COMPLETE TEST BANK QUESTIONS AND
RELIABLE SOLUTIONS SUCCESS KIT
GRADED A+
⩥ What is the minimum number of members required by an IRB.
Answer: 5
⩥ Which of the following are necessary to waive consent?
A.Subject is unable to give consent
B.No time or unable to contact next of kin
C.Life-Threatening Condition
D.No other treatment available
E.All of the above.
Answer: all of the above
⩥ This form is used for the mandatory reporting of adverse events and
product problems
A. 3500 A
B. 1572
,C. 3611.
Answer: A. 3500 A
⩥ 3 Ethical Principals of Respect for Persons, Beneficence and Justice
are outlined in
A.ICH EC GCP
B.45 CFR 46
C.The Belmont Report
D.The Nuremberg Code
E.Declaration of Helsinki.
Answer: C.The Belmont Report
⩥ The "Doctor's Trial" prompted the 1979 Belmont Report. t/f.
Answer: false- tuskegee syphilis experiment
⩥ The Nuremberg Code.
Answer: Set of 10 ethical principles for human experimentation
developed in 1947; Resulted from trials held in Nuremberg, Germany
Along with the Declaration of Helsinki, are the basis for CFR Title 45
Part 46
⩥ Declaration of Helsinki.
, Answer: Set of ethical principles regarding human experimentation
adopted by the World Medical Association (WMA) in June 1964, 7th
revision in October 2013
Declaration is morally binding on physicians, and that obligation
overrides any national or local laws or regulation; if the Declaration
provides for higher standard of protection of humans than the latter.
⩥ Informed consent documents must include the following
A.A statement that the study involves research
B.A statement of possible risk
C.A discussion of possible alternative treatments
D.All of the Above.
Answer: D.All of the Above
⩥ Who signs Short forms and who gets copies.
Answer: -Short Form to be signed by Subject or LAR
-WITNESS signs both Short Form & Copy of summary
-Person obtaining consent shall sign a copy of summary
-Copy of Summary shall be given to the subject or LAR in addition to
copy of short form