CRA IRB & Informed Consent 2

Question 1

A sponsor requests that the IRB waive documentation of informed consent for a minimal-risk telephone survey. Under 45 CFR 46.117(c), this waiver is permissible only if:

Accepted Answer

The only record linking the subject to the research would be the consent document and the principal risk is a breach of confidentiality

Answer

Under 45 CFR 46.117(c)(1), the IRB may waive the requirement for a signed consent form when the only record linking subject to research is the consent document and the main risk is a confidentiality breach.

Question 2

During continuing review, the IRB discovers that enrollment has exceeded the approved maximum by 12 subjects. The most appropriate immediate action is to:

Accepted Answer

Issue a protocol deviation report and determine whether a suspension of enrollment is warranted

Answer

Enrollment exceeding approved limits is a protocol deviation that must be reported and assessed; the IRB must determine whether enrollment should be suspended pending review.

Question 3

Which element of informed consent specifically addresses the possibility that participation may involve risks that are currently unforeseeable?

Accepted Answer

A statement that the research may involve unforeseeable risks to the subject or to others

Answer

45 CFR 46.116(b)(1) requires disclosure of any reasonably foreseeable risks, and 46.116(b)(2) notes that a statement about unforeseeable risks must be included when applicable.

Question 4

An IRB uses expedited review for a study because it qualifies under an expedited review category. Who may conduct this expedited review?

Accepted Answer

The IRB chairperson or one or more experienced reviewers designated by the chairperson

Answer

Under 45 CFR 46.110, expedited review is conducted by the IRB chairperson or one or more experienced IRB members designated by the chairperson.

Question 5

A research coordinator notices that subjects in a Phase II trial are experiencing unexpected adverse events not listed in the consent form. The coordinator's first responsibility is to:

Accepted Answer

Notify the PI immediately so the events can be reported to the IRB and sponsor as required

Answer

Unexpected adverse events must be reported to the PI immediately, who is then responsible for timely reporting to the IRB and sponsor per protocol requirements.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA IRB & Informed Consent 2