AND ANSWERS 100% PASS.
Which of the following is likely to be the level of review determined as appropriate by the IRB? -
ANS Exempt as the study presents no greater than minimal risk and does not collect
identifying information.
Would this research be eligible for exemption? - ANS No. The investigator may be able to
identify subjects based on telephone numbers and birth dates, so this should not be considered
exempt.
An investigator has proposed a multi-site study of PSA (Prostate Specific Antigen) test results
among patients with prostate cancer. The research involves only review of medical records at
institutions in several states. The investigator will not collect any identifying information on the
subjects, only their PSA scores and ages (which will be collected in a range format so as to not
have the person's specific age). The investigator may correctly conclude that: - ANS IRB
review, or similar process, may be required since generally investigators are not able to exempt
their own research.
Decisions about compliance with HIPAA's research provisions may sometimes be made by: -
ANS An organization's IRB, "Privacy Board", "Privacy Officer", or "Security Officer," depending
on the particular issue and the requirements of the HIPAA regulations.
Under HIPAA, a "disclosure accounting" is required: - ANS for all human subjects research
that uses PHI without an authorization from the data subject, except for limited data sets.
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