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To the Editor:
In their article, Saper et al.1 make the following claim, “It should be noted that this treatment program was not a formal research project, but a highly structured clinical treatment program … .”
Their assertion is contrary to the clear definition in the Common Rule. Title 45 part 46.102(d) of the Code of Federal Regulations defines research as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The study they report meets this definition. It was systematic, and, as evidenced by the publication, contributes to generalizable knowledge. However, it is not clear when the research …
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