CIP IRB Administration & Management 5 — Questions and Answers
Question 1: An IRB receives a report that a PI conducted research activities before receiving IRB approval. Under most institutional policies, the most appropriate first response is to:
- Retroactively approve the research if it appears the risks were minimal
- Halt the unapproved research activities and conduct a protocol deviation review (Correct answer)
- Report the PI to federal authorities immediately without internal review
- Allow the research to continue while the application is expedited
Correct answer: Halt the unapproved research activities and conduct a protocol deviation review
Research conducted without IRB approval must be stopped and reviewed as a serious protocol deviation, regardless of perceived minimal risk, because prospective review is a regulatory requirement.
Question 2: Under the 2018 revised Common Rule, broad consent may be obtained for the storage, maintenance, and secondary research use of identifiable private information. Which statement about broad consent is accurate?
- Broad consent eliminates the need for any future IRB review of secondary studies
- Broad consent must include a description of the types of research that may be conducted (Correct answer)
- Broad consent can only be obtained electronically
- Broad consent requires a HIPAA Authorization to be obtained simultaneously
Correct answer: Broad consent must include a description of the types of research that may be conducted
Broad consent under 45 CFR 46.116(d) must describe the types of research, including foreseeable uses, for which identifiable information may be used in the future.
Question 3: A researcher proposes to use existing de-identified biospecimens from a biobank. Under the 2018 Common Rule, this research:
- Requires full-board review because biospecimens always present more than minimal risk
- Is not research involving human subjects if the specimens cannot be re-identified (Correct answer)
- Requires expedited review under Category 5 regardless of identifiability
- Must obtain consent from biospecimen donors before proceeding
Correct answer: Is not research involving human subjects if the specimens cannot be re-identified
Under the 2018 Common Rule, research using de-identified biospecimens that cannot be linked to individuals does not meet the definition of 'research involving human subjects.'
Question 4: Which scenario requires submission of a continuing review report to the IRB for studies approved under the 2018 Common Rule?
- A minimal-risk survey study using only anonymous questionnaires
- A study involving greater than minimal risk that has not yet closed to enrollment (Correct answer)
- An exempt study that has exceeded its original timeline
- A study that uses only publicly available datasets
Correct answer: A study involving greater than minimal risk that has not yet closed to enrollment
Under the 2018 Common Rule, continuing review is no longer required for most minimal-risk studies, but remains required for studies that have not yet closed to enrollment and involve greater than minimal risk.
Question 5: An IRB administrator is training a new IRB member. Which statement about the role of the primary reviewer in a full-board meeting is CORRECT?
- The primary reviewer's vote counts double to reflect their greater preparation
- The primary reviewer presents the protocol to the board but all members vote equally (Correct answer)
- Only the primary reviewer may ask questions of the investigator during the meeting
- The primary reviewer must recommend approval before discussion begins
Correct answer: The primary reviewer presents the protocol to the board but all members vote equally
The primary reviewer leads the discussion and presents the protocol summary, but all board members deliberate and vote with equal weight.
Question 6: A pregnant researcher wants to enroll herself in a minimal-risk survey study at her own institution. This situation primarily raises concerns about:
- Subpart B protections for the fetus
- Undue influence and voluntariness of consent given the dual role (Correct answer)
- The researcher's ability to maintain objectivity in data collection
- Institutional liability if a pregnancy complication occurs during the study
Correct answer: Undue influence and voluntariness of consent given the dual role
When a researcher enrolls themselves in their own study, voluntariness of consent is compromised by the dual role, making this the primary IRB concern.
Question 7: An IRB is reviewing a study that will compensate participants $500 for a single blood draw. The IRB's primary concern regarding compensation should be:
- Whether the payment constitutes taxable income under IRS rules
- Whether the payment amount constitutes undue inducement that compromises voluntary participation (Correct answer)
- Whether the sponsor has sufficient funds to pay all enrolled participants
- Whether the compensation amount is equal to what participants would earn per hour at minimum wage
Correct answer: Whether the payment amount constitutes undue inducement that compromises voluntary participation
The IRB must evaluate whether compensation is so high that it constitutes undue inducement, impairing participants' ability to make a voluntary, rational decision about enrollment.
CIP IRB Administration & Management 5
An IRB receives a report that a PI conducted research activities before receiving IRB approval.
Under most institutional policies, the most appropriate first response is to: