ITIC · ZIUQ ELUDOM
◉ CITI Program
C
★
Collaborative Institutional Training Initiative — A Division of BRANY
EST. 2000
A D V A N C I N G R E S E A R C H E T H I C S A N D E D U C AT I O N
CITI Module Quiz — Comprehensive Review
CO I · R C R · AU T H O RS H I P · DATA M A N AG E M E N T · M E N TO R I N G · I R B · B E L M O N T · VU L N E RA B L E
P O P U L AT I O N S
INSTITUTION CITI Program / BRANY PROGRAM Research Ethics & Compliance Training
ACADEMIC YEAR EXAM TITLE CITI Module Quiz — Comprehensive
TOTAL QUESTIONS 95 Questions COURSE TITLE Human Subjects Research / RCR
FORMAT Multiple Choice — Select the Single Best HQ Fort Lauderdale, Florida
Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Content spans COI, RCR, authorship, data management, mentoring, peer review, Belmont Report, IRB, informed consent,
vulnerable populations, and internet research.
▸ Correct answers and detailed rationales appear below each question for CITI certification preparation.
▸ All content reflects current federal regulations and CITI Program standards.
SECTION I — CONFLICTS OF INTEREST, RCR & AUTHORSHIP Questions 1 – 25
1. According to the U.S. Public Health Service, the definition of the term "investigator" includes:
A. Only the principal investigator named on the grant.
B. Anyone involved in the conduct or reporting of research.
C. Only individuals with a doctoral degree.
D. Only individuals who receive salary from the grant.
CORRECT ANSWER B — Anyone involved in the conduct or reporting of research.
RATIONALE Per PHS regulations, "Investigator means the project director or principal investigator and any other
person, regardless of title or position, who is responsible for the design, conduct, or reporting of
research funded by the U.S. Public Health Service." This broad definition includes students,
postdocs, technicians, and collaborators — anyone with substantive involvement in the research,
not just the PI or those with doctoral degrees.
,2. According to U.S. Public Health Service regulations, investigators are required to disclose travel sponsored
or reimbursed by:
A. Any organization, regardless of type.
B. A publicly traded company.
C. Only foreign governments.
D. Only non-profit organizations.
CORRECT ANSWER B — A publicly traded company.
RATIONALE PHS regulations specifically require disclosure of travel sponsored or reimbursed by a publicly
traded entity. This includes any travel related to the investigator's institutional responsibilities that
is paid for on their behalf — not just travel that is directly reimbursed to the investigator. Travel from
non-publicly traded entities, academic institutions, or government agencies is not covered by this
specific requirement, though other disclosure rules may apply.
3. An investigator has $4,000 of consulting income and $2,000 in stock from a publicly traded drug company,
and is submitting an NIH grant to evaluate a drug produced by the same company. Which is true?
A. Neither amount meets the threshold — no disclosure is needed.
B. The aggregate of consulting income and stock exceeds $5,000 and is a significant financial interest.
C. Only the stock needs to be disclosed.
D. The consulting income alone triggers disclosure.
CORRECT ANSWER B — The aggregate of consulting income and stock exceeds $5,000 and is a significant
financial interest.
RATIONALE Per PHS regulations (42 CFR 50 Subpart F), with regard to any publicly traded entity, a significant
financial interest exists if the aggregate value of remuneration received and equity interest held
exceeds $5,000. The investigator's consulting income ($4,000) plus stock value ($2,000) = $6,000
aggregate, exceeding the $5,000 threshold. Individual amounts below $5,000 do not exempt the
investigator when the aggregate exceeds the limit. This must be disclosed and managed.
,4. Within how many days of acquiring or discovering a significant financial interest must an investigator
submit an updated disclosure to the institution?
A. 14 days
B. 30 days
C. 60 days
D. 90 days
CORRECT ANSWER B — 30 days
RATIONALE PHS regulations require investigators to submit an updated disclosure of significant financial
interests within 30 days of discovering or acquiring a new significant financial interest. This ensures
that the institution can evaluate the new interest, determine if it constitutes a financial conflict of
interest, and implement a management plan if needed — all before the conflict can affect ongoing
research.
5. At a minimum, how often are investigators funded by the NIH required to receive conflict of interest
training under PHS policy?
A. Every year
B. Every two years
C. Every four years
D. Once per career
CORRECT ANSWER C — Every four years
RATIONALE NIH-funded investigators must receive COI training at least every four years. More frequent training
is required when: the institution revises its COI policy in a way that affects investigator
requirements, an investigator is new to the institution, or an investigator is not in compliance with
the COI policy or management plan. The four-year interval is the minimum standard.
, 6. Which financial COI information must institutions make available on a public website or within five
business days upon request?
A. All investigators' financial interests regardless of funding source.
B. The financial conflicts of interest of senior/key personnel on PHS-funded projects.
C. Only the PI's financial interests.
D. No information must be made public.
CORRECT ANSWER B — The financial conflicts of interest of senior/key personnel on PHS-funded projects.
RATIONALE PHS regulations require public accessibility of identified FCOIs for senior/key personnel. The
information must include: investigator's name, title and role, name of the entity in which the
interest exists, nature of the interest, and approximate dollar value in ranges. This must be posted
on a publicly accessible website or provided within five business days of a written request. This
transparency requirement allows the public to evaluate potential bias in federally funded research.
7. The U.S. Public Health Service (PHS) requires institutions to:
A. Keep all COI information confidential and internal.
B. Disclose investigators' new financial conflicts of interest to the PHS awarding component within 60 days of
discovering them.
C. Report all financial interests regardless of value.
D. Wait until the grant renewal to disclose COIs.
CORRECT ANSWER B — Disclose investigators' new financial conflicts of interest to the PHS awarding component
within 60 days of discovering them.
RATIONALE When an institution identifies a financial conflict of interest that was not previously disclosed or
managed, it must disclose this to the PHS awarding component within 60 days of identification. The
institution must also implement a management plan and submit annual FCOI reports. This ensures
federal oversight of conflicts that arise during the course of funded research.
◉ CITI Program
C
★
Collaborative Institutional Training Initiative — A Division of BRANY
EST. 2000
A D V A N C I N G R E S E A R C H E T H I C S A N D E D U C AT I O N
CITI Module Quiz — Comprehensive Review
CO I · R C R · AU T H O RS H I P · DATA M A N AG E M E N T · M E N TO R I N G · I R B · B E L M O N T · VU L N E RA B L E
P O P U L AT I O N S
INSTITUTION CITI Program / BRANY PROGRAM Research Ethics & Compliance Training
ACADEMIC YEAR EXAM TITLE CITI Module Quiz — Comprehensive
TOTAL QUESTIONS 95 Questions COURSE TITLE Human Subjects Research / RCR
FORMAT Multiple Choice — Select the Single Best HQ Fort Lauderdale, Florida
Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Content spans COI, RCR, authorship, data management, mentoring, peer review, Belmont Report, IRB, informed consent,
vulnerable populations, and internet research.
▸ Correct answers and detailed rationales appear below each question for CITI certification preparation.
▸ All content reflects current federal regulations and CITI Program standards.
SECTION I — CONFLICTS OF INTEREST, RCR & AUTHORSHIP Questions 1 – 25
1. According to the U.S. Public Health Service, the definition of the term "investigator" includes:
A. Only the principal investigator named on the grant.
B. Anyone involved in the conduct or reporting of research.
C. Only individuals with a doctoral degree.
D. Only individuals who receive salary from the grant.
CORRECT ANSWER B — Anyone involved in the conduct or reporting of research.
RATIONALE Per PHS regulations, "Investigator means the project director or principal investigator and any other
person, regardless of title or position, who is responsible for the design, conduct, or reporting of
research funded by the U.S. Public Health Service." This broad definition includes students,
postdocs, technicians, and collaborators — anyone with substantive involvement in the research,
not just the PI or those with doctoral degrees.
,2. According to U.S. Public Health Service regulations, investigators are required to disclose travel sponsored
or reimbursed by:
A. Any organization, regardless of type.
B. A publicly traded company.
C. Only foreign governments.
D. Only non-profit organizations.
CORRECT ANSWER B — A publicly traded company.
RATIONALE PHS regulations specifically require disclosure of travel sponsored or reimbursed by a publicly
traded entity. This includes any travel related to the investigator's institutional responsibilities that
is paid for on their behalf — not just travel that is directly reimbursed to the investigator. Travel from
non-publicly traded entities, academic institutions, or government agencies is not covered by this
specific requirement, though other disclosure rules may apply.
3. An investigator has $4,000 of consulting income and $2,000 in stock from a publicly traded drug company,
and is submitting an NIH grant to evaluate a drug produced by the same company. Which is true?
A. Neither amount meets the threshold — no disclosure is needed.
B. The aggregate of consulting income and stock exceeds $5,000 and is a significant financial interest.
C. Only the stock needs to be disclosed.
D. The consulting income alone triggers disclosure.
CORRECT ANSWER B — The aggregate of consulting income and stock exceeds $5,000 and is a significant
financial interest.
RATIONALE Per PHS regulations (42 CFR 50 Subpart F), with regard to any publicly traded entity, a significant
financial interest exists if the aggregate value of remuneration received and equity interest held
exceeds $5,000. The investigator's consulting income ($4,000) plus stock value ($2,000) = $6,000
aggregate, exceeding the $5,000 threshold. Individual amounts below $5,000 do not exempt the
investigator when the aggregate exceeds the limit. This must be disclosed and managed.
,4. Within how many days of acquiring or discovering a significant financial interest must an investigator
submit an updated disclosure to the institution?
A. 14 days
B. 30 days
C. 60 days
D. 90 days
CORRECT ANSWER B — 30 days
RATIONALE PHS regulations require investigators to submit an updated disclosure of significant financial
interests within 30 days of discovering or acquiring a new significant financial interest. This ensures
that the institution can evaluate the new interest, determine if it constitutes a financial conflict of
interest, and implement a management plan if needed — all before the conflict can affect ongoing
research.
5. At a minimum, how often are investigators funded by the NIH required to receive conflict of interest
training under PHS policy?
A. Every year
B. Every two years
C. Every four years
D. Once per career
CORRECT ANSWER C — Every four years
RATIONALE NIH-funded investigators must receive COI training at least every four years. More frequent training
is required when: the institution revises its COI policy in a way that affects investigator
requirements, an investigator is new to the institution, or an investigator is not in compliance with
the COI policy or management plan. The four-year interval is the minimum standard.
, 6. Which financial COI information must institutions make available on a public website or within five
business days upon request?
A. All investigators' financial interests regardless of funding source.
B. The financial conflicts of interest of senior/key personnel on PHS-funded projects.
C. Only the PI's financial interests.
D. No information must be made public.
CORRECT ANSWER B — The financial conflicts of interest of senior/key personnel on PHS-funded projects.
RATIONALE PHS regulations require public accessibility of identified FCOIs for senior/key personnel. The
information must include: investigator's name, title and role, name of the entity in which the
interest exists, nature of the interest, and approximate dollar value in ranges. This must be posted
on a publicly accessible website or provided within five business days of a written request. This
transparency requirement allows the public to evaluate potential bias in federally funded research.
7. The U.S. Public Health Service (PHS) requires institutions to:
A. Keep all COI information confidential and internal.
B. Disclose investigators' new financial conflicts of interest to the PHS awarding component within 60 days of
discovering them.
C. Report all financial interests regardless of value.
D. Wait until the grant renewal to disclose COIs.
CORRECT ANSWER B — Disclose investigators' new financial conflicts of interest to the PHS awarding component
within 60 days of discovering them.
RATIONALE When an institution identifies a financial conflict of interest that was not previously disclosed or
managed, it must disclose this to the PHS awarding component within 60 days of identification. The
institution must also implement a management plan and submit annual FCOI reports. This ensures
federal oversight of conflicts that arise during the course of funded research.
