University of Georgia

Category: Announcements

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Announcements Compliance, Integrity & Safety

Beginning in January, the review of human subjects protocols that typically require review by the convened UGA IRB (Full Board) will be delegated to Western IRB (WIRB), a commercial IRB.  This review arrangement is temporary and will last for the next four to six months.

Very few studies will be affected by this change since only about 3 percent of IRB protocols require Full Board review.

The OVPR has engaged WIRB review services to allow the IRB to advance major initiatives that will strengthen the University’s human subjects protections program.  These initiatives include enhancing the e-Research Portal for IRB, training two new employees, developing policies and procedures, and taking definitive steps to achieve accreditation of the human subjects protection program.  Since Full Board reviews are lengthy, rigorous and time-consuming, this review arrangement will enable the IRB to focus on these initiatives and, more importantly, ensure the review of the majority of the submissions is done expeditiously.

Please contact the Human Subjects Office at irb@uga.edu or 706.542.3199 for questions or WIRB submission details.

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NIH and AHRQ encourages applicants to use the newly published biosketch format for all grant and cooperative agreement applications submitted for due dates on or after January 25, 2015, and will require use of the new format for applications submitted for due dates on or after May 25, 2015. Applicants may submit using the new biosketch format for due dates before January 25, 2015, if they wish.

The revised forms and instructions are now available on the SF 424 (R&R) Forms and Applications page and adjustments have been made to improve their usability.

Individual fellowships, R36 dissertation grants, and diversity supplements should use the Fellowship Application Biographical Sketch Format Page and related pre-doc and post-doc instructions and samples, while research grant applications, career development, training grant, and all other application types should use the general Biographical Sketch Format Page and instructions and sample.

The new format extends the page limit for the biosketch from four to five pages, and allows researchers to describe up to five of their most significant contributions to science, along with the historical background that framed their research. Investigators can outline the central findings of prior work and the influence of those findings on the investigator’s field. Investigators involved in Team Science are provided the opportunity to describe their specific role(s) in the work. Each description can be accompanied by a listing of up to four relevant peer-reviewed publications or other non-publication research products, including audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware that are relevant to the described contribution. In addition to the descriptions of specific contributions and documentation, researchers will be allowed to include a link to a full list of their published work as found in a publicly available digital database such as MyBibliography or SciENcv.

Sally Rockey, NIH Office of Extramural Research, explains that the new format accomplishes two important goals: allowing applicants to describe the magnitude and significance of their scientific contributions (including publications), and providing more detailed information about their research experience in the context of the proposed project.  Read more. 

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Announcements

NIH has removed the requirement to identify ‘substantial scientific changes’ in the text of a Resubmission application by ‘bracketing, indenting, or change of typography’.

Effective immediately, it is sufficient to outline the changes made to the Resubmission application in the Introduction attachment. The Introduction must include a summary of substantial additions, deletions, and changes to the application. It must also include a response to weaknesses raised in the Summary Statement. The page limit for the Introduction may not exceed one page unless indicated otherwise in the Table of Page Limits.

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Effective Jan. 25, NIH grant application submissions involving the generation or use of large-scale genomic data have new requirements. The new policy promotes sharing, for research purposes, of large-scale human and non-human genomic1 data generated from NIH-funded research.

Applicants preparing such grant applications are expected to:

  • state in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data, and
  • include a genomic data sharing plan in the application. If sharing of human data is not possible, applicants should provide a justification explaining why they cannot share these data and provide an alternative data sharing plan.
  • Applicants who plan to use controlled-access human genomic data from NIH-designated data repositories as a secondary user to achieve the specific aims in the application should:
  • briefly address their plans for requesting access to the data, and
  • state their intention to abide by the NIH Genomic Data User Code of Conduct, in the Research Plan of the application.
  • Applicants preparing applications that involve research funded prior to the Policy’s effective date should:
  • make every effort to include a genomic data sharing plan in the application that outlines plans to comply with the expectations outlined in the Policy, and
  • plan to transition to a consent for future research uses and broad sharing, if possible, if the studies involve human participants and were initiated before the Policy’s effective date and used consents that do not meet the expectations of the GDS Policy.

With implementation of the Genomic Data sharing Policy, submission of the Institutional Certification for human genomic data will become part of the standard Just-in-Time process. Additional guidance for, researchers and institutions submitting grant applications and contract proposals involving large-scale genomic data is available on the Genomic Data Sharing website: (https://gds.nih.gov/).

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Investigators who write large proposals (such as training grant applications, REU proposals, equipment grants, large center grants) may need to request commitments towards the project budget from multiple UGA administrative units.

Under the One-Stop-Shopping process, all investigators needing funding from multiple sources will first discuss their proposal plans and needs with Maryann Deom (mtd@uga.edu or 2-8808), Associate Vice President for Research in the Office for Sponsored Programs. She will assist in coordinating the funding requests to appropriate administrative units, who have all been alerted to not make commitments that haven’t first been vetted within OVPR. This process should reduce the work required of principal investigators and simplify the responses of administrators who wish to help.

 

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Announcements

As some of you have noticed over the last few weeks, the online ordering system for Central Research Stores (CRS) and Campus Scientific Stores (CSS) experienced several outages.  We apologize for the inconvenience as well as the disruption to your day.

The ordering system, known as Chito’s, has reached the end of its functional life.  The IT staff within OVPR will work to keep Chito’s operational until mid January 2015 when we will transition to the iLabSolutions chemical ordering system.  Our goal is to make the transition as seamless as possible for each of you so that we can minimize any interruption to your work day.

In the meantime, the biggest concern among faculty and staff is: How to continue using Chito’s for the 6 weeks between now and mid January?  The most visible problem noted by on-campus users is not being able to navigate to the Chito’s login page.  This error occurs because all known internet browsers (Internet Explorer, Safari, Google Chrome, FireFox,…) recently provided software updates that Chito’s can not support.  However, we discovered that individual PC’s can rollback the latest update from FireFox and return to FireFox version 32 in order to view and order from Chito’s on your PC.  This is not an ideal solution, but it is viable solution short term.  If your IT staff would like to discuss other possible measures that your department can employ, then please have a designated IT staff member contact me directly and we will work to find a suitable alternative.

As for the future and iLabSolutions, CRS will contact departments directly to coordinate the rollout of the system.

If you have any questions, please contact:

Brian Tomlinson

Director, Office of Research Services

Financial Director, CoreServe

1125 E. Whitehall Rd.

Athens, GA  30602

706-542-5975

bwt@uga.edu

 

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Announcements

UGA researchers now have access to a Data Management Plan Tool to help them create, review and share data management plans that meet institutional and funding agency  requirements.

In addition, videos and presentations from workshops on how to develop Data Management Plans, held Nov. 5, are now available online.

Many funding agencies, including NIH, NSF, DOE, and NEH, require data management and sharing plans as part of 2013 federal requirement  that “direct results of federally funded scientific research be made available.” The impact that these plans have on funding decisions continues to increase.

The videos and presentations from the workshop explain how a publicly available data management plan tool (DMPTool) enables researchers to create, review, and share draft revisions.

The DMPTool is hosted on the UGA Libraries website, along with other other DMP resources,  and can also be reached via the GrantSMART site.

Thanks to the workshop sponsors: The UGA Libraries, Franklin College of Arts & Sciences, the Department of Computer Science and the GrantSMART Office of OVPR.

 

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Announcements

In response to feedback and suggestions from the UGA community, Finance and Administration (F&A) has modified its home page and related sites to help UGA faculty and staff find regularly used resources.

The first phase of changes includes a new feedback tool, revisions to organize information more succinctly, and additional information about ongoing business process improvements and other specific initiatives.

Feedback Tool – Throughout the F&A website, you will find a button labeled, “Give us Your Feedback.” This feedback tool is a quick and easy way for to alert F&A about support you need or suggestions or comments about the service you receive.

Website Organization – The F&A homepage www.busfin.uga.edu retains links to each division within F&A but now provides five distinct categories with expandable links to resource and informational materials.

New Web pages – Links to new Web pages about key service improvement and enhancement initiatives, as well as the progress on those projects,  have been added. As new initiatives begin, that information will be added to the Web page.

Visit www.busfin.uga.edu to see the recent changes and provide feedback. Additional changes will be forthcoming.

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Announcements

The Office of the Vice President for Research and GrantSMART have developed a list of resources to assist researchers in developing the broader impacts sections of their grant proposals.

The National Science Foundation uses two merit review criterion for evaluating research proposals for funding: Intellectual Merit and Broader Impacts.

  • The Intellectual Merit criterion encompasses the potential to advance knowledge.
  • The Broader Impacts criterion encompasses the potential to benefit society and contribute to the achievement of specific, desired societal outcomes.

Both criteria are to be given full consideration during the review and decision-making processes; each criterion is necessary but neither, by itself, is sufficient. Therefore, proposers must fully address both criteria.

UGA resources listed on the Resources for Broader Impacts Sections include educational and outreach projects and organizations, ranging from Archway Partnership communities to College of Education Outreach & Engagement to Georgia Intern-Fellowships for Teachers.

If you have a resource to add to this list, please contact rcomm@uga.edu.

 

Categories
Announcements Compliance, Integrity & Safety

In an effort to reduce regulatory burden for investigators, the NIH and USDA recently issued new guidance regarding the review process required for significant changes (Amendments) to approved Animal Use Protocols (AUP). The use of IACUC-reviewed and approved policies may now be used for the administrative handling of many significant changes. Recognizing the value of performance standards and professional judgment, this new guidance allows the following types of Amendments to be implemented simply following consultation and verification by the Attending Veterinarian:

1.) changes in anesthesia, analgesia, sedation or experimental substances
2.) changes from one AVMA-approved method of euthanasia to another
3.) changes in duration, frequency, type or number of procedures performed on an animal (provided the change does not result in greater pain or distress, doesn’t change from a nonsurvival to a survival surgery or doesn’t impact study objective or the safety of personnel)

This new Veterinary Verification and Consultation (VVC) process will allow Amendment approval without typical IACUC-review regardless of the AUP category. The VCC process will result in a significant reduction in paperwork associated with study modifications and a faster turn-around time for approval. The decision on whether or not an Amendment meets the criteria for the VCC process is at the sole discretion of the Attending Veterinarian.

Furthermore, and with perhaps more impact on reducing burden, this new guidance also allows for the reference of approved IACUC policies on an AUP in lieu of detailed descriptions. Policies like the “Common Technical Procedures” on the IACUC website can now be referenced in an AUP without inclusion of a full procedure description. The IACUC is currently in the process of expanding its policies to include more reference materials that can be used in protocols. You can find a full listing of IACUC-approved policies on the website at https://research.uga.edu/oacu/iacuc

For additional information, please contact the Office of Animal Care and Use or the IACUC at iacuc@uga.edu You can also find out more from your Attending Veterinarian.