CITI - informed consent Exam
Questions and Answers 100% Pass
An investigator is confronted with a life-threatening situation that necessitates
using a test article in a human subject who is unable to provide informed consent
and there is no time to obtain consent from the individual's legal representative
and no alternative method or recognized therapy is available. Under the FDA
regulations for using test articles, which of the following describes the best course
of action for the investigator: - CORRECT ANSWER-The investigator and an
independent physician agree that the situation necessitates the use of the test
article. An exception or waiver for informed consent can be made under these
circumstances. The IRB will be notified later.
The life- threatening situation requires a timely decision so that the test article can
be ethically used. It would be unethical to withhold emergency treatment until a
research protocol is submitted and approved by the IRB. Not using the test article
in a situation where it might save a life is also unethical. The Federal regulations
(21 CFR 50.24) provide the option of using the test article in a life-threatening
condition involving an individual subject where the following requirements for an
exception from informed consent are met. 1. The investigator, with the
, concurrence of another physician, believes the situation necessitates the use of a
test article (i.e., an investigational drug, device, or biologic). 2. The subject and/or
legally authorized representative is unable to communicate consent 3. There is
insufficient time to obtain consent. And 4. No alternative exists that will provide
an equal or better chance of saving the subject's life.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe
diabetic neuropathy. While the study is on going, a new drug becomes
commercially available that may have equal or greater benefit to the subject. The
investigator should do which of the following? - CORRECT ANSWER-Give the
subject comprehensive information about the new drug, including its side effects.
Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subject to decide whether to withdraw from the
research to take the new drug.
Phase 2 clinical trials involve volunteers who have the disease or condition to be
treated. These trials help physicians and researchers begin to learn more about the
safety of the new drug treatment and how well the drug treats the targeted disease
or condition. Several different doses of the drug may be tested to see which dose
has the desired effects. Subjects are monitored for side effects and for any
improvement in their illness, symptoms, or both. Informed consent is not a one-
time procedure but a continuing and ongoing process. 45 CFR 116(b) and 21 CFR
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
Questions and Answers 100% Pass
An investigator is confronted with a life-threatening situation that necessitates
using a test article in a human subject who is unable to provide informed consent
and there is no time to obtain consent from the individual's legal representative
and no alternative method or recognized therapy is available. Under the FDA
regulations for using test articles, which of the following describes the best course
of action for the investigator: - CORRECT ANSWER-The investigator and an
independent physician agree that the situation necessitates the use of the test
article. An exception or waiver for informed consent can be made under these
circumstances. The IRB will be notified later.
The life- threatening situation requires a timely decision so that the test article can
be ethically used. It would be unethical to withhold emergency treatment until a
research protocol is submitted and approved by the IRB. Not using the test article
in a situation where it might save a life is also unethical. The Federal regulations
(21 CFR 50.24) provide the option of using the test article in a life-threatening
condition involving an individual subject where the following requirements for an
exception from informed consent are met. 1. The investigator, with the
, concurrence of another physician, believes the situation necessitates the use of a
test article (i.e., an investigational drug, device, or biologic). 2. The subject and/or
legally authorized representative is unable to communicate consent 3. There is
insufficient time to obtain consent. And 4. No alternative exists that will provide
an equal or better chance of saving the subject's life.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe
diabetic neuropathy. While the study is on going, a new drug becomes
commercially available that may have equal or greater benefit to the subject. The
investigator should do which of the following? - CORRECT ANSWER-Give the
subject comprehensive information about the new drug, including its side effects.
Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subject to decide whether to withdraw from the
research to take the new drug.
Phase 2 clinical trials involve volunteers who have the disease or condition to be
treated. These trials help physicians and researchers begin to learn more about the
safety of the new drug treatment and how well the drug treats the targeted disease
or condition. Several different doses of the drug may be tested to see which dose
has the desired effects. Subjects are monitored for side effects and for any
improvement in their illness, symptoms, or both. Informed consent is not a one-
time procedure but a continuing and ongoing process. 45 CFR 116(b) and 21 CFR
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
