CITI Training: Biomedical Research Investigator & Social
and Behavioral Research Exam Questions & Answers
What is included in the Nuremberg Code - -voluntary consent
-the National Research Act of 1974: - -established the National Commission
-Issued in 1974, 45 CFR 46 raised to regulatory status: - -US Public Health
Service Policy
-What Belmont principle describes the application of informed consent - -
respect of persons
-Result of Beecher article: - -ethical abuses are not limited to Nazi regime
-Use of prisoners in research is a concern under the the Belmont principle of
justice because: - -Prisoners can only be used in research that benefits the
larger society
-What brought attention to the problems of the IRB system? - -Death of
Jesse Gelsinger
-Under HIPAA, "disclosure accounting" is required: - -for all human subject
research that uses PHI without authorization from the data subject, except
for limited data sets
-When required, the information provided to the data subject in HIPAA
disclosure accounting - -must be detailed for disclosures that involve less
than 50 subject records
-HIPAA's protections for health information used for research purposes: - -
supplement those of Common Rule and FDA
-HIPAA includes in its definition of "research", activities related to: - -
development of generalizable knowledge
-Under HIPAA, "retrospective research" (aka data mining) on collections of
PHI generally: - -is research, and so requires either an authorization/meeting
one of the criteria for a waiver of authorization
-recruiting into research - -can qualify as an activity "preparatory to
research" at least for the initial contact, but data should not leave the
covered entity
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