Plan early so that you give yourself enough time to get familiar with the new forms requirements, and like always Pre Award is her to assist you; x44589, rapreaward@llu.edu

Click on the link for more NIH information.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-119.html

https://grants.nih.gov/grants/how-to-apply-application-guide.html

Notice of policy changes website https://grants.nih.gov/policy/notices.htm

For more information contact Pre Award, rapreaward or X84589

Click on the link for more NIH information.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-010.html

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-001.html

Click on the link for more NIH information

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

Click on the link for more NIH information

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-011.html

• Procedural Change for grant agreements sent directly to Industrial Relations
• New eTransmittal and eRouting for approvals
• New FORMS-E for NIH submissions with Human subjects
• New RFAs for Clinical Trial submissions
• Reminder: NIH definition of a Clinical Trial
• Protect the credibility of published research

How To Demonstrate Scientific Progress in Annual Reports

If a grant is awarded as a result of or in connection with the application, and we receive a Freedom of Information Act (FOIA) request for the awarded application, we will consider your response to this question and the information you marked in determining what information should be disclosed and what information should be withheld. Although we will consult with the grantee institution and the investigator before anything is disclosed in response to a FOIA request, NIH will make the final determination. It is important to note that marking information as proprietary or privileged does not automatically shield the information from disclosure under FOIA. If no information is marked as proprietary at the time of the submission, we will need a significant, substantive, and detailed justification explaining how release of the information will cause commercial competitive harm in order to withhold any information in response to a FOIA request. 

Additionally, while NIH policy is to keep grant applications confidential and while reviewers are required to keep application information confidential regardless of whether it is marked proprietary or privileged, this additional designation may help to preserve invention rights if a patent will be pursued. Checking the box and marking the privileged/proprietary information evidences an applicant’s intent to protect potential patent rights from being compromised by articulating what portions of the application the applicant considers privileged/proprietary.

Original story

When I was asked to do an Items of Interest on Carryover, my brain immediately thought “carry on,” then quickly added “my wayward son.” Ahh, Kansas, Leftoverture, 1976. It is kind of ironic that the name of that album is Leftoverture. Leftover… carryover. Somehow it is all connected, like 6 Degrees of Kevin Bacon.

Carryover is a process in which unobligated funds remaining at the end of the budget period (leftover funds) may be carried forward to a future budget period. In the past, the request to carryover funds from one budget period to another would have been done with the Principal Investigator emailing (with the Signing Official’s sign off) the Grants Management Officer (GMO) to explain why there are funds remaining and to get permission to carry the funds over.

Starting in June 2017, there will be an option to submit Carryover requests electronically under the Prior Approval Module. Carryover requests will join Withdrawal of an Application, $500K or More Requests, Change of PD/PI Requests, and No Cost Extension Requests as an optional electronic submission method.

Grantees are allowed automatic carryover of funds if they have the expanded authorities to do so. For those awards that do not have expanded authorities, grantees need to submit a carryover request to their respective GMO for prior approval. This can be done electronically via the Prior Approval module in eRA Commons, scheduled for early June. Note that the electronic method is optional.

Only a Signing Official can submit the request.

A Carryover request will be available in Prior Approval when the grantee has met these two conditions:

1. Prior year’s FFR (Federal Financial Report) has been submitted.
2. The grant is still active, meaning the project period has not ended and a no-cost extension (NCE) request has been submitted by the institution requesting additional time, and the grant has not been closed.

As part of the process, several key pieces of information will be required to complete the request:

• Unobligated funds to be carried over
• Explanation of unobligated funds
• Budget Justification
• Scientific Justification

Closely related to the Carryover request is the No-Cost Extension request. If a Carryover request is made within 90 days of the project period end date, the Prior Approval Module will allow you to initiate the No-Cost Extension request at the same time as the Carryover request.

So, now (sing it with me people) lay your weary head to rest, don’t you cry no more, because Carryover will let you carry on!

Latest Video Releases

Grab a cold drink, a box of “pup-corn” and enjoy the latest eRA video tutorials. With the Prior Approval module expanding rapidly, we recently added four tutorials demonstrating the functionality of:

1. Withdrawal of an Application
2. $500K or More Requests
3. Change of PD/PI Requests
4. No Cost Extension

And coming soon will be the Carryover Request tutorial (see above for information).

Now, you may find it odd that the links above don’t take you straight to the videos. They take you to a page that then links to the videos on YouTube. Trust me, I am not intentionally making your life more difficult.

The videos are hosted on YouTube. But, since a YouTube URL can only be used once, when these tutorials get updated, the URL will also be updated. By bringing you to our launch page first, we ensure you will get to the latest, most recent versions of the tutorials.

So enjoy and happy viewing!

Posted on June 5, 2017 by Mike Lauer

We appreciate the many thoughtful comments posted to the blog about working together to improve NIH funding support for early- and mid-career investigators to stabilize the biomedical workforce and research enterprise using a measure called the Grant Support Index (GSI). Some clear themes have emerged, including: …. Continue reading →

Getting to Know Federal Funders and their Research Interests

Posted on June 6, 2017 by Mike Lauer

Working with NIH applicants and awardees as an extramural program division director, I often shared the NIH RePORTER resource as a tool for exploring the research topics NIH supports. Learning what projects we support, using a robust database of historical and newly-funded projects (updated weekly), provides researchers valuable insight as they consider developing their own research programs and applications for funding. Another valuable tool which you might be familiar with is Federal RePORTER, which expands the RePORTER concept to support searching over 800,000 projects across 17 Federal research agencies, with trans-agency data updated annually. As Federal RePORTER recently received an update to introduce some new functions and additional agency data we’d like to highlight some of the ways it helps both the public and scientific researchers alike …. Continue reading →

Top Stories

Issued Patent Citations Will Be Accepted As Post-Submission Application Materials

NIH recently updated its policy for what materials will be accepted as post-submission application materials. Beginning with applications submitted for due dates on or after September 25, 2017, citations of newly issued patents can be included in post-submission materials. The NIH post-submission materials policy allows grant applicants to submit limited information …. Continue reading →

New Resources

New Tutorials on Preparing and Submitting Your NIH Grant Application

New to the NIH grant process? Ever wish someone would explain and walk you through applying for NIH grants step by step? If so, we hope our newest resource will be the next best thing to joining you for an in-person lesson. …. Continue reading →

You Ask, We Answer

What Are “Key Biological and/or Chemical Resources” That Should Be Addressed In My Application’s Authentication Plan?

The quality of resources used to conduct research is critical to the ability to reproduce the results, so to address scientific rigor in your NIH application, we ask you to include an authentication plan. Key resources refer to established resources that will be used in the proposed research. Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. Key biological and/or chemical resources may or may not have been generated with NIH funds and: …. Continue reading →

What Kind of Information Should I Include in the “Authentication of Key Biological and/or Chemical Resources” Attachment?

Applicants proposing to use established key biological and/or chemical resources are expected to include an authentication plan in the “Authentication of Key Biological and/or Chemical Resources” attachment, even if the key resources were purchased or obtained from an outside source that provided data on prior authentication. The authentication plan must include only a description of the methods proposed to authenticate key resources prior to use and at regular intervals, if appropriate. The plan should be no more than one page. Key resources and the methods for authentication will vary by research field. For example, …. Continue reading →

• Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms
• Expansion and use of discrete form fields for clinical trial information to
• provide the level of information needed for peer review;
• lead applicants through clinical trial information collection requirements;
• present key information to reviewers and agency staff in a consistent format; and
• align with ClinicalTrials.gov (where possible) and position us for future data exchange with ClinicalTrials.gov
• Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms

Read the NIH Guide Notice for more information: NOT-OD-17-062 

From NIH Notice Number: NOT-OD-17-050

Key Dates

Release Date: March 24, 2017
Effective date for application: Applications submitted for the May 25, 2017 due date and thereafter
Effective date Research Performance Progress Report (RPPR): RPPRs submitted on or after May 25, 2017
  

Related Announcements
NOT-OD-17-006- Request for Information (RFI): Including Preprints and Interim Research Products in NIH Applications and Reports

Purpose

The NIH encourages investigators to use interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work. This notice clarifies reporting instructions to allow investigators to cite their interim research products and claim them as products of NIH funding.

Citing interim research products in applications, proposals and reports

Interim research products can be cited anywhere other research products are cited.  These sections include the following:

• R&R Other Project Information Form, Bibliography & References Cited
• R&R Senior/Key Person Profile (Expanded) Form, Biographical Sketch
• PHS 398 Research Plan, Progress Report Publication List
• PHS 398 Career Development Award Supplemental Form, Progress Report Publication List
• PHS Fellowship Supplemental Form, Progress Report Publication List
• RPPR, section C - Products

To cite the product, applicants and awardees must include the Digital Object Identifier and the Object type (e.g. preprint, protocol) in the citation. Also list any information about the document version (e.g. most recent date modified), and if relevant, the date the product was cited.

Example: Bar DZ, Atkatsh K, Tavarez U, Erdos MR, Gruenbaum Y, Collins FS. Biotinylation by antibody recognition- A novel method for proximity labeling. BioRxiv 069187 [Preprint]. August 11, 2016 [cited 2017 Jan 12].  Available from: https://doi.org/10.1101/069187.

These requirements help reviewers understand that the product is public, interim, and identify the specific version is being referenced.

Note: Applicants are responsible for providing the information necessary to review a section of an application within the page limits of that section.

More information can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html

Appointed members of standing NIH study sections, NIH Boards of Scientific Counselors, NIH Advisory Boards or Councils, or NIH Program Advisory Committees are all eligible for continuous submission (submitting R01, R21, and R34 applications at any time in response to active funding opportunity announcements (FOAs) that have standard due dates).

More

How Can I Check If I Am Eligible to Submit an Application Under NIH's Continuous Submission Policy?:   

You can check your eligibility to submit applications under NIH's continuous submission policy by logging into eRA Commons, and following the instructions outlined here.

More

How Can I Check If I Am Eligible to Submit an Application Under NIH's Continuous Submission Policy?:   

You can check your eligibility to submit applications under NIH's continuous submission policy by logging into eRA Commons, and following the instructions outlined here.

More

NSF Proposal & Award Policy Newsletter – March (sign up for mailing list - Policy Office website)

The Policy Office in the Division of Institution & Award Support at the National Science Foundation is pleased to announce the release of a new quarterly publication designed to provide information about upcoming changes and clarifications to policies and procedures that affect how you prepare and submit proposals and manage NSF awards.  The first issue of the NSF Proposal & Award Policy Newsletter is now available on the Policy Office website.

If you plan on submitting a grant to any funding agency please contact Cindy Dickson, x44571 or cdickson@llu.edu

From Grants.Gov Community Blog

Today, Grants.gov supports a growing community of applicants, grantors, and others interested in learning more about federal grant eligibility.

4 Ways to Learn Grants with Grants.gov [Video] https://youtu.be/bg2T_KQtSOA

If you plan on submitting a grant to any funding agency please contact Cindy Dickson, x44571 or cdickson@llu.edu

All informed consent documents/recruitment materials (for Full Board and Administrative submissions) marked-up with IRB reviewer’s comments will now be e-mailed to the PI/study contact as part of the review.  Contact us at x44531 or e-mail IRB@llu.edu if you have any questions or concerns about this. 

NIH’s Center for Scientific Review posted recordings of their most recent webinar series on peer review.

• 8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant – covering things applicants need to know about the submission and review of a fellowship grant

• 8 Ways to Successfully Navigate NIH Peer Review and Get an R01 Grant – covering things applicants need to know about the submission and review of an R01 grant

• NIH Peer Review Briefing for Basic Research Applicants and Reviewers – covering NIH’s commitment to basic research and helping applicants and reviewers do their part in proposing and reviewing basic research

CSR is the portal for receipt and referral of NIH grant applications, and, for the majority of those applications, carries out the peer review process for assessing scientific and technical merit.

A number of NIH policies became effective in January. Here’s a brief recap:

Effective January 1, 2017:

Final Research Performance Progress Reports: As of January 1, NIH no longer accepts the Final Progress Report (FPR) form for most grants. Instead, grantees must provide final progress reports using the Final Research Performance Progress Report (Final RPPR) format, which is submitted electronically through a new eRA Commons module. Read more in the NIH Guide (NOT-OD-17-022) and Nexus, and read about the “Interim RPPR” further below.

Good Clinical Practice Training:  NIH expects NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials to have Good Clinical Practice (GCP) training. As long as steps are being taken to meet the policy expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the Jan 1, 2017 effective date. See last month’s Nexus for help identifying training opportunities.

Effective January 18, 2017:

Clinical Trial Reporting Requirements: NIH expects investigators conducting clinical trials (funded in whole or in part by the NIH) to ensure that these trials are registered at ClinicalTrials.gov within 21 days of first-patient enrollment and that the results information from these trials is submitted to ClinicalTrials.gov within one year of trial completion. NIH’s policy complements a new federal regulation to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials. Read more on the Open Mike blog and in updated FAQs.

Effective January 25, 2017:

Application Appendix Materials: NIH eliminated most types of appendix materials for grant applications intended for due dates on or after January 25.  Applications will be withdrawn if they are submitted with appendix materials that are not specifically listed in NOT-OD-17-035, or specified in the specific funding opportunity announcement to which you are applying.

Post-submission Materials: NIH clarified the types of materials that can be submitted due to unforeseen events after submission of the grant application but prior to the initial peer review. The consolidated post-submission materials policy also makes changes related to how publications that have been accepted for publication should be communicated as a post-submission material (form and content), post-submission materials for training and fellowship applications, and the timing of post-submission materials submitted to the final due date of a Request for Application (RFA). For details, read more in the NIH Guide (NOT-OD-16-130).

Updated Application Font Guidelines: NIH updated its recommended font list and no longer requires that black text be used within grant application attachments. Read more in the NIH Guide (NOT-OD-17-030) NIH Guide.

Like those little fuzzy, purring, furry Tribbles that came cascading out of the grain silo onto Captain Kirk, we have one more RPPR to bounce off you!

As you may recall we started the transition to the Research Performance Progress Report (RPPR) back in April of 2012. And now, with NIH having transitioned to the Final RPPR as of January 1, 2017, we have one more transition to make. And that is to the Interim RPPR.

The Interim RPPR (IRPPR) will be used when you are submitting a Competing Renewal application (Type 2). Since the Type 2 application is a competing application, there is no guarantee it will be awarded. And whether it is or isn’t awarded, can create some confusion about what to do for a final report.

So here is the scenario of how the Interim RPPR will be used. If you opt NOT to apply for Competing Renewal, complete the Final RPPR as you normally would within 120 days of the project end date. If you are going to complete a Competing Renewal application (or have already submitted such an application), you will submit an Interim RPPR. This must be submitted within 120 days of the project end date.

If you are awarded the renewal, the Interim RPPR will be treated as your annual RPPR and no other progress reporting will be needed for that segment of the study. If the application is NOT awarded, then the Interim RPPR will be accepted as the Final RPPR.

Like the mystery of how the tribbles were able to consume an entire silo of quadrotriticale (notice it ends in “cale?” Probably just as tasty as kale!), there is still one mystery here as well. Who can initiate and submit these various types of RPPRs?  First, annual RPPRs have not changed at all. The Progress Report delegation permits any user with the ASST role the ability to complete progress report information for a specified PI, but they cannot route or submit the report. The Submit delegation permits a specified Principal Investigator (PI) the ability to submit to agency the progress report, listing them as the Signing Official (SO) for that submission.

Second, Interim and Final RPPR work in the same manner as the old Final Progress Report (FPR). With the FPR, both SOs and PIs could initiate and/or submit to agency. They could also route the report back and forth for review and edits. All of this done without the need to delegate any authority. Interim RPPR and Final RPPR work in the same manner. No delegations needed for the initiation and submission of either version of these RPPRs.

Now because the format between the annual RPPR, the Interim RPPR and the Final RPPR are so similar, and permissions and delegations have not changed, this transition will be no tribble at all!  (Come on! You knew I was goin’ there!)

Visit the NIH eRA Items of Interest page for more information.

• Text Color: No restriction. Though not required, black or other high-contrast text colors are recommended since they print well and are legible to the largest audience.
• 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.

The following fonts are recommended:

• Arial
• Georgia
• Helvetica
• Palatino Linotype

For more information: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-030.html

Part 1: Navigating the NIH Public Access Policy
Part 2: Navigating the NIH Public Access Policy: The Submission Process
Part 3: Navigating the NIH Public Access Policy: Properly Citing Manuscripts
Part 4: Navigating the NIH Public Access Policy: My NCBI