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

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

 

 

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

New! MBL Effort Reporting: Semi-Annual Payroll Verification

MBL effort reporting procedures have changed…

The semi-annual payroll verification statement is MBL’s mechanism used to meet federal regulatory compliance for certifying effort expended on sponsored awards.  The new semi-annual payroll verification process will require that MBL PI’s certify effort for ALL project personnel every six months.

The statements will be sent out electronically to PI’s beginning mid-January using AdobeSign.  PI’s will have 30 days to certify/sign/return the document to OSP.

Detailed procedures for this new process are available on the OSP website or by clicking here.

 

General Application Guide for NIH AND Other PHS Agencies

G.100 – How to Use the Application Instructions

 

For more detailed information visit:

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.100-how-to-use-the-application-instructions.htm

Effort Reporting Changes

Effort Reporting Changes

Effective July 1, 2016, and in accordance with federal regulations pertaining to effort certification on federal awards (Uniform Guidance Subpart E §200.430), MBL effort reporting procedures have changed. Sponsored project personnel are no longer required to certify effort on a monthly basis. The new biannual payroll verification process will require that Principal Investigators certify effort for all project personnel every six months. Please note that the process for PI-review of project expenditures and correcting project salary cost allocations (and any applicable cost corrections) will continue on a monthly basis in consult with the appropriate Research Administrator.

Principal investigators will have 30 days to complete the first iteration of the biannual payroll verification in January, 2017 for the 6-month time period beginning July 1 through December 31, 2016. Detailed procedures for this new process will be announced shortly and will be available on the OSP website.

Notice of Change in Animal Welfare Assurance Numbering System

Please note the updated MBL Animal Welfare Assurance No. (aka IACUC) is listed on the MBL Grant Information Sheet (v8.31.16)

For more information please see the NIH policy below regarding this update.

NIH Notice Number: NOT-OD-16-125

Key Dates
Release Date:  August 2, 2016

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

This Notice informs Public Health Service (PHS) awardee institutions that the Office of Laboratory Animal Welfare (OLAW) has implemented a new Animal Welfare Assurance (Assurance) numbering system.

Background

OLAW oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The Policy requires that “No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with the Policy.” Assurance agreements are approved by OLAW and assigned a unique identification number which is used by institutions in applications and proposals for research activities involving the use of vertebrate animals.

Implementation

Effective July 25, 2016, OLAW implemented a new Animal Welfare Assurance database that utilizes a new numbering format (D00-00000). However, the old numbers (A000-01) will be retained for the life of the Assurance. Institutions with an Assurance will receive a new number and may use either the new or old Assurance number in communications with NIH. For convenience, OLAW will reference both new and old Assurance numbers in Assurance-related correspondence. Institutions will be able to view the new Assurance number on the OLAW website list of Assured institutions (Domestic | Foreign) and in any Assurance-related correspondence from OLAW. Institutions seeking a new Animal Welfare Assurance will be provided an Assurance number in the new format only.

original post from Notices of NIH Policy Changes https://grants.nih.gov/policy/notices.htm

 

What is NSF’s Public Access Policy?

NSF requires that either the version of record or the final accepted manuscript in peer-reviewed scholarly journals and papers in juried conference proceedings or transactions (also known as “juried conference papers”) be deposited in a public access compliant repository designated by NSF; be available for download, reading and analysis free of charge no later than 12 months after initial publication; possess a minimum set of machine-readable metadata elements in a metadata record to be made available free of charge upon initial publication; be managed to ensure long-term preservation; and be reported in annual and final reports during the period of the award with a persistent identifier that provides links to the full text of the publication as well as other metadata elements. For more information, see section 3.1 of  “Today’s Data, Tomorrow’s Discoveries: Increasing Access to the Results of Research Funded by the National Science Foundation” at http://www.nsf.gov/pubs/2015/nsf15052/nsf15052.pdf.

For more information also see: http://www.nsf.gov/news/special_reports/public_access/