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Certification for IRB Professionals (CIP) Exam

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? - ANSWER - Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. The most appropriate action for the investigator to take is to report the adverse drug experience i...

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? - ANSWER - Ensuring that risks are reasonable in relationship to anticipated benefits According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - ANSWER -Justice Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a ...

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? - ANSWER - Officials of the institution may overrule an IRB approval. According to the federal regulations, research is eligible for exemption, if: - ANSWER -The research falls into one of eight categories of research activity described in the regulations. According to federal regulations, the expedited review process may be used when the study procedures pose: -...

Ace your CIP® (Certified IRB Professional) Exam with this 2024-updated prep kit! Master FDA 21 CFR 50, Common Rule (45 CFR 46), and ICH-GCP guidelines with 300+ scenario-based questions, consent form critiques, and decision trees for ethical dilemmas. Includes a regulatory change tracker for 2024 updates and templates for IRB workflows. Ideal for IRB administrators, researchers, and compliance specialists.

Which of the following are the three principles discussed in the Belmont Report? A. IRB review, Federal regulations, Declaration of Helsinki. B. Informed Consent, Institutional Assurance, Researcher responsibility. C. Privacy, Confidentiality, Equitable selection of subjects. D. Respect for Persons, Beneficence, Justice. - ANS D. Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human sub...

Certification for IRB Professionals (CIP) Exam UPDATED ACTUAL Exam Questions and CORRECT Answers According to the Belmont Report, respect for persons usually demands that subjects... - CORRECT ANSWER - enter into research voluntarily & with adequate information According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - CORRECT ANSWER A poorly designed protocol is considered unethical...

This document provides a comprehensive set of multiple-choice and short-answer questions with correct answers for the IRB (Institutional Review Board) certification exam for the 2025/2026 academic year. It covers IRB roles and responsibilities, research ethics, risk-benefit assessment, review categories (exempt, expedited, full board), informed consent, vulnerable populations, and regulatory compliance. Aimed at students and professionals in clinical research and human subjects protection, this ...

IRB Exam Combined Set Questions With Revised Correct Detailed Answers Guaranteed Pass 1) A committee that reviews research proposals to determine whether research is ETHICAL. - ANSWER Institutional Review Boards 2) IRB does NOT review research involving animals, foods, or drug testing not involving ________________ subjects. - ANSWER humans IT ONLY STUDIES HUMANS 3) Members are selected based on knowledge & and experience working with vulnerable populations: ...