The Human Research Protection Program professionals provide guidance and support for students and staff developing submissions for IRB review. They can provide guidance on: completing online submission forms; drafting recruitment materials and describing recruitment processes; drafting consent materials; describing data management processes; and collaborations with other entities. Make an appointment using the Support Appointment Form.
By Ian Bennett
Dan Runge has been named director of the newly recreated Office of Research Security & Export Control in the Office of Research. Runge has worked in research compliance at UGA since 2014, previously serving as the export compliance officer.
In his new position, Runge will work to ensure that federally funded research activity at UGA meets evolving federal mandates for the creation of a “research security program.” Additionally, he will help develop the safeguarding requirements for controlled unclassified and classified information.
The research security program is required by federal funding agencies for universities that receive more than $50 million in federally funded research per year by National Security Presidential Memorandum-33. NSPM-33’s requirements will apply to all federally funded research that UGA performs.
“While the safeguarding requirements for controlled unclassified and classified information apply to a narrower research portfolio, it is expanding. This new position will work with stakeholders across campus on cybersecurity, foreign travel security and research security training,” said Runge, who started in his new appointment on May 23.
Runge will continue to provide guidance and training for compliance with federal export control and economic sanctions regulations. These regulations govern the transfer of controlled items abroad, or the access to controlled information by foreign nationals in the United States. These federal regulations exist to protect U.S. national security and foreign policy interests.
Export controls are usually implicated when the research, or research tool or equipment, has military or certain dual military and commercial application. Certain university activity may also be restricted by U.S. economic sanctions.
“Any item, whether it’s a commodity, software, technology, equipment or information that is sent, or hand-carried, from the U.S. to a foreign destination, or accessed by a foreign national within the U.S., can fall under export control rules,” said Runge.
Previously, Runge held positions at Texas Tech University and as a prosecutor in Kansas. He earned an LL.M. at the University of San Diego, his J.D. at the University of Kansas, , and a B.S. at Kansas State University.
The newly created office directed by Runge will implement compliance procedures and policies so that UGA appropriately follows these federal research security and export control regulations.
“It’s important that we have this position because it allows us to coordinate across the university. In a lot of cases, the systems to meet these new requirements already exist, but before Dan’s promotion, we didn’t have the ability to coordinate and standardize these practices,” said Martin Bink, director of defense and security collaborations, who serves as UGA’s designated facility security officer. “With Dan’s background in law and export controls, he is particularly qualified to head this up, and we’re excited to have him in this position.”
A new Office of Research Security and Export Controls (ORSEC) is on the horizon within the Office of Research. Under the Office of Research Integrity and Safety umbrella, ORSEC will continue its export controls and economic sanctions compliance mandate while responding to new and evolving federal guidelines related to research security requirements for federally funded research.
ORSEC also will further shepherd compliance with heightened security and safeguarding requirements when the institution performs certain restricted research projects. As UGA steps up its sponsored research activity with federal “mission agencies” such as the Department of Defense, ORSEC’s responsibilities will become even more important.
The establishment of ORSEC is driven mainly by the research security requirements as outlined in National Security Presidential Memorandum-33 and associated agency implementation guidance. These new federal mandates will require the development of a formal research security program, applicable across research funded by all federal agencies. The research security program will include elements of cybersecurity, foreign travel security, research security training, and, where appropriate, export control training. Additionally, ORSEC will work to ensure that research requiring heightened safeguarding meets federal requirements for safeguarding controlled unclassified and classified information. Marty Bink serves as the facility security officer and the director of defense and secure collaborations in the Office of Research. In his facility security role, Bink will work closely with the ORSEC director as facility security responsibility transitions into that office.
ORSEC will also work closely with Gene Pope and the Office of Conflicts of Interest Review and Management regarding disclosure and reporting obligations mandated in NSPM-33 related to conflicts of interest, conflicts of commitment, and outside activities and affiliations.
More information, including an updated website, an outreach and education effort, and new policy or process, will be communicated to the research and university community over the coming months.
Starting May 23, Dan Runge will serve as the director of ORSEC. Dan has worked in research compliance at UGA since 2014. He is a member of the Association of University Export Control Officers and earned a bachelor of science from Kansas State University, a law degree from the University of Kansas, and a master of laws in international law from the University of San Diego. Runge was a prosecutor when he practiced law in Kansas.
Attention human research investigators: We recognize and value UGA investigators’ experience and expertise in conducting research projects. Further, we understand the demands on researchers’ time, and we strive to create systems and infrastructure that provide a high level of research project management support. However, the PI is ultimately accountable for ensuring that individual research projects meet all reporting and approval requirements. While the IRB portal is programmed to send courtesy reminders at 90, 60 and 30 days prior to a study’s expiration date, this system does not replace the responsibility of PIs to be aware of the approval period for research studies.
We strongly urge investigators to have multiple tools and safeguards to ensure that they meet regulatory and institutional requirements pertaining to continuing review and maintaining approval of human research projects. Setting up calendar reminders for 30 days prior to study expiration is one possible method.
Please remember that all human research procedures related to the approved project must stop when approval expires until a new approval period is granted. When research activities are complete, the PI is responsible for closing the project in the IRB portal, even if the project was for a student’s thesis or dissertation.
Please contact the Human Subject Office at IRB@uga.edu or 706-542-3199 if you have any questions about continuing review and expiration of IRB approval. More information is available in our Policies and Procedures and on the Human Research Protection Program website.
The U.S. government imposes comprehensive economic sanctions and trade embargoes on Cuba, Iran, North Korea, Syria and the Crimea, Donetsk, and Luhansk regions of Ukraine. These restrictions limit nearly all imports and exports of technology, goods and services involving those countries. Services are very broadly defined and include prohibitions on participating in academic conferences in Iran and tourist travel to Cuba, for example. Travel to North Korea by U.S. citizens is, for all intents and purposes, prohibited.
Additionally, the U.S. has recently subjected Belarus and Russia to significantly expanded export controls and economic sanctions. While not comprehensively sanctioned, both countries are subject to significant controls on the import and export of technology, goods,and services.
China and Venezuela are also subject to heighted controls on end-users in those countries.
It is particularly important that activities involving these high-risk countries receive export control review. UGA personnel may contact Dan Runge, in the Office of Export Control, at email@example.com or 2-4188 to discuss travel, shipping and activities involving these countries.
The Office of Export Control can provide in-person or video conference training for international shippers on compliance with export controls and economic sanctions. Details about export control training are available here. University personnel that engage in international shipping are strongly encouraged to complete the “Export Compliance for International Shipping” CITI module available via the Professional Education Portal (PEP). The CITI modules are available by searching for Export Compliance in the PEP search bar.
All university personnel engaging in international shipping on behalf of UGA should request review of international shipments by the Office of Export Control prior to shipment. Anything you ship abroad is considered an export. Export shipments of equipment, tools or research materials, for example, may be submitted for review via the “International Shipping Export Control Review” form. Further details about international shipping are available here.
Please contact Dan Runge, in the Office of Export Control, at firstname.lastname@example.org or 2-4188 if you have questions or concerns.
In response to the change in UGA RIF requirements, the Office of Postdoctoral Affairs has revised its policy and guidelines for postdoc appointments and terminations.
In addition to no longer requiring an RIF for grant-funded postdocs, units now have two distinct options for postdoc appointments: defined term and open term. Faculty/units can choose which best suits their needs based on the nature of the funding available. The defined-term option requires an up-front defined end date and formal continuation letters, and has less notice requirement at the time of separation, while the open-term option does not require a defined end date or formal continuation letters, but requires additional notice at termination (and may be subject to RIF if the position is state funded).
Details of these changes can be found on pages 3 and 4 of the updated UGA Policy for Postdoctoral Appointments, found here. Updated templates for both defined-term and open-term offer letters can be found here and must be used for all new postdoctoral appointments effective April 11, 2022.
Supports teams of three or more PIs to cross boundaries of interdisciplinary collaboration to elucidate the contributions of dynamic circuit activity to a specific behavioral or neural system.
Deadline: June 14, 2022
Shelly Terrazas and Amy Ware have been recruited to positions in the Office of Research. Terrazas is the newly appointed director of finance and human resources, and Ware will serve as special assistant to the vice president for research.
Terrazas, who began her new appointment on March 1, comes to the Office of Research from the School of Public and International Affairs, where she served as director of finance and administration for three years. Prior to working at SPIA, Terrazas held positions at Emory University, The Carter Center and Georgia Tech. She earned an M.B.A. at Georgia State University, an M.S. at Georgia Tech and a B.A. at Centre College.
Ware, who has a start date of March 15, is the assistant director for research communications in the Office of Research, where she has worked for more than eight years. Previously, she worked at P.I.E. Medical LLC, The Summit Agency and Athens Food and Culture Magazine. Ware earned a B.F.A. at Louisiana State University and is pursuing an M.P.A. at UGA.
“I am pleased to welcome Shelly to the senior leadership team in the Office of Research, and I am excited at the wealth of knowledge and enthusiasm she brings. I am also pleased to welcome Amy; her years of experience in research communications and interacting with UGA scholars make her uniquely suited for this new position, which will involve working across disciplines to facilitate research” said Karen Burg, vice president for research. “I look forward to collaborating with each of them.”
For NEW projects beginning on or after April 1, 2022, Principal Investigators will begin receiving monthly, automated project balance snapshots in the form of the Project Status Report (PSR) Lite. This report, designed by PIs for PIs, is like a bank statement that includes direct cost budget, actual expenses and remaining balance. It also shows recent transactions and recent payroll, with the option to drill down for additional information. The automatic subscription process will apply to new awards, and PIs also have the option create a subscription for existing projects. PIs will receive these updates on the 10th of each month. If you have any questions, please contact the Sponsored Projects Administration team.