Submission Resources Information for Investigators
Who should use this Submission Resources Page and Why?
This Submission Resources Page is useful to the following groups of researchers as the NIH Policy for Data Management and Sharing (DMS Policy) goes into effect on January 25, 2023:
- Researchers planning to submit a research grant application to NICHD or another NIH Institute
- NICHD funded or other approved researchers planning to share their study data or biospecimens through DASH
- Researchers who have initiated submissions to DASH
The NIH DMS Policy outlines data management and sharing requirements and expectations for NIH researchers. The DMS Policy strongly encourages the use of established repositories such as DASH for sharing scientific data. DASH adheres to the desired characteristics for data repositories, including support for free and easy access, metadata, curation and quality assurance, confidentiality, provenance, digital object identifiers, broad and measured reuse, and security and integrity.
This Submission Resources Page will help you identify the requirements and expectations for sharing your data or biospecimens through DASH while you develop your Data Management and Sharing Plan (DMS Plan) and associated budget for costs to support preparing data for submission to DASH. [Note: there is no cost for submitting data to DASH].
While the DMS Policy does not address sharing of biospecimens, DASH supports the sharing of biospecimens associated with studies shared in DASH that are available for sharing and are stored in the NICHD Biorepository. Resources are also available on this page for researchers submitting biospecimen catalog metadata, which provides information about the biospecimens (such as type, amount available, participant age, etc.) to DASH.
Email SupportDASH@mail.nih.gov with any questions when planning your submission to DASH.
Can I share data through DASH?
DASH is an NICHD-funded controlled access data repository established to facilitate data sharing and access to biospecimens for all NICHD clinical research. Researchers funded by or seeking funding from NICHD for clinical research should share data in DASH. Researchers seeking funding from another NIH Institute or Center in a research area relevant to the NICHD mission may also be able to share data through DASH. You may Contact SupportDASH@mail.nih.gov with a request to obtain a Letter of Approval for sharing your study data in DASH.
Can I share biospecimens through DASH?
NICHD-funded researchers may also share biospecimens associated with data shared through DASH if the biospecimens are stored in the NICHD Biorepository and prior approval has been received from the NICHD Program Official. Researchers must submit a de-identified biospecimen catalog to DASH and complete the Institutional Certification Form. Refer to the DASH Tutorial for detailed instructions on submitting a biospecimen catalog. Contact SupportDASH@mail.nih.gov with any questions
What are the benefits of sharing data through DASH?
The NIH DMS Policy strongly encourages the use of established repositories such as DASH for sharing scientific data. DASH adheres to the desired characteristics for data sharing repositories described in the Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research, including support for free and easy access, metadata, curation and quality assurance processes, procedures for maintaining confidentiality of sensitive data, provenance tracking, digital object identifier to support study attribution and citation, making data accessible to the broad research community and measuring reuse, and security and integrity.
DASH data sharing aligns with the best practices outlined in the Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data. As per the NICHD DASH Policy, all data submitted to DASH must be de-identified. Access to DASH data is controlled - requesters must verify their identity and the appropriateness of their proposed research use to access protected data in DASH. Research use of DASH data require DASH Data Access Committee approval and establishment of a Data Use Agreement that outlines expectations for appropriate use of DASH data.
How should I plan for data sharing through DASH?
The DMS Policy, which goes into effect for NIH grant applications and contract proposals submitted on or after January 25, 2023, and for NIH Intramural Research Projects conducted on or after that date, requires researchers and contractors to submit a DMS Plan outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations. The DMS Policy expects that in drafting DMS Plans, researchers will maximize the appropriate sharing of scientific data.
NIH DMS Plans should address the six elements as described in the Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan. NIH has provided a DMS Plan format on the Writing a Data Management and Sharing Plan page on the NIH Scientific Data Sharing website.
If you are planning to submit data to DASH, you should incorporate DASH data repository-specific details in your DMS Plan. Information about data sharing through DASH is organized below by the DMS Plan elements. The NICHD Office of Data Science and Sharing website hosts additional information on DMS Policy implementation, including overall guidance for the development of a DMS Plan.
As you develop a DMS Plan, you should develop a data management and sharing budget that considers the personnel expertise and time required to accomplish the data management and sharing activities planned throughout the project period. The DASH Tutorial for Study Submission provides a stepwise overview of the entire data submission process, from completion of the Institutional Certification and DASH Codebook through the annotation and submission of templated study metadata, data files, and associated documentation using the DASH Data Preparation Tool. Review each of these steps to estimate the level of effort for your data manager and/or data submitter to complete each step. Consider in your estimate the upstream work to clean and harmonize data files prior to submission. [Note: there is no cost for submitting data to DASH].
See Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing for information on allowable costs for data management and sharing.
Data Types
DASH accepts clinical data, clinical trial data, survey data, clinical and research laboratory data, demographics data, data derived from medical records, and epidemiology data. The DASH database is flexible enough to accept most other tabular or otherwise structured or unstructured data (example: de-identified interview transcripts) generated from human research participants. Data submitted to DASH should include individual data and aggregate data and summary statistics may also be shared.
DASH does not have any limitations on file numbers or file volume for a given study.
Data submitters must provide all study-level metadata that are described in the Study Submission Worksheet, which is available for offline use from this Submission Resources page in DASH. Study-level metadata include study registration, contact information, policy compliance, study information, study schema, study population, biospecimen information and data distribution information.
DASH requires submitters to provide variable-level metadata using the DASH Codebook, which is a templated data dictionary for submitters to provide detailed information about datasets, variables, and coded values. The DASH Codebook Template as well as a User Guide for completing the Codebook are available for download from this Submission Resources page in DASH.
DASH data submitters must also provide other study-associated documentation such as Study Protocol, Data Collection Instruments, and De-identification Methodology. Data submitters may provide additional study-associated documentation that will be made accessible to facilitate interpretation of the scientific data, such as experimental protocols, sample informed consent, case report forms, and a Manual of Operating Procedures.
Related Tools, Software and/or Code
Data submitted to DASH must be provided in CSV format so that data can be easily accessed by others. Data in other formats, such as SAS, can also be submitted. If your non-CSV datasets will be created using a statistical software package, such as SAS, describe in your DMS Plan the tools, software, and/or code needed to access and analyze your submitted datasets, to support replication and reuse.
Standards
NICHD strongly encourages the use of relevant Common Data Elements (CDEs) and clinical standards, terminologies, and ontologies to enable interoperability of datasets across the DASH database and with related datasets hosted in other NIH data repositories. The NIH Common Data Elements Repository is an NIH-wide resource for CDEs. CDEs associated with COVID-19 research are available in the NIEHS Disaster Research Response (DR2) Resources Portal, including NICHD-recommended pediatric and pregnancy COVID-19 CDEs.
In your DMS Plan, list the CDEs, clinical standards, terminologies, and ontologies you will use for data collection and sharing. These standards should be described as variable-level metadata in the DASH Codebook which is required for data submission to DASH. The template also provides recommended data standards and ontologies.
Data Preservation, Access, and Associated Timelines
List DASH as the data repository where you will submit clinical data, clinical trial data, survey data, clinical and research laboratory data, demographics data, data derived from medical records, epidemiology data, or any other tabular or unstructured (example: de-identified interview transcripts) or qualitative data generated from human research participants. If your study collects other data modalities such as genomics, imaging, videos, or medical device data, such data should be submitted to another established data repository. DASH accepts links to other data repositories as study-level metadata, to support the findability and reusability of full study datasets.
DASH creates a unique and persistent digital object identifier for each study shared through DASH, using the NIH DataCite Consortium. DASH data are findable through the DASH faceted search interface and DASH data are indexed for public search in Google Dataset Search using schema.org.
To support DMS Policy expectations, DASH can release your publication-associated dataset prior to releasing your full study dataset. The DMS Policy expects that all shared scientific data associated with your study be made accessible no later than the end of your award period. Data submitted to DASH are processed using a quality assurance/quality control (QA/QC) pipeline and are reviewed by a data curator to identify data entry or coding errors and personally identifiable information. The QA/QC (and possibly resubmission) process can take from 4-6 months for a given study, provided the DASH Institutional Certification and DASH Codebook are completed according to the timelines specified in the “What should I plan to complete (and when) for DASH data sharing?" section of this page. Plan to submit your publication-associated datasets at least 4 months prior to planned publication date, so that data can be shared on or before initial publication date. Plan to submit your full study dataset at least 6 months prior to the end of your award period.
Data shared in DASH will be preserved for the foreseeable future, and DASH does not currently have any data deprecation or sunsetting protocols.
Access, Distribution, or Reuse Considerations
Your research institution must certify that your study-specific dataset is appropriate for submission to DASH. Within one year of grant award, plan to complete an Institutional Certification from a responsible Institutional Official(s) at your institution stating that an IRB or equivalent Privacy Board has determined that sharing of data via DASH is consistent with the informed consent of your research participants or another appropriate determination, and that the identities of research participants will not be disclosed to NICHD.
Most data available through DASH do not have any consent-based data use limitations and have been consented or approved for general research use. When developing your informed consent, include plain language that addresses data and specimen sharing. NIH resources for consent language include: Informed Consent for Secondary Research and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing developed by the NIH Office of Science Policy and Consent Templates and Guidance that Address Storage, Sharing, and Future Research Using Your Specimens and Data developed by the NIH Office of Intramural Research.
DASH is an NIH controlled-access data repository. The NICHD DASH Data Access Committee reviews all requests to access DASH data and biospecimens from identity-verified requesters, to determine whether the proposed use is scientifically and ethically appropriate and does not conflict with constraints or research data use limitations identified by the institutions that submitted the research data or biospecimens. The Recipient’s institution and the Recipient must sign and agree to the terms and conditions in the NICHD DASH Data Use Agreement for accessing research data and the NICHD DASH Material Transfer Agreement for accessing DASH study-associated biospecimens.
Data must be de-identified prior to submission to DASH, so that the identities of research subjects cannot be readily ascertained or otherwise associated by NICHD DASH staff or secondary data users (45 C.F.R. 46.102(e)). DASH requires submitters to follow the HIPAA Safe Harbor protocol, removing 18 types of identifiers from all data files. See Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule for a list of the 18 types of identifiers. Please also see Section 4.1 Protection of Research Participants in the NICHD DASH Policy for more information.
What should I plan to complete (and when) for DASH data sharing?
You must include DASH submission-specific milestones and timelines in your DMS Plan and should consider the following milestones when developing your DMS budget. Costs associated with biospecimen sharing should not be included in DMS budgets.
- Researchers who plan to share data through DASH are required to submit an Institutional Certification to verify that study data are appropriate for sharing in DASH, within the first year of grant award.
- By the second year of grant award, investigators should submit a draft DASH Codebook, which is a templated data dictionary that captures information about datasets, variables, and coded values for all data submitted for a given study.
- As soon as the data collection protocol is complete, researchers should submit the final DASH Codebook to DASH.
- Investigators will share data associated with a publication through DASH no later than the first date of electronic publication and will share all study data by the end of the award performance period. Plan to submit data to DASH 4-6 months prior to expected publication release date for a given dataset.