4 |
