Find links to information about working with the National Institutes of Health (NIH).
PIs and postdoctoral personnel funded by NIH are required to be registered with the Commons, and to include their Commons user name in their proposals. All non-competing continuation applications subject to the Simplified Non-competing Award Process (SNAP) must now be submitted electronically via the Commons as eSNAP proposals. The UCSD Signing Officials (SOs) have delegated "submit" authority for eSNAPS to UCSD Principal Investigators (PIs)
Contact your program officer and/or your grants specialist at NIH. Discuss whether the grant will be transferred mid-year or on an anniversary date.
Compliance with NIH policy is a statutory requirement and a term and condition of the grant award and cooperative agreement, in accordance with the NIH Grants Policy Statement. For contracts, NIH includes this requirement in all R&D solicitations and awards under Section H, Special Contract Requirements, in accordance with the Uniform Contract Format.
For further assistance, visit the UCSD Biomedical and Medical Center Libraries.
In order to comply with this requirement, University of California Investigators should enclose this letter signed by the Executive Director, Office of Technology Transfer and Research Administration, University of California, Office of the President, with any articles submitted to publishers for possible publication. This letter gives notice to the publishers that if accepted for publication the article will be required by law to be posted on PubMed Central. If this letter is not submitted to the publisher at the time the article is sent in for review, it must be submitted along with any publication agreement signed by a University of California Investigator.
Certain publishers have agreed to automatically submit articles to PubMed Central on behalf of the authors. However, the Investigator should always verify that their published article is submitted to PubMed Central in compliance with this law.
If an Investigator's publisher is not on NIH's list of publishers that automatically submit articles to PubMed Central, then it is the Investigator's responsibility to submit their article to PubMed Central and verify that their article was received.
To facilitate the submission of articles to PubMed Central (PMC), NIH has developed the NIH Manuscript Submission (NIHMS) System. There are also detailed Online Instructions that are available for users.
Any competing NIH proposals or Progress Reports must include the PubMed Central ID number (PMCID) for any papers mentioned in Bibliographies, References Cited, or Biosketches that meet the following conditions:
Accepted for publication on or after April 7, 2008
Authored by the PI of the proposal or funded by an NIH award to the PI of the proposal
Note: The PMCID is not the same as the PubMed ID number. PubMed Central archives complete articles, while PubMed includes only citations and abstracts. NIH has created a tool that will locate the PMCID, if the PMID is known.
If the manuscript was submitted through the NIH Manuscript Submission System (NIHMS) and a PubMed Central reference number is not available yet, include the NIH Manuscript Submission System reference number (NIHMS ID) instead.
If the PMCID is not available yet because the journal will be submitted the manuscript directly to PMC, indicate "PMC Journal - In Process."
In Reminder Notice OD-08-119, NIH has provided charts of all types of application packages and all submission types, listing exactly where to include the PMCIDs. Charts.
NIH Program Officials will email PIs and UCSD officials about any proposals that contain references to papers that appear to fall under this policy, but lack appropriate PMCID citations. PIs will be required to respond with the PMCID number, or an explanation for why that paper is not covered by the policy. Reminder Notice OD-08-119.
Required use of the Research Performance Progress Report (RPPR) module for submitting Streamlined Noncompeting Award Process (SNAP) and Fellowship progress reports will begin in May 2013.
You can read the official Guide Notice for more detailed information. But we urge you to get familiar with the new process now if you have not already tried using the eRA RPPR module. RPPR has been available as an option to all NIH grantees since October 2012. You want to note as well that RPPR will be replacing the eSNAP tab in eRA Commons, and eventually as eSNAP functionality will be retired.
Streamlined Non-Competing Award Process (SNAP) includes a number of provisions that modify requirements for annual progress and financial reports and for Notices of Award. eSNAP is the electronic version of SNAP progress report, which grantees have been required to use for SNAP progress reports since August 2010.
RPPR is a federally mandated reporting format for all federal grant agencies (NIH, NSF, DoD, etc.) designed to provide consistent information on the progress of federally funded research and research related activities. RPPR will replace the eSNAP progress reports for SNAP awards and PHS 416-6 for Fellowship progress reports in May, and will eventually replace the use of the PHS 2590 for non-SNAP awards..
The eSNAP module will be replaced by the RPPR for SNAP awards in May 2013.
There is no change to non-SNAP award progress reports at this time but the eRA team continues to develop an electronic solution for these reports. Of course, you will be updated as when the implementation timeline for non-SNAPs has been defined.
The RPPR website has some very good information on it that might help ease the transition to this federally-mandated reporting scheme. In particular, there is the October 2012 webinar NIH RPPR Training Webinar for Grantees presented by the Office of Policy for Extramural Research Administration (OPERA). And we cannot forget the ever helpful NIH RPPR Instruction Guide (PDF)
To PRAM or Not to PRAM - In addition to all the above changes, you will see the expansion of Progress Report Additional Materials (PRAM) functionality. The PRAM link that can be found in the Action column of the eRA Commons Status page will used to provide either the public access compliance information, the additional materials requested by IC, or both, depending on which is applicable to the particular RPPR. The grantee may provide the requested information, route the response to a Signing Official (SO), or, if the PD/PI has been delegated Submit Progress Report authority by the Signing Official, submit the materials to the agency. The materials may be viewed from the status information screen in Commons.
Grantee use of the PRAM link to respond to PRAM requests is not mandatory at this time; the grantee may respond via email to the Grants Management Specialist. However, NIH expects to mandate use of the electronic PRAM feature in the future and encourages grantees to familiarize themselves with the functionality.
NIH may require a Resource Sharing Plan as part of the Research Plan of a competing proposal. For either electronic submissions using Grants.gov, or paper submissions using the PHS 398 forms, insert the Resource Sharing plan in Section 17 of the Research Plan. Resource Sharing may consist of multiple parts:
Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Specific funding opportunity announcements may also require that all applications include this information regardless of the dollar level.
In accordance with NIH requirements, investigators submitting a research application requesting $500,000 or more in direct costs in any single year to NIH are required to include a plan for sharing of final research data for research purposes, or state why data sharing is not possible. A Data Sharing Plan may also be required by specific RFAs or PAs for proposals of any dollar amount.
The following sample plan guidelines are provided to assist investigators with this requirement when data can be shared:
Plan for Intellectual Property and Sharing of Research Resources
Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.
Ownership of sole or joint inventions developed under the project will be owned by the institution(s) employing the inventor(s). Inventors shall be determined by U.S. Patent law, Title 35 SC. University and Participating investigators/institutions will disclose any inventions developed under the project and such inventions will be reported and managed as provided by NIH policies. Sole inventions will be administered by the institution employing the inventor. Joint inventions shall be administered based on mutual consultation between the parties. Similar procedures will be followed for copyrights.
Materials generated under the project will be disseminated in accordance with University/Participating institutional and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement.
Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.
Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.
PI/Department to complete next section
Describe the following for the specific project:
- Expected schedule for data sharing if different from above.
- Format of the final data set
- How will data be shared (sent electronically, etc.)
In compliance with the NIH requirements, the following Sample Plan may be used for all proposals (except fellowships and training grants) to the NIH that anticipate the generation of model organisms.
"As for our plan to share materials and our management of intellectual property, we will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (PDF) issued December 23, 1999. All 'model organisms' generated by this project will be distributed widely or deposited into a repository/stock center making them available to the broader research community, either before or immediately after publication, in accordance with University policies. If we assume responsibility for distributing the newly generated model organisms, we will fill requests in a timely fashion. In addition, we will provide relevant protocols and published genetic and phenotypic data upon request. Material transfers will be made with no more restrictive terms than in the Simple Letter Agreement (SLA) or the Uniform Biological Materials Transfer Agreement (UBMTA)and without reach through requirements. Should any intellectual property arise which requires a patent, we will ensure that the technology (materials and data) remains widely available to the research community in accordance with University policies and the NIH Principles and Guidelines document."
Optional insert, if applicable:
Our lab has demonstrated its commitment to sharing by providing ___________________ over the past _______________years. The PI needs to fill in the blanks.
Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. See NIH’s instructions.
NIH is currently developing plans to require sharing of sequence and related genomic data Investigators should consider this possibility carefully in designing any study seeking NIH support that includes the use of large-scale advanced sequencing technologies, and within any such applications submitted to the NIH. When designing these studies, PIs should develop appropriate informed consent approaches that permit such data sharing. For more information, see the notice.