PRACTICES OF CLINICAL
RESEARCH (IPPCR) FINAL
EXAM 2024/2025 LATEST
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T or F: Excluded research is a type of research that is subject to the U.S. rules for the
protection of research subjects.
F?
Most guidelines, codes and regulations for ethical research include a requirement for
informed consent. The process of informed consent includes the following elements:
Disclosure of information, understanding, voluntary choice, and authorization
What benefits should an IRB consider when deciding whether a study is acceptable?
Benefits to participants and to society from the knowledge learned
Scientific validity is:
measures what it's supposed to measure. The ability of a study to correctly answer the
research question
Assuming similar access to healthcare services (including screening and vaccinations),
differences in incidence, prevalence and/or severity of a disease between two populations
may reflect:
all the above?
A research participant's decision to participate in research is "voluntary" according to the US
federal regulations if it is free from:
C - coercion or undue influence
Investigators' responsibilities do NOT include:
Auditing of trial
With regard to risks to subjects from participating in research, which of the following is/are
true:
All of ze above
Coffee was reported to cause lung cancer until it was noted that coffee drinkers also smoked.
This is an example of:
confounding!
Which of the following are responsibilities of the Data Safety Monitoring Board?
all of the above; Monitor protocol compliance