Category: 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/.

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.

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

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

Lois Zitzow, director of University Research Animal Resources, is leaving UGA and a search is underway for a new director. During the interim period, URAR asks that researchers with animal use needs allow extra time for requests. Chris King, associate vice president for Research Integrity and Safety, and Leanne Alworth, director of the Office of Animal Care and Use, will share leadership responsibilities during the transition.

More information

Substantial revisions to the federal Policy for the Protection of Human Research Participants, also known as the Common Rule, will take place on Jan. 21, 2019. These changes will apply to all new studies submitted for IRB determination or review on or after Jan. 21, 2019. Please note that the revised Common Rule does NOT apply to FDA-regulated or human subjects research supported by the Department of Justice.

What does this mean for UGA researchers?
The Common Rule changes were designed to reduce administrative burden and to enhance the protection of human subjects. The UGA Human Research Protection Program is working to implement the revised regulations. The revisions will include changes to the IRB Portal, policies, and some procedures. There are some specific changes that may be of interest to many UGA researchers. These changes are described below and on the IRB website.

New Exempt Categories
The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The revised Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 21, benign behavioral interventions conducted with adults may be determined to be exempt. Also, the collection of identifiable, sensitive information from adults may be determined to be exempt; however, this new category requires a limited IRB review to determine that appropriate privacy and confidentiality protections are in place. Submission to the IRB office to obtain the Exempt determination is still required.

Continuing Review Changes
Some minimal-risk research will no longer require continuing review (renewal). A general progress report will be requested at a period determined by the IRB during initial review, but research activities can continue as approved without waiting for the IRB to acknowledge the report. Such projects will not be assigned an expiration date.

Consent Form Changes
Consent forms must begin with a concise and focused presentation of the key information that is most likely to assist in understanding why one might or might not want to participate in the research. Consent forms must now include information regarding the potential for future use of de-identified data and biospecimens.

Learn More
Additional information is available at the links below.

• UGA Human Research Protection Program website: https://research.uga.edu/hrpp/
• CITI training basic information: https://about.citiprogram.org/en/final-rule-resources/#irbimpact
• Department of Health and Human Services revised Common Rule educational materials: https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html

Contact the Human Subjects Office to schedule in-person group sessions (irb@uga.edu or 706-542-3199)

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies have issued revisions to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule). The revised Common Rule will become effective Jan. 21, 2019. See the UGA Human Research Protection Program website for additional information, including an FAQ with information specific to UGA.

The UGA Human Subjects Office will conduct post-approval assessments of active projects beginning January 2019 to ensure the educational needs of investigators are met and human research is compliant with regulations and institutional policies.

Projects that will be assessed are identified through the IRB Portal. Post-approval monitoring will be conducted on non-exempt federally funded studies. The goal is to assess up to 10% of active federally sponsored projects each quarter. These will be selected at random from our database of active studies.

Please contact Angela Bain at 706-542-3821 for questions about this new program.

University of Georgia’s Human Research Protection Program recently received accreditation from the Association for the Accreditation of Human Research Protection Programs. This accreditation demonstrates that UGA has a high-quality human research protection program and is a public affirmation of UGA’s commitment to protecting research participants. The Human Subjects Office takes great pride in this accomplishment and thanks you for your continuing support of its mission.

Brandon Jordan has been named the university’s new radiation safety officer. Jordan has worked at UGA as an assistant radiation safety office with responsibilities such as administering wipe surveys of sealed sources, providing hazardous waste analysis, conducting package testing and managing laboratory quarterly reports. He received his Bachelor of Science from Oklahoma State University and complements his radiation safety experience with professional instruction taken in applied health physics and radiation safety officer training. Jordan supports research groups who use radioactive isotopes, X-rays, lasers or high magnetic fields, and he is open to any comments or improvement suggestions regarding services provided by the Office of Research Safety.

For more information, contact Brandon Jordan at bj66764@uga.edu or 706-542-0526.