The SRA Symposium - College of Medicine

Table #1: Dealing with Therapeutic Misconception
Research is not treatment because… Treatment is not research because…
You are a subject in research, not a patient getting
standard treatment for your disease
You are a patient getting standard treatment for
your disease
All subjects get standard treatment All patients get individualized treatment
Research produces generalizable results that
might help others; it might not help you
You may get an experimental treatment, standard
treatment or a placebo
Your treatment will be based on random assignment
Research requires inclusion and exclusion
criteria for each subject
Research MDs to not now what drug you get in
a double-blind study
You have human subject rights; your research
information may be shared with...
Research is not treatment; informed consent is
always required.
Treatment is expected to help you
Papers
You will get the best available standard treatment
Your treatment will be based on your individual
needs
Standard treatment does not have inclusion or
exclusion criteria for your to be treated
Personal MDs know what drugs you are taking
You have patient rights; your patient information
may be shared with...
Treatment is not research; informed consent is
sometimes required.
Deciding to be in a clinical trial: Decision research has not been incorporated into research on informed
consent in clinical trial, although Princeton University Psychologist Dan Kahneman won
a 2002 Nobel Prize for his work on “…human judgment and decision making under uncertainty.”
(Kahneman, 2003). “Analyses of decision making commonly distinguish risky and riskless choices”
(Kahneman & Tversey, 2000, p 1). But consent forms usually to not “frame” risks and benefits
in ways they make them easily understood or usable to prospective subjects.
How do prospective subjects interpret: “You might have all, some, or none of the following side effects…”
followed by a bulleted list of 39 possible side effects? Or, “All medications have side effects
and, with an investigational drug, these can sometimes be unforeseen. The risks and discomforts
currently seen include but may not be limited to the following…” followed by almost two pages of
text listing every possible risk. Or, “Some of the less common side effects include…” and “Some
uncommon but potentially serious side effects include…?” What does “less common” mean? What
does “uncommon but potentially serious” mean? If prospective subjects don’t have a psychological
frame for the risks, how can they emotionally and logically judge the study’s risk potential?
Like risks, benefits are usually not explicitly described: “Although XYZ is being tested as a treatment
for a condition that you may have, there is no guarantee that you will receive any medical
benefit.” Or “Information obtained from this study will benefit the sponsor of the study and may
benefit patients in the future” or “The study drugs are still being clinically tested so it is not possible
to predict whether they will be of benefit to you.” Perhaps as a way of trying to reduce therapeutic
misconceptions about the benefits of being in a clinical trial, consent form writers often use
ambiguous language to describe a trial’s benefits. In the context of gene transfer research, King,
et al (2005) have categorized benefit statements as 1) Contentless (2% of consent forms) defined as
having no nature information, with examples such as “You may or may not benefit…”, 2) Surrogate
Endpoints (65% of consent forms), defined as a lab measurement that represents a clinical endpoint,
such as tumor shrinkage, and 3) Clinical Endpoint (2% of consent forms), defined as a specific benefit
that subjects can feel or experience, such as living longer, having fewer bleeds and 4) Surrogate
and clinical endpoints (31% of consent forms). Unlike lists of risks, consent forms don’t include
a list of possible medical benefits, only ambiguous statements about “medical benefits,” although
2005 Symposium Proceedings Book 109