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Free CIP Practice Questions

10 free, exam-style Certified IRB Professional (CIP) practice questions with answers and explanations. No signup required. Work through them below, then take the full free CIP practice test to study every exam domain.

Question 1

A research participant is hospitalized during a study. The IRB is deciding whether this is an "unanticipated problem involving risks to subjects or others." For the event to meet that definition, which combination of features must ALL be present?

  1. The event is unexpected, is at least possibly related to participation, and indicates a greater risk than was previously recognized
  2. The event is serious in nature, results in an unplanned overnight hospitalization, and is formally reported to the convened IRB within twenty-four hours
  3. The event is fatal, occurs at the research site itself, and involves an investigational drug rather than an approved one
  4. The event is documented in the record, reviewed by the IRB chair, and reported to the study's commercial sponsor
Show answer & explanation

Correct answer: A - The event is unexpected, is at least possibly related to participation, and indicates a greater risk than was previously recognized

Question 2

An IRB reviews a minimal-risk study in a community where signing official documents is met with deep distrust. The investigator will still explain the study and obtain the participant's agreement, but asks the IRB not to require signatures. What may the IRB appropriately do?

  1. Deny the study outright, on the basis that a signed consent form is always legally required
  2. Waive informed consent in its entirety, given that the overall study is minimal risk
  3. Permit the investigator to begin enrolling participants without any IRB oversight
  4. Waive documentation of consent, while still requiring the consent process itself
Show answer & explanation

Correct answer: D - Waive documentation of consent, while still requiring the consent process itself

Question 3

A pediatric study poses slightly more than minimal risk and offers no direct benefit to the child participants, but is likely to produce important knowledge about the disorder the children have. Under Subpart D, this research may be approved under which provision?

  1. 46.404 - research involving no greater than minimal risk to the children
  2. 46.405 - greater than minimal risk that is justified by a realistic prospect of direct benefit to the child
  3. 46.406 - a minor increase over minimal risk with no prospect of direct benefit
  4. 46.407 - research not otherwise approvable, requiring federal-level review
Show answer & explanation

Correct answer: C - 46.406 - a minor increase over minimal risk with no prospect of direct benefit

Question 4

During an expedited review, the designated reviewer concludes that a protocol should be rejected outright. What is the correct next step under the regulations?

  1. The designated reviewer disapproves the protocol directly and notifies the investigator of the outcome
  2. The protocol is referred to the convened IRB, which alone may disapprove it
  3. The IRB chairperson independently makes the final decision to disapprove the protocol
  4. The protocol is reclassified as exempt research and administratively closed out
Show answer & explanation

Correct answer: B - The protocol is referred to the convened IRB, which alone may disapprove it

Question 5

An IRB agrees that a study's risks have been reduced as far as reasonably possible, but the expected benefits are negligible and the knowledge to be gained is of little scientific importance. Which criterion for approval is most directly unmet?

  1. Risks to the subjects participating in the research have been adequately minimized
  2. The selection of subjects across the eligible population is equitable and fair
  3. Informed consent will be sought from each subject and appropriately documented
  4. Risks are reasonable relative to anticipated benefits and the knowledge expected
Show answer & explanation

Correct answer: D - Risks are reasonable relative to anticipated benefits and the knowledge expected

Question 6

Under the 2018 Common Rule, the mechanism known as "broad consent" is best understood as which of the following?

  1. An optional consent pathway for storing and reusing identifiable data or biospecimens
  2. A waiver that the IRB grants whenever the proposed research is no more than minimal risk
  3. A blanket exemption that removes future secondary studies from any IRB review at all
  4. A specialized form that satisfies the HIPAA Privacy Rule authorization requirement in full
Show answer & explanation

Correct answer: A - An optional consent pathway for storing and reusing identifiable data or biospecimens

Question 7

The Belmont Report links each ethical principle to a practical requirement in research. The principle of respect for persons is applied chiefly through which requirement?

  1. Equitable selection of the subjects who are asked to participate
  2. A favorable assessment weighing the study's risks against its benefits
  3. Obtaining the voluntary informed consent of each research subject
  4. Independent monitoring of accumulating safety data over time
Show answer & explanation

Correct answer: C - Obtaining the voluntary informed consent of each research subject

Question 8

A company funds a clinical trial of an investigational drug entirely with private money. The site's Federalwide Assurance applies the Common Rule only to federally supported research. Which regulations govern this trial?

  1. FDA regulations at 21 CFR parts 50 and 56, because it is a regulated investigation
  2. No federal regulations apply at all, because the study receives no federal funding
  3. The Common Rule alone applies here, regardless of which entity funds the study
  4. Only the research laws of the particular state in which the trial is conducted
Show answer & explanation

Correct answer: A - FDA regulations at 21 CFR parts 50 and 56, because it is a regulated investigation

Question 9

A multi-site U.S. study uses a single IRB of record. Which responsibility generally remains with each relying institution rather than with the reviewing IRB?

  1. Granting the formal protocol approval that applies across all participating sites
  2. Issuing the official IRB determination and approval letter for the study
  3. Applying the federal regulatory criteria for approval to the research protocol
  4. Considering local context, such as applicable state law and the local population
Show answer & explanation

Correct answer: D - Considering local context, such as applicable state law and the local population

Question 10

Staff at a hospital obtain informed consent and perform study procedures on participants for a federally funded protocol that is run by an outside institution. With respect to this research, the hospital is most likely:

  1. Not engaged in the research, and therefore not required to hold any federal assurance
  2. Engaged in the research, and therefore required to hold a Federalwide Assurance
  3. Entirely exempt from oversight because a separate institution leads the protocol
  4. Obligated only to register an IRB of its own, rather than to obtain an assurance
Show answer & explanation

Correct answer: B - Engaged in the research, and therefore required to hold a Federalwide Assurance

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