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  Identify NIH Clinical Trial Funding Opportunity Announcements (FOAs)

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.

  Reminder! Legacy PDF Grant Application Package Retiring Dec. 31

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 Form Set Moving to "FORMS-E"

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.

  Costs Related to the Use of a Single IRB (sIRB)

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. 

  Expanding the Use of ASSIST Beyond NIH Multi-Budget Applications

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.

  Reminder! Cap on Requested Budget Levels for Grant Renewals Submitted to NCI

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.

  New! Professional Office Building F&A 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.

  Reminder! Double Check NIH Biosketch Formatting!

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.

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  • Grants.gov to retire Legacy PDF Application Packages:
    Grants.gov will retire the single PDF application download submission method at the end of 2017. With this old application method being phased out, GCO is preparing to support the MCW research community by expanding MCW’s use of ASSIST, developing resources to support Grants.gov Workspace users, and thoughtfully evaluating expansion of our eBridge System to System functionality. Additional information, resources, and opportunities to interact with GCO will be provided to research teams throughout the remainder of the year to prepare for this transition.
  • Save the Date; GCO Grants.gov Workspace Viewing Party:
    For event location and time, view the GCO Announcement.
  • AHA Tips:
    View the AHA Tip Sheet (PDF) for additional guidance to assist users in submitting their application error free.
  • NIH Grants Closeout:
    Effective January 1, 2017, the Final RPPR (F-RPPR) will replace the Final Progress Report (FPR) for grant closeouts. The F-RPPR is submitted via eRA Commons using a similar format to the annual RPPR. No Participants, Changes, or Budget sections are required in the F-RPPR, but there is one new section: Project Outcomes. The Outcomes section allows PIs an opportunity to provide a concise summary of the significance of their research and will be made available to the general public. Additional information on the F-RPPR can be found on the NIH Implementation of F-RPPR page.
  • New! GCO Staff Assignments:
    GCO is pleased to share that the two recently hired analysts are fully trained and ready to support the MCW research community. As part of GCO’s ongoing commitment to support investigators in submitting high quality, competitive and compliant research, staff responsibilities were reorganized with a focus on sponsor type. Additionally, the GCO Expeditor, a dedicated resource for “first tier” questions, is accessible using the main office number, (414) 955-8563. The GCO Expeditor will also be responsible for Pre-Review of Funding Proposals, office coordination, and various other administrative tasks, such eRA Commons account setup and generating reports. Check out the updated GCO Contact Information on their website.
  • AHA Tipsheet:
    Deadlines coming up February 9-17, 2017. View the AHA Tip Sheet for additional guidance to assist users in submitting their application error free.
  • NIH Grants Closeout:
    Effective January 1, 2017, the Final RPPR (F-RPPR) will replace the Final Progress Report (FPR) for grant closeouts. The F-RPPR is submitted via eRA Commons using a similar format to the annual RPPR. No Participants, Changes, or Budget sections are required in the F-RPPPR, but there is one new section: Project Outcomes. The Outcomes section allows PIs an opportunity to provide a concise summary of the significance of their research and will be made available to the general public. Additional information on the F-RPPR can be found on the NIH Implementation of F-RPPR page.
  • New ! eRA Commons Option to Request Prior Approval for $500,000 in Direct Costs:
    For grant applications in which the direct costs for any one budget year will request $500,000 or more, the NIH continues to require investigators to seek prior approval from the appropriate Program Officer at least 6 week prior to application submission. eRA Commons has introduced a Prior Approval tab in their online system that allows this request to be submitted electronically through that system. View an YouTube online tutorial walking you through the process. Institutional authorization isn’t required for this request so a PI can submit directly to the NIH once the online form is complete. The Grants Office analyst team is available to assist with questions.
  • NIH ASSIST System Reminder:
    NIH has expanded the accessibility for the use of the ASSIST system to support both multi-project and single-project applications. MCW will only use ASSIST when it is required by the FOA. ASSIST is most commonly required for use by PPG Funding Opportunities. The submission of single-project applications will continue to be done system-to-system through eBridge for those applicable funding mechanisms, or will be submitted via the downloaded application package from Grants.gov. The GCO will communicate when and if there are any changes to this practice in the future.
  • Redesigned Projects Section in RPPR:
    PIs are expected to list significant products developed with their grant in the annual RPPR (e.g. websites, technology, databases). This section has now been redesigned to make it easier for PIs to better categorize their products. PIs will describe their product in a text box, and then further categorize their product by choosing from 14 categories in a scrollable menu. PIs are not limited to a single category per product and can select as many as appropriate for the reported product. The RRPR Section C (Products) guide can be reviewed as a resource to help determine which categories may apply to the developed project.
  • The NIH SF424 Application Guide and Supplemental Instructions have been revised. Click each link to learn more.
  • Changes to NIH Biosketch:
    NIH and AHRQ will require use of a new biosketch format in applications for research grants submitted for due dates on or after May 25, 2015. 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.
    The Science Experts Network Curriculum Vitae (SciENcv), which serves as an interagency system designed to create biosketches for multiple federal agencies, will be updated by the end of December to support the new biosketch format and to address some issues found in testing. SciENcv pulls information from available resources making it easy to develop a repository of information that can be readily updated and modified to prepare future biosketches. A YouTube video provides instructions for using SciENcv.
    NIH and AHRQ encourage 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.
    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. For more information on this change, see the NIH Notice and related announcements, and NIH FAQ section.
  • NIH ASSIST System - Only Used for PPG Applications:
    In 2013 and 2014, ASSIST, NIH’s online system for application preparation and submission, was used for applying to NIH’s complex, multi-project grant programs (PPGs, e.g. funding mechanisms like U10, P01 or P50s that contain budgets for multiple Cores and Projects in a single application). In 2015, ASSIST will also become an option for NIH’s single-project grant programs (R03, R21, etc.).  MCW will not be using ASSIST for the submission of any type of application aside from a PPG. The submission of single-budget applications will continue to be done system-to-system through eBridge for those applicable funding mechanisms listed on page C question C6.0, or will be submitted via the downloaded application package from Grants.gov. The GCO will communicate when and if there are any changes to this practice in the future.
  • NIH New Application Policy:
    The NIH has issued a Notice to remind applicants that the basic requirements for allowable applications have not changed with the updated NIH/AHRQ policy on application submission (see Notices NOT-OD-14-074 and NOT-OD-14-082).  Investigators now may submit a New application, following an unsuccessful application or Resubmission, without concern for scientific overlap with previously reviewed applications. The New application, however, should not contain any of the following:
    • Introduction page(s) to respond to critiques from a previous review

    • Mention of previous overall or criterion scores or percentile

    • Mention of comments made by previous reviewers

    • Responses to a prior review

    • Mention of how the application or project has been modified since its last submission

    • Marks in the application to indicate where the application has been modified since its last submission

    • Progress Report

    • Progress Report Publication List

      If the New application contains any of these items, the application will be returned without review and will not be considered for funding.

  • NIH & AHRQ Announce Transition to New Research Training Table Formats for 2015 and Upcoming Release of the xTRACT System:
    NIH and AHRQ have announced the availability of new research training data tables for use with FY 2016 institutional training grant applications and research performance progress reports (RPPRs).  Table formats, instructions, and a completed set of tables with sample data may be found on the NIH website.
    Where specified in the Funding Opportunity Announcement for a program, these tables may also be used in institutional career development and research education applications and RPPRs. Please refer to the full Notice for additional details on background and implementation.
  • NIH & AHRQ Announce Upcoming Changes to Post-Award Forms and Instructions:
    NIH and AHRQ have announced planned changes to policies, forms and instructions for interim and final progress reports, and other post-award documents associated the monitoring, oversight, and closeout of an award. This also applies to revised Ruth L. Kirschstein National Research Service Award (NRSA) forms.  The changes are being phased in starting December 1, 2015, with most becoming effective in early 2016. Please refer to the Notice for full details. GCO will provide communication and resources as more information becomes available.
  • NIH & AHRQ Announce New Form for PHS Awarding Component and Peer Review Requests:
    Applicants to NIH and AHRQ who want to communicate requests pertinent to the assignment and initial peer review of applications must use a new PHS Assignment Request Form beginning with applications for due dates on or after May 25, 2016. Use of this form will ensure applicant requests are effectively communicated to agency staff and may be used to expedite the processing and assignment of applications.  Fields on the new form include the NIH IC request, Study Section or Special Emphasis Panel Requests, Lost of potential reviewers in conflict, and list of scientific expertise needed to review the application. The form will be optional, and will complement the Cover Letter Attachment on the SF 424 (R&R) form. Read the full Notice for more information.
  • NIH & AHRQ Change to Font Guidelines:
    NIH and AHRQ are changing the guidelines regarding the fonts used in PDF attachments included in grant applications. For applications submitted for due dates on or after May 25, 2016, text in PDF attachments must follow these minimum requirements:
    • Font size: must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%)
    • Type density: must be no more than 15 characters per linear inch (including characters and spaces)
    • Line spacing: must be no more than six lines per vertical inch
    • Text Color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable as long as it is legible)

      Since some PDF converters may reduce font size, it is important to confirm that the final PDF document complies with the font requirements. See the full Notice for additional information.
  • RPPR Open for all Type 5 Non-SNAP Progress Reports:
    Beginning on April 25, 2014, NIH will open up the use of the Research Performance Progress Report (RPPR) in eRA Commons for the electronic submission of annual progress reports for all Type 5 non-SNAP progress reports.  Funding mechanisms and grants not subject to SNAP will now submit an RPPR for the annual progress report instead of PHS2590 forms. The expanded RPPR will require submission of detailed budgets and budget justifications for primary and subcontract sites as well as additional required information. These Continuation applications will still be submitted to the MCW Grants and Contracts Office via either eBridge or with a Non-eBridge (paper) registration form, with a completed copy of the RPPR attached. For more information, please see the Submit Progress Report page, the Guide Notice NOT-OD-14-079, and the updated NIH Research Performance Progress Report (RPPR) Instruction Guide (PDF).
  • CDMRP replaces eReceipt System with eBrap - Required Registration:
    For FY14, CDMRP has replaced the eReceipt system with the electronic Biomedical Research Application Portal (eBRAP). Application submissions for CDMRP, more commonly recognized as Department of Defense (DOD), are a 2 step process that now requires (1) pre-application submission through the eBRAP system, and (2) the customary SF424 application submission through Grants.gov.
    Investigators interested in applying for DOD funded grant opportunities must now create an eBrap registration. PIs can access the eBRAP website. All interested applicants will be required to register, and though it is not required before submission of a pre-application using eBrap, it is strongly encouraged that PIs request to be affiliated with MCW during registration.
  • New Post Submission Review Functionality and Verification Period:
    Invited applicants (PIs) who successfully submit a full proposal using the Grants.gov system can use the eBRAP system to modify the full application.  During this verification period, the PI may upload missing files, replace files, and re‐categorize files.  The Project Narrative and Budget cannot be changed after the application submission deadline. Any other application component cannot be changed after the end of the verification deadline.  All modifications must be completed by the end of the verification period. The verification period is listed within the RFA.
    The ability to view and modify the Grants.gov application in eBRAP is contingent upon the registration and affiliation of the PI with their institution in eBRAP. At this time MCW is only allowing PIs to register for a role in eBRAP. There are no roles currently available in the eBRAP system for an assistant or a secondary submitter that can be allowed by MCW for security reasons. For more information on the eBrap system, view the eBRAP User Guide (PDF).
  • New NIH Requirement - Use of the Inclusion Management System (IMS):
    NIH has added a new feature to eRA Commons, the Inclusion Management System (IMS), for reporting sex/gender, race, and ethnicity information as required by the NIH Policy on the Inclusion of Women and Minorities in Clinical Research. The new Inclusion Management System was released October 17, 2014, and takes advantage of the structured inclusion data being collected on competing applications to pre-populate inclusion data records and allow grantees to directly manage their inclusion data in the system throughout the awarded project period.

    NIH grantees completing their RPPR (Research Performance Project Report) will be prompted in question G.4.b to access and update inclusion records directly in IMS.  Going forward, PIs will be able to access their inclusion enrollment data through the IMS, found through the eRA Commons Status page, and can review or update their inclusion data as needed. For more information on IMS and the NIH changes to reporting this information, see the complete NIH Notice.

  • Letters of Intent Resources and Reminders:
    Please remember that a Letter of Intent (LOI) is required from all proposed subcontract/consortium sites on an MCW-led grant or contract application, and MCW will provide a LOI for all proposed pass-through applications when MCW will be a subcontract site on another institution’s application. When MCW will be the institution submitting the grant application to the sponsoring agency, a LOI is required for each proposed subcontract site at the time the Funding Proposal or paper registration forms and application are submitted to the GCO for review.  Please contact GCO staff if you have any questions regarding LOIs.

  • NIH eRA Commons User IDS Now Mandatory for Graduate and Undergraduate Students:
    As of October 2014 NIH has implemented a requirement that all individuals in graduate and undergraduate student roles who participate in NIH-funded projects for at least one person month or more must have an eRA Commons User ID, and a completed Personal Profile section in their Commons account. The IDs are now required in the All Personnel section of NIH progress reports, known as the Research Performance Progress Report (RPPR). RPPRs lacking the eRA Commons ID for Graduate and Undergraduate Students will receive an error, and the RPPR will not be able to be submitted without a User ID/Commons account for each student. The User ID requirement also still applies to all individuals with the PD/PI role and the Postdoc role.

    If you need to request a new eRA Commons account for a student or other individual, complete a Request eRA Commons Account form from the GCO website, have it signed by the account holder and appropriate department or division person, and email to the GCO at aor@mcw.edu. See the full NIH Notice for more information on this requirement.


  • NIH Public Access Policy - My NCBI:
    Compliance with the NIH Public Access Policy is a mandatory requirement for NIH grants.  The NIH has now mandated the use of the My NCBI electronic resource to enter papers on to Continuation progress reports (RPPR and PHS 2590) in order to demonstrate compliance with the Public Access Policy; see the NIH Notice for more information.
    Refer to the NIH site at NIH site for information and resources on how to create a My NCBI account, link your eRA Commons account to My NCBI, and manage compliance of the NIH Public Access Policy in progress reports. 
    See the MCW Libraries NIH Public Access Policy site and contact library staff for assistance using My NCBI.

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