SOCRA certification: Class Quizzes Week
1-5 Questions with Correct Verified
Solutions 100% Guaranteed Pass
Selecting subjects based on reasons directly related to the problem being
studied is a reflection of what ethical principal?
A. Boundaries between practice and research
B. Respect for persons
C. Beneficence
D. Justice - ANS ✓D. Justice
According to DHHS and FDA regulations, who can conduct expedited
review? - ANS ✓The IRB chair, other IRB members designated by the chair, or a
sub-committee of the IRB
The IRB may invite non-members with expertise in special areas for
assistance. True or False - ANS ✓True
In accordance with DHHS and FDA regulatory requirements, expedited
review can be conducted on: - ANS ✓A study involving no more than minimal
risk and is on the DHHS and FDA specified list of categories eligible for expedited
review
SOCRA certification
, 2
SOCRA
Private information must be individually identifiable in order to constitute
research involving human subjects. True or False - ANS ✓True
The following statement supports which one of the criteria for IRB approval
of research?
Blood for research lab tests will be drawn at the same time as for clinically
indicated labs so that an extra needle stick is not necessary. - ANS ✓Risks to
subjects are minimized.
According to regulation an IRB must ensure that it does not consist of
entirely one - ANS ✓gender or profession
A systemic investigation including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge is
the regulatory definition of
A. Clinical Trial
B. Investigation
C. Research
D. All of the above - ANS ✓All of the above
Research may receive approval if there is a minority of the IRB members
present at the convened meeting. True or False? - ANS ✓False
Which 45 CFR 46 subpart did the FDA adopt?
SOCRA certification
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