CRA IRB & Informed Consent 4

Question 1

An IRB is composed of 10 members. A quorum is present when at least how many members are present, and what additional requirement must be met?

Accepted Answer

A majority (at least 6) must be present, including at least one nonscientist member

Answer

45 CFR 46.108(b) requires a majority of members, including at least one nonscientist, to constitute a quorum for IRB review.

Question 2

A subject enrolled in a long-term study becomes decisionally incapacitated due to a stroke. The study PI wants to continue collecting data. The most appropriate next step is:

Accepted Answer

Seek consent from the subject's legally authorized representative (LAR) and assess whether the subject's previously expressed wishes should guide continued participation

Answer

When a subject loses capacity, the investigator must seek LAR consent and consider the subject's prior expressed wishes regarding continued participation.

Question 3

FDA regulations at 21 CFR 50.25 differ from the Common Rule primarily in that FDA requires an additional consent element disclosing:

Accepted Answer

That the FDA may inspect records and that, in certain circumstances, confidentiality cannot be guaranteed

Answer

21 CFR 50.25(a)(5) requires a statement that the FDA may inspect study records, a disclosure not explicitly required by the Common Rule.

Question 4

Under the Belmont Report, the principle of 'justice' in the context of subject selection requires that:

Accepted Answer

The burdens and benefits of research be distributed equitably across social, racial, and economic groups

Answer

The Belmont principle of justice requires fair distribution of research burdens and benefits, preventing exploitation of vulnerable groups while not excluding them from beneficial research.

Question 5

A sponsor's protocol specifies a particular ICF template. The local IRB modifies the template significantly. According to GCP guidelines, the PI should:

Accepted Answer

Use the IRB-approved version and notify the sponsor, because the IRB-approved form takes precedence at the local site

Answer

The IRB-approved consent form governs at the local site; the PI must use it and inform the sponsor, who may need to update their master template.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA IRB & Informed Consent 4