CRS Institutional Review Board Procedures 3 — Questions and Answers
Question 1: Which element is NOT required to be included in informed consent documents according to 45 CFR 46.116?
- A statement that participation is voluntary
- The expected duration of participation
- The researcher's home address (Correct answer)
- A description of foreseeable risks
Correct answer: The researcher's home address
The researcher's home address is not a required element of informed consent; required elements include risks, benefits, voluntariness, and contact information for questions.
Question 2: A study involves deception. Under what condition may an IRB approve waiver of informed consent for this study?
- If the PI promises to publish the results
- If the research cannot practicably be carried out without the waiver and involves no more than minimal risk (Correct answer)
- If participants are compensated adequately
- If the deception involves only the study hypothesis
Correct answer: If the research cannot practicably be carried out without the waiver and involves no more than minimal risk
An IRB may waive consent when research involves no more than minimal risk, cannot practicably proceed without the waiver, and participants will be debriefed when appropriate.
Question 3: What is the purpose of a Data Safety Monitoring Board (DSMB) in clinical research?
- To replace IRB oversight for clinical trials
- To independently monitor participant safety and data integrity during a trial (Correct answer)
- To audit financial compliance of research grants
- To review publications before submission
Correct answer: To independently monitor participant safety and data integrity during a trial
A DSMB independently monitors accumulating safety data and trial integrity, recommending early termination if harm or clear benefit is detected.
Question 4: Which population requires special IRB protections specifically outlined in Subpart C of 45 CFR Part 46?
- Elderly individuals
- Prisoners (Correct answer)
- Economically disadvantaged persons
- Non-English speakers
Correct answer: Prisoners
Subpart C of 45 CFR Part 46 specifically addresses additional protections for prisoners as a vulnerable population.
Question 5: A researcher modifies their approved protocol to add a new survey instrument. What must they do before implementing the change?
- Notify participants in writing
- Submit an amendment for IRB review and receive approval (Correct answer)
- Inform their department chair and proceed
- Wait until the next continuing review cycle
Correct answer: Submit an amendment for IRB review and receive approval
Any modification to an approved protocol must be submitted to the IRB as an amendment and approved before implementation, except to eliminate immediate hazards.
Question 6: Under the 2018 Common Rule, which type of research is eligible for broad consent as an alternative to traditional informed consent?
- Interventional drug trials
- Storage and secondary use of identifiable biospecimens and data (Correct answer)
- Deception studies
- International multi-site studies
Correct answer: Storage and secondary use of identifiable biospecimens and data
The 2018 Common Rule introduced broad consent as an option for the storage and secondary use of identifiable private information or biospecimens.
Question 7: What is an 'unanticipated problem' that must be reported to the IRB?
- Any adverse event, regardless of relatedness
- An event or problem that is unexpected, related to the research, and suggests increased risk to participants (Correct answer)
- A deviation from the approved protocol that was deliberate
- Participant withdrawal from the study
Correct answer: An event or problem that is unexpected, related to the research, and suggests increased risk to participants
Unanticipated problems are unexpected occurrences related to the research that suggest greater risk to participants or others than previously recognized.
CRS Institutional Review Board Procedures 3
Which element is NOT required to be included in informed consent documents according to 45 CFR 46.116?