Category: Compliance, Integrity & Safety

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.

The Sponsored Projects Administration Grants Transmittal Form now includes check boxes for required training in Laboratory Safety Basics. This new requirement allows verification of compliance with Academic Affairs Policies 6.01 and 6.02 prior to release of any grant funding.

These policies and change to the transmittal are designed to ensure safety, accountability and compliance in conducting laboratory-based research. This two-step verification process 1) identifies individuals working in laboratory environments, and 2) documents the required training.

Questions about the Laboratory Basics Safety Training can be directed to Safe Secure Science Training at SSSTraining@uga.edu.

The U.S. Department of Health and Human Services and 15 other federal agencies issued a final rule on the Protection of Human Subjects on Jan. 18 to update regulations that safeguard individuals who participate in research. Most provisions in the new rule will go into effect in 2018. See the final rule. 

The University of Georgia Human Subjects Office will announce its plan for phased implementation of the final rule, and will be providing education through a variety of methods (e.g., guidance documents, in-person sessions, etc.).

The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. It also allows more flexibility in keeping with today’s changing research environment, including the increasing diversity of research studies and the digitization of data.

The current regulations, which have been in place since 1991, are often referred to as the “Common Rule.” They were developed at a time when research was conducted predominantly at universities and medical institutions, and each study generally took place at a single site. Since then, research with human participants has grown in scale and become more diverse and data has become digital.

The final rule will now generally expect consent forms to include a concise explanation – at the beginning of the document – of the key information that would be most important to individuals contemplating participation in a particular study, including the purpose of the research, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject.

Important elements in the final rule include:

• The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
• Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
• For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
• The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
• Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
• Requirement that consent forms for certain federally funded clinical trials be posted on a public website.

More information will be forthcoming in Research Announcements.

Frank Macrina, Vice President for Research at Virginia Commonwealth University and author of “Scientific Integrity,” will visit UGA on Nov. 10-11 to help us to re-envision our culture for the responsible conduct of research (RCR).

RCR is an important issue that has the potential to severely impact our ability to secure federal support for research and scholarship. RCR issues will become even more important for UGA as we expand experiential learning opportunities for undergraduates, many of whom will be involved in research and scholarship.

The following is a summary of events:

Thursday, Nov. 10, 12:45-4:00, Georgia Center K/L: Train the trainers, hands on session: In this session, Frank will provide training on best practices for training our undergraduate, graduate, and postdoctoral students in the responsible conduct of research. This session is appropriate for any faculty member or administrator. Space is limited, so please use the link below to register for the event:
https://www.surveymonkey.com/r/RCR_Registration

Friday, Nov. 11, 10:30-11:30, Georgia Center, Masters Hall: Keynote address: Research Ethics Education in Context: In this session, Frank will provide some context, documenting the need for RCR education. This session is appropriate for all members of the UGA research/scholarship community. Please encourage your students (undergraduate and graduate) and postdocs to attend.

Friday, Nov. 11, 2:00-3:00, Georgia Center Y/Z: RCR Discussion Session: This session, a follow up to the workshop and keynote address, is an opportunity to have more focused discussion with Dr. Marcina.

Space is limited; RSVP so we can prepare for the event.

Sponsored by the Office of Research and The Graduate School.