IRB Regulations and Responsibilities

Question 1

IRBs must be registered with FDA before it can review and approve

Answer 1

FDA regulated products

Question 2

IRB registration must

Answer 2

Be accepted by HHS before it begins reviewing protocols and be renewed every 3 years

Question 3

IRB registration revisions to be reported

Answer 3

90 days for changes to contacts or chairperson.
30 days for changes to reviewing aspects of FDA regulated products reviewed, or if IRB disbands.
All other changes can be reported at renewal.

Question 4

How long must IRB retain records of its activities

Answer 4

3 years after completion of study

Question 5

The IRB will enforce written procedures for

Answer 5

Documenting its actions and requirements of investigators. Including UAE reporting, termination/ suspension of approval, and serious or continuing noncompliance

Question 6

IRB can allow ICF waiver if:

Answer 6

1. Participation presumed to directly benefit sub 2/2 life threatening situation.
2. Associated risks reasonable compared to medical condition.
3. Investigation could not be reasonably carried out without a waiver.
4. There is a therapeutic window in which investigator will attempt to contact LAR before ICF is waived.

Question 7

If IRB declines to approve an investigation, they must:

Answer 7

Document and provide their findings to investigator, sponsor, FDA, and other sites as applicable