Introduction
Institutional Review Boards (IRBs), also known as Ethical Review Boards or Independent Ethics Committees (IECs) in many countries 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, a protocol, informed consent documents, and recruitment materials must pass through this review process.
This practice test is designed for clinical research coordinators, investigators, regulatory affairs professionals, and anyone preparing for a certification such as the Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) credential. It assesses understanding of how ethical review boards are structured, the types of review a study may receive, and the ongoing obligations researchers have once a study is approved.
Work through each question, then read the explanation — even for questions you answer correctly — since the explanations expand on regulatory context that’s useful for both exams and day-to-day trial conduct.
Fundamentals
Question 1 (Beginner)
What is the primary purpose of an Institutional Review Board?
A) To approve a study’s budget and funding sources
B) To protect the rights, safety, and welfare of human research participants
C) To manage the sponsor’s relationship with regulatory agencies
D) To determine which pharmaceutical company sponsors a trial
Correct answer: B
Why B is correct: An IRB’s core mandate is participant protection. Boards evaluate whether the risks of a study are reasonable in relation to anticipated benefits, whether informed consent procedures are adequate, and whether vulnerable populations receive additional safeguards.
Why the others are incorrect:
– A: Budget and funding review is a sponsor or institutional finance function, not an IRB responsibility.
– C: Regulatory agency communication is typically handled by the sponsor’s regulatory affairs team, though the IRB’s approval letter may be part of a regulatory submission.
– D: IRBs are independent of sponsor selection; their role is ethical oversight regardless of which company is funding the work.
Knowledge expansion: IRBs trace their origins to the Nuremberg Code and were formalized in U.S. federal regulation following research ethics failures in the mid-20th century. Today, an IRB review is a prerequisite for studies under FDA oversight and for federally funded research under the Common Rule.
Question 2 (Beginner)
Which of the following is a required composition element of an IRB under U.S. federal regulations?
A) At least one member who is a licensed attorney
B) At least one member with a scientific or medical background, one without such a background, and one community representative unaffiliated with the institution
C) A majority of members must be physicians
D) All members must hold a doctoral degree
Correct answer: B
Why B is correct: Federal regulations specify a composition designed to bring varied perspectives to risk-benefit evaluation, including someone whose primary concerns are non-scientific (such as ethical or community-based) and at least one person with no institutional affiliation.
Why the others are incorrect:
– A: A legal background is not a mandatory composition requirement, though some boards do include members with legal expertise.
– C: There is no requirement that physicians form a majority; the requirement is about diversity of expertise, not professional dominance.
– D: Community representatives, by design, often do not hold doctoral degrees — the requirement values lived community perspective, not academic credentials.
Knowledge expansion: This composition requirement exists so that a study isn’t evaluated purely from a scientific lens. A community member can flag concerns about how a study might be perceived or experienced by the population it recruits from, which scientific reviewers might overlook.
Safety Procedures
Question 3 (Intermediate)
A researcher proposes a study that involves only the analysis of existing, publicly available, de-identified datasets. No new data will be collected from human subjects. What level of IRB review is this study most likely to receive?
A) Full board review
B) Expedited review
C) Exempt review
D) No review of any kind is needed, and the IRB does not need to be informed
Correct answer: C
Why C is correct: Research involving the collection or study of existing data that is publicly available or in which subjects cannot be identified generally falls into one of the federally defined exempt categories. This represents the lowest-risk tier of research.
Why the others are incorrect:
– A: Full board review is reserved for studies presenting more than minimal risk, which a de-identified secondary data analysis typically does not.
– B: Expedited review covers minimal-risk research that doesn’t meet exempt criteria — usually involving some new data collection from identifiable subjects, such as biological specimens.
– D: Even research that qualifies as “exempt” still requires an IRB determination of that exemption — exempt is not the same as “no review needed.”
Knowledge expansion: A common mistake among new researchers is assuming that “exempt” means they can skip the IRB process altogether. In practice, the IRB (or an exempt/expedited review team) still has to formally make that determination — researchers cannot self-certify their study as exempt.
Question 4 (Intermediate)
Which of the following would most likely require full board review rather than expedited review?
A) Collection of saliva samples via a non-invasive swab from healthy adult volunteers
B) A study involving procedures that are personally intrusive, stressful, or potentially traumatic to participants
C) Secondary analysis of de-identified hospital records
D) A survey of adult employees about workplace satisfaction, with no sensitive personal data collected
Correct answer: B
Why B is correct: Studies that plan to use procedures that are personally intrusive, stressful, or potentially traumatic — where stress can be physical, psychological, social, financial, or legal — are examples of research requiring full board review.
Why the others are incorrect:
– A: Collection of samples such as hair, saliva, or dental plaque via non-invasive means is a commonly cited example of research eligible for expedited review.
– C: Secondary analysis of de-identified records is more likely to qualify for exempt or expedited review, depending on the specifics, since it presents minimal risk and doesn’t involve direct interaction with subjects.
– D: A low-sensitivity workplace survey of adults typically presents minimal risk and would not require the full convened board.
Knowledge expansion: Full committee review is required for studies that are minimal risk but don’t fit any expedited category, as well as for any study judged to involve more than minimal risk. Full board review also typically applies when a study involves protected populations such as children or prisoners, regardless of the procedures used.
Question 5 (Advanced)
A clinical trial has been running for 18 months under expedited review. New safety data from another study suggests a previously unrecognized side effect of the investigational drug. What is the most appropriate next step regarding IRB oversight?
A) No action is needed until the study’s annual continuing review
B) The sponsor should quietly update the investigator brochure without informing the IRB
C) The new safety findings should be reported to the IRB, which may require updated informed consent language and additional communication with already-enrolled participants
D) The study should be immediately terminated without further review
Correct answer: C
Why C is correct: If a clinical trial uncovers new risks or side effects, the IRB may require updated informed consent language or additional participant communications to ensure participants understand the new information and their ongoing right to end their participation based on new findings.
Why the others are incorrect:
– A: Significant new safety information is a reportable event and should not wait for a scheduled annual review — it requires prompt reporting.
– B: Updating safety documentation without IRB involvement bypasses the oversight process entirely and would be a serious protocol and regulatory violation.
– D: Termination is not automatic; the IRB evaluates the new information and determines the appropriate response, which could range from a consent update to, in severe cases, a hold or termination — but that decision sits with the IRB and sponsor, not as a default first action.
Knowledge expansion: IRB oversight continues for as long as researchers maintain interactions with participants or continue collecting identifiable data, and IRBs routinely review enrollment updates, protocol deviations, and new safety findings as part of continuing review. This is a frequently tested area because it highlights that IRB involvement does not end at initial approval — it is an ongoing relationship for the life of the study.
Compliance Requirements
Question 6 (Intermediate)
Before a clinical trial involving an investigational drug can enroll its first participant, which of the following must be in place?
A) FDA marketing approval for the drug
B) IRB/IEC approval of the protocol, informed consent documents, and any recruitment materials
C) Completion of the full trial at a different site
D) A signed contract with a commercial insurance provider
Correct answer: B
Why B is correct: Federal regulations and ICH guidelines require that approval be obtained from an IRB or Independent Ethics Committee before any human patients participate in a research study, and the protocol, informed consent forms, recruitment advertisements, and any other patient-facing materials must be approved by the IRB or IEC before study onset.
Why the others are incorrect:
– A: Marketing approval is the end goal of the broader drug development process, not a prerequisite for starting a clinical trial — trials are how the evidence for that approval is generated.
– C: While multi-site trials exist, completion of a trial elsewhere is not a prerequisite for IRB approval at a new site.
– D: Insurance arrangements are a business and risk-management matter, separate from the ethical review process, though they may be addressed elsewhere in study setup.
Knowledge expansion: Documentation of all IRB or IEC approvals, along with evidence of the board’s compliance with the ICH E6(R1) Good Clinical Practice guideline, must be maintained by the study site and made available for review by the sponsor or its designee. This documentation is one of the first things checked during a sponsor audit or regulatory inspection.
Question 7 (Intermediate)
What information must an IRB/IEC approval letter typically include?
A) Only the date of approval
B) The IRB/IEC name and address, identification of the protocol by title or number, and the date approval or a favorable opinion was granted
C) The personal contact information of every enrolled participant
D) A summary of the sponsor’s financial statements
Correct answer: B
Why B is correct: All IRB/IEC approvals must identify the IRB/IEC name and address, the clinical protocol by title or protocol number or both, and the date approval or a favorable opinion was granted, and should be signed by the IRB/IEC chairman or designee.
Why the others are incorrect:
– A: The date alone is insufficient — the letter must clearly tie the approval to a specific protocol and reviewing body.
– C: Participant contact information would violate confidentiality and has no place in an approval letter.
– D: Financial statements are unrelated to the ethical approval of a protocol.
Knowledge expansion: Auditors and inspectors specifically check that approval letters are properly signed, dated, and tied to the correct protocol version. A mismatch between the protocol version referenced in the IRB letter and the version actually being used at site is a common audit finding.
Equipment Usage
Question 8 (Beginner)
A research site is preparing a binder of “essential documents” for an upcoming sponsor audit. Which document set relates directly to ethical review board oversight?
A) Equipment calibration logs only
B) IRB/IEC approval letters, the approved protocol and consent forms, and any continuing review documentation
C) Staff parking assignments
D) Marketing brochures for the investigational product
Correct answer: B
Why B is correct: Documentation showing that the IRB/IEC reviewed and approved the protocol, the informed consent form, and any amendments — along with evidence of ongoing/continuing review — forms a core part of the regulatory and ethical documentation expected at a site.
Why the others are incorrect:
– A: Equipment calibration logs are part of essential documents too, but they relate to equipment quality control, not ethical review oversight specifically.
– C: Parking assignments have no regulatory relevance.
– D: Marketing brochures for an investigational product would typically not exist before approval, and are not part of IRB documentation.
Knowledge expansion: Maintaining a well-organized regulatory binder with current IRB approvals, consent form versions, and continuing review letters is one of the simplest ways a site can demonstrate compliance during an audit or FDA inspection.
Emergency Response
Question 9 (Advanced)
During an ongoing trial, a participant experiences a serious adverse event that the investigator believes may be related to the study drug. What is the appropriate sequence of actions regarding the IRB?
A) Wait until the study’s annual continuing review to report the event
B) Report the serious adverse event to the IRB according to the timeline specified in institutional policy and the approved protocol, in addition to any sponsor/regulatory reporting requirements
C) Only report the event if the participant withdraws from the study
D) The IRB does not need to be informed of adverse events, only the sponsor
Correct answer: B
Why B is correct: Serious adverse events that may be related to the study intervention are exactly the kind of “new safety findings” that IRBs expect to be notified about promptly, separate from — and in addition to — sponsor and regulatory agency reporting obligations.
Why the others are incorrect:
– A: Annual review is far too slow for a serious, potentially related adverse event; prompt reporting is expected.
– C: Reporting obligations are triggered by the event and its potential relatedness, not by whether the participant subsequently withdraws.
– D: IRBs maintain ongoing safety oversight and are a required recipient of significant safety information, independent of sponsor reporting.
Knowledge expansion: IRBs routinely review safety reports as part of continuing oversight, and new safety findings may prompt the board to require updated informed consent or additional communication with participants. Sites should have a clear internal procedure — and a named responsible person — for IRB adverse event reporting so that timelines aren’t missed during a busy trial.
Compliance Requirements (continued)
Question 10 (Beginner)
Which population requires enhanced protections during IRB review, beyond the standard protections applied to adult participants?
A) Adult volunteers with no health conditions
B) Children, prisoners, and other vulnerable groups such as economically disadvantaged or low-literacy individuals
C) Research staff conducting the study
D) Members of the sponsor’s executive leadership
Correct answer: B
Why B is correct: Vulnerable groups such as children, low-literacy individuals, or economically disadvantaged participants require enhanced protections, and IRBs must be proactive and critically evaluative of evolving consent tools and methodologies to preserve participant rights for these groups.
Why the others are incorrect:
– A: Healthy adult volunteers receive standard protections; enhanced protections are specifically tied to factors that increase vulnerability to coercion or reduced capacity to consent.
– C: Research staff are not “subjects” in the regulatory sense and are not the target of these enhanced protections.
– D: Sponsor leadership has no special protected status under human subjects research regulations.
Knowledge expansion: Enhanced protections might include additional consent safeguards, independent advocates, simplified consent language, or restrictions on the types of research that can be conducted with these populations at all. A protocol involving children, for example, will typically require full board review regardless of how minimal the procedures might otherwise seem.
Scenario-Based Learning
Question 11 (Advanced — Scenario)
A site coordinator realizes, three weeks after a protocol amendment was implemented, that the amendment was never submitted to the IRB for approval. The amendment added one additional optional blood draw per visit. What should the site do?
A) Continue as normal since the change was minor and didn’t affect the consent form
B) Submit the amendment to the IRB as soon as possible, document the deviation, and follow institutional procedures for reporting protocol deviations — informing the sponsor as appropriate
C) Wait for the next scheduled monitoring visit to mention it
D) Remove the additional blood draw from future visits and say nothing, since the issue is now “fixed”
Correct answer: B
Why B is correct: Any change to study procedures generally requires prior IRB approval before implementation. Once a site discovers an unapproved change was implemented, the appropriate response is prompt disclosure: submit the amendment for retroactive review, document the deviation, and follow the protocol deviation reporting pathway — which often includes notifying the sponsor.
Why the others are incorrect:
– A: Even procedural changes that seem minor — such as an additional blood draw — affect participant burden and risk, and require IRB review regardless of whether the consent form’s wording technically changed.
– C: Waiting for a scheduled monitoring visit delays disclosure of a known compliance issue, which generally makes the situation worse from an audit and integrity standpoint.
– D: Quietly reverting the change without reporting it does not address the fact that participants underwent an unapproved procedure for three weeks — this needs to be documented and reported, not hidden.
Knowledge expansion: Protocol deviations — especially ones involving unapproved changes to study procedures — are among the most common findings in sponsor audits and regulatory inspections. Sites that proactively identify, document, and report their own deviations are generally viewed far more favorably than sites where deviations are only discovered externally.
Question 12 (Intermediate — Scenario)
An investigator wants to recruit participants using a flyer posted in a hospital waiting room. What must happen before the flyer is used?
A) Nothing — recruitment materials don’t require IRB review
B) The flyer must be reviewed and approved by the IRB/IEC as part of the study’s recruitment materials
C) Only the hospital’s marketing department needs to approve it
D) The flyer can be used immediately as long as it doesn’t mention the drug’s name
Correct answer: B
Why B is correct: Advertisements used for the recruitment of study patients must be approved by the IRB/IEC before they are used, just like the protocol and consent forms.
Why the others are incorrect:
– A: Recruitment materials are explicitly within the scope of what an IRB reviews, precisely because how a study is advertised can affect whether consent is truly voluntary and informed.
– C: Hospital marketing approval may be a separate institutional requirement, but it does not substitute for IRB review of recruitment materials.
– D: Omitting the drug’s name does not exempt a recruitment flyer from IRB review — the review covers the framing, claims, and incentives described, not just specific terminology.
Knowledge expansion: Common issues IRBs flag in recruitment materials include overstating potential benefits, understating risks, using coercive language (e.g., emphasizing payment amounts prominently), and failing to clearly identify the activity as research.
Advanced Scenarios
Question 13 (Advanced)
A multi-site clinical trial is being conducted across five institutions. Which IRB review model described in current guidance allows for streamlined oversight across all sites?
A) Each site must convene a full separate IRB with entirely different members for every site
B) A single or central IRB can review the study on behalf of multiple sites
C) No IRB review is needed if even one site has already approved the study
D) Sites can choose to skip IRB review if the study is funded internationally
Correct answer: B
Why B is correct: For multisite studies, IRB approval can be obtained through a single or central IRB, which has been approved by the relevant federal human subjects protection office.
Why the others are incorrect:
– A: Requiring entirely separate full boards at every site is the traditional, more resource-intensive model that central IRB arrangements were designed to streamline — it isn’t a requirement.
– C: Approval at one site does not automatically extend to other sites unless a central/single IRB arrangement or formal reliance agreement is in place.
– D: International funding does not exempt a study from IRB/ethics committee review; if anything, multinational trials often involve coordination across multiple ethics committees or a central IRB arrangement.
Knowledge expansion: Central IRB models have become increasingly common for multi-site trials because they reduce duplicated review effort and improve consistency of decisions across sites, while still allowing local context (such as community representation) to be incorporated through local context reviews where required.
Question 14 (Intermediate)
True or False: An IRB can require modifications to a study protocol as a condition of approval, rather than only approving or disapproving it outright.
Correct answer: True
Why True is correct: In accordance with FDA regulations, an IRB has the authority to approve, require modifications to secure approval, or disapprove research. “Modifications required” is a standard outcome distinct from outright approval or rejection.
Knowledge expansion: A “modifications required” determination is extremely common for initial submissions. It typically means the board has identified specific, addressable concerns — such as consent form clarity, risk disclosure, or recruitment language — that must be resolved before final approval is granted. This is not a failure of the protocol; it’s a normal part of the iterative review process.
Question 15 (Beginner)
True or False: Once an IRB approves a study, no further IRB involvement is required until the study ends.
Correct answer: False
Why False is correct: IRBs conduct both initial and continued reviews of research activities to ensure the ongoing ethical treatment of participants, and approved research is reviewed by the IRB at least annually, or sooner if the research could potentially result in physical, social, or psychological harm to participants.
Knowledge expansion: Continuing review requirements mean that even a smoothly running study generates ongoing IRB-related work: annual reviews, reporting of safety information, and review of any amendments. Sites that treat IRB approval as a “one and done” event often run into compliance gaps when continuing review deadlines are missed.
Supporting Resources
To build on what this practice test covers, the following resources go deeper into related areas:
- A guide to the full clinical trial regulatory submission process, covering how protocols, consent forms, and recruitment materials move from draft to IRB approval.
- A checklist for preparing a regulatory binder ahead of a sponsor audit or FDA inspection.
- A situational walkthrough of how a site should respond when a protocol deviation is discovered after the fact.
- An overview of Good Clinical Practice (GCP) principles under ICH E6(R1) and how they intersect with IRB oversight.
For further study, reviewing the federal exempt and expedited review categories in detail — and working through real (de-identified) IRB submission examples — will help reinforce how these classifications apply in practice.
Sources
- FDA, “Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials”
- Advarra, “Beginner’s Guide to Institutional Review Boards”
- Advarra, “What Level of IRB Review Does Your Study Need?”
- University of California, Merced, “Types of IRB Review”
- University of Pittsburgh HRPO, “Exempt, Expedited and Full Board Review”
- ACRP, “What Every Clinical Researcher Should Know About Institutional Review Boards”
- NIH Office of Research on Women’s Health, “Institutional Review Board”
- ClinicalTrials.gov protocol documentation, Section 8 (Ethics/IRB requirements)