CITI Defining Research with Human
Subjects - SBE/ The Federal
Regulations – SBE Questions and
Answers | Latest Version | 2025/2026 |
Correct & Verified
What defines research under federal regulations for human subjects?
✔✔ A systematic investigation designed to develop or contribute to generalizable knowledge.
Who is considered a human subject in research?
✔✔ A living individual about whom a researcher obtains data through intervention, interaction,
or identifiable private information.
What is intervention in human subjects research?
✔✔ Physical procedures or manipulations of the subject or the subject’s environment for
research purposes.
What is interaction in research with human subjects?
✔✔ Communication or interpersonal contact between the investigator and the participant.
1
,What constitutes identifiable private information?
✔✔ Information where the identity of the participant is or may readily be ascertained by the
investigator.
What is the difference between generalizable knowledge and local program evaluation?
✔✔ Generalizable knowledge aims to inform beyond the study population; local evaluation
assesses specific programs without broader conclusions.
When does research involving human subjects require IRB review?
✔✔ Whenever the study meets the federal definition of human subjects research, regardless of
risk level.
What is the purpose of federal regulations 45 CFR 46?
✔✔ To protect the rights, welfare, and privacy of human subjects in research.
What populations are considered vulnerable under federal regulations?
✔✔ Children, prisoners, pregnant women, mentally disabled, or economically/socially
disadvantaged individuals.
2
, What is minimal risk in SBE research?
✔✔ When the probability and magnitude of harm are no greater than those encountered in daily
life or routine procedures.
Why is informed consent essential in SBE research?
✔✔ To ensure participants understand the purpose, procedures, risks, and benefits and participate
voluntarily.
What is a waiver of consent under federal regulations?
✔✔ When the IRB allows research to proceed without obtaining consent because risks are
minimal or consent is impractical.
What type of research can qualify for exempt status?
✔✔ Research involving educational tests, surveys, interviews, or observation of public behavior
with minimal risk.
When is an expedited IRB review appropriate?
✔✔ For minimal risk research involving non-invasive procedures or data collection without
identifiers.
3
Subjects - SBE/ The Federal
Regulations – SBE Questions and
Answers | Latest Version | 2025/2026 |
Correct & Verified
What defines research under federal regulations for human subjects?
✔✔ A systematic investigation designed to develop or contribute to generalizable knowledge.
Who is considered a human subject in research?
✔✔ A living individual about whom a researcher obtains data through intervention, interaction,
or identifiable private information.
What is intervention in human subjects research?
✔✔ Physical procedures or manipulations of the subject or the subject’s environment for
research purposes.
What is interaction in research with human subjects?
✔✔ Communication or interpersonal contact between the investigator and the participant.
1
,What constitutes identifiable private information?
✔✔ Information where the identity of the participant is or may readily be ascertained by the
investigator.
What is the difference between generalizable knowledge and local program evaluation?
✔✔ Generalizable knowledge aims to inform beyond the study population; local evaluation
assesses specific programs without broader conclusions.
When does research involving human subjects require IRB review?
✔✔ Whenever the study meets the federal definition of human subjects research, regardless of
risk level.
What is the purpose of federal regulations 45 CFR 46?
✔✔ To protect the rights, welfare, and privacy of human subjects in research.
What populations are considered vulnerable under federal regulations?
✔✔ Children, prisoners, pregnant women, mentally disabled, or economically/socially
disadvantaged individuals.
2
, What is minimal risk in SBE research?
✔✔ When the probability and magnitude of harm are no greater than those encountered in daily
life or routine procedures.
Why is informed consent essential in SBE research?
✔✔ To ensure participants understand the purpose, procedures, risks, and benefits and participate
voluntarily.
What is a waiver of consent under federal regulations?
✔✔ When the IRB allows research to proceed without obtaining consent because risks are
minimal or consent is impractical.
What type of research can qualify for exempt status?
✔✔ Research involving educational tests, surveys, interviews, or observation of public behavior
with minimal risk.
When is an expedited IRB review appropriate?
✔✔ For minimal risk research involving non-invasive procedures or data collection without
identifiers.
3
