Study Guide / Actual Exam Questions &
Quiz____?
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: -
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.
Quiz____?
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? -
Answer✓✓
1
Quiz____?
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: -
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.
Quiz____?
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? -
Answer✓✓
1
