eRA Enhancements: Prior Approval to Include Carryover Option

The ability to electronically submit a carryover request to NIH will be available through the Prior Approval module in eRA Commons after a release scheduled on Thursday, June 8, 2017 after 5 p.m. Carryover allows leftover, unobligated grantee funds to be carried over from one budget year to another, and may require permission be obtained from the awarding IC.

The Prior Approval module currently supports the electronic submission of the following requests:

  • Withdrawal of an application
  • $500K or more in direct costs
  • Change of PD/PI
  • No Cost Extension requiring Prior Approval

It is important to note that these features are optional and currently apply only to NIH awards. You can learn more about these electronic submission options by reviewing the tutorials found at: https://era.nih.gov/era_training/era_videos.cfm#eracommons.

Features

 · Carryover Request

Only a Signing Official (SO) will be able to initiate the carryover request.

When is a grant eligible for a carryover request?

  • The grant does not have expanded authority.
  • The Project period has not ended or a no-cost extension (NCE) request has been submitted by the institution requesting additional time.
  • The grant is not in closeout.
  • The grant has not been closed.

What information will an SO need to provide for a carryover request?

The carryover request form requires:

  • Amount of funds to be carried over
  • Explanation of unobligated balance
  • Detailed Budget
  • Scientific Justification

The high level steps In Prior Approval are as follows:

  • A list of eligible grants will be displayed.
  • The SO will pick a grant and initiate the request
  • If there is an overdue Federal Financial Report for that grant, the system will issue a warning. The SO can choose to ignore the warning and continue. However, the FFR will have to be submitted before the carryover can be approved by the funding agency.

Note: If the SO wants to initiate a no cost extension request in tandem with the carryover request (and it is within 90 days of the project period end date), a button will allow the SO to do that without searching for the grant again.

Any clarifications and back and forth between the SO and the program official will occur outside of the system.

Please note that the subsequent review and approval process remains the same.

Following the release, please look for details and screenshots in the eRA Commons Online Help.

The video tutorial for the Prior Approval Carryover Request can be found at:

https://era.nih.gov/era_training/era_videos.cfm#carryover

NSF Pilots New Collaborators and Affiliations Template

The National Science Foundation (NSF) initiated a new pilot requiring the use of a spreadsheet template for identifying Collaborators and Other Affiliations information for Principal Investigators (PIs), co-PIs, and other senior project personnel identified on proposals that went into effect April 24, 2017.  Please be advised that the new Collaborators and Other Affiliations pilot will only be for FastLane proposal submissions. Grants.gov proposal submissions will continue to follow the instructions in NSF Grants.gov Application Guide Chapter VI.2.4.

The NSF Proposal and Award Policies & Procedures Guide (PAPPG) (NSF 17-1) requires PIs, co-PIs, and other senior project personnel identified on NSF proposals to individually upload Collaborators and Other Affiliations information as a Single Copy Document (see PAPPG Chapter II.C.1.e).

NSF will use this information during the merit review process to help manage reviewer selection. To expedite identification of potential reviewers, having a standard, searchable format for this information is essential. The new pilot will standardize Collaborators and Other Affiliations information across the Foundation and will ensure that the information is submitted in a searchable format. Results from the pilot will be assessed and will determine how to proceed with this section of the proposal in the future.

Effective April 24, 2017 NSF will require the submission of a spreadsheet template to identify collaborators and other affiliations. Please note that the spreadsheet template:

  • Has been developed to be fillable. However, the content and format requirements must not be altered by submitters.
  • Must be saved in .xlsx or .xls formats and directly uploaded into FastLane as a Collaborators and Other Affiliations Single Copy Document.
  • Will be converted by FastLane from an .xlsx or .xls file to a PDF file.
  • Has been tested in Microsoft Excel, Google Sheets, and LibreOffice.
  • Will enable preservation of searchable text that otherwise would be lost. Must be uploaded in .xlsx or .xls formats only. Uploading a Collaborators and Other Affiliations Single Copy Document in any other format may delay the timely processing and review of your proposal.
  • Will be directly linked in FastLane. The template and associated instructions may also be accessed directly at: https://www.nsf.gov/bfa/dias/policy/coa.jsp.

In addition to the merit review process benefits, the Collaborators and Other Affiliations template will reduce administrative burden and improve efficiencies by providing submitters with a compliant and reusable format to maintain this information for use in subsequent proposal submissions to NSF.

For system-related questions, please contact FastLane User Support at 1-800-673-6188 or fastlane@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.

OMB Extends Uniform Guidance Procurement Rules

The Office of Management and Budget (OMB) issued an addendum to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) on May 17, 2017. The amendment allows non-federal entities an additional year to implement the Uniform Guidance requirements related to procurement. These procurement standards were previously on a delayed implementation timeframe, and this extension allows an additional year. Therefore, the new standards will apply starting with fiscal years beginning on or after Dec. 26, 2017.

 

 

NIH Fiscal Operations and Interim Salary Cap Guidance

NIH continues to operate under a continuing resolution, meaning that they will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level), as they have in past years. See the March 17 Guide notice for details.
They have also issued interim guidance on salary limits for NIH grants and cooperative agreements. The direct salary limitation follows Executive Level II of the Federal Executive pay scale, which was previously set at $185,100, and increased to $187,000 effective January 8, 2017. This means that for awards issued in previous years that were restricted to Executive Level II, including competing awards already issued in fiscal year 2017, grantees may rebudget to accommodate the current Executive Level II salary level as long as:

  1. adequate funds are available in active awards; and
  2. the salary cap increase is consistent with the institutional base salary.

However, no additional funds will be provided to these grant awards.

Note that they provide the Ruth L. Kirschstein National Research Service Award (NRSA) postdoctoral stipend levels and tuition/fees for FY 2017 in NOT-OD-17-003. Until further notice, the NRSA undergraduate and predoctoral stipends and tuition/fees will remain at the levels announced in NOT-OD-16-062.

Once the Department of Health and Human Services Appropriation for FY 2017 is enacted, additional guidance will be published in the NIH Guide.

Original post by on March 30, 2017

NIH: Reporting Preprints and Other Interim Research Products

NIH Notice Number: NOT-OD-17-050
Effective date for NIH application: Applications submitted for the May 25, 2017 due date and thereafter
Effective date NIH 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
Issued by
National Institutes of Health (NIH)

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.

Definitions

Interim Research Products are complete, public research products that are not final.

A common form is the preprint, which is a complete and public draft of a scientific document. Preprints are typically unreviewed manuscripts written in the style of a peer-reviewed journal article. Scientists issue preprints to speed dissemination, establish priority, obtain feedback, and offset publication bias.

Another common type of interim product is a preregistered protocol, where a scientist publicly declares key elements of their research protocol in advance. Preregistration can help scientists enhance the rigor of their work.

Notes:

  • Awardees are not required to create interim research products through their NIH award.
  • Applicants are not required to cite interim research products as part of their grant applications.
  • Since preprints are not published in peer-reviewed journals, they do not fall under the NIH public access policy.
  • This guide notice does not apply to clinical trial registration.  See ClinicalTrials.gov about registration of clinical trial protocols.

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:

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.

Claiming interim research products as products of NIH awards

NIH intends to maximize impact of interim research products that are developed with NIH funds.  Therefore, NIH expects awardees to ensure a high level of public access to NIH supported interim products.  To facilitate text mining and other analysis of these products as data, the NIH expects standardized terms of use. NIH also expects awardees will adhere to other norms of responsible scientific communication.

Specifically, to claim an interim research product as a product of an NIH award, the NIH expects that the awardee will:

  • Make the product publicly available. To maximize the impact of an interim research product, the NIH strongly encourages awardees to select a Creative Commons Attribution (CC-BY) license or dedicate their work to the public domain.
  • In the text of the document:
    • Acknowledge NIH funding in accordance with NIH Grants Policy Statement Chapter 8.2.1
    • Clearly state that the work is not peer-reviewed
    • Declare any competing interests, as an author would do for any journal article

For applications submitted for the May 25, 2017 due date and thereafter, awardees can claim these products on their progress report publication list.  They can also report them on their RPPR as of May 25, 2017, and link them to their award in their My Bibliography account.

Guidance for selecting interim research product repositories

Interim research products rely on repositories to make them public.  The repository market is growing rapidly, and in many scientific disciplines, norms for interim research products are still evolving.

The NIH would like to ensure that practices for interim products facilitate the impact, measurement and the integrity of the scientific record. Specifically, the NIH strongly encourages interim research products arising from NIH funds to be deposited in repositories that ensure:

  • Content is findable, accessible, interoperable and reusable.
  • Interim product metadata, including usage statistics, are open, and easy to access by machines and people (e.g. via application program interfaces).
  • Content is easy to use by machines and people. This access is both a function of permission (e.g. use of Creative Commons licenses) and technology (e.g. application program interfaces).
  • Policies about plagiarism, competing interests, misconduct and other hallmarks of reputable scholarly publishing are rigorous and transparent.
  • Records of changes to the product are maintained, and users have clear ways to cite different versions of the product.
  • Links to the published version, if available.
  • A robust archiving strategy that ensures long-term preservation and access.

Background and public comments

In the Request for Information (RFI) NOT-OD-17-006, the NIH sought input on the use of interim research products in NIH applications and reports, and the standards for reporting them. The NIH wanted to know if interim research products can increase the rigor and impact of NIH funded research. It also wanted to learn how interim research products arising from NIH funds can be created and used with integrity.

RFI respondents
The NIH received 351 responses, the majority (79%) submitted by scientists/authors. Twenty-two professional societies representing groups of scientists also submitted responses. Note, requests for information are not surveys.  Some responses are from organizations representing thousands of people; other responses are from individuals. The NIH is grateful to receive rich responses and thoughtful advice through this information request, and used these findings to shape this policy.

Defining interim products
Some respondents were confused about what interim research products are and where they were used in the NIH grant process. The RFI could have more clearly stated that the NIH has never restricted the materials that can be cited in the reference section of a research plan.  Further, several respondents referred to data and software as if NIH had not allowed them to be cited or claimed as a product of NIH funds, which is not correct. This guide notice, and related updates to application and RPPR instructions, intend to clarify these points.

Scientific impacts
Almost all respondents supported increasing the use of interim research products in NIH award processes. Many described specific scientific benefits. These include speeding dissemination by eliminating the months-long interval between submitting a manuscript to a publisher to the first public release of the manuscript.  Several respondents reported that they would submit a manuscript to a journal and a preprint repository at the same time. Respondents also noted that public comments on their interim product can improve the rigor of their work, and are an opportunity to form new scientific collaborations.  Finally, since interim research products are issued at the discretion of the author, they avoid publication bias.

Many respondents noted that interim research products can be especially helpful for new investigators. New investigators’ best work is sometimes so recent it has not had the time to be published.  Preprints can help investigators share the complete drafts of their work sooner. Further, other interim research products, such as protocols, help new investigators to document their progress and engage other scientists in discussion about their work.  Hosting repositories can amplify these benefits if they track utilization, comments, and other impact measures.

A few respondents claimed that interim products could help rivals finalize their research faster, thereby scooping the authors of interim products. However, several other respondents noted that since interim products are public, they establish priority for any inventions. Further, since authors have full control over the timing of an interim product release, they can always choose to not issue an interim product until a patent application is filed.

Information quality
Almost all respondents, even those that were strongly supportive of interim research products, felt that interim research products offered lower quality information than work that was formally peer-reviewed.

A few respondents noted special risks for the general public, clinicians, patients, and the media in accessing research products that have not been peer-reviewed.  These risks are especially great for clinical research, and there are examples when even peer-reviewed findings have been hyped and misinterpreted by the media. The NIH expects the research community to be judicious in its use of interim research products, and for some disciplines (and their leading journals) to explore the use of interim products more slowly than other disciplines.

Interim research products and NIH processes
Several responses, including some from prominent scientific societies, noted that NIH processes can already be burdensome and involve many peer-reviewed products.  They felt that including more non-peer-reviewed information into these processes will generate more burden than benefit.

Even more respondents argued that, on balance, interim products will be helpful.  Interim products are similar in quality to the preliminary data section of a research plan that reviewers are already comfortable with. These respondents suggested that reviewers should be skeptical of all claims and citations, whether peer-reviewed or not.

The NIH agrees that interim research products offer lower quality information than peer-reviewed products. This policy is not intended to replace peer-review, nor peer-reviewed journals. Instead, the NIH sees interim research products complementing final research products.

The RFI collected the fewest responses to questions about how interim research products should be cited.  Many respondents wanted to make sure that reviewers were aware that the interim product citation is not peer-reviewed, and suggested adding the label ‘not peer- reviewed’ to the citation.  This suggestion is difficult to enact because so many other standard citation formats that are not peer-reviewed do not say so in their citations (e.g. most book chapters and journal commentaries do not mention peer-review in the citation or text).

Instead, the NIH is instructing applicants and awardees that choose to cite interim research products to list the interim research product type (e.g. preprint) in the citation.  Further, the NIH is instructing awardees to explicitly state in preprints text that the work is not peer-reviewed.  These two practices should help reviewers easily identify interim products.  The NIH will offer explicit guidance to reviewers reminding them that interim research products are not peer-reviewed. Further, since interim products are new to so many biomedical disciplines, the NIH hopes that these conventions will become the norm for all interim products, and will help the media and the public understand that interim products have undergone less review than peer-reviewed articles.

Finally, to ensure the integrity and impact of interim products, the NIH is borrowing from practices established for final products. This is why NIH is asking authors and repositories to ensure the integrity of these products by declaring competing interests, track versioning, etc. To ensure impact, the NIH is asking authors and repositories to ensure interim products are findable through DOIs, open metadata, etc. To ensure these products are usable as individual documents and in aggregate through computation analyses, the NIH is encouraging authors to adopt a number of license and technical processes (e.g. Creative Common Attribution licenses (CC-BY), application programming interfaces, archival plans, etc.), and to use repositories that support these practices.

Overall, the RFI responses described interim research products as a relatively small change that can provide benefits to NIH processes, and science as a whole. The NIH will be monitoring the use of interim products, their infrastructure, and their impacts.  It may revise these standards as practice evolves.

Please direct all inquiries to:

Office of Policy for Extramural Research Administration (OPERA)
Email: grantspolicy@od.nih.gov

Original post by NIH 3/24/2017


It’s Going Away: The Legacy PDF Application Package Will Be Retired

If you don’t know what that means and missed the previous blog posts here and here, or the Grants.gov Notices page, here’s a quick summary:

In the past, applicants have downloaded and filled out a single, big, stitched PDF application package that contained all the forms (i.e., the “legacy PDF application package”). To work as a team, you had to email the file back-and-forth while making sure all are using the same exact version of Adobe software.

How Do I Apply for a Grant, Then?!

To improve your application experience with Grants.gov, they launched Workspace in October 2015. Since its launch, they have added functionality and developed training resources that have helped many applicants transition to Workspace.

By December 31, 2017, the 2+ year lead time for transitioning will end and the legacy PDF application package will be retired.

Okay, I Get It. How Do I Apply using Workspace?

Grants.gov can help with that. First, read through this overview of how to apply for grants using Workspace, which has pages that explain the full process and roles. There are links to more specific instructions on those pages as well.

Prefer video? Watch the Learning Workspace Video Series below:

If you are still looking for more, read through the Workspace Roles 3-part series on how the core roles work together as a team: #1 Manage Workspace Role, #2 Workspace Participants, and #3 Authorized Organizational Representatives (AOR) Role.

There’s also online help covering how-to instructions and finer details of the system. Of course, as you use workspace there are blue question mark icons that link directly to help articles for that page.

Original Post on March 29,2017

NSF: Reminder of Fastlane Changes to Support PAPPG (NSF 17-1)

Effective January 30, 2017, NSF implemented the following changes in FastLane to support the policy updates in the Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 17-1) and to run new and enhanced automated compliance checks on proposals:

Updated References and Terminology

  • The PAPPG (NSF 17-1) has been modified in its entirety, to remove all references to the Grant Proposal Guide (GPG) and Award & Administration Guide (AAG). The document will now be referred to solely as the NSF Proposal & Award Policies & Procedures Guide and is sequentially numbered from Chapter I-XII. All FastLane and Research.gov references and links to the GPG and AAG were updated to corresponding references and links in the PAPPG (NSF 17-1).
  • “International Travel” type of proposals were renamed to “Travel” and were expanded to include domestic and international travel.
  • “Facility/Center” type of proposals were renamed to “Center/Research Infrastructure.”

Enhanced Automated Compliance Checks

  • In addition to the new compliance checks for the GOALI, RAISE, and FASED types of proposals, FastLane is running enhanced automated compliance checks across several proposal types and will generate errors or warnings when the submission or deadline validation compliance checks are not met.
  • Checks are run during “Check Proposal,” “Forward to SPO,” and “Submit Proposal.” The complete list of FastLane automated compliance checks effective January 30, 2017, is available here.

Note About Proposal File Update (PFU):

The automated compliance checks also apply when a PFU is performed on a proposal. The compliance checks will be run on all sections of the proposal, regardless of which section was updated during the PFU. Proposers should be aware that if a proposal was previously submitted successfully, a PFU performed on the proposal will be prevented from submission if the proposal does not comply with the compliance checks in effect at the time.

Proposal Submission

  • Two new types of proposals were incorporated into the PAPPG with new required supporting documents and automated proposal compliance checks.
  • Grant Opportunities for Academic Liaison with Industry (GOALI):GOALI is a type of proposal that seeks to stimulate collaboration between academic research institutions and industry. The new GOALI automated compliance checks require that at least one Co-Principal Investigator (PI) exists on the proposal and the “GOALI-Industrial PI Confirmation Letter” is uploaded at the time of proposal submission. All automated compliance checks applicable to Research proposals apply to GOALI proposals. GOALI proposals were previously submitted via a program solicitation.
  • Research Advanced by Interdisciplinary Science and Engineering (RAISE):The RAISE proposal type supports bold, interdisciplinary projects. The new RAISE automated compliance checks require that a “RAISE-Program Officer Concurrence Email” is uploaded at the time of proposal submission, the proposal award budget is less than or equal to $1 million, and the proposal duration is less than or equal to 5 years. All automated compliance checks applicable to Research proposals apply to RAISE proposals.
  • The Facilitation Awards for Scientists and Engineers with Disabilities (FASED) type of proposal was included on the FastLane dropdown menu. All automated compliance checks applicable to Research proposals apply to FASED proposals.

Deadline Submission

  • Organizations that are unable to submit a proposal prior to a deadline due to a natural or anthropogenic disaster will be required to submit a new Single Copy Document, “Nature of Natural or Anthropogenic Event,” when attempting to submit a late proposal using the “Special Exception to the Deadline Date Policy” box on the NSF Cover Sheet.

For system-related questions, please contact FastLane User Support at 1-800-381-1532 or fastlane@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.

Federal-Wide Research Terms and Conditions

Research Terms and Conditions – April 2017

Federal Register Notice – Final Notice of Standard Terms and Conditions for Research Grants

Comments received in response to the request for public comment on the updated Research Terms and Conditions to address and implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) issued by the U.S. Office of Management and Budget (OMB) in the Federal Register [80 FR 61849, October 14 2015]

Federal Register Notice – Research Terms and Conditions to address and implement the Uniform Guidance, 2 CFR § 200 – October 14, 2015

Research Terms and Conditions Agency Implementation Statements – April 3, 2017

Research Terms and Conditions

Research Terms and Conditions Appendix A Prior Approval Matrix – March 14, 2017

Research Terms and Conditions Appendix B Subaward Requirements – March 14, 2017

Research Terms and Conditions Appendix C National Policy Requirements – March 14, 2017

Agency Specific Requirements

Research Terms and Conditions 2008-2011 (including supporting documents)

Draft Research Terms and Conditions Overlay to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance), 2 CFR § 200

Federal Register Notice – Final Notice of Standard Terms and Conditions for Research Grants

Research Terms and Conditions Agency Implementation Statements – Updated August 19, 2008

Research Terms and Conditions

Research Terms and Conditions Appendix B Subaward Requirements – June 2011

Research Terms and Conditions Appendix C National Policy Requirements – November 2014

Prior Approval Matrix

Agency Specific Requirements

RELEVANT LINKS

Research Business Models Subcommittee

Research.gov

National Science and Technology Council

 

 

eRA Enhancements: Two More Prior Approval Requests Go Electronic March 2, 2017

The ability to request a No Cost Extension requiring a prior approval and the ability to request a change of PD/PI will be available through the Prior Approval section in eRA Commons after a release scheduled for Thursday, March 2, 2017.

The Prior Approval tab was introduced to eRA Commons in September 2016 to initially provide an electronic option for executing a request for application withdrawal (see Guide Notice NOT-OD-143). In October 2016, the ability to request to submit an unsolicited application with $500K or more in direct costs was added to Prior Approval (see Guide Notice NOT-OD-17-005).

It is important to note that these features currently only apply to NIH awards. They are also an optional method. You should contact your awarding IC to determine the best method for making these requests before initiating either a No Cost Extension or Change of PD/PI.

Features

  • Prior Approval Request for No Cost Extension (NCE)

Signing Officials (SOs) will be able to request an NCE electronically through eRA Commons via Prior Approval.

o    When is a grant eligible for a NCE through Prior Approval?

  • When an NCE under expanded authority has already been used and the grant is within 90 days of the project end date.
  • When the grantee is not under expanded authority and the grant is within 90 days of the project end date.
  • When the project end date has expired and has not been closed or has not entered unilateral closeout, whichever comes first.

o    When is a grant NOT eligible for a NCE through Prior Approval?

  • When an NCE under expanded authority has never been requested and the grant is within 90 days of the project end date. In this case,
  • the NCE will be processed normally through the Extension link in Status.
  • When the grant is closed.
  • When the grant is a fellowship grant.

o    What information will an SO need to provide?

  • The NCE request form includes:
  • Request Detail – Here you will be asked such things as the number of months you wish to extend the project end date; the amount of unobligated money still available, etc.
  • Three PDF upload fields: Progress Report, Budget Document, Justification Document

Contact the awarding IC for details on the content of these documents.

  • Prior Approval Request for Change of PD/PI

Signing Officials (SOs) can initiate the request for a Change of Program Director/Principal Investigator (PD/PI) electronically through eRA Commons via Prior Approval.

o    The following conditions must be met for a grant to be eligible for a Change of PD/PI Request:

  • The grant is awarded, and the Project Period End Date has not passed.
  • The grant is not a Fellowship or Career.

o    The details for the request require some basic information:

  • Who is being replaced, removed or added to the grant?
  • What will their level of effort be?
  • What is the effective start date for the requested changes?

o    Additionally, some files will need to be uploaded as an attachment to the request.

  • Biosketch for any new PD/PI
  • Other Support for any new PD/PI
  • Justification Document

Once the request is submitted, the system creates a PDF of all the submitted information and sends a notification to the SO, the Grants Management Specialist, and Program Officer so they can review the request.

NOTE: Principal Investigators cannot see Change of PD/PI Requests.

Please note that the subsequent review and approval process remains the same.

Following the release, please look for details and screenshots in the eRA Commons Online Help.

Original post 2/28/2017 by eRA Communications Office

Reminder of New NIH Policies Now – Or Soon To Be – In Effect

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-17-030NIH Guide.

Effective February 9, 2017:

Interim RPPRs: If you submitted a renewal (Type 2) application that is under consideration, NIH Guide notice NOT-OD-17-037 explains that you must still submit a progress report via eRA Commons no later than 120 calendar days from the period of performance end date of your existing award. If the competing renewal is funded, NIH will treat this “Interim RPPR” as the annual performance report for the final year of the previous competitive segment.  If the competing renewal is not funded, NIH will treat the Interim RPPR as the institution’s Final RPPR.

Original post on February 1, 2017 by