Lorraine Tosiello, MD
Potential Conflicts of Interest: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L13-1152.
Tosiello L.; Unusual Exclusion Criteria. Ann Intern Med. 2014;160:368. doi: 10.7326/L14-5005-3
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Published: Ann Intern Med. 2014;160(5):368.
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.
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