A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF? a. The benefits section should be left out of the ICF, as it is not applicable. b. Wording indicating that there is no expected benefit should be included. c. A section on the benefits of clinical research in general should be added. d. A description of the subject visit stipends should be included as a benefit. - CORRECT ANSWERS Wording indicating that there is no expected benefit should be included A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences? reference ICH E6 (R2), section-topic: Ethical and Participant Safety Considerations.Ref 1 Page: 4.8.10 - CORRECT ANSWERS ICF When would an impartial witness be needed during the consent process for an illiterate subject? Reference ICH E6 (R2), section-topic: Ethical and Participant Safety Considerations. Ref 1 Page: 4.8.9 - CORRECT ANSWERS To observe the consent process A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the subject? a.Consenting in the presence of PI b.Offering a stipend for participating in the study c. Allowing flexibility in scheduling research visits d. Consenting in the presence of figure of authority reference ICH E6 (R2), section-topic: Ethical and Participant Safety Considerations. Ref 1 Page: 1.61 - CORRECT ANSWERS Consenting in the presence of figure of authority An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocol therapy was initiated. The subject showed significant improvement in his clinical condition, and regained consciousness. The Investigator should inform the subject about the study and: a.obtain assent from the subject for the study. b. tell the subject he is benefiting from the study therapy. c. obtain consent from the subject for the study. d. tell the subject that an LAR provided consent for his participation. reference Declaration of Helsinki; section-topic: Ethical and Participant Safety Considerations. - CORRECT ANSWERS obtain consent from the subject for the study. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? a.The subject's primary physician b. The subject's legally acceptable representative c. The impartial witness d. The subject's significant other - CORRECT ANSWERS The subject's legally acceptable representative