Clinical trial FOAs highlight the intent to accept clinical trials in both the title and Section 2. FOAs will also include clinical trials review criteria. The requirement to respond to clinical-trial-specific-FOAs begins for applications submitted for due dates on or after Jan. 25, 2018. NIH has developed an online tool to determine if a study meets their definition of a clinical trial. Determining this before preparing your application documents will ensure that the submission is in response to the correct FOA, ensures the application includes all the information required for peer review, and complies with NIH policy.
Grants.gov will retire the downloadable, Legacy PDF grant application package at the end of 2017. Please refer to the Grant Submission Portal Chart when determining how your federal grant will be submitted by MCW’s GCO. Grants that will be submitted after 1/1/2018 should use the chart to determine their submission method. For more information on using ASSIST, consider attending the Overview Party on Thurs, Dec. 21. Any additional questions can be submitted to the GCO Expeditor.
NIH Grant applications due on or after Jan. 25, 2018, will use new Grant Application Forms, commonly referred to as FORMS-E. The heavy emphasis of change incorporated with this new form set is in the Human Subject arena. Users will see consolidation of Human Subject attachments, inclusion enrollment, and clinical trial information into a single new form, PHS Human Subjects and Clinical Trials Information. Resources are already and available on the NIH public announcement NOT-OD-17-119. eBridge will incorporate the new changes in the December patch.
Recently, the NIH published additional guidance on the implementation of their Single IRB for Multi-site Research policy. If you are planning a project that will utilize an sIRB, please review NOT-OD-16-109 to determine the categorization of direct versus F&A costs for your project. MCW expects that any direct costs that may be charged for an sIRB project will be managed as personnel expenses within your budget. Please note: No new expenditure types will be added to our budget categories when sIRB Policies take effect for applications due on or after Jan. 25, 2018.
Beginning Jan. 1, 2018, any NIH applications that are not submitted directly to Grants.gov from eBridge utilizing the system to system (S2S) function must use the ASSIST system to prepare and submit the application electronically. This change expands the current use of ASSIST at MCW to single budget applications in a limited capacity. Applications that are prepared in ASSIST are not eligible for the additional 2 days for scientific documentation preparation and should be routed to the Grants & Contracts Office for review 5 business days in advance of the posted sponsor deadline. Contact the GCO for specific questions on routing or submission of an NIH application.
Please be mindful of the National Cancer Institute’s (NCI) direct cost cap policy on renewal applications. The requested budget cannot exceed 10% over the direct cost budget awarded for the last year of the prior project period. If you are a submitting a renewal R01, U01 or P01 application to the NCI, please review NIH Guide Notice: NOT-CA-08-026 for more information.
Are you relocating to the Professional Office Building (POB) this fall? Although the POB has not yet been set up in Oracle and is not thus available as a location in eBridge, we do know that it will be an “On Campus” research location. As you plan for grants that will use this facility, please be sure to select an on-campus location (e.g., HRC), until the POB is made available. Selection of this location is temporary and will incorporate the correct F&A rate in your application’s budget. A location change can be made at the time of award.
All biosketches included in NIH applications must be created within agency guidance. Submitting applications that include biosketches that fall outside the lines of the NIH requirements can put your application is at risk of being withdrawn from competition. The NIH has online resources available such as templates and instructions to assist with development of an individual’s biosketch. Or, try using SciENcv, a tool created to help you develop your biosketch and automatically format it per NIH requirements. Contract the GCO Expeditor, Jennifer Ward, with questions or concerns.