HSR Safety and Compliance 5

Question 1

Under the Common Rule, how long must institutions retain IRB records relating to research?

Accepted Answer

At least 3 years after completion of the research

Answer

45 CFR 46.115(b) requires IRB records to be retained for at least 3 years after completion of the research.

Question 2

Under FDA regulations, investigators must retain IND study records for how long?

Accepted Answer

2 years after a marketing application is approved, or 2 years after the investigation is discontinued and FDA notified

Answer

21 CFR 312.62(c) sets retention at 2 years after marketing approval or after discontinuation with FDA notification.

Question 3

Under HIPAA, which body may approve a waiver of individual authorization for use of protected health information in research?

Accepted Answer

An IRB or Privacy Board

Answer

The HIPAA Privacy Rule allows an IRB or Privacy Board to approve a waiver or alteration of authorization when criteria are met.

Question 4

A researcher wants to use a HIPAA limited data set that includes dates and zip codes but no direct identifiers. What is required?

Accepted Answer

A data use agreement

Answer

A limited data set may be used for research without authorization if a data use agreement is in place.

Question 5

After an emergency use of a test article without prior IRB approval, FDA requires the emergency use to be reported to the IRB within:

Accepted Answer

5 working days

Answer

21 CFR 56.104(c) requires emergency use to be reported to the IRB within 5 working days.

HSR - Human Subjects Research Certification Practice Test