INFORMED CONSENT| SCIENCE|
MEDICINE
An elderly gentleman, whose wife is his legally authorized representative since his
strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a
clinical trial using a new investigational drug that aims to treat lung cancer. He is able to
express interest, shows a basic understanding of the nature of the trial, and gives his
assent to participation. The subject's wife is out of town on a business trip.
Which of the following is the most appropriate action to take for the investigator? -
ANSWER-Send a copy of the informed consent via facsimile to the subject's wife. After
she has had the opportunity to speak to the investigator, she can sign the informed
consent and fax it back.
A general requirement for the informed consent is that no informed consent may include
any exculpatory language. Exculpatory language is that which waives or appears to
waive any of the subject's legal rights or releases or appears to release those
conducting the research from liability for negligence. Which of the following statements
in a consent form is an example of exculpatory language? - ANSWER-I waive any
possibility of compensation for injuries that I may receive as a result of participation in
this research.
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-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.
The purpose of informed consent is: - ANSWER-To provide a potential subject with
appropriate information in an appropriate manner and allow that person to make an
informed decision about participation in research.
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
