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


Ken Carson, J.D.
Data Protection Subcommittee Co-chair
Assistant Provost for Research Policy, Harvard University

Kristen Bolt
Research Data Compliance and Conflict of Interest Officer
Office of the Vice Provost for Research, Harvard University

Sabune Winkler, JD
Director, Regulatory Affairs Operations

Scott Edmiston, J.D.
Data Privacy and Security Manager