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 NIH’s New Data Sharing Policy: Maximizing the Value of Research through Data Re-use and Data Access on the Vivli Repository

Learn how the Vivli repository is making it easier for scientists to share and access data, and how you can comply with the NIH’s data management and sharing policy (DMSP) to maximize the value of your research

The National Institutes of Health (NIH) has a policy in place to ensure that data generated by NIH-funded research is accessible to the scientific community starting on January 25, 2023.

Data should be made available as soon as possible or the acceptance for publication of the main findings from the final dataset but the latest date is the end of the award. Data sharing can be done through a variety of mechanisms, including NIH domain repositories or NIH generalist repositories. These can be open-access or controlled-access systems. One such controlled-access repository recognized by the NIH is Vivli, a generalist repository for sharing of clinical data for human research studies.

As a condition of their grant application, investigators are now required to prospectively plan for management of their data and preparing it for re-use, submit a data management and sharing plan (DMSP), and comply with the drafted plan. The NIH Data Sharing Policy (DSMP) encourages investigators to share their data in order to maximize the value of NIH research funds.  But what exactly is a DMSP and how do you draft one for submission to the Vivli Repository? The DMSP is a set of principles and guidelines that outline the requirements for sharing data generated by NIH-funded research. It includes 6 major elements that were selected to ensure that the data is shared as widely and promptly as possible, to maximize the scientific and public health value of the research, while protecting participant privacy and confidentiality. To fill out the DMSP, decisions should be made about the choice of repository, how long the repository will hold/archive the data, whether special tools/software will be provided to access the data, whether consensus data standards apply or exist, whether controlled access will be required and the oversight management details.

To help investigators on their journey to fulfilling the NIH data sharing policy, we have created a list of all the other resources available on our website, including the DMSP template guidance and budget guidance specific to using Vivli to help you navigate the process. Vivli has a step-by-step guide to understanding each of these elements and items to consider when developing a DMSP. We also have a customizable DMSP exemplary language available for download and adaptation, which includes sample text as well as guidance on preparing and submitting a budget as part of the DMSP.

Fill out the form below to access all the DMPS Guidance provided by Vivli.

Vivli has recently released new features timed to the NIH policy launch including: branded portals for research programs / institutions; academic credit; streamlined process for data sharing and reporting for institutions.

In summary, the NIH encourages data sharing as part of its mission to advance biomedical research and to promote collaboration among scientists. Vivli is a non-profit organization that provides a platform recognized by the NIH for funded researchers to share and access anonymized clinical trial data in a secure and compliant way.

    What best describes your current role?

    Do you plan to include Vivli in any future data management plans?

     

    Share NIH-Funded Data

    Guidance for researchers on preparing a DMSP and sharing NIH-funded data

    The NIH has updated its policies on data management and sharing (DMS). Effective January 25, 2023, the NIH DMS policy applies to most research funding by the NIH, and requires all applicants planning to generate scientific data to prepare a DMS Plan (DMSP) that describes how they will manage and share data. An effective DMSP requires thoughtful planning, preparation, and execution. We’ve compiled information and resources here to support every step of the process.

    How to prepare a DMSP

    The DMSP is a set of principles and guidelines that outline requirements for sharing data generated by NIH-funded research. It includes six major elements:

    1. A description of the data type
    2. Related tools, software, and/or code
    3. Common data standard that will be applied to the data
    4. Information about data preservation, access, and associated timelines
    5. Factors affecting access, distribution, or reuse of data
    6. Overview of how compliance with plans for management and sharing will be managed

    The DMSP should also include information about direct costs required to support the activities outlined in the Plan.

    Vivli has a step-by-step guide to understanding each of these elements and items to consider when developing a DMSP. We also have a customizable DMSP exemplary language available for download and adaptation, which includes sample text as well as guidance on preparing and submitting a budget as part of the DMSP.

    Fill out the form below to access all the DMSP Guidance provided by Vivli.

      What best describes your current role?

      Do you plan to include Vivli in any future data management plans?

      How to choose the right repository to share your data

      To enable the implementation of the updated DMS policy, NIH has supported the establishment of the Generalist Repository Ecosystem Initiative (GREI). GREI is a collaboration of seven established generalist repositories who are working together to develop consistent standards and processes to facilitate sharing and reuse of data from NIH-funded studies. As part of preparing a DMSP, researchers will have the opportunity to review repository options and choose the one that best aligns with their needs. Vivli is part of the GREI initiative. The Vivli platform is the only GREI repository that focuses on sharing completed clinical research data at the individual participant level. To assist in considering these options, NIH has prepared guidance on selecting a data repository.

      Once your grant is approved – what next?

      How to submit studies to Vivli for data sharing

      If you’ve decided that Vivli is the right repository for your study data, great! We’ve developed a straightforward and efficient submission process, and we’ve got detailed guidance on how to submit your data and a checklist when you’re ready to begin the process to share your data.

      ResourceDescription
      Vivli Study Submission GuideHow to submit studies for sharing via the Vivli platformDownload PDF
      Study Submission ChecklistA checklist of all information needed for the submission of a studyDownload

      Further questions?

      Email Vivli at support@vivli.org and we will be delighted to assist you.

       

      Submitting Your NIH Data Management and Sharing Plan using Vivli

      The NIH Data Management and Sharing (DMS) policy went into effect in January 2023 to promote the sharing of scientific data.

      Please watch Vivli’s recent webinar and find out more about how Vivli can help you navigate the NIH Data Management and Sharing policy. Hear from academic staff on their experiences in supporting researchers with their Data Management and Sharing Plans (DMSP).

      During this webinar, we:

      • Provide an overview of Vivli, including what types of data should be shared in Vivli
      • Discuss the benefits of using Vivli to meet the data sharing requirements of your NIH grant
      • Review the steps to completing the NIH DMSP and budget justification
      • Hear views from academic staff on their experiences supporting researchers to complete the new NIH DMSP

      Speakers include:

      • Anne Seymour, Johns Hopkins University
      • Amy Nurnberger, Massachusetts Institute of Technology
      • John Borghi, Stanford University
      • Rebecca Li and Julie Wood, Vivli

      Participants had the opportunity to ask questions. This webinar is most useful for current or prospective NIH grantees or those who support them.

      View Recording

      How to Guides

      Vivli provides the following resources to assist users of the Vivli Platform:

      Data Request Guidance and Support

      ResourceDescription
      Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit a request for study data.Download PDF
      Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
      Vivli How To – Requesting StudiesHow to request studies through the Vivli platform.Download PDF
      Vivli Data Request Quick Start (Video)A 3-minute video showing how to submit a data request.Watch video
      Vivli Platform demo – How to search, request, and analyze data on VivliA short video showing how to request data on VivliWatch video
      Vivli Lay Summary Training VideoHints and tips for completing your Vivli Lay Summary as part of your data request.Watch video

      Download PDF
      Vivli Data Request Form WorksheetWorksheet of information needed to complete a Vivli data requestDownload
      Vivli Data Request Form Tips and TricksHints and tips for completing your Vivli Data Request Form.Download PDF
      Data Request Form SampleExample of fully completed Data Request FormDownload PDF
      Vivli Policies in BriefSynopsis of key policies governing interactions between researchers and data contributors during the lifecycle of a research proposal.Download PDF
      Software and R Packages Available in the Research EnvironmentAnalytical and other software available in the research environmentDownload PDF

      Study Submission Guidance and Support

      ResourceDescription
      Vivli User Account Quick Start guideHow to join the Vivli platform as a user so that you can submit your study.Download PDF
      Vivli How To – Sign up for a Vivli AccountVideo detailing how to sign up for a Vivli platform accountWatch Video
      Vivli Study Submission GuideHow to submit studies for sharing via the Vivli platformDownload PDF
      Vivli How To – Single study submissionData sharing instructional videoWatch Video
      Study Submission ChecklistA checklist of all information needed for the submission of a studyDownload
      ICMJE Data Sharing RequirementsHow to use Vivli to meet ICMJE data sharing requirementsDownload PDF

      NIH DMSP Guidance

      Fill out the form below to access all the DMSP Guidance provided by Vivli.

        What best describes your current role?

        Do you plan to include Vivli in any future data management plans?