Version | 2025/2026 | Correct & Verified
What is the primary purpose of the CITI Program training?
✔✔ To ensure researchers understand ethical principles and regulatory requirements in human
subjects research.
Why is informed consent essential in research?
✔✔ It ensures participants understand the study, its risks, benefits, and their rights.
What is the role of the Institutional Review Board (IRB)?
✔✔ To review, approve, and monitor research to protect human subjects.
What must a researcher do if a participant withdraws from a study?
✔✔ Respect the decision and ensure no further data is collected without consent.
Why is confidentiality important in human subjects research?
✔✔ To protect participants’ private information and maintain trust.
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,What is considered vulnerable population in research?
✔✔ Groups such as children, prisoners, pregnant women, or those with cognitive impairments.
What is a key principle of the Belmont Report?
✔✔ Respect for persons, beneficence, and justice.
Why must risks and benefits be clearly explained to participants?
✔✔ To allow them to make an informed decision about participation.
What is an example of minimal risk in research?
✔✔ Completing a survey or observation study that does not exceed daily life risk.
What is the difference between anonymity and confidentiality?
✔✔ Anonymity means researchers cannot link data to participants; confidentiality means data is
protected but link exists.
What should a researcher do if an unexpected adverse event occurs during a study?
✔✔ Report it immediately to the IRB and follow safety protocols.
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, Why are continuing reviews by the IRB necessary?
✔✔ To ensure ongoing compliance and participant safety throughout the study.
What is coercion in the context of research participation?
✔✔ Pressuring or influencing someone to participate against their free will.
What is undue influence in research?
✔✔ Offering excessive incentives that may impair voluntary consent.
What must be disclosed to participants regarding conflicts of interest?
✔✔ Any financial, personal, or professional interests that could affect study outcomes.
Why is training in human subjects protection required before starting research?
✔✔ To ensure researchers understand ethical standards and regulations.
What is the purpose of documentation in research?
✔✔ To provide a clear record of consent, procedures, and compliance.
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