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

Data Protection


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


For Investigators
For Institutions


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

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations