Category: Compliance, Integrity & Safety

The Trump Administration has announced the revocation, effective October 12, 2017, of most of the U.S. sanctions levied against Sudan. Prior to the General License issued in January 2017, and this revocation, a Specific License from the U.S. Department of Treasury was required for most activities in Sudan, including research activities within Sudan or with Sudanese resident collaborators, conference attendance in Sudan, and providing online professional development courses to Sudan, for example. These restrictions were within the sanctions’ broad prohibition on the export to, or import from, Sudan of goods and services.

With the lifting of the sanctions, research, collaborations, online course delivery, and travel to Sudan becomes more straightforward. However, the U.S. Department of Commerce still requires an export license for many commercial items to be permanently or temporarily exported to Sudan. A number of Sudanese remain sanctioned individually as “Specially Designated Nationals.” As Sudan is still listed as a State Sponsor of Terrorism, certain exports of agricultural commodities, medicine, and medical devices continue to require the use of General License A, issued by the Department of Treasury, in addition to any other export licensing. The U.S. Department of State still maintains a general prohibition on the export of defense articles and associated technical data and defense services to Sudan. Finally, while contemplating transactions with Sudan, there are certain risks related to U.S. anti-boycott regulations which prohibit U.S. persons from complying with the Arab League boycott of Israel.

More details on the revocation are available in the Department of State Press Statement.

Please contact Dan Runge, Export Compliance Officer, at 2-4188 or drunge@uga.edu with any questions.

As part of its new measures to improve the quality and transparency of NIH-supported clinical trials, NIH is instituting important changes.

NIH has provided the following guidance for conducting NIH-funded research that involves human subjects, or applying to NIH for support of such research. The changes may affect how you:

• select the right NIH funding opportunity announcement
• write the research strategy and human subjects sections of your application
• comply with appropriate policies and regulations

1. Familiarize yourself with the new PHS Human Subject and Clinical Trial Information form. For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.
2. Take a moment to answer these four questions about your current or proposed research:

1) Does the study involve human participants?

2) Are the participants prospectively assigned to an intervention?

3) Is the study designed to evaluate the effect of the intervention on the participants?

4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.

Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure?  Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

3.  Familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:

• the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
• Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
• updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
• new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
• use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
• expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

Improving the design, efficiency, and transparency of clinical trials is important because it:

• respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
• facilitates design of clinical trials while reducing unnecessary duplication
• promotes broad, timely, and responsible dissemination of research information and results
• fosters responsible stewardship of the public’s investment in biomedical research

NIH has have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page that consolidates information; please review this information carefully.  Additional resources will be available in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on NIH blog.

The Trump Administration announced on Wednesday, August 2, 2017, that it would prohibit Americans from traveling to North Korea. The prohibition will formally go into effect on September 1, 2017 and will be in effect for one year, unless extended or sooner revoked by the Secretary of State.

The prohibition will prevent the use of U.S. passports to travel to, in, or through North Korea. Travel to, in, or through North Korea by U.S. citizens would require the traveler obtain a passport with a special validation, but only in limited special circumstances and at the State Department’s discretion. The validation may be determined to be in the national interest if the applicant’s travel is related to professional journalism or reporting, the applicant is a representative of the Red Cross, or is justified by compelling humanitarian considerations, or the travel is otherwise in the national interest.

While American citizen travel to North Korea is already exceedingly rare, the ban will end all travel absent State Department permission in special circumstances.

Contact Dan Runge, Export Compliance Officer, at drunge@uga.edu or 542-4188 with any questions.

Join the Office for Human Research Protections (OHRP) staff at a Research Community Forum called “Navigating a River of Change: Bringing Research Up to Par” in Augusta, GA, July 18-19.

The workshop will feature interactive presentations by OHRP staff on a range of topics related to the HHS regulations, including discussion of the revised Common Rule. The conference will include break-out sessions covering a variety of research topics such as central IRBs and related issues, genetics research, online consent, and reporting concerns. Connect with human research professionals from across the country and learn about the regulations directly from OHRP staff—don’t miss out!  This event is co-sponsored by UGA.

The Office of Biosafety has issued updated guidance on the “Safe Handling of Sharps in the Biological Research Laboratory” as part of its efforts to ensure that work is conducted in a manner that does not pose significant risk to the health and safety of laboratory workers.

The new guidance includes information on reducing use of sharps in the laboratory, use of safer sharps alternatives, training on safe use of sharps, use of scalpels, environmental awareness, sharps handling, sharps disposal, and reporting and responding to an injury.

See the new guidance.

For more information on sharps safety or additional training, please contact the Office of Biosafety: 706-255-2697 or biosfty@uga.edu.

Kim Fowler, who has served as interim director of the Human Subjects Office since late 2015, has been appointed its director, effective April 1, 2017.

The announcement was made by Vice President for Research David Lee and Chris King, Associate Vice President for Research Compliance.

Kim joined the office in early 2007 as an administrative assistant. She steadily worked her way up through program specialist and coordinator positions to assistant director in late 2012.

Lee noted, “This exceptional progression is a testament to Kim’s knowledge of (and superb ability to explain) the rules and regulations concerning human subjects protection, her ability to work effectively with a broad range of individuals, and the important leadership she has provided as we seek to fully implement the IRB  portal for electronic Human Subjects proposal submission and review.”

Additionally, Kim has played an important role in helping to expand biomedical/clinical research at UGA and in Athens, and has worked with others in the UGA community as we seek accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an important next step in the evolution of our human subjects protection program.