by László M. Szabó, Esq., Director of the Office of Research Regulatory Affairs at Rutgers, The State University of New Jersey
While the 2013 Advancing Ethical Research (AER) Conference is over for the year, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference happenings.
On the second day of the 2013 Advancing Ethical Research (AER) Conference, I attended Paul Appelbaum’s keynote address, Therapeutic Misconception in Clinical Research: A 30-Year Retrospective. Dr. Appelbaum is an expert on informed consent, decisional capacity, and related issues, and has written widely on research ethics. Importantly, Paul was the first to identify the phenomenon of “therapeutic misconception” about 30 years ago, and reflected upon the matter with his depth of experience.
Therapeutic misconception takes place when a research subject incorrectly attributes therapeutic or ordinary treatment benefits to participation in research, thereby misconstruing the intent of research and treatment. Obviously, the impact on the informed consent process is substantial. Therapeutic misconception can be triggered when established treatment options are lacking or when a research study is similarly designed to clinical care. For the latter, subjects often either underestimate the risks associated with the research or are overly optimistic about the outcomes of the research.
Because the informed consent process is so vital to overcoming therapeutic misconception, it is important to convey several points to subjects to construct a clear distinction between research and clinical therapy:
- Explain that research = experiment = unknown/untested methods. Research is intended to test hypotheses (it is, after all, an experimental undertaking) that will ideally lead to theories that can be translated to clinical treatment.
- Clearly define how the research differs from treatment (e.g., the use of placebos), and incrementally prompt the subject for understanding. A recommended way to accomplish this is to have fewer open-ended prompts and, instead, more structured assessments.
- Explain that one key aspect of how research differs from treatment is that the protocol spells out what needs to be done for research, whereas in treatment the treating physician has greater professional discretion to decide on a course of treatment. The effects of this, for example, may be that if the subject needs more medication they may not be able to receive it because it may be prohibited under the research protocol.
- Limit the use of study acronyms that sound overly optimistic (e.g., “BEST”, “MAGIC”—both real acronyms).
- Pay attention to the connotations of verbiage. For example, many researchers avoid the term “experimental” in lieu of “study,” or “project,” which can increase the likelihood of therapeutic misconception.
A key consideration—really a threshold matter to address the possibility of such misconception taking place—is to first consider how close the research resembles treatment. This assessment, of course, should disregard the intent of the researcher and be made from the perspective of the target subject population.
So, what can you do to avoid therapeutic misconception? Clearly define ways by which the research is different from treatment (e.g., by explaining what random assignment is), pay attention to the verbiage used in the study, and conduct informed consent face-to-face to support a comprehensive understanding by the subject.
Resources cited by Paul: