Guide to NIH Data-Sharing Plans
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This guide outlines a writing strategy for creating a data-sharing plan based on the NIH Data Sharing Policy and Implementation Guide. Before you start writing, please review carefully the NIH Data Sharing Policy and Implementation Guide for official instructions. This guide assumes that you have read and understood the NIH instructions and have determined which requirements apply to your proposal.
Identify all relevant requirements
An NIH solicitation may have data management and sharing requirements in two places. Comply with the requirements in this order:
- NIH Data Sharing Policy and Implementation Guide
Your plan should describe what data you will share with other researchers and how you will format, documents, and distribute those data. The NIH expects that you will, as much as possible, share data and other products with other researchers. Your plan should also address the long-term availability of your data.
Note: If ethical, legal, contractual, or technical conditions prevent you from sharing or distributing data, you still have to submit a data-sharing plan according to the NIH requirements. In this situation, your plan should explain why you cannot share data.
In most cases, your strategy will reflect the unique needs of your project and the prevailing norms and practices in your field. You should make reference to those norms and practices whenever appropriate.
Identify a public-access repository, archive, or database before you start writing
Ideally, you should use a public-access repository, archive, or database to preserve and share data. If possible, identify a potential repository or archive and review its submission requirements before you start drafting a plan. The submission requirements will shape your data management strategy and provide material for your plan. In some cases, you may have to use different repositories for different types of data. Start by consulting the list of NIH-supported data sharing repositories.
Note: You may be able to archive final data and other research products at the Digital Repository at the University of Maryland (DRUM). DRUM is managed and maintained by the University Libraries. Please contact us if you're interested in this option (email: firstname.lastname@example.org).
If you cannot find an appropriate data repository or archive, contact the NIH Program Officer associated with your solicitation for direction.
Dealing with multiple investigators, institutions, and sponsors
If your project involves multiple investigators or teams, either domestic or international, your plan should describe how you will harmonize and synchronize data management and post-project data sharing. At a minimum, indicate who is responsible for data management and sharing.
If your project involves multiple funding sources or partnerships, your plan should describe how you will accommodate and balance the data management expectations of the different sponsors or partners.
The amount of detail in your plan will depend on the characteristics of your research. While NIH data-sharing plans are typically short, this guide will prompt you to provide more detail in a few important places.
It can be helpful to identify any relevant rules, standards, or codes of practice that will affect how you manage and share data. This demonstrates to the reviewers that your data sharing practices are consistent with the standards in your field.
In certain situations, it is appropriate to state that a particular issue will not affect your plan. For example, if there are no restrictions, limitations, or conditions on sharing data, it can be useful to state that fact (e.g. “This project will not collect or produce confidential or sensitive data.”).
This guide covers topics that frequently appear in data-sharing plans, but individual solicitations may have additional guidelines. We provide information and advice about the following topics:
- Types of data and formats, and what data will be shared
- Access and sharing
- Re-use and re-distribution
To help you complete your plan, we break down each topic into a series of basic questions. Your answers will provide the content for your plan. Not all questions will be relevant to your research.
For this topic, describe your final research data. The NIH concept of final research data covers "data on which summary statistics and tables are based," but not "laboratory notebooks, partial datasets, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as gels or laboratory specimens" (NIH Data Sharing Policy and Implementation Guide). Use this section to outline how you will store and manage your data during the project. You should also identify what data you will retain after the project.
What types of data will you produce, how much, and for how long long? (This is about the volume and variety of data.)
What are the data sources? Are you collecting data yourself or using publicly available data from open-access repositories or data centers?
What is your plan for data storage, security, and backup during your project? Who will be responsible for these activities?
Of all the data you will collect or produce, what data will you retain after the project is finished, and why?
- Consider what data are necessary for replication and what data may stimulate new research in your field and beyond. See our criteria for retaining and sharing data for additional considerations.
- If possible, reinforce your decision to retain data with reference to potential user communities. Who could use your data?
- If you choose not to retain certain data, explain why.
What file formats will you use for data sharing?
- Many commercial software formats and instrument formats are not suitable for public access and long-term preservation because they can only be opened and manipulated by the specific software or instrument that created them. See our format recommendations for open alternatives.
Tip: If you identify a potential public-access repository or archive before you start writing your plan, the data managers can often direct you to specific file formats.
For this topic, describe how you will document your data. The NIH maintains that "proper documentation is needed to ensure that others can use the dataset and to prevent misuse, misinterpretation, and confusion” (NIH Data Sharing Policy and Implementation Guide).
Useful documentation includes all the information about your data that another researcher would need to understand and use your data for replication, reference, or new research. Depending on how you document your research, you may already collect this information in a codebook, data dictionary, readme file, or lab notebook. Typically, the documentation will include general information about your project, data collection methods, variables, locations, data processing, codes or abbreviations, terms and conditions of use, software required, and so on.
Note: You do not have to include any documentation in your data-sharing plan, only a description of your method of documentation.
Tip: If you identify a potential public-access repository or archive before you start writing your plan, the data managers can often direct you to specific documentation standards.
How will you record documentation for your data? Will you use a standard form of documentation? Who will be responsible for this documentation?
- In some fields, documentation is highly standardized and requires specific information. If this applies to you, identify the standard.
- If there is no commonly used documentation standard appropriate to your situation, state that fact and describe how you will document your data.
For this topic, describe how you will share data. The NIH identifies four major ways to share data:
- Under the auspices of the PI
- Data archive
- Data enclave
- Mixed mode sharing
The method(s) you choose will depend on the nature of your data and the facilities available. Review the NIH Data Sharing Policy and Implementation Guide for additional details, and consult the list of NIH-supported data sharing repositories.
What data will you share with other researchers?
Who will have access to your data? How will they find and obtain your data?
- Common people to consider in this situation are other researchers (in your field and beyond) and the general public. In some cases, depending on the nature of your project, you can share data with both groups without restriction. In other cases, you may be able to share data with other researchers but not the general public. Explain any such conditions.
- If you plan to submit your data to a repository or archive, you will have to comply with their policies and requirements for access and sharing. Note any restrictions on access.
- You may be able to share final data and other research products through the Digital Repository at the University of Maryland (DRUM). Please contact us if you're interested in this option (email: email@example.com).
- You may be able to use your personal website, or your team's website, to share data. However, there is always a risk that the data files will be moved or deleted at some point. If you choose this option, we encourage you to contact us. We may be able to archive a permanent copy of your data in the Libraries.
- If you use data from a public-access repository, you may be able to refer people to the original data rather than distribute it yourself. In this case, you should provide links to these data in any documentation and publications.
- If you cannot find an appropriate data repository or archive, contact the Program Officer for direction.
How soon will other researchers or the public have access to your data?
- The NIH “expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset” (NIH Data Sharing Policy and Implementation Guidance). If you plan to release data on a different schedule, provide a justification.
If you will produce confidential or sensitive data, how will the measures you take to protect subjects affect data sharing?
If you are working under the terms of an IRB, how will they affect data sharing?
Are there any additional federal, institutional, professional, or sponsor regulations that will affect data sharing?
Are there any intellectual property issues, such as ownership, copyright, or potential commercialization, that will affect data sharing?
- For research products generated under an NIH award, all intellectual property developed by researchers and students and all intellectual property rights therein shall belong to the University unless an exception or waiver is granted. In many cases, this will not prevent you from sharing data and other materials with researchers or the general public, but conditions apply when your activities involve materials transfer, inventions, patents, royalties from inventions, third-party contracts, and other special circumstances. Contact the Office of Research Administration for guidance on your situation.
Will you have any special security provisions or data sharing agreements?
Will you release any analytic tools (e.g. software code) along with your data?
For how long will you (or a repository) preserve your data? This depends on wide variety of factors:
- The NIH instructs you to retain data for at least three years, but there may be additional instructions in the solicitation.
- UMD’s retention policy for most research records is a minimum of seven years after the completion of research. Different terms apply to investigational new drugs and investigational devices (UMD Records Schedule, Item 84).
- If you conduct research under HIPAA regulations, you should plan to retain data for a minimum of six years.
- Data related to patents should be retained for the life of the patent.
- In addition, consider the potential value of your data in temporal terms: will the value increase, decrease, or remain constant over time? Social and environmental observations that cannot be recreated may increase in value.
If there are costs associated with data sharing, such as deposit fees at a repository, how will you cover them?
- You can request funds in your grant application (NIH Data Sharing Policy and Implementation Guide).
For this topic, describe how intellectual property, licensing, or terms and conditions may affect re-use and re-distribution. This section is chiefly about terms and conditions of use.
Are there any intellectual property issues that will affect re-use and re-distribution?
- If your project uses data, software, or materials that belong to another individual, group, or institution, you must comply with any terms, conditions, permissions, licenses, or agreements specified by the data owner. Note any conditions that affect re-use.
- If you plan to submit your data to a repository or archive after your project is complete, you will have to comply with their policies and requirements for re-use and re-distribution. Note any conditions that affect re-use.
Will you make your data available with specific terms and conditions, licenses, or disclaimers?
- If there are no legal or contractual issues that will affect re-use or re-distribution, the simplest option is to refrain from adding any terms or conditions. However, you may wish to insist upon attribution, citation, or another form of credit whenever someone uses your data.
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