ACRP Practice Exam Questions | 100% Correct Answers | Verified | Latest 2024 Version

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. - 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 - 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 - 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 studyc. Allowing flexibility in scheduling research visi