CRA IRB & Informed Consent 3

Question 1

A clinical trial sponsor asks the PI to omit the cost of an experimental drug from the consent form to avoid discouraging enrollment. The PI should:

Accepted Answer

Refuse, because subjects must be informed of any additional costs they may incur as a result of participation

Answer

45 CFR 46.116(b)(9) requires disclosure of any additional costs to subjects that may result from participating in the research.

Question 2

Which of the following best describes the concept of 'therapeutic misconception' in the context of informed consent?

Accepted Answer

A subject's erroneous belief that research procedures are tailored to their personal medical benefit rather than to test a hypothesis

Answer

Therapeutic misconception occurs when subjects conflate research participation with individualized clinical care, undermining truly voluntary, informed consent.

Question 3

An IRB is reviewing a study that will enroll prisoners. Under Subpart C of 45 CFR 46, which of the following is NOT an allowable category of research involving prisoners?

Accepted Answer

Research on pharmaceutical products for enhancement of cognitive performance unrelated to prisoner conditions

Answer

Subpart C limits permissible prisoner research to specific categories; cognitive enhancement pharmaceuticals unrelated to prisoner-specific conditions do not qualify.

Question 4

When must an IRB's approval of research expire according to 45 CFR 46.109(e)?

Accepted Answer

No later than one year after the date of approval unless the IRB determines a shorter period is appropriate

Answer

The Common Rule requires that IRB approval expire no later than one year from the date of approval, with the option for a shorter period.

Question 5

A prospective subject is a ward of the state. Under 45 CFR 46 Subpart D, who may provide permission for the child's enrollment in research that presents greater than minimal risk with no direct benefit?

Accepted Answer

An IRB-appointed advocate who has no conflicting interest and is acting in the child's best interest, along with assent from the child

Answer

For wards of the state in research not otherwise approvable under Subpart D, an IRB-appointed advocate must substitute for the parent or guardian, and the child's assent is still required.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA IRB & Informed Consent 3