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

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

Sheila Fireman, J.D.
Data Protection Subcommittee Co-chair
Director, Research Integrity and Compliance, Harvard Pilgrim Health Care Institute
Email
617-509-9981

Ken Carson, J.D.
Data Protection Subcommittee Co-chair
Assistant Provost for Research Policy, Harvard University
Email
617-495-9829

Kristen Bolt
Research Data Compliance and Conflict of Interest Officer
Office of the Vice Provost for Research, Harvard University
Email
617-495-9901

Sabune Winkler, JD
Director, Regulatory Affairs Operations
Email

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