ACTUAL EXAM WITH COMPLETE
QUESTIONS AND DETAILED ANSWERS
GRADED A | 100% VERIFIED
What should be communicated in informed consent about
disclosing clinically relevant research results?
A statement regarding whether clinically relevant research
results, including individual research results, will be disclosed
to subjects, and if so, under what conditions
What is the primary purpose of an Institutional Review Board
(IRB)?
Protect participants' welfare and rights
Regulations require IRB review and approval for research
involving human subjects if it is:
Conducted, supported, or regulated by US federal
departments and agencies
,According to federal regulations, an IRB can do all of the
following EXCEPT:
Disburse research grants
What type of IRB review is required for studies that are not
eligible for expedited review or exemption?
Full committee review
Expedited review can be used for which of the following?
Minor changes in previously approved research
Which of the following is a category for expedited review?
Research involving no more than minimal risk
, Which type of IRB submission involves re-reviewing a study not
less than once per year?
Continuing review
Which department is responsible for 45 CFR 46?
U.S. Department of Health and Human Services
Which agency provides federal funding for biomedical
research?
National Institutes of Health (NIH)
Which organization oversees the use of drugs, devices, and
biologics in research with human subjects?
U.S. Food and Drug Administration (FDA)
Which council provides Good Clinical Practice (GCP) guidelines?
International Council for Harmonisation (ICH)