Categories
Announcements Compliance, Integrity & Safety Uncategorized

Before engaging in an international shipment, UGA personnel should contact the Office of Export Control to request review of the shipment. This review will ensure an export license is not needed for the equipment or research material (including pathogens, toxins and biologicals, for example) and a due diligence review of the end-use and end-user at the foreign destination.

The Department of Commerce has taken export enforcement actions, including monetary settlements, against U.S. academic institutions for unlicensed export of strains and recombinants of animal pathogens to non-U.S. research institutions, as well as for shipments of basic research equipment to embargoed non-U.S. research institutions.

Please contact Dan Runge at drunge@uga.edu to begin any international shipment review.

Further detailed information about international shipping is available here and a list of export controlled items, software, and technology is available here. Any export classification process should include review by the Office of Export Control.

Categories
Announcements Compliance, Integrity & Safety

Many researchers are unsure of what to do when their fume hood alarms or ceases to work entirely. Some fear that any repairs are their financial responsibility, so necessary services are often neglected, leading to potential safety concerns and possible exposures. However, most fume hood repairs and maintenance at UGA are covered under a campus-wide contract. To take advantage of this readily available service, the lab only needs to submit a work order through the Facilities work request system describing the problem and location of the hood. More information can be found on this quick reference guide or by calling the Office of Research Safety at 706-542-5288.

Categories
Announcements Compliance, Integrity & Safety

NIH’s Office of Laboratory Animal Welfare (OLAW) has notified institutions that the new 2020 AVMA Guidelines on Euthanasia of Animals are to be implemented October 1, 2020. After October 1, 2020, grant applications and contract proposals must be consistent with the AVMA 2020 Guidelines.

The main change that will affect the most researchers is the method of CO2 exposure for rodents. The new required CO2 displacement rate is 30-70% of the chamber volume/minute.

Note that the UGA IACUC Policy on Rodent Euthanasia Using Carbon Dioxide has already been updated to reflect the new requirements.

Instructions posted at CO2 euthanasia stations should no longer reflect the old flow rate range, and must reflect the new required flow rate range.

Categories
Announcements Compliance, Integrity & Safety

The Office for Human Research Protections (OHRP) has posted on its website a set of decision charts that are consistent with the 2018 Requirements (i.e. the revised Common Rule). The decision charts are necessarily generalizations and may not be specific enough for particular situations. The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, the National Institutes of Health, other sponsors, or state or local governments. These decision charts can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html.

Categories
Announcements Compliance, Integrity & Safety

The Human Research Protection Program (HRPP) has developed a Toolkit for researchers who are planning to resume in-person research activities involving human participants. Please look for forms and materials on the HRPP website or in the IRB Portal Library. Contact IRB@uga.edu if you have any questions.

Categories
Announcements Compliance, Integrity & Safety

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 https://research.uga.edu/hrpp/.

Categories
Announcements Compliance, Integrity & Safety

In order to improve animal welfare and research outcomes, the IACUC will require specific online training, beginning July 1, 2019, for all persons on protocols that involve rodent surgery and/or general anesthesia.

What researchers need to know about this mandatory training:

  • Starting July 1, 2019, training will be required for all personnel on Animal Use Protocols (AUPs) that include survival surgical procedures on rodents and/or general anesthesia of rodents.
    • Training validation will be required for approval of new AUPs and Annual Renewals.
    • For amendments adding new personnel, the new personnel will need to complete this training to be added to the AUP.
  • The required training is the online training module, “LAT 13: Aseptic Technique and Surgical Support and Anesthesia”, in the Professional Education Portal (PEP).
  • Individuals only need to complete this training module one time. There will be no expirations or repeat expectations for this course.

This course is already available via PEP for anyone that would like to take this training proactively. You can find the course by searching for “LAT 13” or “surgical support” from the search bar in the upper right corner of the PEP dashboard. Principal investigators can assign this course in PEP to personnel on their AUPs effective immediately. For assistance with assigning training to your personnel, please contact the Office of Research Integrity and Safety Support Services at pep@uga.edu.

Categories
Announcements Compliance, Integrity & Safety

The Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services released a new informational video that describes social and behavioral health research (SBER) and explains how it is different from biomedical research. The video is for potential participants and is designed to help them consider whether or not they want to participate in research. Researchers may also find this helpful when designing consent processes and materials. View the SBER in English. Watch video: www.youtube.com/watch?v=CGOYerqfsNc&feature=youtu.be

Categories
Announcements Compliance, Integrity & Safety Find Funding

The Final Rule includes a new definition of research and identifies scholarly and journalistic activities as categories deemed not to be research. The new definition of research excludes “scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected… It is not the particular field that removes the activity from the definition, but rather that the purpose and design of the particular activity is to focus on specific individuals and not to extend the activity’s findings to other individuals or groups… For example, a medical case report could fall within this category, if the point of the report were to describe an unusual and interesting case-specific medical complaint and its treatment.” In contrast, if a purpose of a project is to gather information from individuals in order to understand the beliefs, customs and practices, not only of those individuals, but also of the community or group to which they belong, the project would be deemed research according to the new definition.

For more information about the Final Rule and upcoming changes, visit the HRPP website or contact the Human Subjects Office at 706-542-3199 or IRB@uga.edu.

Categories
Announcements Compliance, Integrity & Safety

The Revised Common Rule for the protection of human subjects in research includes new consent requirements. Key Information (information that presents the most important information to consider if you are thinking about enrolling in a research project) must be presented at the beginning of the consent document. 

Find the new templates and samples: https://research.uga.edu/documents/#hso