IRB Ethical Review Boards: 15 Practice Test Questions

Institutional Review Boards (IRBs), also known as Ethical Review Boards or Independent Ethics Committees (IECs) outside the United States, exist to protect the rights, safety, and welfare of people who take part in research. Before any clinical trial involving human subjects can begin, an IRB must review and approve the protocol, the informed consent process, and the risk-benefit balance of the proposed research.

This practice test covers IRB composition and authority, review categories, informed consent requirements, vulnerable population protections, and scenario-based questions reflecting real-world IRB decision points. Reveal each answer only after choosing your own.

Regulatory basis: IRB requirements in the United States are governed by 45 CFR Part 46 (the Common Rule) and 21 CFR Parts 50 and 56 for FDA-regulated research. Internationally, the equivalent framework is ICH E6 Good Clinical Practice and the Declaration of Helsinki.

Section 1: Fundamentals

Question 1 | Beginner

What is the primary purpose of an Institutional Review Board?

A) To approve the budget for clinical research
B) To protect the rights, safety, and welfare of human research subjects
C) To manage the recruitment timeline for a clinical trial
D) To certify investigators as qualified to conduct research

Question 2 | Beginner

Which federal regulation establishes the Common Rule governing IRB oversight of federally funded human subjects research in the United States?

A) 21 CFR Part 11
B) 45 CFR Part 46
C) 42 CFR Part 2
D) 29 CFR Part 1910

Section 2: IRB Composition and Review Types

Question 3 | Intermediate

Under 45 CFR 46.107, what is a minimum requirement for IRB membership composition?

A) At least one member must be a licensed physician
B) The IRB must have at least five members with varying backgrounds, including at least one member whose primary concerns are scientific and one whose primary concerns are non-scientific
C) All members must hold a doctoral degree
D) The IRB must consist exclusively of institutional employees

Question 4 | Intermediate

A study proposes minimal risk research involving only anonymous survey data with no identifiable information. Which IRB review category most likely applies?

A) Full board review
B) Expedited review
C) Exempt review
D) No review is required because the data is anonymous

Question 5 | Advanced

What distinguishes expedited review from full board review under the Common Rule?

A) Expedited review is conducted by the full board but completed within 24 hours
B) Expedited review may be conducted by the IRB chair or designated experienced reviewers for research involving no more than minimal risk that falls into specific federally defined categories
C) Expedited review applies only to research involving children
D) Expedited review eliminates the requirement for informed consent

Section 3: Informed Consent and Documentation

Question 6 | Intermediate

Under 45 CFR 46.116, which of the following is a required element of informed consent?

A) A statement that the research has been approved by the institution’s legal counsel
B) A statement describing the purposes of the research, the expected duration, and a description of the procedures to be followed
C) A guarantee that the research will not be published without subject approval
D) Confirmation that the subject has private health insurance

Question 7 | Intermediate

A research participant wishes to withdraw from a clinical trial midway through the study. What must the informed consent document have established about this right?

A) Withdrawal is only permitted with sponsor approval
B) Participation is voluntary and the subject may discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled
C) Withdrawal forfeits any compensation already earned
D) Withdrawal requires a formal hearing before the IRB

Section 4: Vulnerable Populations and Special Protections

Question 8 | Beginner

Which of the following groups is specifically addressed by additional protections under 45 CFR Part 46, Subpart B?

A) Graduate students
B) Pregnant women, human fetuses, and neonates
C) Hospital administrators
D) Healthy adult volunteers in Phase I trials

Question 9 | Advanced

A study proposes to enrol prisoners in a behavioural research protocol unrelated to incarceration. What additional safeguard does 45 CFR Part 46, Subpart C require?

A) Prisoners may only be enrolled with written approval from the warden
B) The IRB must include a prisoner or prisoner representative when reviewing research involving prisoners, and the research must meet specific permissible category criteria
C) Research involving prisoners is categorically prohibited under federal regulation
D) Prisoners may not receive any compensation for participation

Section 5: Scenario-Based Questions

Question 10 | Intermediate — Scenario

An investigator submits a protocol amendment that changes the inclusion criteria for a study from “adults 18 to 65” to “adults 18 and older,” with no other changes to study procedures or risks. How should this amendment typically be processed?

A) It requires full board review because any change to eligibility criteria is automatically a major change
B) It may be eligible for expedited review as a minor change to previously approved research, since it does not alter the risk profile of the study procedures themselves
C) It does not require any IRB notification since eligibility criteria are an investigator decision
D) It requires the study to restart from initial submission

Question 11 | Advanced — Scenario

During a continuing review, an IRB discovers that an investigator enrolled three additional subjects after the study’s approved enrolment cap was reached, without prior IRB notification. What is the most appropriate IRB response?

A) No action is needed since the additional subjects consented voluntarily
B) The IRB should treat this as a reportable protocol deviation, assess whether subjects were placed at increased risk, and determine corrective and preventive actions including potential reporting to the institutional official
C) The investigator should simply be asked to stop enrolling further subjects
D) The study should be immediately and permanently terminated without further review

Section 6: Advanced Scenarios

Question 12 | Advanced

An IRB is reviewing a multi-site clinical trial and is asked to rely on a single IRB (sIRB) review conducted by another institution’s IRB, as required for most NIH-funded multi-site research. What is the local IRB’s residual responsibility under this arrangement?

A) None; the local site has no further obligations once sIRB review is in place
B) The local site retains responsibility for local context review (such as local laws, institutional policies, and the qualifications of local investigators), even though the sIRB conducts the primary ethical review
C) The local site must still conduct its own full independent ethical review in parallel
D) The local site only retains responsibility for billing compliance

Question 13 | Advanced

A sponsor requests that an IRB approve a placebo-controlled trial design for a serious illness where an established effective treatment already exists. Under what circumstances might this design still be ethically and regulatorily acceptable to the IRB?

A) Placebo controls are never acceptable when an established effective treatment exists
B) Placebo controls may be acceptable where scientifically and ethically justified, such as add-on designs, short-term studies with monitored risk, or where the standard treatment’s effectiveness has not been definitively established for the specific population
C) Placebo controls are automatically acceptable as long as subjects sign a waiver
D) The IRB has no authority to evaluate trial design; this is solely a sponsor and FDA decision

Question 14 | Intermediate

What is the purpose of continuing review for an approved research protocol?

A) To re-verify the investigator’s curriculum vitae annually
B) To reassess the study’s risk-benefit balance, review accumulated data including adverse events, and confirm the research continues to meet approval criteria
C) To collect updated billing information from the sponsor
D) To re-issue the original informed consent form without changes

Question 15 | Beginner

What action should an investigator take if a subject experiences a serious, unexpected adverse event during a clinical trial?

A) Wait until the next scheduled IRB meeting to report it
B) Report the event to the IRB and, where applicable, the sponsor and FDA, within the timeframe specified by institutional policy and applicable regulation
C) Only document the event in the subject’s medical record with no further reporting
D) Report the event only if the subject specifically requests it be reported

Quick Reference: IRB Review Categories

The three IRB review pathways under the Common Rule

ExemptMinimal-risk research falling into specific federal categories; determination must still be made by IRB or designee, not the investigator alone

ExpeditedMinimal-risk research in defined federal categories; reviewed by IRB chair or designated experienced reviewers, not the full board

Full BoardGreater than minimal risk research; requires review and vote by a convened quorum of the full IRB

Ethical Review Boards: 15 IRB Practice Questions