CITI Training HFH Questions With All Correct Answers
Which of the following is likely to be the level of review determined as
appropriate by the IRB? correct answer -Exempt as the study presents no
greater than minimal risk and does not collect identifying information.
Would this research be eligible for exemption? correct answer -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: correct answer -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: correct answer -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: correct answer -for all
human subjects research that uses PHI without an authorization from the data
subject, except for limited data sets.
If you're unsure about the particulars of HIPAA research requirements at your
organization or have questions, you can usually consult with: correct
answer -An organizational IRB or Privacy Board, "Privacy Officer", or
"Privacy Official," depending on the issue.
The HIPAA "minimum necessary" standard applies correct answer -to all
human subjects research that uses PHI without an authorization from the data
subject.
Which of the following is likely to be the level of review determined as
appropriate by the IRB? correct answer -Exempt as the study presents no
greater than minimal risk and does not collect identifying information.
Would this research be eligible for exemption? correct answer -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: correct answer -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: correct answer -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: correct answer -for all
human subjects research that uses PHI without an authorization from the data
subject, except for limited data sets.
If you're unsure about the particulars of HIPAA research requirements at your
organization or have questions, you can usually consult with: correct
answer -An organizational IRB or Privacy Board, "Privacy Officer", or
"Privacy Official," depending on the issue.
The HIPAA "minimum necessary" standard applies correct answer -to all
human subjects research that uses PHI without an authorization from the data
subject.
