CIP Practice Test Video Answers

1. B
The primary purpose of an Institutional Review Board (IRB) is to ensure the protection of human research participants by reviewing and overseeing all research involving them.

2. B
According to the Common Rule (45 CFR 46), an IRB must have a minimum of five members with varying backgrounds.

3. B
An informed consent document must include a statement that participation is voluntary and that a participant can withdraw at any time without penalty.

4. A
For IRB approval of research involving prisoners, a required condition is that the study offers direct benefits that outweigh the risks and that the research objective is relevant to the unique circumstances of prisoners.

5. B
An example of an expedited review is minor changes to a previously approved research protocol that presents no more than minimal risk to participants.

6. A
An IRB may waive the requirement for signed informed consent when the research presents no more than minimal risk and the participant requests anonymity, or if the research involves a survey and the signed consent form is the only record linking the subject to the research.

7. C
The primary role of an IRB Chair is to lead IRB meetings and ensure regulatory compliance during the review process.

8. B
The Belmont Report outlines three core ethical principles: Respect for Persons, Beneficence, and Justice.

9. C
Under federal regulations, a “vulnerable population” is a group of individuals who may be susceptible to coercion or undue influence. This includes economically disadvantaged individuals, children, prisoners, and pregnant women.

10. B
The primary focus of a continuing review by an IRB is to conduct an ongoing risk-benefit assessment of approved research to ensure participant safety and ethical standards are maintained throughout the study.

11. B
When an IRB member has a conflict of interest, they must disclose the conflict and recuse themselves from both discussion and voting on that protocol to avoid bias.

12. A
The federal definition of “minimal risk” in research with children is that the procedures are similar to those encountered in their daily life or during routine physical or psychological examinations.

13. A
A case study with a single patient and no generalizable intent is an activity that generally does NOT require IRB review, as it is not considered “research” aimed at developing or contributing to generalizable knowledge.

14. B
The primary role of the Office for Human Research Protections (OHRP) is to enforce compliance with HHS human subject protection regulations.

15. C
Under HIPAA, medical records containing identifiable information are considered Protected Health Information (PHI).

16. B
When reviewing research involving prisoners, an IRB must have at least one member who is either a prisoner or a prisoner representative to ensure the prisoners’ interests are adequately represented.

17. A
The maximum length of IRB approval for research involving greater than minimal risk is one year, after which it must undergo a continuing review for renewal.

18. B
A study that proposes to collect identifiable private information without interacting with subjects requires the IRB to consider the requirement for informed consent or a waiver of consent.

19. B
A primary responsibility of an IRB administrator is to prepare meeting agendas and minutes to accurately document the review process and decisions.

20. C
The likelihood of investigator publication success is NOT an allowable basis for IRB approval of research. Approval is based on the protection of human subjects, scientific validity, and ethical principles.

21. C
The “minimal risk” standard compares research risk to the risks encountered in daily life or routine medical exams.

22. B
Under federal regulations, IRBs may allow a one-time emergency use of an investigational drug if certain criteria are met, with prompt reporting required afterward.

23. B
A finding of “continuing noncompliance” describes a repeated or serious failure to adhere to regulations or IRB requirements, which can lead to sanctions.

24. B
Research that may qualify for exemption from IRB review includes anonymous educational tests with adult participants, as it presents minimal risk and doesn’t involve sensitive information.

25. B
When an IRB uses an alternate member, the replacement must meet the membership qualifications and their participation must be documented in the minutes.

26. B
The primary purpose of a data and safety monitoring plan is to evaluate data quality and ensure participant safety by monitoring for adverse events or other issues.

27. C
A required element for IRB records under 45 CFR 46 is written procedures for conducting reviews, which ensures a consistent and compliant process.

28. A
The Belmont principle of “Justice” accurately reflects that the risks and benefits of research should be fairly distributed among all groups and that no single group should bear the burden of research.

29. B
“Assent” in research involving children is the agreement by a child to participate, when they are capable of understanding the research, even though they cannot provide legal consent.

30. B
If an IRB discovers unanticipated problems involving risks to participants, it should suspend or modify the research as appropriate and notify the institution to protect subjects.

31. A
The primary difference is that expedited review can be conducted by the IRB chair or a designated reviewer for studies presenting minimal risk, whereas full board review requires a meeting of the entire IRB committee.

32. B
A major criterion for IRB approval of research involving pregnant women is that the risks are minimized and the potential benefits justify their inclusion in the study.

33. A
A key requirement for IRB membership diversity is the inclusion of at least one member whose primary concerns are in nonscientific areas, such as a lawyer, ethicist, or community representative.

34. A
The Nuremberg Code is the document most closely associated with the origin of modern human subjects protections, as it was a set of ethical principles for human experimentation established after World War II.