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Announcements Compliance, Integrity & Safety

Any time a principal investigator vacates a lab, moves into a lab, or relocates to a different lab, an opening or closing form should be filed with the Office of Research Safety (ORS).

Information from the forms helps ORS properly track chemical inventories, perform accurate lab inspections, and monitor hazardous waste generation. It  helps ensure the accuracy of UGA’s chemical inventory system and helps maintain the safety of UGA faculty, students, and local first responders. The form for opening or closing/re-locating a lab can be submitted online.

More information, along with the opening & closing/re-locating forms can be found here: https://research.uga.edu/safety/chemical-laboratory/opening-closing-lab/

Questions: Contact Brandon Foskey,  Office of Research Safety,  706-542-9088

 

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Announcements Compliance, Integrity & Safety

When you hear “export control regulations,” your mind might conjure up images of professors behind bars for disclosing national secrets. Or, it could be an image of bewildering forms covered with government legal jargon. Neither is an attractive option.

But neither need be the case, said Dan Runge, UGA’s export compliance officer, who in 2014 joined the Office of Research Compliance in the Office of the Vice President for Research, to assure that UGA and its researchers can continue growing its international engagement while reducing the risk of violating national security concerns.

Chris King, associate vice president for research compliance, acknowledges that the regulation of export controls is an exceedingly complex area, in large part because it is governed by three different federal agencies with overlapping—and sometime contradictory—rules and guidance.

“A few years ago, we realized that UGA’s burgeoning international engagement in research, teaching and outreach along with an expanding scope of research in engineering, biological, agricultural, veterinary and marine sciences was creating export control risks,” King said.

A 2013 study commissioned by Vice President for Research David Lee confirmed those risks and paved the way for a set of recommendations to mitigate the institution’s risk while minimizing the burden to researchers and others.

The key recommendation of the study was to dedicate a staff resource—an export compliance professional—to develop “user-friendly” control procedures and implement these in a way that supports compliance while not impeding research and business activities.

Before coming to UGA, Runge worked in law school admissions at Texas Tech University School of Law and as a prosecutor in Kansas state court. His bachelor’s degree in history; a law degree from the University of Kansas; and a Master of Laws in International Law, with an emphasis in international trade and business, from the University of San Diego, prepared him to deal with the intricacies of export control law in UGA’s academic and research environment.

“Dan has the perfect balance of technical knowledge, abilities in project management and interpersonal skills to be successful in building UGA’s export compliance program,” King said.

Runge has been instrumental in building awareness of export controls and, in addition to creating right-sized policies and procedures, he has created a campuswide network of knowledgeable individuals who serve as “eyes and ears” in proactively and cohesively managing UGA’s export control obligations.

He recently explained his job in an interview in UGA’s Columns:

Columns: In a nutshell, what is export compliance?
Runge: Export compliance assures that research limited to participation by U.S. persons only, access to equipment limited to U.S. persons only and exports of equipment or information comply with federal law.

Columns: What does export compliance mean for UGA researchers?
Runge: Export compliance is not a bar to research or international activities. The researcher and his or her lab will simply need to follow guidelines from the Export Control Office related to access to restricted research or equipment, or travel to sanctioned or embargoed countries. The Export Control Office facilitates university activities in a way that limits risks and burdens on the UGA community.

Columns: When should a researcher worry? What about travel?
Runge: Export control has an impact on UGA research when sponsored research includes limitations on foreign national participation or publication for national security or proprietary reasons. Research without these restrictions is considered “fundamental research” and is excluded from control. However, “fundamental research” may still be subject to control if it involves the export, even temporarily, of controlled equipment, or access to or use of controlled equipment by foreign nationals. Controlled items will have dual commercial and military use or be a defense article or service with distinct defense applications.

Export controls have an impact on international travel when university equipment or research information is taken abroad, if the equipment or research is export controlled. Additionally, economic sanctions may limit travel to and activities in certain destinations, such as Cuba, Iran and Sudan, or transactions with certain sanctioned parties.

Columns: It sounds like most of the research conducted at UGA is excluded from these controls.
Runge: That’s right. The fundamental research exclusion is available except when foreign national participation and/or certain publication limitations are applicable. While these restrictions are generally the exception, the Export Control Office will be available to facilitate compliance. Research equipment, in limited circumstances, may still be subject to controls even when engaging in fundamental research.

Columns: Are UGA researchers the only ones who need to be concerned?
Runge: At the outset of building the export control compliance program, the focus was on research efforts. It rapidly became apparent that this was a universitywide issue that created potential risks and responsibilities in many academic departments as well as units as diverse as EITS, Biosafety, Sponsored Projects, Office of Legal Affairs, Technology Commercialization, Procurement, Accounts Payable, International Education and HR, among others. The Export Control Office has worked with these units to raise awareness and implement process as needed.

Columns: Is export compliance a “when in doubt, call us” kind of thing?
Runge: Yes. There are no dumb questions when it comes to export controls or sanctions compliance.

The Export Control Office is receptive to questions and willing to discuss concerns. To find out more, contact the Export Compliance Office at 706-542-4188, email me at drunge@uga.edu or visit https://research.uga.edu/export-control.

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Announcements Compliance, Integrity & Safety

New UGA policies and safety training courses aimed at promoting a culture of health and safety at UGA were announced in April.

The policies address UGA’s commitment to provide a safe workplace for all UGA students, faculty, staff, administrators and visitors, and provide the administrative processes and policies to support a culture of safety by defining roles and responsibilities and ensuring accountability. The policies apply to all stakeholders at UGA.

“Safety belongs to everyone, not just a few,” said Chris King, Associate Vice President for Research Compliance, Office of the Vice President for Research.

“Education is a key component of assuring a safe secure environment in which to conduct research,” he continued. “The new policies assure that all lab personnel have the consistent training that makes for a safe workplace.”

Links to the first required safety course were sent to faculty on March 21 and staff links were sent on April 18.

King noted that while many faculty have years of experience in safe lab practices, the training will provide a consistent baseline and assure that training for all is documented.  Faculty participation in the training also will assure that those who supervise students will be familiar with the content of the training required for personnel in laboratory spaces.  Individuals not involved in laboratory work can opt out of the training via a preliminary one-question qualifier quiz.

Questions about EHS training can be directed to Lisa Kelly, lmkelly@uga.edu.

Policy 6.01, “Environmental Health and Safety,” and Policy 6.02, “Policy and Procedures for Adoption and Ongoing Review of the University of Georgia’s Comprehensive Environmental Health and Safety Management System and Roles and Responsibilities.”

Policies can be found in the Academic Affairs Policy Manual, and on other websites, including Office of the Vice President for Research, Office of the Vice President for Finance and Administration, and the Environmental Health and Safety Division.

 

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Announcements Compliance, Integrity & Safety

Office of Biosafety has recently updated its webpage with the latest information on NIH Guidelines for Recombinant or Synethetic Nucleic Acid Molecules.

NIH Guidelines for Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) is a set of federal guidelines that specify the practices for constructing and handling (i) recombinant nucleic acid molecules; (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules; and (iii) cells, organisms, and viruses containing such molecules.

ALL recombinant DNA research conducted at UGA, irrespective of the source of funding, must be reviewed by the Institutional Biosafety Committee (IBC) as a condition for UGA to receive NIH funding. Noncompliance with this requirement jeopardizes all NIH funding for recombinant DNA research at UGA .

To help UGA researchers understand these requirements and requirements associated with recombinant DNA research at UGA, the Office of Biosafety has recently updated the IBC webpage. These updates include the most recent version of the NIH Guidelines, an introduction to the NIH Guidelines and IBC responsibilities, FAQs on reporting of incidents involving  rDNA, and training on Dual Use Research of Concern (DURC).

The University IBC has the responsibility of assessing the safety of research involving biological agents and recombinant DNA to identify potential risks to personnel, the public, or the environment through the review and approval of proposed activities.

Prior to commencement of work, the UGA IBC must approve any teaching or research projects that involve the use of:

  • Recombinant DNA, including transgenic animals, plants, or invertebrate organisms
  • BSL2 or higher human or zoonotic pathogens
  • Animal pathogens that cause diseases reportable to the State Veterinarian
  • Plant pathogens that have not been established in the State
  • Any work involving a select agent or toxin

If you have any questions regarding any of this information, please contact Nancy Mead (IBC Coordinator) at ngm@uga.edu or Patrick Stockton (Director of Biosafety) at pstock@uga.edu.

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Announcements Compliance, Integrity & Safety

The Institutional Review Board (IRB) and Human Subjects Office, Office of the Vice President for Research,  is pleased to announce the new Chair of the IRB, Dr. Gerald E. Crites.

Dr. Crites is a professor of medicine and director of program evaluation and educational research at the GRU/UGA Medical Partnership. His scholarly interests include curriculum design and evaluation and evidence-based health care.  Dr. Crites has served on the IRB since 2012.

 

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Announcements Compliance, Integrity & Safety

The offices overseeing research safety and environmental safety at UGA have reorganized to better assure compliance with UGA, local, state, and national research and environmental safety regulations. These offices provide guidance to UGA faculty, staff and students with the goal of protecting safety, health and the environment and, wherever possible, reducing regulatory burden.

Chemical & Laboratory Safety, Radiation Safety and Special Hazards Safety now comprise the new Office of Research Safety (ORS), a unit of the Office of Research Integrity and Safety (ORIS). The three units, previously part of the Environmental Safety Division (ESD), report to Zeke Barrera, director of the ORS. They have temporarily relocated to the building known as the Electronics Shop, located behind Hardman Hall, on South Campus. Office of Research Safety reports to Chris King, associate vice president for research compliance/OVPR.

A new Research Safety website https://research.uga.edu/safety provides clear organization of information for researchers, staff and faculty looking for policies, guidelines, forms and tools related to chemical and laboratory safety, radiation safety and special hazards.

Environmental Compliance, Environmental Health & Food Safety, and Industrial Hygiene continue to report to John McCollum, associate vice president of Environmental Safety Division, Finance & Administration. The three environmental safety offices are located in the ESD building on Riverbend Road. All forms, policies and procedures related to those offices remain on the ESD website https://esd.uga.edu/

The reorganization will enable UGA to better assist researchers and students through cross-training of staff within the research safety and the environmental safety offices, and through better communication with researchers about compliance requirements. Office of Research Safety and Environmental Safety Division will continue to work closely together.

A new Research Integrity & Safety Support Services https://research.uga.edu/compliance-training/ includes mandatory training and additional training opportunities for UGA researchers, staff and students who work with laboratory chemicals, radioactive materials and lasers. It also includes training for those using respirators; personal protective equipment (PPE), fire extinguisher and fire safety training, and hazardous material shipping information and resources.

 

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Announcements Compliance, Integrity & Safety

Beginning in January, the review of human subjects protocols that typically require review by the convened UGA IRB (Full Board) will be delegated to Western IRB (WIRB), a commercial IRB.  This review arrangement is temporary and will last for the next four to six months.

Very few studies will be affected by this change since only about 3 percent of IRB protocols require Full Board review.

The OVPR has engaged WIRB review services to allow the IRB to advance major initiatives that will strengthen the University’s human subjects protections program.  These initiatives include enhancing the e-Research Portal for IRB, training two new employees, developing policies and procedures, and taking definitive steps to achieve accreditation of the human subjects protection program.  Since Full Board reviews are lengthy, rigorous and time-consuming, this review arrangement will enable the IRB to focus on these initiatives and, more importantly, ensure the review of the majority of the submissions is done expeditiously.

Please contact the Human Subjects Office at irb@uga.edu or 706.542.3199 for questions or WIRB submission details.

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Announcements Compliance, Integrity & Safety

In an effort to reduce regulatory burden for investigators, the NIH and USDA recently issued new guidance regarding the review process required for significant changes (Amendments) to approved Animal Use Protocols (AUP). The use of IACUC-reviewed and approved policies may now be used for the administrative handling of many significant changes. Recognizing the value of performance standards and professional judgment, this new guidance allows the following types of Amendments to be implemented simply following consultation and verification by the Attending Veterinarian:

1.) changes in anesthesia, analgesia, sedation or experimental substances
2.) changes from one AVMA-approved method of euthanasia to another
3.) changes in duration, frequency, type or number of procedures performed on an animal (provided the change does not result in greater pain or distress, doesn’t change from a nonsurvival to a survival surgery or doesn’t impact study objective or the safety of personnel)

This new Veterinary Verification and Consultation (VVC) process will allow Amendment approval without typical IACUC-review regardless of the AUP category. The VCC process will result in a significant reduction in paperwork associated with study modifications and a faster turn-around time for approval. The decision on whether or not an Amendment meets the criteria for the VCC process is at the sole discretion of the Attending Veterinarian.

Furthermore, and with perhaps more impact on reducing burden, this new guidance also allows for the reference of approved IACUC policies on an AUP in lieu of detailed descriptions. Policies like the “Common Technical Procedures” on the IACUC website can now be referenced in an AUP without inclusion of a full procedure description. The IACUC is currently in the process of expanding its policies to include more reference materials that can be used in protocols. You can find a full listing of IACUC-approved policies on the website at https://research.uga.edu/oacu/iacuc

For additional information, please contact the Office of Animal Care and Use or the IACUC at iacuc@uga.edu You can also find out more from your Attending Veterinarian.

 

 

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Announcements Compliance, Integrity & Safety

UGA is taking deliberate steps to enhance its export control compliance program, with the goal of facilitating compliance by the research community.

Export controls are the U.S. laws and regulations that govern the transfer of controlled items or information to foreign nationals, countries, and entities for reasons of national security and foreign policy. Compliance enhancements include the addition of a dedicated export control compliance officer within the Office of the Vice President for Research, and the development of user-friendly export procedures, awareness training, and an export control website that provides compliance related information.

Export controls are implicated in the physical international shipment of controlled items, the disclosure of controlled information to foreign nationals on the UGA campus, and in transactions with sanctioned parties.

Please contact Dan Runge, Export Compliance Officer, at 542-4188 or drunge@uga.edu if you have questions or concerns.

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Announcements Compliance, Integrity & Safety

The University of Georgia Institutional Review Board (IRB) has instituted new procedures that streamline the review of human subjects research qualifying for exempt review.  UGA recently joined the Flexibility Coalition, a group consisting of major U.S. research institutions and medical centers that has a major goal of identifying “flexibility” measures that institutions can implement in the IRB review to reduce regulatory burden for researchers and/or workload for IRBs without diminishing human subject protections.  This flexibility is permitted for an institution that has limited the scope of its Federalwide Assurance (FWA) for the Protection of Human Subjects to federally sponsored research.  UGA is one of those institutions, which means that it is allowed a degree of flexibility in the review and oversight of unfunded research involving no risk or no greater than minimal risk to the participants.

As its first flexibility initiative, UGA IRB has approved the addition of two new “Flex” Exempt categories for non-federally funded studies.  Also, only certain modifications to exempt research will now require IRB review and approval.  These changes are all embodied in the new Policies and Procedures for Exempt Review available at https://research.uga.edu/docs/policies/compliance/hso/IRB-Exempt-Review.pdf.

The Human Subjects Office (HSO) and the IRB are committed to continuously improving our human research protection program and identifying opportunities for flexibility within the IRB review process.  If you have any questions or suggestions, please feel free to contact the HSO Director, Dr. Benilda Pooser at bpooser@uga.edu or 706.542.3199, or the IRB Chair, Dr. Larry Nackerud, at nackerud@uga.edu.

 

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