Human Subjects Learners
(CITI) Questions and Answers | Latest
Version | 2025/2026 | Correct & Verified
Who is considered a human subject in research?
✔✔ A living individual from whom data is obtained through intervention, interaction, or
identifiable private information.
Why is informed consent essential in human subjects research?
✔✔ It ensures participants understand the risks, benefits, and purpose of the study before
agreeing to participate.
What are the three core principles outlined in the Belmont Report?
✔✔ Respect for persons, beneficence, and justice.
What does respect for persons require researchers to do?
✔✔ Treat individuals as autonomous agents and protect those with diminished autonomy.
How does the principle of beneficence guide research?
1
,✔✔ By minimizing harm and maximizing potential benefits to participants.
What is the principle of justice in human subjects research?
✔✔ Ensuring equitable selection of participants and fair distribution of risks and benefits.
Why must researchers obtain IRB approval before starting a study?
✔✔ To ensure ethical standards and federal regulations are followed.
What is the role of an Institutional Review Board (IRB)?
✔✔ To review research protocols for ethical compliance and participant safety.
When can a waiver of informed consent be ethically acceptable?
✔✔ When the research involves minimal risk and obtaining consent is impracticable.
What is a key requirement for protecting participant privacy?
✔✔ Keep identifiable data confidential and secure.
Why is continuous monitoring of research important?
2
, ✔✔ To detect and address any adverse events or ethical concerns promptly.
What should a researcher do if an unanticipated problem occurs during a study?
✔✔ Report it immediately to the IRB and implement corrective actions.
What is a vulnerable population in research?
✔✔ Individuals who may have limited capacity to provide informed consent, such as children or
prisoners.
Why must children have parental or guardian consent to participate in research?
✔✔ Because they are not legally able to give full informed consent themselves.
What is the difference between anonymity and confidentiality?
✔✔ Anonymity means researchers cannot identify participants; confidentiality means identifying
information is kept private.
What is an example of minimal risk research?
✔✔ A survey asking participants about daily habits without sensitive personal data.
3
(CITI) Questions and Answers | Latest
Version | 2025/2026 | Correct & Verified
Who is considered a human subject in research?
✔✔ A living individual from whom data is obtained through intervention, interaction, or
identifiable private information.
Why is informed consent essential in human subjects research?
✔✔ It ensures participants understand the risks, benefits, and purpose of the study before
agreeing to participate.
What are the three core principles outlined in the Belmont Report?
✔✔ Respect for persons, beneficence, and justice.
What does respect for persons require researchers to do?
✔✔ Treat individuals as autonomous agents and protect those with diminished autonomy.
How does the principle of beneficence guide research?
1
,✔✔ By minimizing harm and maximizing potential benefits to participants.
What is the principle of justice in human subjects research?
✔✔ Ensuring equitable selection of participants and fair distribution of risks and benefits.
Why must researchers obtain IRB approval before starting a study?
✔✔ To ensure ethical standards and federal regulations are followed.
What is the role of an Institutional Review Board (IRB)?
✔✔ To review research protocols for ethical compliance and participant safety.
When can a waiver of informed consent be ethically acceptable?
✔✔ When the research involves minimal risk and obtaining consent is impracticable.
What is a key requirement for protecting participant privacy?
✔✔ Keep identifiable data confidential and secure.
Why is continuous monitoring of research important?
2
, ✔✔ To detect and address any adverse events or ethical concerns promptly.
What should a researcher do if an unanticipated problem occurs during a study?
✔✔ Report it immediately to the IRB and implement corrective actions.
What is a vulnerable population in research?
✔✔ Individuals who may have limited capacity to provide informed consent, such as children or
prisoners.
Why must children have parental or guardian consent to participate in research?
✔✔ Because they are not legally able to give full informed consent themselves.
What is the difference between anonymity and confidentiality?
✔✔ Anonymity means researchers cannot identify participants; confidentiality means identifying
information is kept private.
What is an example of minimal risk research?
✔✔ A survey asking participants about daily habits without sensitive personal data.
3
