CITI★ CITI Program
ZIUQ · IOC
★
PROGRAM Collaborative Institutional Training Initiative
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 & C O M P L I A N C E E D U C AT I O N
CITI Program — Conflicts of Interest Quiz
H U M A N S U BJ E CTS R E S E A R C H · P H S & F DA R E G U L AT I O N S
INSTITUTION CITI Program MODULE Conflicts of Interest in Human
Subjects Research
SUBJECT Research Ethics & Compliance ACADEMIC YEAR
ASSESSMENT Quiz — Conflicts of Interest TOTAL QUESTIONS 10 Questions
REGULATIONS PHS · FDA · Institutional Policy FORMAT Multiple Choice — Select the
Single Best Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Covers PHS and FDA regulations on financial conflicts of interest, institutional COI, management plans,
and IRB procedures.
▸ Correct answers and detailed rationales appear below each question.
, CONFLICTS OF INTEREST — HUMAN SUBJECTS
Questions 1 – 10
RESEARCH
1. A researcher plans to submit a proposal to the NIH for a human subjects research study.
By when must he and his study team submit COI disclosures to comply with PHS
regulations?
A. After the research is completed
B. No later than the time of proposal submission
C. Within 30 days of receiving funding
D. Only when a COI is identified by the IRB
CORRECT ANSWER B — No later than the time of proposal submission
RATIONALE PHS regulations (42 CFR Part 50, Subpart F) require that financial conflict of
interest disclosures be submitted no later than the time of proposal submission.
This ensures that potential COIs are identified and addressed before research
funding is awarded.
2. The peer review process can create conflicts of interest because the choice of who
reviews a potentially publishable project may show:
A. The reviewer has no interest in the research topic
B. Bias by the peer reviewer as to the area of research
C. Complete objectivity in all review decisions
D. That peer review is unnecessary for publication
CORRECT ANSWER B — Bias by the peer reviewer as to the area of research
RATIONALE Peer reviewers may have personal or professional biases toward certain research
areas, methodologies, or competing laboratories. This creates potential COIs that
can affect the fairness and objectivity of the review process.
ZIUQ · IOC
★
PROGRAM Collaborative Institutional Training Initiative
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 & C O M P L I A N C E E D U C AT I O N
CITI Program — Conflicts of Interest Quiz
H U M A N S U BJ E CTS R E S E A R C H · P H S & F DA R E G U L AT I O N S
INSTITUTION CITI Program MODULE Conflicts of Interest in Human
Subjects Research
SUBJECT Research Ethics & Compliance ACADEMIC YEAR
ASSESSMENT Quiz — Conflicts of Interest TOTAL QUESTIONS 10 Questions
REGULATIONS PHS · FDA · Institutional Policy FORMAT Multiple Choice — Select the
Single Best Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Covers PHS and FDA regulations on financial conflicts of interest, institutional COI, management plans,
and IRB procedures.
▸ Correct answers and detailed rationales appear below each question.
, CONFLICTS OF INTEREST — HUMAN SUBJECTS
Questions 1 – 10
RESEARCH
1. A researcher plans to submit a proposal to the NIH for a human subjects research study.
By when must he and his study team submit COI disclosures to comply with PHS
regulations?
A. After the research is completed
B. No later than the time of proposal submission
C. Within 30 days of receiving funding
D. Only when a COI is identified by the IRB
CORRECT ANSWER B — No later than the time of proposal submission
RATIONALE PHS regulations (42 CFR Part 50, Subpart F) require that financial conflict of
interest disclosures be submitted no later than the time of proposal submission.
This ensures that potential COIs are identified and addressed before research
funding is awarded.
2. The peer review process can create conflicts of interest because the choice of who
reviews a potentially publishable project may show:
A. The reviewer has no interest in the research topic
B. Bias by the peer reviewer as to the area of research
C. Complete objectivity in all review decisions
D. That peer review is unnecessary for publication
CORRECT ANSWER B — Bias by the peer reviewer as to the area of research
RATIONALE Peer reviewers may have personal or professional biases toward certain research
areas, methodologies, or competing laboratories. This creates potential COIs that
can affect the fairness and objectivity of the review process.
