Data Sharing Toolkit
One of the main barriers to data sharing is the lack of clarity around legal and regulatory policies and practices.
This toolkit includes new and existing resources from trusted partners that may provide guidance on same key data sharing issues.
Decision Tree
Decision tree to determine if consent forms permit sharing data with third parties for secondary research on Alzheimer's disease.
Download the Decision TreeModel 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
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:
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
- 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:
Disclaimer: The material available in the Resources section of this website (the “Information”) is for informational purposes only. The Information is not legal advice. The Information may not be suitable for your intended purposes. Where possible, the Information is dated to reflect when it was last updated, but the Information may not be current. The Information may not reflect laws or regulations specific to your place of residence or the location of your research. You should not consider the Information a replacement for seeking your own legal advice.