Informational Links:

Upcoming Galter Library Class: JANUARY 26, 2023 10:00 AM CST Online (Zoom) Getting to Know the NIH Policy on Data Management and Sharing

Final NIH Policy for Data Management and Sharing

• Final NIH Policy for Data Management and Sharing (DMS): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html
• NIH’s one-stop-shop DMS policy and information page: https://sharing.nih.gov/
• Other NIH data sharing policies: https://sharing.nih.gov/other-sharing-policies/nih-institute-and-center-data-sharing-policies

What, Precisely, does the NIH Require to be Shared?

• Definitions of data to share and data not to share per the NIH Policy: https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56772

Elements of an NIH Data Management and Sharing Plan (DMSP)

• Elements of an NIH Data Management and Sharing Plan (DMSP): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html
• DMP Format Page: on the NIH Grants & Funding, Forms & Applications page (https://grants.nih.gov/grants/forms/all-forms-and-formats.htm), near the bottom there is a link to a Data Management and Sharing Plan Format Page: https://grants.nih.gov/sites/default/files/DMS-Plan-blank-format-page.pdf

DMPTool

• DMPTool: https://dmptool.org/

Standards

Common data standards utilized in biomedical research:

• NIH Common Data Elements: https://cde.nlm.nih.gov/home
• Clinical Data Interchange Standards Consortium (CDISC): https://www.cdisc.org/
• Center for Expanded Data Annotation and Retrieval (CEDAR): https://metadatacenter.org/
• Johns Hopkins Sheridan Libraries’ Documenting Research Data LibGuide: https://guides.library.jhu.edu/documenting_data/medical_research
• org: https://fairsharing.org/

Data Preservation, Access, and Associated Timelines

• When should scientific data be shared? https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56773
• Does the data sharing timeline change for a no-cost extension? https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56548
• Northwestern University, Research Data: Ownership, Retention, and Access Policy: https://osr.northwestern.edu/files/2020/02/Research_Data_Policy.pdf

Data Preservation, Access, and Associated Timelines

• Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-016.html
• NIH’s Repositories for Sharing Scientific Data: https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/repositories-for-sharing-scientific-data
• NIH-supported domain-specific data sharing repositories: https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/repositories-for-sharing-scientific-data
• NIH guide for locating generalist data repositories: https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/generalist-repositories
• NIH-backed Generalist Repository Ecosystem Initiative: https://datascience.nih.gov/news/nih-office-of-data-science-strategy-announces-new-initiative-to-improve-data-access
• PubMed Central (for very small datasets as supplementary materials to articles) https://www.ncbi.nlm.nih.gov/pmc/about/guidelines/#suppm
• Registry of Research Data Repositories: https://www.re3data.org/
• DigitalHub, FSM’s institutional repository: https://digitalhub.northwestern.edu/

Access, Distribution, or Reuse Considerations

• Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-213.html
• NIH’s “Informed Consent for Secondary Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing”: https://osp.od.nih.gov/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf
• Northwestern University informed consent templates: https://irb.northwestern.edu/resources-guidance/consent-templates-hipaa-requirements/

Access, Distribution, or Reuse Considerations

• NIH: What are justifiable reasons for limiting sharing of data?: https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56549
• Feinberg Information Technology – Information Security: https://www.feinberg.northwestern.edu/it/policies/information-security/index.html

Access, Distribution, or Reuse Considerations

• Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/ Alaska Native Participant Data: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-214.html

Oversight of Data Management and Sharing

• National Academies of Science, Engineering, and Medicine’s (NASEM) guide: Forecasting Costs of Biomedical Data Preservation: A User Guide for Biomedical Researchers http://nap.nationalacademies.org/resource/25639/Researcher_User_Guide_Biomedical_Data.pdf
• NASEM’s Ad Hoc Committee for Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data nationalacademies.org/our-work/forecasting-costs-for-preserving-archiving-and-promoting-access-to-biomedical-data , whose products include:
  • Report: Life-Cycle Decisions for Biomedical Data: The Challenge of Forecasting Costs: https://nap.nationalacademies.org/catalog/25639/life-cycle-decisions-for-biomedical-data-the-challenge-of-forecasting
  • Cost Drivers Template Video: https://vimeo.com/444647256

Oversight of Data Management and Sharing

• Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-015.html
• NIH guidance on Budgeting for Data Sharing: https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/budgeting-for-data-management-sharing

Galter DataLab resources

• Data Clinic consultations (form): https://galter.northwestern.edu/contact/data/clinic
• Contact Data Librarian Sara Gonzales: https://galter.northwestern.edu/contact/sara/gonzales/
• Galter Library Data Management Trainings: https://galter.northwestern.edu/subject_info/8
• Galter Library Biosciences and Bioinformatics Trainings: https://galter.northwestern.edu/subject_info/5
• Data and Data Management LibGuides: https://galter.northwestern.edu/galterguides?url=https%3A%2F%2Flibguides.galter.northwestern.edu%2Fdata-management
• Biosciences and Bioinformatics LibGuides: https://galter.northwestern.edu/galterguides?url=https%3A%2F%2Flibguides.galter.northwestern.edu%2Fbiosciences-bioinformatics
• Creating an NIH Data Management and Sharing Plan LibGuide: https://galter.northwestern.edu/galterguides?url=https%3A%2F%2Flibguides.galter.northwestern.edu%2FNIH-Data-Management-Plan

Northwestern Data Management and Storage Resources

• Northwestern Information Technology Research Computing Services data-related trainings: https://www.it.northwestern.edu/research/training.html
• NU Document Sharing and Data Storage Finder: https://www.it.northwestern.edu/service-catalog/collab/doc-collab/storage-finder/index.html

NIH Resources on the Data Management and Sharing Policy

• NIH Data Management and Sharing Policy overview site: https://sharing.nih.gov/
• Implementation Details: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-189.html
• FAQs: https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm
• DMP Format Page: https://grants.nih.gov/sites/default/files/DMS-Plan-blank-format-page.pdf
• Budgeting for Data Management and Sharing: https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/budgeting-for-data-management-sharing#after
• Tool: Which NIH data sharing policies apply to my research?: https://sharing.nih.gov/other-sharing-policies/which-policies-apply-to-my-research
• Tool: (filterable) List of NIH Institute and Center Data Sharing Policies: https://sharing.nih.gov/other-sharing-policies/nih-institute-and-center-data-sharing-policies
• Points to consider / sample language for informed consents for secondary research with data and biospecimens: https://osp.od.nih.gov/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf
• Request for Public Comments on DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-131.html
• NIH-hosted webinars on the Data Management and Sharing Policy: https://sharing.nih.gov/about/learning/DMS-Update