CIP Human Subjects Protection & Safety 2

Question 1

Under the Common Rule, which of the following activities is NOT considered 'research' requiring IRB oversight?

Accepted Answer

Quality improvement projects designed solely to improve local practice

Answer

Quality improvement projects intended solely to improve local practice, not to generate generalizable knowledge, do not meet the regulatory definition of research.

Question 2

A researcher wants to conduct a secondary analysis of de-identified data from a hospital registry. Under 45 CFR 46, this would most likely be:

Accepted Answer

Exempt under Category 4 if the data cannot be re-identified

Answer

Research involving secondary analysis of existing de-identified data commonly qualifies for exemption under Category 4 of the revised Common Rule when re-identification is not possible.

Question 3

The principle of 'respect for persons' in the Belmont Report requires that:

Accepted Answer

Individuals with diminished autonomy must be protected and autonomous agents must be treated as such

Answer

Respect for persons incorporates two convictions: individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.

Question 4

A DSMB (Data Safety Monitoring Board) is most critically needed in which type of study?

Accepted Answer

A phase III randomized controlled trial with a mortality endpoint

Answer

DSMBs are most essential in trials with serious endpoints such as mortality, where ongoing safety monitoring may require early stopping to protect participants.

Question 5

Which of the following best describes a 'waiver of documentation of informed consent' under 45 CFR 46.117(c)?

Accepted Answer

Allowing consent without a signed form when the only link to identity is the signature itself

Answer

A waiver of documentation of consent is appropriate when the signature would be the only record linking the subject to the research, creating a greater breach risk than the research itself.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Human Subjects Protection & Safety 2