University of Georgia

Category: Compliance, Integrity & Safety

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Compliance, Integrity & Safety

The Human Subjects Office and the Institutional Review Board (IRB) would like to clarify information on IRB submissions regarding “Primary Contact.”

It seems that there is some confusion about who should be listed as the Primary Contact on the protocol. The “Primary Contact” is the person that will receive all key correspondence related to the submission.  This does not necessarily have to be the “Principal Investigator.”  Note that in cases where the protocol is being submitted for a student thesis or dissertation, the student should be listed as the “Primary Contact.”  The Principal Investigator will always receive all correspondence, whether or not he/she is listed as the Primary Contact.

If you have any questions related to this issue or other issues in the submission of a Human Subject Research Protocol, please contact the Human Subjects Office at IRB@uga.edu or 706-542-3199.

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Compliance, Integrity & Safety

Are there areas of research compliance that you don’t understand?  Are your students confused on requirements or procedures related to federal regulation?  Does your research involve human subjects, research animals, biosafety or quality assurance?

Training is now available through the Office of Research Compliance.  We are eager to know of your educational needs as we work to develop new training programs and outreach initiatives.  If you have any suggestions or requests, please contact Lisa Kelly, Compliance Training Coordinator at lmkelly@uga.edu

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Compliance, Integrity & Safety

Investigators who are collaborating with individuals not affiliated with UGA or any institution with an IRB (e.g., local schools and private doctors’ clinics), must inform collaborators to contact the Human Subjects Office (see contact information below) to obtain an affiliate account to access the required CITI training.

Individuals who have never registered or created a CITI account are requested to use the UGA CITI Login Portal found at https://gear.ovpr.uga.edu/applications-and-databases/uga-citi-login-portal/.  Additional information and FAQs with answers to commonly asked training questions are found also in the portal and at  https://research.uga.edu/hrpp/citi-training/

If you have other questions related to the IRB training, please contact the Human Subjects Office at irb@uga.edu or 706.542.3199.  For technical problems with the CITI site or course, please contact the CITI Office at citisupport@med.miami.edu or 305.243.7970.

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Compliance, Integrity & Safety

Several new and revised animal care and use policies were made over the last year by the UGA IACUC in response to important changes to two key benchmark documents: the NIH Guide for the Care and Use of Laboratory Animals and the AVMA Guidelines for the Euthanasia of Animals.

Following are summaries and links to the new/revised policies. Complete information can be found on the IACUC website.

Acclimation of animals after arrival at UGA. This pertains to ALL research or instruction projects. The standard acclimation period (before any procedures can be performed) is seven days.

Anesthesia and surgery. This pertains to any project which involves anesthesia OR surgery. There are very specific requirements for written documentation of anesthesia (with or without surgery) and surgery. Surgery records must permanently remain in the animal’s record, and the records must be in the same room with the animal until it is euthanized.

Satellite animal facilities. This pertains to animals being housed outside of a standard URAR animal facility or farm, and research teams providing husbandry for their animals.

Reporting unanticipated research outcomes.   Principal investigators must report unanticipated outcomes and/or adverse experimental events to the IACUC.

Social housing policy.   According to the new Guide, single housing of social animal species is now considered the exception, not the default. There are legitimate exceptions to this, as outlined in the policy. However, these exceptions should be reviewed and approved by the IACUC and/or by the attending veterinarian for laboratory animals (for medical or behavioral reasons).

Visitor policy (revised).

AUP-to-AUP transfer form.
The Office of Animal Care and Use and the IACUC appreciate your understanding and patience as we continuously coevolve with ever-changing compliance requirements.  If you have any questions or concerns, please contact the office at IACUC@uga.edu

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Compliance, Integrity & Safety

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The Office of Animal Care and Use and the Office of Human Subjects are moving to new administrative spaces  on the 6th floor of the Boyd Graduate Studies building.  The Office of Animal Care and Use will now be located in Room 624, and the Office of Human Subjects will now be located in Room 621.

Additionally, telephone service may be interrupted during this move.  Those needing assistance from either office during the next few weeks are encouraged to email the Office of Animal Care and Use at iacuc@uga.edu or the Office of Human Subjects at irb@uga.edu.  Thank you for your understanding and patience during this transition.

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Compliance, Integrity & Safety

The use of Animal Care (Artemis) and Human Subjects (IRB Click) software solutions are allowing the tracking, measuring, and reporting of compliance protocol approval times.  Average throughput times for the IACUC are now available for Calendar Year 2013. For example, the overall average throughput of the 230 new animal use protocols submitted in CY2013 was 35 days.

Additional detailed data for the IACUC and IRB will be available in the near future.  Data for Biosafety protocols (IBC) will start to be collected with the launch of IBC Click software later this year.  Eventually all these data will be posted in a dashboard view on the Research Compliance home page.

For more information contact Chris King at cking@uga.edu.

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Compliance, Integrity & Safety

The Office of Animal Care and Use is available to UGA researchers for one on one guidance when completing an Animal Use Protocol (AUP).

Whether you are a new researcher to campus, have a complex protocol, or would just like to have a better understanding of the protocol and the review process, please don’t hesitate to contact the Office of Animal Care and Use at 706-542-5933 or IACUC@uga.edu.

For those needing hands on training for handling or procedures, the training coordinator is here to help.  You can contact the Research Compliance training coordinator at 706-583-0816 or ANITRAIN@uga.edu.

 

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Compliance, Integrity & Safety

Effective January 1, 2014, projects or activities involving human subjects that will be conducted by students to satisfy the requirements for a course and are only being carried out for teaching or training purposes (e.g., research methodology courses) will no longer need to be submitted to the Human Subjects Office (HSO).

These projects do not meet the federal definition of human subjects research and are outside the purview of the University of Georgia Institutional Review Board (IRB).  As with any instructional activity, the course instructor is responsible for providing the oversight and guidance to students for these types of class projects.  It is, however, expected that all these activities will uphold the principles of ethical treatment and respect, and ensure the safety and protection, of the individuals who will be involved in these projects.  When a class project meets the definition of human subjects research, this activity must be reviewed by the IRB.  Masters or doctoral theses involving human participants meet the definition of human research and must be submitted for IRB review.

The new policy, including relevant definitions and faculty/student responsibilities for the conduct of class projects, is described in detail at IRB Guidelines XII.

The HSO professional staff, upon request, can provide educational seminars/training sessions for faculty, staff, and students on this topic or other IRB matters.  For questions or guidance related to this policy change or to schedule an educational seminar/training session, please call 706.542.3199 or email irb@uga.edu.

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Compliance, Integrity & Safety

To facilitate the preparation of Animal Use Protocols, UGA’s Institutional Animal Care and Use Committee (IACUC) has recently endorsed a variety of commonly used technical procedures for basic animal research.  Details of these procedures are available on the Animal Care and Use website at https://ovpr.uga.edu/oacu/procedures

Abstracts of these procedures can be cut and pasted directly into an Animal Use Protocol.  Since the procedures are pre-reviewed, this step will reduce the time associated with regulatory evaluation.  The abstracts for use in protocols can be found at https://ovpr.uga.edu/oacu/procedures/#abstracts

These procedures are not meant to serve as the complete listing of acceptable techniques.  Other, equally appropriate techniques, can be similarly employed with IACUC approval.  Any deviations from the endorsed procedures or any alternate procedures should be discussed with the Attending Veterinarian.

Additional procedures and related-species are planned for future editions and updates to this list.  For questions related to these procedures, please contact the Research Compliance Training Coordinator at anitrain@uga.edu

 

 

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Compliance, Integrity & Safety

Beginning in 2014, the Institutional Animal Care and Use Committee (IACUC) will require all personnel listed on an Animal Use Protocol to complete at least 1 hour of continuing education (CE) related to animal use in research every 3 years.  This additional hour of CE supplements the existing requirement to update every 3 years the basic animal care and use training with the “UGA IACUC 101 Refresher.”  The CE requirements are the result of new regulatory guidance that specifies the need for ongoing education with documentation.  The IACUC has been charged with the oversight of these new requirements.

This additional hour of CE can come from a variety of sources but must be specifically related to the use of animals in research. The CEU can be satisfied through relevant coursework, seminars, lectures, and webinars as long as documentation can be provided. The hour can also be completed through online coursework using the American Association for Laboratory Animal Science (AALAS) Learning Library at www.aalaslearninglibrary.org.  A unique Username and Password is required.   Accounts are provided free-of-charge to all personnel engaged in animal-based research at UGA. The training course, “Staying Healthy While Working with Laboratory Animals” can also be used to meet this requirement provided that credit occurred within the last 3 years.

2014 Animal Use Protocols and Renewals will be placed on Training Hold if any personnel on the protocol have not received this CE credit on their training transcript.  Any documented training done in 2013 or 2014 will be eligible for the 2014 credit. Documentation of this CE must be submitted to the Research Compliance Training Coordinator at anitrain@uga.edu or faxed to 706-542-5638.  Additionally, please contact the Coordinator if you need access to the online library or have additional questions.