CITI TRAINING EXAM STUDY GUIDE
2026/2027 COMPLETE QUESTIONS WITH
VERIFIED CORRECT ANSWERS ||
100% GUARANTEED PASS
<NEWEST VERSION>
1. Example of how the principle of beneficence is applied to a study involving
human subjects - ANSWER ✔ Ensuring that the risks are reasonable in
relationship to anticipated benefits
2. Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this
primary ethical violation - ANSWER ✔ The researcher's failure to protect
research subjects from deductive disclosure (primary ethical violation)
3. "The Public Health Service Tuskegee Study of Untreated Syphilis in the
Negro Male" Study - ANSWER ✔ The study most directly linked to the
establishment of the "National Research Act" (1974) and ultimately the
"Belmont Report and Federal Regulations for Human Subject Protection"
4. The Belmont principle of Beneficence - ANSWER ✔ Requires that:
potential benefits justify the risks of harm
5. The Belmont principle of Justice - ANSWER ✔ Moral Requirement that:
there be fair outcomes in the selection of research subjects
,6. Identifiable Private Information (according to Federal regulations) -
ANSWER ✔ Data obtained by an investigator about human subjects/living
human beings through interaction/intervention with an individual
7. Example of a study that meets the definition of research with human subjects
(according to Federal regulations) - ANSWER ✔ 1 - A developmental
psychologist videotapes interactions between groups of toddlers and their
care givers to determine which intervention methods most effectively
manage aggression.
2 - A study of twenty 4th grade classrooms in which researchers ask the
school to systematically vary the time of day reading is taught, and collect
weekly assessments of reading comprehension for each child over a three-
month period.
3 - An experiment is proposed on the relationship between gender-related
stereotypes in math and the subsequent performance by males and females
on math tests.
4 - A cognitive psychologist enrolls undergraduate students for a computer-
based study about the effect of mood on problem solving behaviors.
8. Example of Public Information - ANSWER ✔ Census data (final report as
published by the Census Bureau)
9. Example of Private Information - ANSWER ✔ A medical record
10.Example of a study the IRB will not review because it is not research (as
defined by the Federal regulations) - ANSWER ✔ A professor at Big State
University is writing a biography about Bill Gates and conducting oral
histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the
institution's IRB
,11.What is the term for management controls that are built in to a research
study (for example, independent data analysis)? - ANSWER ✔ Inherent
controls
12.The FDA regulations governing disclosure of individual COIs require: -
ANSWER ✔ Applicants submitting marketing applications to disclose
nancial COIs of researchers who conducted clinical studies
13.The PHS regulations about nancial con ict of interests require which party to
disclose signi cant nancial con icts of interest? - ANSWER ✔ Researcher
14.An example of an individual nancial COI is: - ANSWER ✔ A researcher's
wife holds equity in a publicly traded pharmaceutical company that is also
the sponsor of the
researcher's study.
15.During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should: - ANSWER ✔
Disclose their potential COI and may answer questions, but recuse
themselves from voting
16.The Belmont Report's principle of respect for persons incorporates at least
two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that:
A. Persons with diminished autonomy should only participate in no more
than minimal risk research.
B. Persons with diminished autonomy should be excluded from research.
C. Persons with diminished autonomy are entitled to protection.
D. Persons involved in research cannot financially benefit. - ANSWER
✔ C. Persons with diminished autonomy are entitled to protection.
, 17.Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects?
A. Ensuring that persons with diminished autonomy are protected.
B. Providing detailed information about the study and obtaining the
subject's consent to participate.
C. Determining that the study has a maximization of benefits and a
minimization of risks.
D. Ensuring that the selection of subjects includes people from all
segments of the population. - ANSWER ✔ C. Determining that the
study has a maximization of benefits and a minimization of risks.
18.The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest?
A. IRB Member
B. Sponsor
C. Applicants submitting marketing applications for drugs, biologics, or
devices
D. Organization
E. Researcher - ANSWER ✔ E. Researcher
19.Unless the IRB or privacy board waives the requirement, HIPAA requires
the patient's authorization for the use and disclosure of protected health
information (PHI):
A. If the use or disclosure of PHI is for the purpose of treatment.
B. For clinical use, since IRB review and approval is required.
C. For reporting HUD safety information to the HDE holder.
D. If the use or disclosure of PHI is for the purpose of a clinical
investigation with a HUD. - ANSWER ✔ D. If the use or disclosure
of PHI is for the purpose of a clinical investigation with a HUD.
20.All of the following regulatory requirements apply to an investigation of a
HUD consistent with the HDE approved indication(s), EXCEPT:
A. HIPAA authorization requirements for covered entities.
B. Financial disclosure requirements.
2026/2027 COMPLETE QUESTIONS WITH
VERIFIED CORRECT ANSWERS ||
100% GUARANTEED PASS
<NEWEST VERSION>
1. Example of how the principle of beneficence is applied to a study involving
human subjects - ANSWER ✔ Ensuring that the risks are reasonable in
relationship to anticipated benefits
2. Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this
primary ethical violation - ANSWER ✔ The researcher's failure to protect
research subjects from deductive disclosure (primary ethical violation)
3. "The Public Health Service Tuskegee Study of Untreated Syphilis in the
Negro Male" Study - ANSWER ✔ The study most directly linked to the
establishment of the "National Research Act" (1974) and ultimately the
"Belmont Report and Federal Regulations for Human Subject Protection"
4. The Belmont principle of Beneficence - ANSWER ✔ Requires that:
potential benefits justify the risks of harm
5. The Belmont principle of Justice - ANSWER ✔ Moral Requirement that:
there be fair outcomes in the selection of research subjects
,6. Identifiable Private Information (according to Federal regulations) -
ANSWER ✔ Data obtained by an investigator about human subjects/living
human beings through interaction/intervention with an individual
7. Example of a study that meets the definition of research with human subjects
(according to Federal regulations) - ANSWER ✔ 1 - A developmental
psychologist videotapes interactions between groups of toddlers and their
care givers to determine which intervention methods most effectively
manage aggression.
2 - A study of twenty 4th grade classrooms in which researchers ask the
school to systematically vary the time of day reading is taught, and collect
weekly assessments of reading comprehension for each child over a three-
month period.
3 - An experiment is proposed on the relationship between gender-related
stereotypes in math and the subsequent performance by males and females
on math tests.
4 - A cognitive psychologist enrolls undergraduate students for a computer-
based study about the effect of mood on problem solving behaviors.
8. Example of Public Information - ANSWER ✔ Census data (final report as
published by the Census Bureau)
9. Example of Private Information - ANSWER ✔ A medical record
10.Example of a study the IRB will not review because it is not research (as
defined by the Federal regulations) - ANSWER ✔ A professor at Big State
University is writing a biography about Bill Gates and conducting oral
histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the
institution's IRB
,11.What is the term for management controls that are built in to a research
study (for example, independent data analysis)? - ANSWER ✔ Inherent
controls
12.The FDA regulations governing disclosure of individual COIs require: -
ANSWER ✔ Applicants submitting marketing applications to disclose
nancial COIs of researchers who conducted clinical studies
13.The PHS regulations about nancial con ict of interests require which party to
disclose signi cant nancial con icts of interest? - ANSWER ✔ Researcher
14.An example of an individual nancial COI is: - ANSWER ✔ A researcher's
wife holds equity in a publicly traded pharmaceutical company that is also
the sponsor of the
researcher's study.
15.During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should: - ANSWER ✔
Disclose their potential COI and may answer questions, but recuse
themselves from voting
16.The Belmont Report's principle of respect for persons incorporates at least
two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that:
A. Persons with diminished autonomy should only participate in no more
than minimal risk research.
B. Persons with diminished autonomy should be excluded from research.
C. Persons with diminished autonomy are entitled to protection.
D. Persons involved in research cannot financially benefit. - ANSWER
✔ C. Persons with diminished autonomy are entitled to protection.
, 17.Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects?
A. Ensuring that persons with diminished autonomy are protected.
B. Providing detailed information about the study and obtaining the
subject's consent to participate.
C. Determining that the study has a maximization of benefits and a
minimization of risks.
D. Ensuring that the selection of subjects includes people from all
segments of the population. - ANSWER ✔ C. Determining that the
study has a maximization of benefits and a minimization of risks.
18.The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest?
A. IRB Member
B. Sponsor
C. Applicants submitting marketing applications for drugs, biologics, or
devices
D. Organization
E. Researcher - ANSWER ✔ E. Researcher
19.Unless the IRB or privacy board waives the requirement, HIPAA requires
the patient's authorization for the use and disclosure of protected health
information (PHI):
A. If the use or disclosure of PHI is for the purpose of treatment.
B. For clinical use, since IRB review and approval is required.
C. For reporting HUD safety information to the HDE holder.
D. If the use or disclosure of PHI is for the purpose of a clinical
investigation with a HUD. - ANSWER ✔ D. If the use or disclosure
of PHI is for the purpose of a clinical investigation with a HUD.
20.All of the following regulatory requirements apply to an investigation of a
HUD consistent with the HDE approved indication(s), EXCEPT:
A. HIPAA authorization requirements for covered entities.
B. Financial disclosure requirements.
