MAXE · EVISNEHERPMOC
CITI★
★ CITI Program
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 — Comprehensive Examination
D U R C · B I O S A F E TY · B LO O D B O R N E PAT H O G E N S · N A N OT E C H N O LO G Y · R C R
INSTITUTION CITI Program MODULES DURC · IBC · OSHA BBP · Nano ·
RCR
SUBJECT Research Ethics & Laboratory ACADEMIC YEAR
Safety
ASSESSMENT Comprehensive Training TOTAL QUESTIONS 95 Questions
Examination
REGULATIONS NIH · OSHA · PHS · FDA · NSF FORMAT Multiple Choice — Select the
Single Best Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Covers DURC, IRE/IBC responsibilities, biosafety levels, bloodborne pathogens, nanotechnology safety,
responsible conduct of research, and authorship.
▸ Correct answers and detailed rationales appear below each question.
, CITI COMPREHENSIVE — DURC · BIOSAFETY · BBP · NANO
Questions 1 – 95
· RCR
1. If the PI does not agree with the IRE findings, they can request:
A. Immediate termination of the research project
B. Review by the USG (United States Government)
C. A new IRE to be appointed
D. Self-regulation without oversight
CORRECT ANSWER B — Review by the USG (United States Government)
RATIONALE When a PI disagrees with the Institutional Review Entity (IRE) findings regarding
DURC (Dual Use Research of Concern), they may request review by the United
States Government funding agency for a final determination.
2. Which of the following is a responsibility of the IRE?
A. Conducting the laboratory experiments
B. Notification within 30 days of organizational review to the USG funding agency
C. Publishing research findings
D. Training laboratory personnel
CORRECT ANSWER B — Notification within 30 days of organizational review to the USG funding
agency
RATIONALE The IRE must notify the USG funding agency within 30 days of completing its
organizational review of potential DURC. This ensures timely federal oversight of
dual-use research concerns.
,3. For research to qualify as potential DURC, the PI and IRE must perform an initial
assessment on which of the following?
A. The researcher's financial conflicts of interest only
B. Use of a listed agent or toxin that may result in one or more of the seven experiments of
concern
C. The laboratory's physical security measures only
D. The publication record of the research team
CORRECT ANSWER B — Use of a listed agent or toxin that may result in one or more of the
seven experiments of concern
RATIONALE DURC assessment evaluates whether research involves one of 15 listed
agents/toxins AND may produce, as a result, one or more of the seven categories
of experiments of concern (e.g., enhancing virulence, disrupting immunity, etc.).
4. What organizations are required to have an IRE if DURC is being considered?
A. Only private research institutions
B. Any organization that receives money from the federal government
C. Only universities with medical schools
D. Only pharmaceutical companies
CORRECT ANSWER B — Any organization that receives money from the federal government
RATIONALE The USG DURC policy applies to all institutions and organizations that receive
federal funding for life sciences research. These entities must establish an IRE to
review potential DURC.
, 5. How often is IRE review required to determine if research still falls under DURC or
enhanced measures are required?
A. Only at the beginning of the project
B. At least annually
C. Every 5 years
D. Only when requested by the PI
CORRECT ANSWER B — At least annually
RATIONALE DURC determinations require ongoing review. The IRE must review the research
at least annually to determine whether it still falls under DURC and whether
enhanced risk mitigation measures continue to be appropriate.
6. Which is accurate regarding NIOSH exposure limits for nanomaterials?
A. NIOSH has no recommendations for nanomaterials
B. NIOSH provides recommended occupational exposure limits for carbon nanotubes,
carbon nanofibres, silver nanoparticles, and titanium dioxide
C. NIOSH only regulates nanomaterials in food products
D. NIOSH exposure limits are identical for all nanomaterials
CORRECT ANSWER B — NIOSH provides recommended occupational exposure limits for
carbon nanotubes, carbon nanofibres, silver nanoparticles, and titanium
dioxide
RATIONALE NIOSH has established Recommended Exposure Limits (RELs) for specific
nanomaterials including carbon nanotubes, carbon nanofibers, silver
nanoparticles, and titanium dioxide, recognizing their unique occupational health
risks.
CITI★
★ CITI Program
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 — Comprehensive Examination
D U R C · B I O S A F E TY · B LO O D B O R N E PAT H O G E N S · N A N OT E C H N O LO G Y · R C R
INSTITUTION CITI Program MODULES DURC · IBC · OSHA BBP · Nano ·
RCR
SUBJECT Research Ethics & Laboratory ACADEMIC YEAR
Safety
ASSESSMENT Comprehensive Training TOTAL QUESTIONS 95 Questions
Examination
REGULATIONS NIH · OSHA · PHS · FDA · NSF FORMAT Multiple Choice — Select the
Single Best Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Covers DURC, IRE/IBC responsibilities, biosafety levels, bloodborne pathogens, nanotechnology safety,
responsible conduct of research, and authorship.
▸ Correct answers and detailed rationales appear below each question.
, CITI COMPREHENSIVE — DURC · BIOSAFETY · BBP · NANO
Questions 1 – 95
· RCR
1. If the PI does not agree with the IRE findings, they can request:
A. Immediate termination of the research project
B. Review by the USG (United States Government)
C. A new IRE to be appointed
D. Self-regulation without oversight
CORRECT ANSWER B — Review by the USG (United States Government)
RATIONALE When a PI disagrees with the Institutional Review Entity (IRE) findings regarding
DURC (Dual Use Research of Concern), they may request review by the United
States Government funding agency for a final determination.
2. Which of the following is a responsibility of the IRE?
A. Conducting the laboratory experiments
B. Notification within 30 days of organizational review to the USG funding agency
C. Publishing research findings
D. Training laboratory personnel
CORRECT ANSWER B — Notification within 30 days of organizational review to the USG funding
agency
RATIONALE The IRE must notify the USG funding agency within 30 days of completing its
organizational review of potential DURC. This ensures timely federal oversight of
dual-use research concerns.
,3. For research to qualify as potential DURC, the PI and IRE must perform an initial
assessment on which of the following?
A. The researcher's financial conflicts of interest only
B. Use of a listed agent or toxin that may result in one or more of the seven experiments of
concern
C. The laboratory's physical security measures only
D. The publication record of the research team
CORRECT ANSWER B — Use of a listed agent or toxin that may result in one or more of the
seven experiments of concern
RATIONALE DURC assessment evaluates whether research involves one of 15 listed
agents/toxins AND may produce, as a result, one or more of the seven categories
of experiments of concern (e.g., enhancing virulence, disrupting immunity, etc.).
4. What organizations are required to have an IRE if DURC is being considered?
A. Only private research institutions
B. Any organization that receives money from the federal government
C. Only universities with medical schools
D. Only pharmaceutical companies
CORRECT ANSWER B — Any organization that receives money from the federal government
RATIONALE The USG DURC policy applies to all institutions and organizations that receive
federal funding for life sciences research. These entities must establish an IRE to
review potential DURC.
, 5. How often is IRE review required to determine if research still falls under DURC or
enhanced measures are required?
A. Only at the beginning of the project
B. At least annually
C. Every 5 years
D. Only when requested by the PI
CORRECT ANSWER B — At least annually
RATIONALE DURC determinations require ongoing review. The IRE must review the research
at least annually to determine whether it still falls under DURC and whether
enhanced risk mitigation measures continue to be appropriate.
6. Which is accurate regarding NIOSH exposure limits for nanomaterials?
A. NIOSH has no recommendations for nanomaterials
B. NIOSH provides recommended occupational exposure limits for carbon nanotubes,
carbon nanofibres, silver nanoparticles, and titanium dioxide
C. NIOSH only regulates nanomaterials in food products
D. NIOSH exposure limits are identical for all nanomaterials
CORRECT ANSWER B — NIOSH provides recommended occupational exposure limits for
carbon nanotubes, carbon nanofibres, silver nanoparticles, and titanium
dioxide
RATIONALE NIOSH has established Recommended Exposure Limits (RELs) for specific
nanomaterials including carbon nanotubes, carbon nanofibers, silver
nanoparticles, and titanium dioxide, recognizing their unique occupational health
risks.
