NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources

It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public.  PIs and funding recipient institutions are expected to make the results and accomplishments of their activities available to the research community and to the public at large.  The following links highlight selected NIH policies and related guidance on sharing of research resources developed with NIH funding.

• Policy on Dissemination of NIH-Funded Clinical Trial Information (8/2016)
   
• NIH Intramural Human Data Sharing Policy (8/2016)
   
• NIH Public Access Plan  for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research (02/2015) (PDF - 474 KB) –  This document describes NIH’s plans to build upon and enhance its longstanding efforts to increase access to scholarly publications and digital data resulting from NIH-funded research.
   
• Genomic Data Sharing (GDS) (8/2014) Final Genomic Data Sharing (GDS) Policy that provides for the sharing, for research purposes, of large-scale human and non-human genomic data generated from NIH-funded research. Effective for grant applications and contract proposals submitted for January 25, 2015 due date and thereafter.
   
• NIH Grants Policy Statement (Availability of Research Results) (11/2015) - Section of the NIH Grants Policy Statement discussing the availability of research results developed with NIH funding, including publications, data, unique research resources, and intellectual property (inventions and patents).
   
• Common Data Element (CDE) Resource Portal (03/2013) - The Common Data Element (CDE) Resource Portal provides access to NIH-supported CDE initiatives and other tools and resources which can help researchers use common data elements (CDEs) in clinical research, patient registries, and other human subject research in order to improve data quality and opportunities for comparison and combination of data from multiple studies and with electronic health records.
   
• Table of NIH Data Sharing Policies (03/2013) - This table lists additional data sharing policies in effect at NIH at the NIH, IC, division, and program levels that apply to broad sets of investigators and data.
   
• Table of NIH Data Sharing Repositories (03/2013) - This table lists various NIH-supported data repositories that accept submissions of appropriate data from NIH-funded investigators and others, as well as including resources that aggregate information about biomedical data and information sharing systems.
   
• Data Repositories Resource Guide (09/2012) - (MS Word - 30 KB) - This resource guide document is designed to assist the NIH extramural community by identifying examples of data repositories which may be used for sharing data developed under NIH funding programs, consistent with NIH sharing policies.
   
• Data Standards and Common Data Elements Resource Guide (09/2011) - (MS Word - 29 KB) - This resource guide document is designed to assist the NIH extramural community in identifying and utilizing certain data standards and common data elements in NIH programs.
   
• Example Plan addressing Key Elements for a Data Sharing Plan under NIH Extramural Support (08/2010) - (MS Word - 55 KB) - This resource document is designed to assist the NIH extramural applicant community in preparing data sharing plans by providing an example that shows how a sharing plan addresses the key elements for a data sharing plan.
   
• Key Elements to Consider in Preparing a Data Sharing Plan under NIH Extramural Support (12/2009) – (PDF - 32 KB) - This resource document is designed to assist the NIH extramural applicant community in preparing data sharing plans by identifying key elements that should be addressed in the plan.
   
• NIH Genome-Wide Association Studies (GWAS) Policy (Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)) (08/2007) - Policy concerning sharing of GWAS data obtained in NIH supported or conducted research.  (Please refer to Genomic Data Sharing (GDS) Policy webpage.)
   
• Data Sharing Regulations/Policy/Guidance Chart for NIH Awards (08/30/2006) - (MS Word - 62 KB) - This chart is designed as a quick guide only for the purpose of identifying various data sharing regulation/policy/guidance documents applicable to NIH funding.
   
• NIH Public Access Policy (02/2005) - Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research.
   
• NIH Model Organism Sharing Policy (NIH Policy on Sharing of Model Organisms for Biomedical Research) (05/2004) - Policy concerning the sharing and distributing of model organisms and related research resources generated using NIH funding.
   
• NIH Data Sharing Policy (Final NIH Statement on Sharing Research Data) (02/2003) - Policy concerning the sharing of research data for funding applications seeking $500,000 or more in direct costs in any year of the project period.
   
• NIH Research Tools Policy (Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources) (12/1999) - (PDF – 150 KB) - Policy designed to provide NIH funding recipients with guidance concerning appropriate terms for disseminating and acquiring unique research resources developed with federal funds, and intended to assist recipients in complying with their obligations under the Bayh-Dole Act and NIH funding policy.
   
• Biological Materials Policy (NIH Procedures for Handling Non-Election of Title to Patentable Biological Materials) (05/1996) - NIH policy for allowing NIH funding recipients to retain and license biological materials for which patent protection might not be pursued.
   
• Developing Sponsored Research Agreements (Considerations for Recipients of NIH Research Grants and Contracts) (11/1994) - Issues and points to consider in developing sponsored research agreements with commercial entities, where such agreements may include research activities which are fully or partially funded by NIH, in order to assist funding recipients ensure such agreements comply with the requirements of the Bayh-Dole Act and NIH funding agreements while upholding basic principles of academic freedom.
   

For any questions or further guidance or assistance, please email sharing@nih.gov.

For any questions or further guidance or assistance for extramural invention reporting and related intellectual property policy issues, please refer to http://inventions.nih.gov or email Inventions@nih.gov.