Plans to travel outside the US that's related to research?
Export Control and Travel
Our post from last month described the updates to the Traveler Certification Letter, used by international travelers who plan to carry university-owned equipment on trips outside the United States.
This post provides revised information about US Department of State and Federal Bureau of Investigation (FBI) travel guidance.
Click on our page to learn more on how to access Department of State country travel warnings and alerts and The Smart Traveler Enrollment Program (STEP) as well as useful information and best practices from the FBI for students, business travelers and academics to follow when travelling abroad.
Why worry? If you are taking university owned laptop or other common electronic devices to a foreign country, be aware that any physical material or technical data in your possession is considered by US export control regulations to have been “exported” from the US to your final destination and any intermediate destinations. If these devices have encryption source code or technical know-how (e.g. designs, schematics, non-public technical data), there may be a need to obtain an export control license before you leave the US. Also, if you lose your device or it's stolen, there's the problem of losing what's important to you and your research.
Please click on the above link to download the certification letter and send to the ORPC
before you leave the US with university equipment. The
Export Control and Travel website also has important information and tips to "
know before you go".
As UMBC begin to use the revised Rule, let us know if you have any questions. Contact us at
compliance@umbc.edu.
]]>
As the ORPC prepares for the January 21, 2019 compliance date of the revised Common Rule, all current IRB documents will be taken off line 3:00 pm EST on January 18, 2019. Revised forms and...
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Mon, 14 Jan 2019 11:14:21 -0500
Tue, 27 Apr 2021 11:55:49 -0400
Revisions to the Common Rule - II
The January 21 2019 compliance date is fast approaching!
Here's information we've gleaned so far from guidance from the Office of Human Research Protections:
1) all non-exempt (expedited) protocols approved by the IRB before 1/21/19 will continue to follow pre-2018 provisions. This means continuing as normal, including continuing renewal of annual reports through the term of the approved projects. Currently enrolled participants will not need to be re-consented with a revised (2018 version) consent version.
2) new participants enrolled in current protocols continuing after 1/21/19 will need to be consented using the revised consent document format.
3) current exempt approved protocols will follow the above steps as well.
4) exempt and expedited protocols submitted on or after 1/21/19 will follow the new application forms and procedures.
The ORPC will be in contact the PIs by early next week informing them of the above.
The IRB webpages are continuing to be updated. These updated pages will be posted to the IRB website (as well as updates to application forms and consent templates) during the Jan 19-20 weekend.
Stay tuned to the IRB webpage for information and further updates.
]]>
Here's information we've gleaned so far from guidance from the Office of Human Research Protections: 1) all non-exempt (expedited) protocols approved by the IRB before 1/21/19 will continue to...
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Thu, 10 Jan 2019 21:16:19 -0500
Tue, 27 Apr 2021 11:55:58 -0400
The threat of China’s "Thousand Talents Program"
Specifically with research involving export control concerns
We've posted the FBI’s analysis of how this program poses a serious threat science and technology programs in US businesses and universities through economic espionage and theft of IP. One of the greatest threats is transferring or transporting proprietary, classified, or export-controlled information, or IP, which can lead to criminal charges.
Other related news items are:
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We've posted the FBI’s analysis of how this program poses a serious threat science and technology programs in US businesses and universities through economic espionage and theft of IP. One of the...
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Wed, 09 Jan 2019 14:09:10 -0500
Tue, 27 Apr 2021 11:56:08 -0400
Revisions to the Common Rule
The January 21 2019 compliance date is fast approaching!
Stay tuned to the IRB webpage for information, application and form changes and updates.
]]>
Stay tuned to the IRB webpage for information, application and form changes and updates.
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Mon, 07 Jan 2019 14:10:01 -0500
Tue, 27 Apr 2021 11:56:19 -0400
CITI Program Updates for the Revised Common Rule
As we have posted on the group page, the upcoming compliance date of January 21, 2019 adhering to the revisions to the Common Rule is quickly approaching. Stay tuned for
forthcoming information announcing the roll out of the updated IRB website and application forms. We anticipate performing these updates to coincide with the compliance date of January 21.
We also wanted to let you know that several human subjects use training modules on CITI Program website will be updated to reflect changes as a result of the revised Common Rule. CITI informs us their website will be taken off line in the evening of January 19 to modify the content of modules with revised Common Rule information . They expect the CITI Program website to be available to learners beginning the morning of January 20, 2019. No changes to module ID numbers or gradebooks (courses) are planned, so past course completion dates are to remain the same.
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As we have posted on the group page, the upcoming compliance date of January 21, 2019 adhering to the revisions to the Common Rule is quickly approaching. Stay tuned for forthcoming information...
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Thu, 06 Dec 2018 16:29:55 -0500
Tue, 27 Apr 2021 11:56:29 -0400
Kuali and Animal Research Review
UMBC is continuing to transition its research related processes
into the Kuali system. The Proposal Submission, Awards and Conflict of Interest
modules handling funding submissions and financial COI disclosures are already
live. The next steps in Kuali implementation are Protocols. Protocols will
replace the current paper/email based submission process for animal care and
use and human subjects research. For more information of the past integration
efforts, see Kuali at UMBC.
The next step of transition involves the IACUC part of the Kuali
Protocols module. The Office of Research Protections and Compliance
(ORPC) is in the process of configuring the Protocols module to mirror the
current animal research use protocol application process. Instead of submitting
paper, Protocols allows for submission of protocol applications via the Kuali
cloud-based system. Investigators can expect an improvement in review
processing time and more efficient communication with the staff of the ORPC. In
turn, compliance committee members will experience a more streamlined process
to review and ultimately approve animal research studies.
Estimated Kuali Protocols Timeline
1. Kuali inputs current UMBC IACUC forms in to system to create
on-line forms – September 2018
2. Kuali creates IACUC process configuration in the system- September
2018/October 2018
3. UMBC performs form testing and IACUC process review – October 2018
4. UMBC Identifies testing groups of IACUC stakeholders (department admins,
investigators, IACUC committee member) – November 2018
5. UMBC develops training manuals – November/December 2018
6. IACUC protocols Go Live – January 2019
7. IRB Scheduled for implementation in mid 2019?
Regarding #4 of the timeline, the ORPC is in search of testers
to help us ensure: 1) our investigators and research team members understand
the process of protocol submission in Kuali; 2) the process runs smoothly and
efficiently; and 3) that approvals of animal use protocols meet the
expectations of our faculty to conduct animal research. All work is done in
Kuali’s sandbox environment. If you’d like to help in this effort, or just kick
the tires, please contact us at compliance@umbc.edu.
The next phase of Protocol evolution involves human subjects
(the IRB). Stay tuned to this page for further developments.
For training information and to sign up for classes, visit Kuali Training
]]>
UMBC is continuing to transition its research related processes into the Kuali system. The Proposal Submission, Awards and Conflict of Interest modules handling funding submissions and financial...
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Mon, 05 Nov 2018 12:12:33 -0500
Tue, 27 Apr 2021 11:56:40 -0400
New staff in Office of Research Protections and Compliance
We are pleased to announce a new member of our compliance group in the Office of Research Protections and Compliance (ORPC).
Andy Glenn joined the OPRC on October 15 as a compliance specialist. Andy comes from the University of Maryland, Baltimore and brings his vast experience in facility management and protocol development as well as knowledge of research regulations and processes that can be applied to UMBC's compliance areas. He will work with Mary Lilly and myself in all areas managed by ORPC, but concentrate on animal care and use and bisoafety. Andy will also have an active role in conducting compliance education.
Say hi when you see Andy on campus; he can be reached at 3-5455 or
aglenn@umbc.edu.