d**o
发帖数: 618 | 1 Annals of Internal Medicine
4 March 2014, Vol. 160. No. 5
Unusual Exclusion Criteria
TO THE EDITOR: I have never seen the exclusion criteria “going abroad” and
“away on business” used in a clinical trial before reading Li and
colleagues’ article (1). Because I am sensitive to human rights issues in
China, my innate cynicism asks whether these criteria are not euphemisms for
“politically detained” or the ever-ominous “missing.” One wonders
whether the concept of completely voluntary informed consent can even exist
in the climate of coercion that is present in China. I do not intend to
disparage our physician colleagues in China, but I do ask that the Annals be
certain that the enrollment processes used in clinical trials in countries
with oppressive regimes are truly voluntary.
Lorraine Tosiello, MD
Jersey City Medical Center
Jersey City, New Jersey
IN RESPONSE: We understand Dr. Tosiello’s concern about the exclusion
criteria, specifically what we called “going abroad” and “away on
business.” The terminology that we used refers to the population that was
not eligible when we conducted this screening survey. Local residents who
were going abroad or on a long business trip were excluded due to
ineligibility. “Going abroad” and “away on business” are indeed 2
detailed reasons for ineligibility and have nothing to do with participants
being “politically detained.”
In addition, as we mention in our article, several persons declined to
participate in this study. However, all of the participants who enrolled did
so voluntarily. We hope that our explanation helps to enhance readers’
understanding of the enrollment processes.
Ming-Hua Li, MD, PhD
Yong-Dong Li, MD, PhD
Sixth People’s Hospital
Shanghai, China | A*******s
发帖数: 9638 | 2 oppressive regime, lol
and
for
exist
【在 d**o 的大作中提到】
: Annals of Internal Medicine
: 4 March 2014, Vol. 160. No. 5
: Unusual Exclusion Criteria
: TO THE EDITOR: I have never seen the exclusion criteria “going abroad” and
: “away on business” used in a clinical trial before reading Li and
: colleagues’ article (1). Because I am sensitive to human rights issues in
: China, my innate cynicism asks whether these criteria are not euphemisms for
: “politically detained” or the ever-ominous “missing.” One wonders
: whether the concept of completely voluntary informed consent can even exist
: in the climate of coercion that is present in China. I do not intend to
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