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
• AD Data Initiative Data Use Agreement Template

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

• 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