by Scott Y. H. Kim, Renee Wilson, Raymond De Vries,
H. Myra Kim, Robert G. Holloway, and Karl Kieburtz
Could the High Prevalence of Therapeutic Misconception Partly
Be a Measurement Problem?
Figure A.
Amyotrophic Lateral Sclerosis Phase I Study Scenario
Imagine that you have ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s
Disease). In ALS, nerve cells waste away so that they can no longer send messages to
your muscles. Eventually your muscles will become so weak that you won’t be able to
move your arms, legs, and other parts of your body. ALS gets worse over months to
years until you’re paralyzed and cannot care for yourself. Eventually you’ll lose the
strength to swallow and breathe. Most of the time, thinking is not changed, but there’s
a small chance you’ll develop dementia. Death usually occurs within 3 - 5 years of diagnosis. You could try to prolong your survival by using artificial means, but this would
require using a feeding tube and ventilator support (lung machine).
You were diagnosed with ALS about 1 year ago.
There is no cure for ALS. There is one FDA approved drug but it does not work very
well. You have tried this drug but it has not helped. You feel like you’ve run out of options.
But then your doctor brings up the possibility of participating in a research study.
Your doctor, who is an ALS researcher, asks you if you would like to participate in a
research study testing an experimental drug called TC10.
The researchers have done some genetic testing to better characterize your ALS and
believe that there are scientific reasons to use TC10 to target your ALS. Also, animal
experiments have shown TC10 to be promising. So there is some but very small chance
that you might benefit from TC10. But the reality is that researchers do not know how
humans will respond to this drug. That is why they are doing this research.
The study you’re being asked to enroll in is a small study to see if TC10 has serious
side effects and to see if it has promise as a treatment for ALS, in order to find out if
larger studies should be conducted.
IRB: E t h i c s & H u m a n R e s e a rc h
J u ly -A u g u st 2015
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Table A.
“Is the research study mostly intending to help research and gain knowledge or mostly intending
to help you as a person?” (N = 100)
ResponseFollow-up Question ArmN
%
% Total
Correct response Mostly intending to help research Closed-ended 39
78%
(no TM)and gain knowledge.75%
Open-ended
36
72%
Incorrect response
Mostly intending to help you as a Closed-ended 7
14%
person.15%
Open-ended 8
16%
Other
Don’t know/not sure.
Closed-ended 4
8%
10%
Open-ended
6
12%
Table B.
Subject Interpretations of the Purpose Question, Closed-Ended Question Arm (N = 50)
Response OptionsN
%
It was asking what my own intentions would be for participating (or not participating). In other words, which of the intentions best reflects why I
would or would not participate in the study. [PERSONAL MOTIVATION]
It was asking whether the research is being done to create knowledge for knowledge’s sake or to help actual people. [KNOWLEDGE VS. PEOPLE]
10
20%
12
24%
It was asking about the official purpose of the research study. That is, the researchers’ overall main goal in doing the study. [OFFICIAL PURPOSE]
28
56%
I am not sure what the question was asking. 0
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IRB: E t h i c s & H u m a n R e s earc h
Table C.
Subject Interpretation of Purpose Question, Open-Ended Question Arm (N = 49)
Interpreted question as “purpose” question, and the purpose was . . . 30 (61.2%)
for the sake of science/the benefit of future patients
27
for the benefit of participants in the study
0
generic3
Interpreted question as “personal motivation” question (“why I would 15 (30.6%)
participate”) and motivated by the idea that the research was . . . for science or knowledge/the benefit of future patients
4
for the respondent’s own benefit3
for both reasons above or generic
8
Interpreted question as knowledge for knowledge’s sake or to help actual
2 (4.1%)
people
Other or response not clear
2 (4.1%)
Total
49
IRB: E t h i c s & H u m a n R e s e a rc h
J u ly -A u g u st 2015
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