IRB Approval Process Quiz

What are the three levels of IRB review?

• Exempt, Expedited, Full Board

• Primary, Secondary, Tertiary

• Initial, Intermediate, Final

• Basic, Advanced, Expert

What is the process for obtaining an exemption determination for a research protocol?

• Submit the protocol and wait for self-exemption

• Submit the protocol and the IRB will identify it as exempt

• Submit the protocol and the PI will determine exemption

• Submit the protocol and the department head will determine exemption

What is the maximum duration for which a protocol can be approved at a time?

• 6 months

• 1 year

• 2 years

• 3 years

What type of research may qualify for expedited review?

• Research involving minors as subjects

• Research involving significant risks to subjects

• Research involving non-invasive procedures and minimal risk

• Research involving X-rays or sedation

Where are the IRB meetings held?

• At the University of Arkansas campus

• At the FDA or CDC offices

• At the researcher's office

• At MLKG at the corner of Razorback Road and MLK

What is the process for renewing a protocol for another year if there have been no significant changes or new risks identified?

• Submit for primary review

• Submit for full board review

• Submit for expedited review

• Submit for exemption determination

What type of research may qualify for exemption under category 4?

• Secondary research for which consent is not required

• Research and demonstration projects conducted by a federal agency

• Secondary research for which consent is required

• Research involving minors

What is the role of the principal investigator at the full board review meeting?

• To submit the protocol and leave

• To present an overview of the protocol and answer questions

• To observe silently without participating

• To send a representative in their place

What is the purpose of the limited review for certain exempt categories?

• To ensure data and participants are adequately protected

• To exempt the protocol without review

• To expedite the review process

• To disapprove the protocol

What is the process for amending an approved protocol?

• Submit the amendment for full board review

• Submit the amendment for expedited review

• Submit the amendment for exemption determination

• Submit the amendment and the PI will determine approval