Question

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?
A. 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.
B. A general requirement for the informed consent is that no informed consent may include any exculpatory language.
C. 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

Answer 1

Answer:

A. 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.

Explanation:

In the medical sector, the right of an individual is highly sort after before an decision is taken regarding to the patient's health. For example, a patient decision would be required before an operation is carried out on him irrespective of the critical state of the medical issue.

In the case of the 46-year-old man, it is the right of the man to take the decision whether to withdraw from the research drugs and embark on the commercially available treatment drug.

What the doctor (investigator ) can only be able to do is to offer all informations regarding to the new treatment drugs that would allow the patient make informed decision.