CITI Training, Modules 1-24 (Biomedical Research) 2022 Questions and Answers With Complete Solution
A 46-year-old man is currently enrolled in a Phase 2
... [Show More] study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
A. Do not tell the subject about the new drug because physicians have the right to try out new treatments with their patients.
B. Withhold this new information to avoid confusing the subject with other treatment options or alternatives.
C. Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
D. Tell the subject about the new drug but discourage him from switching treatments until the study is completed. - C. Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
A clinician may use a HUD without IRB approval:
A. In a clinical investigation to collect data on an HDE approved indication.
B. For compassionate use where no alternative device is available for a patient's condition.
C. If the clinician determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient.
D. For clinical use only. - C. If the clinician determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient.
A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. This event required revision of the informed consent form to disclose the higher rate. A change in the eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be reconsented.
A. This is not an unanticipated problem because the adverse event was acknowledged in the consent form.
B. This is an unanticipated problem.
C. Current subjects should never be reconsented.
D. This study was an investigator-initiated study. There is no need to report to the IRB or any federal agency. - B. This is an unanticipated problem.
A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves:
A. No risk to the child and no further IRB review is required. [Show Less]