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
Choose the statements that are NOT applicable for NIH Guidelines for Recombinant and Synthetic Nucleic Acids.
A. Was first proposed in 1999 following death of Jesse Gelsinger from the fault of a gene therapy clinical trial back in 1999
B. It specifies the biosafety practices and containment requirement for biological research involving recombinant and synthetic nucleic acids and in cells, organisms and viruses containing those molecules
C. It does not discuss risk assessment for hazardous biological agents
D. It does not suggest how local Institutional Biosafety Committee should be run
Choices:
1) A & B
2) A & C
3) B & D
4.) A & D
Answer: A & D
A. Was first proposed in 1999 following death of Jesse Gelsinger from the fault of a gene therapy clinical trial back in 1999
D. It does not suggest how local Institutional Biosafety Committee should be run
Under Export Control, what does ECCN stand for?
Export Control Classification Number
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
Select Agents are biological agents that pose severe threat to public health and safety. Identify statements that are INCORRECT for select agents.
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 not a select agent
Choices:
1) A & B
2) B & C
3) C & D
4) A & D
Answer: A & D
A. Only agents that affect humans are called select agents
D. Equine Encephalitis (EEE) virus is not a select agent
What do SBIR and STTR stand for?
SBIR = Small Business Innovation Research
STTR = 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
Biosafety containment level 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. Choose the INCORRECT statements about working with West Nile Virus (WNV).
A. WNV work may be done in a BSL2 containment as the associated disease is rarely serious and preventive or therapeutic intervention is available.
B. WNV work may 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.
C. WNV work may be done in a BSL4 containment because WNV infection causes serious or lethal human disease and has no preventive or therapeutic interventions and has very high individual and high community risk.
Choices:
1) A & B
2) B & C
3) A & C
3) A & C
A. WNV work may be done in a BSL2 containment as the associated disease is rarely serious and preventive or therapeutic intervention is available.
C. WNV work may be done in a BSL4 containment because WNV infection causes serious or lethal human disease and has no preventive or therapeutic interventions and has very high individual and high community risk.
The three "R" stand for what in Animal Research?
a. Reduce, Reuse, Recycle
b. Replace, Reduce, Refine
c. Read, Write, Arithmetic
b. Replace, Reduce, Refine
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
1. 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
IBC is insisting PI’s to switch to 3rd generation lentivirus vector system over the traditional 2nd generation vector. Which statements ARE appropriate for this effort?
A. IBC negotiated with vendors to provide 3rd generation vectors to BU investigators at a cheaper price.
B. The system consists of 4 plasmids (over 3 plasmids in earlier version) eliminating the possibility of generation of original virus by recombination and thereby making the system lot safer.
C. These vectors do not integrate into the host genome any longer and thereby avoid insertional mutagenesis.
D. Contain deleted 5’-long terminal repeat and eliminates dependency of viral transactivator Tat which blocks self-replication of the vector adding to the safety of the system.
1) A & B
2) A & C
3) B & D
4) A & D
Answer: B & D
B. The system consists of 4 plasmids (over 3 plasmids in earlier version) eliminating the possibility of generation of original virus by recombination and thereby making the system lot safer.
D. Contain deleted 5’-long terminal repeat and eliminates dependency of viral transactivator Tat which blocks self-replication of the vector adding to the safety of the system.
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.
5. The USDA regulates the following species of animals?
a. Mice
b. Rabbit
c. Rats
d. Zebrafish
b. Rabbit
IBC critically evaluates any work involving tissue samples from adult brain for handling practices and waste disposal. These concerns stem from the risk associated with presence of Prion in those samples and their infectious nature. Choose statements that ARE appropriate for Prion diseases.
A. Prion diseases are infectious because prion particles are viruses that multiply in infected cells.
B. Prion diseases are the result of misfolding of mutated prion protein (as a result of inherited or acquired mutation in the protein coding sequence) which catalyzes clumping of normal prion protein in brain cells inhibiting their normal function.
C. Prion proteins can be easily decontaminated with commonly used laboratory disinfectants or heat.
D. Prions are not transmitted through the air or through touching or most other forms of casual contact. However, they may be transmitted through contact with infected tissue, body fluids, or contaminated medical instruments.
1) A & B
2) A & C
3) B & D
4) A & D
Answer: B & D
B. Prion diseases are the result of misfolding of mutated prion protein (as a result of inherited or acquired mutation in the protein coding sequence) which catalyzes clumping of normal prion protein in brain cells inhibiting their normal function.
D. Prions are not transmitted through the air or through touching or most other forms of casual contact. However, they may be transmitted through contact with infected tissue, body fluids, or contaminated medical instruments.
If an investigator receives a notice of award with potential export implications in the terms and conditions, which office should you contact to relay any concerns at BU?
a. The Office of Global Programs
b. The Office of Research Integrity
c. The International Students & Scholars Office
b. The Office of Research Integrity
Why should you care about following export control laws as a BU Employee? Which of the following is an accurate potential repercussion for the institution?
a. Civil Fines
b. Penalties
c. Debarment & Suspension of Government Contracts
d. Loss of Export Privileges
d. Prison
e. All of the Above
e. All of the Above