CPI CPI Informed Consent & Human Subjects Protection 2

Question 1

What is the primary role of an Institutional Review Board (IRB) in human subjects research?

Accepted Answer

To protect the rights and welfare of research participants

Answer

The IRB's primary role is to protect the rights, safety, and welfare of human research participants through independent review.

Question 2

Which of the following research activities qualifies as 'exempt' from full IRB review under 45 CFR 46.104?

Accepted Answer

Research involving educational tests with no identifiable information

Answer

Research involving educational tests, surveys, or observation of public behavior where subjects cannot be identified may qualify for exempt status.

Question 3

A PI discovers that a unanticipated problem involving risk to participants occurred. Within what timeframe must most IRBs be notified?

Accepted Answer

Promptly, typically within 5–10 business days

Answer

Unanticipated problems involving risks to subjects or others must be reported promptly to the IRB, sponsor, and regulatory authorities as required.

Question 4

What is 'continuing review' as it relates to IRB oversight of an ongoing study?

Accepted Answer

Periodic re-evaluation of the study to ensure ongoing protection of participants

Answer

Continuing review is the IRB's periodic re-evaluation of an approved study, at least annually, to confirm ongoing protection of participants.

Question 5

The Belmont Report identifies three core principles for ethical research involving human subjects. Which answer lists all three correctly?

Accepted Answer

Respect for persons, beneficence, and justice

Answer

The Belmont Report's three principles are respect for persons (autonomy), beneficence (do good/minimize harm), and justice (fair distribution of burdens and benefits).

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI CPI Informed Consent & Human Subjects Protection 2