Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program
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Data Protection

Overview

Applying appropriate privacy and security safeguards to data obtained through human subject research is vital to ensuring public trust in the medical research enterprise. The varied and complex regulations governing research uses and disclosures of identifiable information often lead to confusion and misunderstandings. It is imperative that researchers, IRBs, and institutional IT departments appreciate the applicable legal and ethical principles and are equipped with the right tools and policies for:

  • Identifying best practices for information governance
  • Designing strategic responses to proposals for the sharing of research data
  • Navigating the broad array of privacy regulations and ethical standards
  • Reconciling state, federal, and international laws with professional and industry standards

Resources

For Investigators
For Institutions

Contacts

Kristen Bolt
Program Manager, Global Data Sharing
Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital
Email

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Email
617-432-7811

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Email
617-432-5755