Category: Announcements

UGA Human Subjects Office has updated CITI course offerings for both Biomedical and Social & Behavioral research, following benchmarking of requirements at our peer and aspirational institutions.

The updated requirements do not affect completion status for currently certified users; however, any additional coursework is available on each user’s grade book. The updated courses will be required for any new learners or during refresher training.

Access the UGA CITI portal 

Contact the Human Subjects Office, IRB@uga.edu or 706-542-3199 with any questions about the course content.

Ongoing training opportunities on human subjects research are now available for graduate students and busy researchers.

Graduate student researchers can attend a bi-weekly Open House to learn about the IRB review process. Graduate students will have opportunities to speak with Human Subjects staff/IRB members about their research. They are encouraged to bring draft study materials for hands-on guidance.

See the schedule at  https://research.uga.edu/hso/resources/

Contact the Human Subjects Office, IRB@uga.edu or 706-542-3199 with any questions.

Recorded presentations on the UGA IRB Review Process is now available for those who don’t have time for in-person human research training, “Basic Overview of the UGA IRB Review Process” takes approximately 45 minutes. However, learner’s can self-select sections they would like to know more about.

Visit:  https://research.uga.edu/hso/resources/

Contact the Human Subjects Office, IRB@uga.edu or 706-542-3199 with any questions.

The Department of Homeland Security recently announced new security protocols that impact the transport and use of personal and University of Georgia issued electronics that may be taken abroad for research, collaborative, or conference attendance purposes. Direct travel from, or a transfer through, these 10 airports to the United States are impacted by these protocols:

• Queen Alia International Airport (AMM) – Amman, Jordan
• Cairo International Airport (CAI) – Egypt
• Ataturk International Airport (IST) – Istanbul, Turkey
• King Abdul-Aziz International Airport (JED) – Jeddah, Saudi Arabia
• King Khalid International Airport (RUH) – Riyadh, Saudi Arabia
• Kuwait International Airport (KWI) – Kuwait City, Kuwait
• Mohammed V Airport (CMN) – Casablanca, Morocco
• Hamad International Airport (DOH) – Doha, Qatar
• Dubai International Airport (DXB) – United Arab Emirates
• Abu Dhabi International Airport (AUH) – United Arab Emirates

Carriers on these routes include Royal Jordanian, EgyptAir, Turkish Airlines, Saudia, Kuwait Airways, Royal Air Maroc, Qatar Airways, Emirates, and Etihad Airways.

These travelers will have to adhere to more stringent security measures. All personal electronic devices larger than most cell phones (e.g., laptops, tablets, e-readers, cameras), excluding necessary medical devices, can no longer be taken on board as carry-on items. They must be placed in checked luggage. For more information, please see the Department of Homeland Security fact sheet.

The United Kingdom has also issued a similar set of restrictions for inbound direct flights into the U.K. originating from Turkey, Lebanon, Jordan, Egypt, Tunisia, and Saudi Arabia.

Travelers should be mindful of these U.S. and U.K. restrictions and be aware of further changes.

Individuals traveling with university owned devices or university data on personal devices are advised to:

• Consider if electronic devices are necessary for their travel, and leave unnecessary devices behind
• Remove all sensitive data and proprietary information from devices that is not pertinent to their travel
• Encrypt devices, especially if you must take sensitive or proprietary data
• Choose strict passwords for devices and online accounts
• Backup all data
• Enable remote wiping capabilities, in case your devices is lost or stolen
• Ensure that your devices remain fully charged in case you are required to enable it for inspection
• Have the device scanned by departmental IT staff or EITS upon return, to detect and remove any malicious spyware

Those individuals traveling with electronic devices that travel as checked luggage are advised to plan for safe storage of their devices, including the use of TSA recognized locks for their checked baggage.

The UGA Research Misconduct Policy, formerly known as the Policy on Responsible Conduct in Research and Scholarship, was recently updated. The update was approved by the President’s Cabinet on February 15, 2017.

Following a periodic review, the Policy was updated to better align with the Public Health Service Policies on Research Misconduct, streamline administrative procedures, and reinforce due process. The UGA Research Misconduct Policy is applicable to all individuals at the University of Georgia engaged in scientific and scholarly research.

Dr. Christopher S. King, Associate Vice President for Research Integrity and Safety, is the Research Integrity Officer and is responsible for administering the policy. For questions about the policy update or other research misconduct matters, please contact Dr. King at 706-542-5933 or cking@uga.edu.

View UGA Research Misconduct Policy.

The Food and Drug Administration (FDA or Agency) has issued a final rule banning all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves intended for use by humans because these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by a change in labeling.

The ban, effective Jan. 18, 2017, applies to all powdered medical gloves regardless of application (medical, research, etc.) used by humans except powdered radiographic protection gloves. The ban includes powdered medical gloves used in the practice of veterinary medicine. It includes gloves powdered with cornstarch and talcum powder.

The FDA advises stakeholders and institutions to dispose of pre-existing supplies of powdered medical gloves in accordance with standard industry practices and established procedures of the local community’s solid waste management system.

NIH recently established a policy that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonization.  (See definition of “clinical trial” below.)

Effective Jan. 1, 2017, NIH requires institutions to develop an implementation plan to ensure compliance. The policy applies to all active grants and contracts, no matter what point they are in the life cycle of the trial.

The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors.  GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials.

The University of Georgia is establishing the process for ensuring all investigators and key study staff involved in an NIH-sponsored clinical trial or an FDA-regulated clinical trial complete GCP training.  GCP training may be accessed through the UGA CITI Portal (https://paul.ovpr.uga.edu/CITI/ ).  Instructions to enroll in the course and links to the NIH policy and FAQs can be found at https://research.uga.edu/hso/citi-training/ .

It is the Principal Investigator’s responsibility to ensure this responsibility is met by all key study personnel. GCP Training must be refreshed every three years.

The IRB will confirm compliance with this requirement at:

• Initial Submission for new studies submitted on or after 03/01/2017.
• Protocol revisions/modifications that involve a personnel change (i.e., personnel additions) submitted on or after 03/01/2017.
• Continuing Review- at which time all research team members’ current CITI completion is assessed submitted on or after 03/01/2017.

NOTE: A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.