More information can be found at: https://nexus.od.nih.gov/all/2016/07/31/your-one-page-guide-to-rigor-and-reproducibility/

Beginning with the January 25, 2017 application due date, NIH will change what post-submission materials are allowable, and will eliminate most appendix materials currently allowed in applications. In November 2016, NIH will update the application guide and all funding opportunity announcements to reflect the changes for due dates on or after January 25, 2017.

For more information click on the links or contact Cindy Dickson, x44571.

New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017 – NOT-OD-16-129

Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017 – NOT-OD-16-130

For additional information contact Cindy Dickson, x44571 or cdickson@llu.edu

• The U.S. Food & Drug Administration (FDA) found that a physician-investigator conducting two GlaxoSmith-Kline multisite studies of albiglutide (to treat diabetes) failed to follow the investigational plan.  Specifically, FDA’s Warning letter found that an ineligible subject was enrolled and received a dose correction after screening, rather than within the specified time frame.  The investigator’s response can be paraphrased as “I promise to do better next time.”  FDA was unable to determine whether this corrective action was adequate to prevent similar violations in the future.

If you need clarification about avoiding Protocol Violations or how to prospectively obtain a protocol exception from the IRB, call Anu Diekmann at x86215.

Dates:

The training course will be held on November 7, 2016, from 8:20 a.m. to 5:30 p.m. (registration begins at 7:30 a.m.); on November 8, 2016, from 8:30 a.m. to 4:45 p.m.; and on November 9, 2016, from 8:30 a.m. to 3:30 p.m.

More information:

https://www.federalregister.gov/documents/2016/09/16/2016-22348/clinical-investigator-training-course

Perinatal Stroke (R01: RFA-HL-18-002

LOI: Due January 7, 2017

Application Due: February 7, 2017

The purpose of this FOA is to solicit applications that propose basic and/or translational research studies regarding the developing neurovascular unit, perinatal stroke injury/repair response, and/or stroke related etiologies and risk factors. Research addressing vascular, hemostatic, hematopoietic, and/or immune cell activities in the developing brain is of particular interest. The intent is to stimulate research that will identify therapeutic targets in perinatal stroke.

http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-002.html

BRAIN Initiative: New Concepts and Early-Stage Research for Large-Scale Recording and Modulation in the Nervous System (R21): RFA-EY-17-001

Application Due: December 7, 2016

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is a new Presidential project aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat, cure, and even prevent brain disorders.

http://grants.nih.gov/grants/guide/rfa-files/RFA-EY-17-001.html

For additional information contact Cindy Dickson, x44571 or cdickson@llu.edu

Looking for research funding opportunities, give SPIN a try

Did you know that our electronic research administration (eRA) software also known as LLeRA and/or InfoEd has a feature that allows you to search funding opportunities.  This feature located on the left side of the home screen is known as SPIN (Sponsored Programs Information Network). Log into your LLeRA account to give SPIN a try.

Have questions, contact Cindy Dickson or Sherie Donahue in Research Affairs

• submitting a prior approval request for an application with 500k or more in direct costs per budget period;
• submitting a prior approval request for a change of PI (and pre-award change of PI);
• no-cost extensions for institutions that have already submitted one; 
• eRA Commons will display the status if requests were approved or denied.

For additional information contact Cindy Dickson, x44571 or cdickson@llu.edu

The new capability ­­in eRA Commons via the new Prior Approval tab – can be initiated by the Principal Investigator (PI) or SO, but can only be submitted by the SO.

For more information click on the link or contact Cindy Dickson, x44571.

For additional information contact Cindy Dickson, x44571 or cdickson@llu.edu