ACTUAL EXAM COMPLETE 200
QUESTIONS WITH DETAILED
VERIFIED ANSWERS (100% CORRECT
ANSWERS) / ALREADY GRADED A+
Who is the Declaration of Helsinki mainly meant to
address?
A. Physicians
B. Nurses
C. Study Coordinators
D. Research Technicians. - ....ANSWER...A. Physicians
Who published a manuscript in the New England Journal
of Medicine presenting evidence that unethical studies
were wide spread and represented a systemic problem in
medical research?
A. Peter Buxton
B. Henry Beecher
C. Stanley Milgram
,D. Laud Humphreys - ....ANSWER...B. Henry Beecher
What does part A of the Belmont Report Cover?
A. Boundaries between practice and research
B. Respect for persons.
C. Beneficence.
D. Justice. - ....ANSWER...A. Boundaries between
practice and research
Ensuring that a subject is treated as an autonomous agent
is a reflection of what ethical principle? -
....ANSWER...Respect for Persons
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 - ....ANSWER...D. Justice
According to DHHS and FDA regulations, who can
conduct expedited review? - ....ANSWER...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 - ....ANSWER...True
In accordance with DHHS and FDA regulatory
requirements, expedited review can be conducted on: -
....ANSWER...A study involving no more than minimal
risk and is on the DHHS and FDA specified list of
categories eligible for expedited review
Private information must be individually identifiable in
order to constitute research involving human subjects.
True or False - ....ANSWER...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. - ....ANSWER...Risks to subjects are
minimized.
, According to regulation an IRB must ensure that it does
not consist of entirely one - ....ANSWER...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 - ....ANSWER...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? - ....ANSWER...False
Which 45 CFR 46 subpart did the FDA adopt?
A. B
B. C
C. D
D. All of the above - ....ANSWER...All of the above
OHRP is an oversight body primarily concerned with: -
....ANSWER...Protection of human research subjects