IRB Continuation Exam Questions & Answers.
What is PPRA? - CORRECT ANSWER A federal law that seeks to protect the rights of parents and students in ED-funded programs
What three questions must an IRB include in its FERPA checklist? - CORRECT ANSWER Is there written permission to collect the d...
IRB Continuation Exam Questions &
Answers.
What is PPRA? - CORRECT ANSWER A federal law that seeks to protect the rights of parents and students
in ED-funded programs
What three questions must an IRB include in its FERPA checklist? - CORRECT ANSWER Is there written
permission to collect the data? Will the use of the data be for a legitimate educational interest? Will the
disclosure be to another educational institution?
"Scrambling identifiers" refers to what procedure? - CORRECT ANSWER Distorting student IDs using an
algorithm, so that researchers can conduct longitudinal studies
Under FERPA, which of the following types of studies are eligible for an exception from consent? -
CORRECT ANSWER Studies that focus on improving instruction
What must be included in a FERPA-compliant consent form? - CORRECT ANSWER Specificity about the
data being collected and used for the study
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How
should the investigator proceed, with respect to the IRB, after the discovery of the adverse event
occurrence? - CORRECT ANSWER Report the adverse drug experience in a timely manner, in keeping
with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and research
records? - CORRECT ANSWER For a minimum of three years after completion of the study
According to federal regulations, which of the following best describes when expedited review of a new,
proposed study may be used by the IRB? - CORRECT ANSWER The study involves no more than minimal
risk and meets one of the allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: - CORRECT
ANSWER The changes must be immediately implemented for the health and well-being of the subject.
, IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling
subjects must: - CORRECT ANSWER Occur at least annually.
An investigator obtains consent and HIPAA authorization from subjects to review their medical records
and HIV status. He plans to go back to the medical record, so the HIV status information is stored along
with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This
incident constitutes: - CORRECT ANSWER A breach of confidentiality
A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention
(CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The
researcher did not participate in the initial collection of the data. The database is publicly available. The
database does not include any identifiers. The IRB makes a determination that the individuals whose
records will be reviewed do not meet the federal definition of human subjects. Which of the following
considerations was relevant to the IRB's determination that this activity does not constitute research
with human subjects? - CORRECT ANSWER The researcher will not be interacting/intervening with
subjects and the data has no identifiers.
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which
of the following: - CORRECT ANSWER The research could not practicably be carried out without the
waiver of consent.
A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty
of obtaining employment based on whether the subjects had been convicted of felony versus
misdemeanor crimes. She needs to: - CORRECT ANSWER Do nothing in regards the Subpart C because
the research does not meet the criteria for prison research -- individuals on parole are not considered
prisoners. The definition applies to both minors and adults.
Which of the following statements about prison research is true? - CORRECT ANSWER Researchers may
study the effects of privilege upgrades awarded by the prison.
A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by
interview. The IRB must ensure that: - CORRECT ANSWER Confidentiality of the prisoners' health status
is maintained.
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