Safety and Compliance Flashcards

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

Answer: At least 3 years after completion of the research

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

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

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

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

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

Answer: An IRB or Privacy Board

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

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

Answer: A data use agreement

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

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

Answer: 5 working days

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

What is a Federalwide Assurance (FWA)?

Answer: An institution's written commitment to OHRP to comply with human subjects protection regulations

An FWA is the institution's formal assurance to OHRP that it will comply with 45 CFR 46 for HHS-supported research.

Under the HIPAA Privacy Rule, using the Safe Harbor method to de-identify data requires:

Answer: Removing 18 specified identifiers and having no actual knowledge the remaining information could identify an individual

Safe Harbor de-identification requires removal of 18 listed identifiers and no actual knowledge of re-identification risk.