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When an original consent form has been lost, the only steps that must be taken are that study staff report the loss immediately to the IRB, the sponsor, and get another signed as soon as possible.A. TRUE

B. FALSE

2According to 45 CFR 46 Subpart B, when research involves pregnant women as participants, both mother and father must always be informed about any potential impact of the research on the fetus.A. TRUE

B. FALSE

3Because of being incarcerated, prisoners may not be able to make a voluntary decision about participating in a clinical trial.A. TRUE

B. FALSE

4To document that the research participant has voluntarily agreed to participate in the study, the research participant must:A. Pass a test of comprehension.

B. Meet with the institution's Institutional Review Board (IRB).

C. Sign and date the Informed Consent Form.

D. All of the above.

5Of the following factors, which one does not influence the capacity to consent?A. Age

B. Cognitive (mental) impairment

C. Illness

D. Financial factors

Sagot :

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