Question 1

The medical care given to, and medical decisions made on behalf of,
subjects
should not be the responsibility of physician
Response: False
Correct answer: False
Score: 1 out of 1 Yes

Question 2
The nurse has authority, accountability, and responsibility for nursing
practice; makes decisions; and takes action consistent with the
obligation to provide optimal patient care.
Response: True
Correct answer: True
Score: 1 out of 1 Yes

Question 3
This guidelines emphasizes that Research must be based on sound
theory and prior animal testing
Response: Nuremberg Code
Correct answer: Nuremberg Code
Score: 1 out of 1 Yes

Question 4
This guideline was established by the World Medical Association
Response: Helsinki Declaration
Correct answer: Helsinki Declaration
Score: 1 out of 1 Yes

Question 5
Investigational products should be manufactured, handled, and
stored in
accordance with applicable good manufacturing practice
Response: True
Correct answer: True
Score: 1 out of 1 Yes

Question 6
_____ A study should be designed in a way that will get an
understandable answer to the important research question.
Response: Scientific Validity
Correct answer: Scientific Validity
Score: 1 out of 1 Yes

Question 7
Nurse committees and board memberships are encouraged to
contribute to health policy and professional standards only be for
those in the managerial positions.
Response: False
Correct answer: False
Score: 1 out of 1 Yes

Question 8
_____ in this guideline Individuals should be treated with respect from
the time they are approached for possible participation — even if they
refuse enrollment in a study
Response: Respect for potential and enrolled participants
Correct answer: Respect for potential and enrolled participants
Score: 1 out of 1 Yes

Question 9
The first attempt to craft regulations began during the _____ of _____
involving _____ _____
Response: Doctors Trial
Response: 1946-1947
Response: 23 German Nazi
Response: Physicians
Correct answer: Doctor's Trial, 1946-1947, 23, Doctors
Score: 1 out of 4

Question 10
this guideline focused on vulnerable subjects on research with
children and mentally incompetent persons
Response: Helsinki Declaration
Correct answer: Helsinki Declaration
Score: 1 out of 1 Yes

Question 11
_____ implies the answer should be important enough to justify asking
people to accept some risk or inconvenience for others
Response: Social and clinical values
Correct answer: social and clinical value
Score: 0 out of 1 No

Question 12
_____ This is a document where potential participants should make
their own decision about whether they want to participate or continue
participating in research
Response: Informed Consent
Correct answer: Informed consent
Score: 1 out of 1 Yes

Question 13
This outlines concepts of respect for persons, beneficence, and
justice
Response: Belmont report
Correct answer: Belmont report
Score: 1 out of 1 Yes
Question 14
Provide here examples of Level b Evidence based researches
Response: Case Controlled Study
Response: Uncontrolled Study
Response: Epidemiological Study
Response: Qualitative Study/ Quantitative Study
Correct answer: Cohort study (20%), Case Controlled Study (20%),
Uncontrolled Study (20%), Epidemiological Study (20%), Qualitative
Study/ Quantitative Study (20%)
Score: 4 out of 5

Question 15
It's not entirely important that patient's families are also afforded
regard and consideration as the nurse must only focus on the patient. f
Response: False
Correct answer: False
Score: 1 out of 1 Yes

Question 16
The Nurse's primary commitment to the patient must stay
unquestionable even if it will require sacrifice on her welfare.
Response: True
Correct answer: False
Score: 0 out of 1 No

Question 17
Nurses should be concerned for personal growth in regards to
continued learning of the profession
Response: True
Correct answer: True
Score: 1 out of 1 Yes

Question 18
 four major groups or countries who established the ICH GCP
Guidelines
Response: European Union
Response: Japan
Response: United states of America
Response: Australia
Correct answer: European Union (25%), Japan (25%), United states of
America (25%), Australia (25%)
Score: 4 out of 4 Yes

Question 19
Freely given informed consent should be obtained from every
subject after the
clinical trial participation.
Response: False
Correct answer: False
Score: 1 out of 1 Yes

Question 20
this set the boundaries between medical practice and research
Response: Belmont report
Correct answer: Belmont report
Score: 1 out of 1