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For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?
Consent forms must present information in language understandable to the subject, avoiding technical jargon.
21 CFR 50.20: ''The information... shall be understandable to the subject... and not include any exculpatory language.''
ICH E6(R2) 4.8.6: Information should be presented in language non-technical and understandable to the subject.
Thus, while medical terms (myalgia, arthralgia) are precise, they may not be understandable to laypersons. The correct format uses layman's terms: ''muscle aches, joint pain, and tiredness'' (B).
Correct answer: B.
21 CFR 50.20.
ICH E6(R2), 4.8.6.
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