Data Sharing Toolkit

Model informed consent language for prospective studies

• NICH Consent template (without data sharing)
• NCRAD’s recommended consent language for studies involving biological samples
• HHS OHRP Q&A: Broad Consent and informed consent in the Revised Common Rule
• UK MRC Consent form template
• UK MRC Guidance on patient consent
• Additional Consent Request Template

Guidance for navigating consent in existing studies:

• UK MRC Policy and Guidance on Sharing of Research Data from Population and Patient Studies

Model data use agreements and guidelines

• UK MRC Data Sharing Agreement Expectation
• ADDI Data Use Agreement Template

Genetics data sharing guidance:

• NIA AD Genomics Sharing Plan Toolkit
• National Institute on Aging Genetics of Alzheimer's Disease Data Storage (NIAGADS)
• NIAGADS related documents and guidance
• International code of conduct for data sharing in genomics
• European Biofinformatics Institute Training

GDPR:

• HHS Office for Human Research Protections Compilation of Guidances on the EU GDPR
• NHS Health Research Authority GDPR Guidance for researchers and study coordinators
• UK MRC GDPR Resources
  • Guidance Note 3 : consent in research and confidentiality
  • Guidance Note 4 : public interest, approvals and “technical and organizational
  • Guidance Note 5 : Identifiability, anonymization and pseudonymization
• UK MRC NHS Health Research Authority GDPR and Data Protection Act 2018 : Key facts for research
• UK MRC GDPR and research - an overview for researchers
• Privacy Shield Framework
• UK Anonymisation Network Anonymisation Decision Making Framework book
• GDPR Frequently Asked Questions
• Legal and regulatory Frequently Asked Questions (non-GPDR)

HIPAA privacy requirements:

• NIH HIPAA -- How covered entities use and disclose PHI for research and comply with HIPAA
• HHS Clinical Research and the HIPAA Privacy Rule
• Guidance Regarding Methods for De identification of PHI in Accordance with HIPAA
• Data sharing model edits to HIPAA authorization for future research purposes

Data sharing considerations in research planning:

• NIH Key Elements to Consider in Preparing a Data Sharing Plan under NIH Extramural Support
• NIAID Checklist for Planning and Writing a Human Subjects Grant Application
• NIH Policy for Data Management and Sharing
• Data Sharing Workbook (MS Word)
• NIAID 'Create Resource Sharing Plan'
• NIH Data Sharing Brochure
• UK MRC Research practice guidance on data management, integrity, retention, and preservation
• UK MRC Data Management Plan Resources
  • Data Management plans Guidance for applicant
  • Data Management Plan Template
  • Data Management Plan FAQs and guidance
• UK Data Service Questions about how to manage data
• UK Research Integrity Office code of practice for research

UKMRC data management plan template: Data Management Plan Template

Technical and monetary resources:

• List of NIH Data Sharing Repositories
• CPAD
• DPUK
• GAAIN
• NIH Guidance for requesting funds in grant applications for data sharing
• UK MRC Supporting research data management costs through grant funding

Other Data Sharing Resources:

• NIA Data Sharing Resources for Researchers
• NIH Sharing Policies and Related Guidance on NIH Funded Research Resources
• NIH Data Sharing FAQs