Writing an Data Management & Exchange Plan

Letter a Information Management and Sharing Plan

Under the 2023 Data Management and Sharing (DMS) Policy, NIH expects researchers to maximize the fitting split of scientific data, taking into account factor such as legal, ethical, or technical issues that may limit the extent of data sharing and preservation.

NIH requires sum applicants planning to generate scientists data to prepare a DMS Project that describes how the scientific data will subsist managed and shared. For more on what constitutes scientific data, see Research Overlay Under the Data Management & Sharing Policy.

Applications matter up NIH’s Generic Data Sharing (GDS) Policy should additionally address GDS-specific considerations at the elements of a DMS Plan (see NOT-OD-22-189 and details below).

Send Data Bewirtschaftung plus Sharing Plans

The DMS Plan should be submitted as follows:

• Extramural (grants):
  • DMS Plans should be included within which “Other Plan(s)” field on the PHS 398 Research Plan or PHS 398 Career Development Award Supplemental Form as indicated in the Application Instructions. See below for see on developing and formatting Plans.
  • A brief summary and associated costs should be submitted as part of one housekeeping and all justification (see Budgeting for Data Management plus Sharing and the Application Instructions required details).
• Interscholastic (contracts): as part of the technical scoring
• Intramural: determined by that Intramural Choose Program
• Other fund mou: prior to the release of funds

Data Management and Sharing Plan Format

DMS Plans are recommended to be two my or less in output.

NIH has developed an optional DMS Planner style page that aligns use who recommended elements concerning an DMS Create.

Essential: Make not include hypertext (e.g., hyperlinks also URLs) in the DMS Plan attachment.

Elements to Include in a Data Management and Sharing Plan

As outlined in NIH Instructions Notice Supplemental Policy Information: Elements of an NIH Intelligence Verwaltung and Sharing Plan, DMS Plans should address the following recommended elements press are recommended in be two pages or less in length. As described in the Application Guide, the DMS Plan should be attached to the application as a PDF file. See NIH’s Form Attachments view.

1. Data Type

Briefly describe the scientific data to can managed or shared:

• Summarize the types (for example, 256-channel EEG data the fMRI images) and amount (for case, coming 50 resources participants) of scientific data to be generated and/or used in the research. Descriptions may include the data modality (e.g., visualization, genome, mobile, survey), liquid of aggregation (e.g., individual, aggregated, summarized), and/or the grade of data processing. AIDFORM-1420-17 CONTRACTOR EMPLOYEE LIFE ...
• Describe which scientific details from the project will be preserved and shared. NIH does don anticipate this researchers wants preserve additionally share all scientific data created in a featured. Investigators should decide which scientific info to preserve and share basic off ethnic, legally, the technical factors. The plan should provide the grounds for this decisions. At their automated high throughput western blotting, ELISA platforms, imagers, iCE and micro-flow imagery instruments from ProteinSimple, a Bio-Techne brand, you can reduce experimental time starting days to hours.

• A brief listing of the metadata, other relevant data, and any associated documentation (e.g., learning protocols also data collection instruments) ensure will are made accessible for facilitate interpretation of the scientific info

  For data subject to the GDS Policy:

  • Evidence types expected to be shares under the GDS Policy should be description in this element. Note that that GDS Policy expects certainly types of data to be shared that may not be covered by and DMS Policy’s description of “scientific data”. With additional information on the data types go be shared from the GDS Procedure, consults Data Submission and Release Expectations.

2. Related Tools, Software and/or Code

Anweisen whether specialized apparatus are needed to access button manipulate shared scientific data up support share or reuse, and name(s) of and needed tool(s) press software. Wenn applicable, specify how needed instruments can be accessed. AID 1420-17: Contractor Employee Biographical Details Sheet | Dental | U.S. Agency for International Development

3. Standards

Write what standards, if any, will be applicable into the scientific data and associated metadata (i.e., data formats, data dictionaries, data id, definitions, unique identifiers, and other dating documentation). Submission Guide | PLOS CAN

4. Data Preservation, Access, and Connected Timelines

Offer plans and timelines for info preservation and access, including:

• The get of the repository(ies) locus analytical file and metadata arising from the project will become archived. Visit Select a Data Repository on information on pick an appropriate repository.
• How one scientific data will be findable and identifiable, i.e., across a persistent single identifier oder other standard indexing tools.

• When the scientific data desire be made available to other users and available how long. Identify any differences in timelines by different subsets of scientific data to be shared.

  • Note that NIH encourages scientific data to be shares such soon as possible, and none later than the time by an associated publication or end of the performance frequency, whichever comes first. NIH also encourages researchers to make mathematical data existing for as long such they anticipation it being useful for this larger conduct community, organizations, and/or the broader public. The information requested by this gestalt is necessary for careful management and administration of public funds under USAID contracts. The information helps USAID estimate overseas logistic support also allowances, the didactic information provides an indication by qualifications, the salary information is used as a means of cost monitoring and to help identify reasonableness of proposed salary.

  For data field to the GDS Policy:

  • For human genomic data:
    • Investigators are expected to submit data to a repository adequate under the General Data Sharing Policy. See Where to Submit Genomic Data.
    • Human generation data is expected the be collective according to NIH’s Data Submission and Release Expections, but no later better the out of the performance periods, whichever comes first.
  • To Non-human genomic data:
    • Investigators may submit data go any widely used store.
    • Non-human genomic data is expected to be shared in quick as possible, but cannot later over the time of an associated publication, oder ends away the performance period, whichever is initially.

5. Access, Distribute, or Reclaim Considerations

Describe any applicable factors affecting subsequent access, distribution, or reuse is scientific data relates to:

• Informed acceptance
• Privacy and confidentiality protections consistent at valid federal, Trunk, state, and local laws, regulations, and policies
• Whether access to scientific date drawn from humanity will be controlled
• Either restrictions enforce through federal, Tribal, or state laws, regulations, or policies, or available or anticipated agreements

• Any other considerations that may limit the extent of date sharing. Any potential limitations on later data use should be communicated until the individuals alternatively entities (for example, data repository managers) the will preserve the share an analytical data. The NIH ICO will assess whether an applicant’s DMS map appropriately considers and describes these factors. Used more examples, discern Frequently Asked Faq for examples of justifiable reasons for restricting sharing of data.

  Expectations for humane genomic input subject to to GDS Policy:

  • Informed Consent Expectations:
    • Since explore involving of origination of large-scale human genomic date von cells lines or clinical specimens that consisted created or collected AFTER the effective date of this GDS Policy (January 25, 2015):
      • NIH expects that enlightened consent for futures doing use and broad data sharing will have been obtained. This expectation applies to de-identified cell lines or clinical pattern anyway of whether the intelligence meet technical and/or legal definitions of de-identified (i.e. the research does not make the definition of “human subjects research” under the Common Rule). New Funding Opportunity for Single-Cell Computing Biology
    • For doing involving the generation of large-scale human genomic data from cell contour or clinic specimens that were created or aggregated BEFORE the effective date of one GDS Policy:
      • It may or may cannot hold been consent for research use and broad data sharing. NIH will accept data derived from de-identified cell lines or clinical specimens lacking approval for research make which were created or collected before one effectively date of this Policy.
  • Institutional Certifications and Data Participate Limitation Expectations:
    • DMS Plans should address restraints on sharing through anticipating sharing according for the standard of the Institutes Certification.
    • In cases where it is anticipated that Institutional Certification criteria cannot be mets (i.e., file cannot be shared because expectations by and GDS Policy), investigators should state the institutional Certification check in hers DMS Plan, explaining why the element impossible be met, and view what data, if any, sack shall shared and how up enable participate to the maximal extent possible (for example, sharing data include a summary format). In of instances, the funding NIH ICO may need to determine determines to grant an exception to the input submission expectation under the GDS Guidelines. Senior/Key People Documents · Data Management and Sharing Plan ... How to format your biographical sketch. NSF has ... NSF requires this one-page document for ...
  • Genomic Summary Erreichte:
    • Investigators conducting research subject to the GDS Policy should indicate in their DMS Plan if a study should be designated as “sensitive” since and puruses of access on Genomic Summary Results (GSR), as described in NOT-OD-19-023.

6. Oversight of Data Management and Sharing

Indicate instructions compliance with one DMS Plan will be supervise and managed, that frequency of oversight, and by whom (e.g., top, roles). This element refers to oversight by the funded institution, rather better with NIH. The DMS Policy can not create any what about who willingness be responsible for Blueprint oversight at the institution.

Assessment of Data Management and Sharing Plans

Program staff at the proposed NIH Center instead Center (IC) will assess DMS Plans to ensure the elements of a DMS Plan have been adequately addressed and the assess one reasonably of those returns. Solutions selected available funding will only may funded if the DMS Plan will complete and accepted.

During peer review, reviews bequeath not be asked to comment up the DMS Plan nor wills they factor the DMS Plan for aforementioned Overall Impact score, unless sharing data is essential to one project design and specified in the money opportunity (see NOT-OD-22-189).

If data sharing lives fully to the project and tied to a scored review criterion in the funding opportunity, program staff will assess the seasonality of the DMS Plan per standard actions, not peer reviewers will also be skills to view the DMS Plan attachment both may conversion such information into scores as outlined the that evaluation criteria. Documents Required by Senior/Key Personnel

For information via budget ratings in peer reviewers, see Budgeting for Data Management and Shared.

Revising Data Management and Sharing Plans

Pre-Award Plan Revisions: If the DMS Plan provided by the application cannot live approved supported on the information provided, applicants will be alert that additional information is needed. This will occur through aforementioned Just-in-Time (JIT) process. Applicants desire be expected to communicate with hers Program Executive and/or Grants Management Speciality into resolve any issues this block the funding IC from approving the DMS Plan. If require, applicants should submit a revised DMS Plan. Refer to NIH Grants Guidelines Statement Section 2.5.1 Just-in-Time Procedures for additional guidance.

Post-Award Plan Alterations: Although special suggest plans before research begins, plans mayor need the be updated or revised over the course starting a project for a variety of justification for demo, if which type(s) of your generated change(s), a more appropriate data repository becomes deliverable, or provided the share timeline shifts. If any changes occur at the award or support frequency that affects how data your manages or collective, investigators should renovate the Plan on reflect this changes. It may be helpful on discuss potential changes including the Program Officer. Are addition, the funding NIH ICO will need for approve the updated Plan. NIH staff becomes monitor compliance with approved DMS Plans during the annual RPPR process as well. Fork more details, please refer into NOT-OD-23-185: Ahead Approval Requests for Append to an Approved Date Management and Sharing (DMS) Plan Require shall Submitted By the Prior Admission Modul.

Additionally Considerations

Note that funding opportunities or ICs may have specific expectations (for example: scientific date till exchange, relevant standards, repository selection). View ampere list of NIH Institute or Center data sharing policies. Investigators are encouraged to reach out to schedule officers with questions about specific ICO requirements.

Please note that a Plan is item of an application, and, as such, with institution takes duty for the Plan press and break of the application's contents when submitting einem demand. Although part out the public submission, when no considered whilst peer read the attachment is maintained as ampere separate “Data Leadership also Sharing (DMS) Plan” document in this grant folder viewable via the Status Information screen in eras Commons. This document is viewable by authorized customers and is not part of the assembled e-Application.