CITI TRAINING QUIZ 2026/2027 | Verified Questions &
Detailed Rationales | Human Subjects Protection | Pass
Guaranteed - A+ Graded
Section 1: Biomedical Research (30 Questions)
Q1: According to the Belmont Report, which principle requires that subjects be treated
fairly and that the benefits and burdens of research be distributed equitably?
A. Respect for persons
B. Beneficence
C. Justice [CORRECT]
D. Scientific validity
Correct Answer: C
Rationale: The Belmont Report's principle of Justice requires fair distribution of
research benefits and burdens, ensuring that vulnerable populations are not
disproportionately selected for risky research or systematically excluded from beneficial
research. Respect for persons (A) involves autonomy and protection of those with
diminished autonomy. Beneficence (B) requires maximizing benefits and minimizing
harms. Scientific validity (D) is important but not one of the three Belmont principles.
Q2: Under 45 CFR 46, research involving pregnant women, fetuses, and neonates
requires:
A. No special protections beyond standard informed consent
B. Additional safeguards including justification of risk and direct benefit requirements
[CORRECT]
,C. Only that the father provides consent
D. Automatic exclusion from all research
Correct Answer: B
Rationale: Subpart B of 45 CFR 46 provides specific additional protections for pregnant
women, fetuses, and neonates. Research must meet criteria including: minimal risk to
fetus unless direct benefit, or risk justified by vital importance and no alternative. The
father (C) is not the sole decision-maker. Automatic exclusion (D) would deny pregnant
women access to potentially beneficial research.
Q3: Which of the following constitutes human subjects research under 45 CFR 46?
A. Analysis of publicly available, de-identified data sets
B. Interaction or intervention with living individuals for research purposes [CORRECT]
C. Quality improvement activities with no generalizable knowledge intent
D. Analysis of deceased patient records only
Correct Answer: B
Rationale: Human subjects research involves: (1) living individual, (2) investigator
interaction/intervention or identifiable private information, (3) systematic investigation
contributing to generalizable knowledge. Publicly available de-identified data (A)
generally does not constitute human subjects research. Quality improvement (C)
without generalizable knowledge intent is not research. Deceased individuals (D) are not
"living individuals" under the regulation.
Q4: The informed consent process must include all of the following EXCEPT:
A. Description of reasonably foreseeable risks
B. Statement that participation is voluntary
C. Guarantee of research benefit to the subject [CORRECT]
,D. Explanation of procedures involved
Correct Answer: C
Rationale: Informed consent elements under 45 CFR 46.116 include: risks (A), voluntary
participation (B), and procedures (D). However, researchers cannot guarantee benefits
(C)—this would be coercive and potentially deceptive. Benefits must be described as
"possible" or "potential," not guaranteed.
Q5: [Select all that apply] Which are elements of valid informed consent? (Select all that
apply.)
A. Disclosure of appropriate alternative procedures [CORRECT]
B. Statement that the study involves research [CORRECT]
C. Description of confidentiality protections [CORRECT]
D. Promise of financial profit for the subject
Correct Answers: A, B, C
Rationale: Required elements per 45 CFR 46.116 include: statement that research is
involved (B), description of procedures, risks, benefits, alternatives (A), and
confidentiality protections (C). Promise of profit (D) is not required and may be coercive
if excessive.
Q6: A researcher wants to conduct a study involving deception about the true purpose
of the research. Under 45 CFR 46, this is:
A. Never permitted under any circumstances
B. Permitted if the IRB approves and finds that the research could not practicably be
carried out without deception, and adequate debriefing is provided [CORRECT]
C. Permitted if the researcher believes the deception is minor
D. Permitted without IRB review if the deception is disclosed in the consent form
, Correct Answer: B
Rationale: 45 CFR 46.116(c) permits deception when: (1) research could not practicably
be carried out without deception, (2) subjects will not be placed at increased risk, and
(3) adequate debriefing is provided. IRB approval is always required. Researcher belief
alone (C) is insufficient. IRB review cannot be waived (D).
Q7: Expedited IRB review may be used when:
A. The research involves no more than minimal risk and falls into specific categories
published by the Secretary [CORRECT]
B. The principal investigator is in a hurry
C. The research involves prisoners as subjects
D. The research is federally funded
Correct Answer: A
Rationale: Expedited review under 45 CFR 46.110 applies when research presents no
more than minimal risk and involves procedures in federally specified categories.
Investigator convenience (B) is not a criterion. Prisoner research (C) requires full board
review. Federal funding (D) does not determine review type.
Q8: Minimal risk is defined as:
A. No risk whatsoever
B. Risk no greater than that ordinarily encountered in daily life or routine examinations
[CORRECT]
C. Risk that is acceptable to the researcher
D. Risk that all subjects agree to accept
Correct Answer: B
Detailed Rationales | Human Subjects Protection | Pass
Guaranteed - A+ Graded
Section 1: Biomedical Research (30 Questions)
Q1: According to the Belmont Report, which principle requires that subjects be treated
fairly and that the benefits and burdens of research be distributed equitably?
A. Respect for persons
B. Beneficence
C. Justice [CORRECT]
D. Scientific validity
Correct Answer: C
Rationale: The Belmont Report's principle of Justice requires fair distribution of
research benefits and burdens, ensuring that vulnerable populations are not
disproportionately selected for risky research or systematically excluded from beneficial
research. Respect for persons (A) involves autonomy and protection of those with
diminished autonomy. Beneficence (B) requires maximizing benefits and minimizing
harms. Scientific validity (D) is important but not one of the three Belmont principles.
Q2: Under 45 CFR 46, research involving pregnant women, fetuses, and neonates
requires:
A. No special protections beyond standard informed consent
B. Additional safeguards including justification of risk and direct benefit requirements
[CORRECT]
,C. Only that the father provides consent
D. Automatic exclusion from all research
Correct Answer: B
Rationale: Subpart B of 45 CFR 46 provides specific additional protections for pregnant
women, fetuses, and neonates. Research must meet criteria including: minimal risk to
fetus unless direct benefit, or risk justified by vital importance and no alternative. The
father (C) is not the sole decision-maker. Automatic exclusion (D) would deny pregnant
women access to potentially beneficial research.
Q3: Which of the following constitutes human subjects research under 45 CFR 46?
A. Analysis of publicly available, de-identified data sets
B. Interaction or intervention with living individuals for research purposes [CORRECT]
C. Quality improvement activities with no generalizable knowledge intent
D. Analysis of deceased patient records only
Correct Answer: B
Rationale: Human subjects research involves: (1) living individual, (2) investigator
interaction/intervention or identifiable private information, (3) systematic investigation
contributing to generalizable knowledge. Publicly available de-identified data (A)
generally does not constitute human subjects research. Quality improvement (C)
without generalizable knowledge intent is not research. Deceased individuals (D) are not
"living individuals" under the regulation.
Q4: The informed consent process must include all of the following EXCEPT:
A. Description of reasonably foreseeable risks
B. Statement that participation is voluntary
C. Guarantee of research benefit to the subject [CORRECT]
,D. Explanation of procedures involved
Correct Answer: C
Rationale: Informed consent elements under 45 CFR 46.116 include: risks (A), voluntary
participation (B), and procedures (D). However, researchers cannot guarantee benefits
(C)—this would be coercive and potentially deceptive. Benefits must be described as
"possible" or "potential," not guaranteed.
Q5: [Select all that apply] Which are elements of valid informed consent? (Select all that
apply.)
A. Disclosure of appropriate alternative procedures [CORRECT]
B. Statement that the study involves research [CORRECT]
C. Description of confidentiality protections [CORRECT]
D. Promise of financial profit for the subject
Correct Answers: A, B, C
Rationale: Required elements per 45 CFR 46.116 include: statement that research is
involved (B), description of procedures, risks, benefits, alternatives (A), and
confidentiality protections (C). Promise of profit (D) is not required and may be coercive
if excessive.
Q6: A researcher wants to conduct a study involving deception about the true purpose
of the research. Under 45 CFR 46, this is:
A. Never permitted under any circumstances
B. Permitted if the IRB approves and finds that the research could not practicably be
carried out without deception, and adequate debriefing is provided [CORRECT]
C. Permitted if the researcher believes the deception is minor
D. Permitted without IRB review if the deception is disclosed in the consent form
, Correct Answer: B
Rationale: 45 CFR 46.116(c) permits deception when: (1) research could not practicably
be carried out without deception, (2) subjects will not be placed at increased risk, and
(3) adequate debriefing is provided. IRB approval is always required. Researcher belief
alone (C) is insufficient. IRB review cannot be waived (D).
Q7: Expedited IRB review may be used when:
A. The research involves no more than minimal risk and falls into specific categories
published by the Secretary [CORRECT]
B. The principal investigator is in a hurry
C. The research involves prisoners as subjects
D. The research is federally funded
Correct Answer: A
Rationale: Expedited review under 45 CFR 46.110 applies when research presents no
more than minimal risk and involves procedures in federally specified categories.
Investigator convenience (B) is not a criterion. Prisoner research (C) requires full board
review. Federal funding (D) does not determine review type.
Q8: Minimal risk is defined as:
A. No risk whatsoever
B. Risk no greater than that ordinarily encountered in daily life or routine examinations
[CORRECT]
C. Risk that is acceptable to the researcher
D. Risk that all subjects agree to accept
Correct Answer: B
