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

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

Yes, only in some circumstances

IRB/IEC approval for the trial can be obtained verbally.

Yes

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

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

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

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