CRS Institutional Review Board Procedures 3

Question 1

Which element is NOT required to be included in informed consent documents according to 45 CFR 46.116?

Accepted Answer

The researcher's home address

Answer

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?

Accepted Answer

If the research cannot practicably be carried out without the waiver and involves no more than minimal risk

Answer

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?

Accepted Answer

To independently monitor participant safety and data integrity during a trial

Answer

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?

Accepted Answer

Prisoners

Answer

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?

Accepted Answer

Submit an amendment for IRB review and receive approval

Answer

Any modification to an approved protocol must be submitted to the IRB as an amendment and approved before implementation, except to eliminate immediate hazards.

(CRS) Certified Research Specialist Practice Test

(CRS) Certified Research Specialist Practice Test

CRS Institutional Review Board Procedures 3