Medical Research Participants Should Understand That Research Is Not The Same As Treatment

Main Category: Clinical Trials / Drug Trials
Article Date: 26 Nov 2007 - 17:00 PDT

email to a friend   printer friendly   opinions  

Some research participants do not appreciate important differences between medical research and treatment, says a team of researchers in a policy paper in this week's PLoS Medicine.

Failure to appreciate the difference between research and treatment has been called "therapeutic misconception." Some trial participants, for example, may not be aware of the implications of being randomly assigned to a new treatment versus a control treatment-instead, they may falsely believe that they are being assigned to a medication based on what is best for them personally.

The researchers, led by Gail Henderson at the University of North Carolina at Chapel Hill, say that despite considerable empirical research on therapeutic misconception since the early 1980s, a consistent definition of therapeutic misconception has not emerged in the literature.

"Without such a definition," they say, "meaningful empirical work to measure and assess the prevalence of therapeutic misconception, or to test interventions to reduce it, is difficult to conduct."

The authors met in 2005 to begin working on a definition of therapeutic misconception, and spent a year refining their final definition, which reads:

"Therapeutic misconception exists when individuals do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled in the trial may potentially benefit from the intervention under study or from other aspects of the clinical trial."

The authors also drafted five dimensions of research that should be understood by trial participants in order to fully evaluate the risks and benefits of participation: (1) the scientific purpose of the trial (i.e. to produce generalizable scientific knowledge); (2) the purpose of study procedures; (3) uncertainty about the risks and benefits of the intervention being tested; (4) the use of a strict research protocol; and (5) the fact that the clinician is acting as an investigator.

The policy paper is also discussed in this month's PLoS Medicine editorial on the boundary between clinical care and medical research

Citation: Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, et al. (2007) Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 4(11): e324.
Please click here.

Related PLoS Medicine editorial:

Citation: The PLoS Medicine Editors (2007) How can we draw the line between clinical care and medical research? PLoS Med 4(11): e340.
Please click here.

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues.

http://www.plosmedicine.org

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource.

Public Library of Science
185 Berry Street, Suite 3100
San Francisco, CA 94107
USA

• Additional
• References
• Citations