Module 2: Quiz about Institutional Review Board /Independent Ethics Committee (IRB/IEC)

IRB/IEC members should collectively have the qualifications and experience to review and evaluate following topics of the proposed trial:
Science, medical aspects and ethics.
Medical aspects, ethics and economy
Ethics, science and statistical methods
How many members of the IRB/IEC should be independent of the trial site?
At least 2
At least 1
No specification
Why should IRB/IEC review both the amount and method of payment?
To avoid coercion or undue influence on the subject.
To ensure that the subject will not withdraw from the trial.
How often should the IRB/IEC conduct continuing review of each ongoing trial?
At least once a year
At intervals appropriate to the degree of risk to human subjects, but at least once per year.
There is no guidance provided.
Should the investigator's qualifications be reviewed by the IRB/IEC?
Yes
No
Which of following documents should be reviewed by the IRB/IEC?
Protocol and amendment
Informed consent form
Monitoring plan
Written information provided to the subjects
How long should the IRB/IEC records be retained after trial completion at a minimum?
1 year
2 years
3 years
Can the sponsor communicate with IRB/IEC directly?
Yes
No
Yes, only in some circumstances
IRB/IEC approval for the trial can be obtained verbally.
Yes
No
Only members who participate in the IRB/IEC review and discussion should vote or provide their opinion/advice.
True
False
All changes to the protocol requires written IRB/IEC approval before implementing them.
Yes
No
Yes - except when necessary to eliminate immediate hazards to the subjects or when the change involves only logistical or administrative aspects of the trial (e.g. change of monitor, telephone number).
Can the regulatory authority have access to the IRB/IEC records and membership list?
Yes
No
0
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