Data Sharing Plan ()

The goal of this data sharing plan is to support the FAIR Data Principles (Findable, Accessible, Interoperable, and Reusable). It serves as a general guide and allows the data contributor to describe the data that will be shared and how/when they will be released.

Commitment to Data Sharing

Data contributors are required by the to upload data generated in the performance of research funded by or on behalf of or one of its affiliates into a customized Synapse NF-OSI project space by the associated progress report deadline, though contributors are encouraged to upload data as soon as possible after being generated. Data will be embargoed from the public and accessible only to the data contributor, the NF-OSI data curation team at Sage Bionetworks, or staff and consultants, during the award period and for after the end date of the award, unless your contract with states otherwise. The embargo period will end earlier if the data is published or at the data contributor’s discretion. After the embargo period, the data will be made available to the broader research community via the Synapse platform. Any requests by an investigator for an extension of the embargo period (e.g., due to a delay in primary publication), must be made in writing to the Project Manager.

Data Sharing

Data contributors should upload the raw data from their research to enable the data to be analyzed by a third party. This includes any information necessary to interpret the data, such as a description of the cohort or the model system, experimental protocols, descriptions of study instruments and equipment, and code used to generate processed data. It is not necessary to share aggregated/finalized results (e.g. figures). Please see our help documentation for some data-specific examples and feel free to email us at nf-osi@sagebionetworks.org with questions or for assistance.

Data will be shared in three stages:

  1. Data and all associated metadata will be uploaded to the contributor’s Synapse NF-OSI project space hosted by Sage Bionetworks.

  2. During the embargo period, file metadata will be made publicly visible upon annotation of the uploaded data through the NF Portal to enable discovery of the dataset. The data itself, however, will only be accessible to , the Co-PIs of the project, and the Sage NF-OSI data curation team via the Synapse platform.

  3. Following publication of the data by the data contributor, or otherwise when chooses to make such data public in accordance with the terms of the applicable funding agreement (which in no event will be earlier than following completion of research), the data will be made available to the broader NF-OSI research community.

Data Licensing

Non-human-subjects data will be made publicly available under CC0 1.0 Universal, a Creative Commons license, by default. This is the equivalent to depositing the data in the public domain. Please be aware that you may be required to obtain permission from your institution to release data under this Creative Commons license. You are responsible for consulting with your institutional contacts and obtaining any required permission. Contributors may indicate certain Conditions of Use of the data by the broader research community under the Data Sharing Plan section below based on the nature of the data, any applicable informed consent, or prior contractual obligations.

Study Information

(Names may only contain: letters, numbers, spaces, underscores, hyphens, periods, plus signs, apostrophes, and parentheses!)

Datasets to be Deposited

Please complete details below about the datasets you expect to upload for this study. Use a unique name for each. (These datasets will be set up as folders in your Synapse project). For example, if you have a RNA Sequencing dataset in multiple aims, the Data Folders might be labeled RNA Sequencing - Aim 1, RNA Sequencing - Aim 2, etc. Use the "Description" field to provide more details of the experiment. If you cannot find the term "Type", "Assay", "Species", or "File format" that is appropriate for your experiment in the provided dropdown list, please email nf-osi@sagebase.org to request addition of the term. "Upload by" dates, "#Files", and "#Samples" can be estimates.

Other Resources

Optional non-data resources to be shared in Synapse. We currently accept protocols or materials related to tools. If the resource type of interest is not in the selection options, please let us know.

Governance Information
Data Use Modifiers/Conditions

Please indicate any additional Data Use Modifiers/Conditions as required by your contract, institutional policy, applicable informed consent form (e.g., IRB approval requirement), project-specific terms of use, etc. This will help us plan additional governance controls for data access and usage that may be needed.

For Human Data

Addendum 1

Guidelines for human sample data

Prior to submitting data each contributor will ensure that:

  • The data submission and subsequent data sharing for general research purposes are consistent with applicable national, tribal and state laws and regulations as well as institutional policies.

  • An Institutional Review Board/Privacy Board or equivalent body, as applicable, has assured that submission and subsequent sharing of human data for general research purposes (including data such as that being submitted by the contributor) are consistent with the informed consent of study participants from whom the data was obtained.

  • The identity of research participants will not be disclosed to DCC members and/or Sage Bionetworks:

    • All submitted human data has been de-identified according to HHS 45 CFR 46.102(f) regulation and the de-identification standards of the HIPAA privacy rules, 45 CFR § 164.514(b), so that individual subjects’ identities cannot be ascertained by DCC members or through secondary data use.

    • The de-identified data has been assigned random, unique identifier codes that legally may be made visible to anyone on the web (i.e., the identifier codes do not include any information that can be used to re-identify the study participant).

    • The study PI will inform Sage Bionetworks if any metadata contains potentially identifiable information.

    • The data contributor will review data after submission, before they are released, to verify that no identifying information has been submitted accidentally.

    • Filenames will not contain identifiable information and legally may be made visible to anyone on the web.

  • The study PI will notify Sage Bionetworks if there are quality concerns about any data that has been submitted (not limited to potentially identifiable information).

  • Data quality corrections will be submitted as soon as possible.

Characterization of human samples

Please provide additional details for the human samples to help us determine governance.

Where were the human samples obtained?

Are the data being provided to Sage Bionetworks anonymized? Anonymization eliminates all personal data and any links between the data and a data subject held by any person anywhere, so that no one could identify the data subjects from the data, either alone or in combination with other information.

Is the data being provided to Sage Bionetworks de-identified according to HIPAA? De-identification in accordance with HIPAA requires removing all of 18 specific types of identifiers listed at 45 C.F.R. § 164.514(b)(2) or obtaining an expert opinion that the data are de-identified, following the standards set forth at 45 C.F.R. § 164.514(b)(1).

Does the human data constitute a Limited Data Set? A Limited Data Set is Protected Health Information (PHI) that excludes all identifiers of an individual except for ages over 89, dates related to the data subject (except for years) and geographic information at the zip code, town, city, or state level. Data that is Safe Harbor de-identified is not a limited data set.

Is the data from a vulnerable population (i.e., children, prisoners, pregnant women)?

Does the data include information about individuals that was collected either from the individuals or others located outside of the United States of America?