QUESTION 1 Which of the following would be considered to be study procedure that
ID: 3499335 • Letter: Q
Question
QUESTION 1
Which of the following would be considered to be study procedure that generally places human subjects at MORE than minimal risk?
A.College athletes being asked to walk one-half mile.
B. Senior citizens having their blood pressure checked with an electronic sphygmomanometer.
C. Having patients with diabetes take a placebo injection each day (normal saline injection), but informing them that the injection contains insulin.
D. Having senior citizens have their blood pressure checked one time using an electronic sphygmomanometer.
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QUESTION 2
In which of the following scenarios would a “Community Consent” be most appropriately used?
A. The placebo-controlled evaluation of a novel chemical entity incorporated into a topical cream that will be used to treat severe psoriasis.
B. A controlled study (using HCTZ 25mg as the comparator) evaluating the usefulness of a new beta-blocker in the treatment of stage 1 HTN in patients with osteoporosis. Assume that the study will last 2 years.
C. A trial to compare over-the-phone pharmacist counseling to face-to-face pharmacist counseling in the setting of a community pharmacy.
D. A study of a new type of clamp that will be used in the emergency room to treat acute gunshot wounds to the head (assume the clamp will need to be used immediately upon the patient’s arrival at the emergency department and the patients will likely be unconscious).
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QUESTION 3
A large trial is designed to compare three traditional hypertension regimens to a new antihypertensive regimen. It is unknown what the risks of the new agent may be when compared to the older agents. What is the group of uninvolved scientists who will assess the study outcomes without being blinded, and without waiting for the end of study period?
A. Institutional Review Board
B. Data Safety Monitoring Board
C. Helsinki Patient Board
D. Neutral Party Consensus Panel
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QUESTION 4
The requirement that human experiments must be based upon prior animal research comes from what set of guidelines (originally and today)?
The Belmont Report
The Controlled Substance Act
The Nuremburg Code
The Wheeler-Lea Act
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QUESTION 5
You are asked to evaluate the animal risk classification for a lab at your university. When you arrive, the mice are in spacious, sanitary cages, and appear to be well fed and comfortable. You are told that the mice are being bred for future research projects, and none of them are currently being used for research purposes. What risk classification should you assign to these animals?
Class A
Class b
Class c
Class D
A.College athletes being asked to walk one-half mile.
B. Senior citizens having their blood pressure checked with an electronic sphygmomanometer.
C. Having patients with diabetes take a placebo injection each day (normal saline injection), but informing them that the injection contains insulin.
D. Having senior citizens have their blood pressure checked one time using an electronic sphygmomanometer.
Explanation / Answer
1) answer is C.
Saline inhe tiontcan develop complexity like metabolic acidosis etc
2) ans is dD
In emergency situation of head injury , person is incorrect scious and hence community ci sent necessary
3) ans is B DSMB.
A GROUP of scientist working individually .It is responsible for safety of new trial and termination at any point
4) ans us a. Belmont report.
Belmont report published in 1978 provides for ensuring furst tgetanimal research before human trial.
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