Export Controls
What is the term used in export control regulations that applies to basic or applied research in science and/or engineering at an accredited institution of higher learning in the United States, where the resulting information is ordinarily published and shared broadly in the scientific community?
a. Fundamental research
b. Export administration
c. Open research
d. License exclusion
a. Fundamental Research
This is required for all PHS-sponsored research and must be updated every four years.
A. A COI Disclosure
B. Blackboard COI Training
C. CITI COI Training
ANSWER: C. CITI COI training is required for PHS-sponsored research only. Blackboard COI training is no longer used. Training must be retaken every 4 years.
1. What does ‘IACUC’ stand for?
a. I Can Already Use Critters
b. Institutional Animal Care and Use Committee
c. Individual Animal Control and Use Committee
d. Intramural Assessment for Characterization of Unknown Compounds
b. Institutional Animal Care and Use Committee
Use of Viral vectors are on the rise in research laboratories as they provide easier ways to introduce foreign genes in systems that are easy to study. IBC review and approval is required before use in laboratories because:
A. Unsafe use of these vectors may cause health concerns
B. Anyone can easily order viral vectors online but users must have appropriate training for their use
C. These studies fall under specific NIH guidelines
D. All of the above
D. All of the above
What does FCOI stand for?
Financial Conflicts of Interest
The Fundamental Research Exclusion permits investigators to travel or share certain publically accessible information with the international community or foreign nationals without an export license. What nullifies an investigator’s fundamental research exclusion?
a. When the investigator is a foreign national
b. A U.S. college professor conducting a standard engineering class overseas
c. any restrictions set forth on publications
d. When an export license is not needed
c. any restrictions set forth on publications
What should an investigator disclose in a COI disclosure?
A. All of his or her Significant Financial Interest (SFIs), and those of the Investigator’s spouse and dependent children, whether related to this research or not, that reasonably appear to be related to the Investigator’s Institutional Responsibilities
B. All of his or her Significant Financial Interest (SFIs), and those of the Investigator’s spouse and dependent children, that reasonably appear to be related to the Investigator’s Institutional Responsibilities
C. All of his or her Significant Financial Interest (SFIs, whether related to this research or not, that reasonably appear to be related to the Investigator’s Institutional Responsibilities
ANSWER: A. An investigator must disclose his/her SFIS AND the SFIs of their spouse/dependent children, whether or not those SFIs are related to the research for which they are disclosing.
2. What is the name of the Protocol Management Software used by the IACUC at BU?
a. INSPIR
b. TOPAZ
c. eSirius
d. Huron/Click
d. Huron/Click
A PI is required to submit an IBC application and secure approval if they plan to work with recombinant or synthetic nucleic acids and/or hazardous biological agents.
Which of the following statements is TRUE:
A. All new BSL1/BSL2 projects require IBC and Boston Public Health Commission approval before a PI may start laboratory work
B. Amendments to a protocol (including minor changes such as personnel change or adding a new title) can only be made during the annual renewal of the protocol
C. Changing the PI of a protocol requires review and approval of the IBC at a fully convened IBC meeting
D. All of the above
C. Changing the PI of a protocol requires review and approval of the IBC at a fully convened IBC meeting
What does SBIR stand for?
What does STTR stand for?
Small Business Innovative Research
Small Business Technology Transfer
Which of the following may subject the University to Export Controls?
a. Traveling overseas to conduct University business (e.g., conferences, field work, international symposia)
b. Traveling with some types of equipment including laptop computers, web-enabled cell phones, or other items
c. Traveling with unpublished, proprietary information or restricted information
d. Research collaborations with foreign nationals (here in the U.S. or abroad)
e. Visits or tours of research facilities by foreign nationals
f. All of the above
f. All of the above
An investigator must disclose Reimbursed or Sponsored Travel for all research.
A. TRUE
B. FALSE
ANSWER: B. False.
Reimbursed or Sponsored Travel must be reported for PHS-sponsored research only.
3. Which of the following is not an acceptable review method for an IACUC Protocol?
a. Full Committee Review
b. Designated Member Review
c. Expedited Review
d. Administrative Review
c. Expedited Review
The Biosafety Level (BSL) for working with an agent should be determined based on its potential to cause human disease, severity of the disease, available preventive or treatment options, transmission route and community risk. BSL1 is the lowest containment level and BSL4 is the highest containment level.
Which of the following statements about a researcher working with West Nile Virus (WNV) is TRUE:
A. WNV work does not require any containment as safe handling methods have been established and the risk for exposure has been mitigated
B. WNV work must be done in a BSL2 containment as the associated disease is rarely serious and preventive and therapeutic intervention is available
C. WNV work must be done in a BSL3 containment as WNV infection is associated with serious or lethal human disease, and although preventive or therapeutic intervention may be available and has low community risk, there is high individual risk
D. WNV work must be done in a BSL4 containment because WNV infection causes serious or lethal human disease, has no preventive or therapeutic interventions, and has very high individual and high community risk
C. WNV work must be done in a BSL3 containment as WNV infection is associated with serious or lethal human disease, and although preventive or therapeutic intervention may be available and has low community risk, there is high individual risk
What does OLAW stand for?
Office of Laboratory Animal Welfare
In addition to the physical transfer of items out of the country, the U.S. Government also actively regulates the release or transmission of controlled technology or information to Foreign Nationals within the U.S (e.g., a foreign national graduate student at BU). This is referred to as what kind of export?
a. Deemed export
b. Dual use export
c. Release export
a. Deemed export
The following financial interests must be reported as an SFI if the financial interest is in a Non-Publicly Traded Entity:
ANSWER: D. All of the above interests must be reported as an SFI in a privately held company. Unlike an SFI in a Publicly-Traded Entity, any amount of equity must be disclosed. For a publicly-traded Entity, equity in excess of $5,000 must be reported.
4. How soon should the IACUC office be notified of a JIT request?
a. The day of the deadline
b. When the grant is originally submitted
c. When notified of favorable funding score
d. When the PI gets around to doing it
c. When notified of favorable funding score
The NIH Guidelines for Recombinant and Synthetic Nucleic Acids (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
Which of the following statements are TRUE:
A. The NIH Guidelines were developed in 1999 following death of Jesse Gelsinger, who died as a result of participating in a gene therapy clinical trial.
B. The NIH Guidelines specify biosafety practices and containment requirement for biological research involving all types of research with cells, organisms and viruses containing rDNA molecules
C. The NIH Guidelines address risk assessment for hazardous biological agents
D. The NIH Guidelines do not address how local Institutional Biosafety Committee should be run
E. All of the above
B. The NIH Guidelines specify biosafety practices and containment requirement for biological research involving all types of research with cells, organisms and viruses containing rDNA molecules
What does RIMS stand for?
Research Information Management System
A foreign national (a person who is not a naturalized citizen of the US) is set to work on a BU Principal Investigator's research project next week. The project involves controlled or classified export information from the Sponsor, and the foreign national is from Syria. What is the appropriate course of action?
a. Contact the Office of Research Integrity right away with the details to determine whether or not the investigator will need an export license.
b. Allow the foreign national to expend effort on the project since BU has an Openness in Research Policy and is exempt from restrictions on data that falls outside the public domain.
c. Since the foreign national has a H1-B Visa, s/he is in the country legally and therefore would not need a license to partake in the research.
a. Contact the Office of Research Integrity right away with the details to determine whether or not the investigator will need an export license.
If an SFI is reported:
A. The investigator is precluded from conducting the research
B. The COI Office will determine whether the SFI is related to the research
C. The COI will send the project to the Faculty Review Committee for review
D. The investigator’s conflict will be managed with a Management Plan
ANSWER: B. Every disclosure is reviewed by the COI Office. If an SFI is reported, the COI will determine if the SFI is related to the research, meaning the SFI could be affected by the research or the SFI is in an entity whose financial interests could be affected by the research. If it is not related, the inquiry ends. If it is related to the research, the project is sent to the COI Faculty Review Committee for review. The COI Committee determines whether the SFI creates a Financial Conflict of Interest, meaning the conflict could directly and significantly affect the design, conduct, or reporting of the research. If there is a FCOI, the COI Committee then determines whether the conflict can be managed and how.
The three "R's" stand for what in animal research?
a. Reduce, Reuse and Recycle
b. Replacement, Reduction and Refinement
c. Reading, Writing and Arithmetic
(answer is b.)
Replacement, Reduction and Refinement
Select Agents are biological agents that pose severe threat to public health and safety.
Which of the following statements are FALSE:
A. Only agents that affect humans are called select agents
B. The Select Agent Program is regulated by Center for Disease Control and Prevention (CDC)
C. Select agents can be viruses, toxins and bacteria
D. Equine Encephalitis (EEE) virus is a select agent
A. Only agents that affect humans are called select agents
Under Export Control, what does ECCN stand for?
Export Control Classification Number