REVISED OCTOBER 2018. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2018

Sharing research resources, data sharing policy, sharing model organisms, genomic data sharing, GDS, genome-wide association studies (GWAS)

8.2.3 Sharing Research Resources

Investigators conducting biomedical research frequently develop unique research resources. NIH considers the sharing of such unique research resources (also called research tools) an important means to enhance the value of NIH-sponsored research. Restricting the availability of unique resources can impede the advancement of further research. Therefore, when these resources are developed with NIH funds and the associated research findings have been accepted for publication, or after they have been provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. At the same time NIH recognizes the rights of recipients and contractors to elect and retain title to subject inventions developed with federal funding pursuant to the Bayh-Dole Act. See the Office of Extramural Research, Division of Extramural Inventions & Technology Resources (DEITR), Intellectual Property Policy page: http://grants.nih.gov/grants/intell-property.htm.

Program staff are responsible for overseeing resource sharing policies and for assessing the appropriateness and adequacy of any proposed resource sharing plans.

To provide further clarification of the NIH policy on disseminating unique research resources, NIH published Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; http://grants.nih.gov/grants/intell-property_64FR72090.pdf). This document will assist recipients in determining reasonable terms and conditions for disseminating and acquiring research tools.

The terms of those agreements also must reflect the objectives of the Bayh-Dole Act and the Technology Transfer Commercialization Act of 2000 to ensure that inventions made are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery.

In addition to sharing research resources with the research community, upon request of the NIH awarding ICThe NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award., the recipient also must provide a copy of documents or a sample of any material developed under an NIH grant award. The recipient may charge a nominal fee to cover shipping costs for providing this material. Income earned from these charges must be treated as program income (see Administrative Requirements-Management Systems and Procedures-Program Income).

To facilitate the availability of unique or novel materials and resources developed with NIH funds, investigators may distribute the materials through their own laboratory or organization or submit them, if appropriate, to entities such as the American Type Culture Collection or other repositories and should ensure that those entities distribute them in a way that is consistent with the above referenced Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. Investigators are expected to submit unique biological information, such as DNA sequences or crystallographic coordinates, to the appropriate data banks so that they can be made available to the broad scientific community. When distributing unique resources, investigators are to include pertinent information on the nature, quality, or characterization of the materials.

8.2.3.1 Data Sharing Policy

NIH believes that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve human health. NIH endorses the sharing of final research data to serve these and other important scientific goals and expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers. "Timely release and sharing" is defined as no later than the acceptance for publication of the main findings from the final data set. All investigator-initiated applications with direct costsCosts that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. of $500,000 or more (excluding consortium F&A costsNecessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.) in any single year are expected to address data-sharing in their application. In some cases, FOAs may request data-sharing plans for applications that are less than $500,000 (excluding consortium F&A costsNecessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.) in any single year.

NIH recognizes that data sharing may be complicated or limited, in some cases, by organizational policies, local IRB rules, and local, State and Federal laws and regulations, including the HIPAA Privacy Rule (see Public Policy Requirements and Objectives-Confidentiality of Patient Records: Health Insurance Portability and Accountability). The rights and privacy of individuals who participate in NIH-sponsored research must be protected at all times. Thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. When data-sharing is limited, applicants should explain such limitations in their data-sharing plans.

Investigators must exercise great care to ensure that resources involving human cells or tissues do not identify original donors or subjects, directly or through identifiers such as codes linked to the donors or subjects.

Organizations that believe they will be unable to meet these expectations should promptly contact the GMO to discuss the circumstances, obtain information that might enable them to share data, and reach an understanding in advance of an award.

8.2.3.2 Sharing Model Organisms

All applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding so that other researchers can benefit from these resources, or state appropriate reasons why such sharing is restricted or not possible. Model organisms include but are not restricted to mammalian models, such as the mouse and rat; and non-mammalian models, such as budding yeast, social amoebae, round worm, fruit fly, zebra fish, and frog. Research resources to be shared include genetically modified or mutant organisms, sperm, embryos, protocols for genetic and phenotypic screens, mutagenesis protocols, and genetic and phenotypic data for all mutant strains.

This expectation is for all applications where the development of model organisms is anticipated, regardless of funding amount.

For additional information on this policy, see the NIH Model Organism for Biomedical Web site.

8.2.3.3 Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS)

The National Institutes of Health (NIH) Genomic Data Sharing (GDS) Policy sets forth expectations that ensure the broad and responsible sharing of genomic research data. Sharing research data supports the NIH mission and facilitates the translation of research results into knowledge, products, and procedures that improve human health.

The GDS Policy, an extension of the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the NIH GWAS Policy), applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. For the purposes of this Policy, the genome is the entire set of genetic instructions found in a cell and large-scale genomic data include GWAS, single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Supplemental Information to the GDS Policy provides examples of genomic research projects that are subject to the Policy and the timeline for submission and sharing of data from such projects.

The GDS Policy became effective on January 25, 2015 for grant applications with due dates on or after that date. Research that was initiated prior to the effective date of the GDS Policy will continue to operate under the terms of the policies that were in effect when the research began, such as the NIH GWAS Policy, however, NIH strongly encourages investigators to comply with the expectations outlined in the GDS Policy. All applications, regardless of the amount requested, proposing research that will generate large-scale genomic data, are expected to include a genomic data sharing plan (see Developing GDS Plans for guidance on developing a genomic data sharing plan).

Effective March 27, 2015, investigators who wish to use cloud computing for storage and analysis will need to indicate in their Data Access Request (DAR) that they are requesting permission to use cloud computing and identify the cloud service provider or providers that will be employed. They also will need to describe how the cloud computing service will be used to carry out their proposed research.

As with data stored in institutional systems, the institution's signing official, Program Director/Principal InvestigatorThe individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI., IT Director, and any other personnel approved by NIH to access the data are responsible for ensuring the protection of the data. The institution, not the cloud service provider, assumes responsibility for any failure in the oversight of using cloud computing services for controlled-access data.

The NIH Security Best Practices for Controlled Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy, which have been updated to include best practices for cloud computing, are available at http://www.ncbi.nlm.nih.gov/projects/gap/pdf/dbgap_2b_security_procedures.pdf. The Model Data Use Certification has also been updated and is available at http://gds.nih.gov/pdf/Model_DUC.pdf.

For additional information including best practices see: Genomic Data Sharing Policy. Questions about the GDS policy can be e-mailed to GDS@mail.nih.gov.