Protecting research participants.
Evolving science policy.

We help:

  • Public and private organizations develop, deploy, and evolve their human subjects protection and regulatory compliance programs

  • Investigators, sites, and industry develop informative materials for research participants and improve study start-up efficiency by providing timely and accurate research reviews

  • The federal government engage with the public as they develop and enhance health and science policy

  • Mission focused organizations develop and clearly articulate health and science policy positions

Our Leadership

Lauren Hartsmith, JD, CIP
Principal Consultant

Lauren Hartsmith is an administrative law and regulatory compliance attorney, and the Principal Consultant for Hartsmith Consulting, LLC.  Lauren has experience working with government, institutional, non-profit, and for-profit IRBs and HRPPs, and is excited to help evolve the research ethics/compliance field in this new capacity.   

Lauren’s experience includes serving as a Policy Analyst/Senior Advisor for Public Health Education with the Office for Human Research Protections (OHRP) where she led scientific, regulatory, and legal experts to develop and revise policies and regulations.  During her tenure at OHRP, she was a key analyst involved in all aspects of the revised Common Rule rulemaking process.  Lauren has given over 150 trainings on research requirements such as the Common Rule, FDA regulations, and Good Clinical Practice guidelines.

Most recently, Lauren was the Director of IRB Support and Regulatory Affairs at Advarra, where she managed a variety of functions including oversight/development of IRB guidance and policies, IRB member education, IRB meeting minutes, and written reports to regulatory authorities. 

Lauren holds a bachelor’s degree in Geography from Vassar College and a Juris Doctorate degree from Wake Forest University School of Law.  She is a member of the Maryland State Bar and a Certified IRB Professional.

You can see examples of Lauren’s work on Linkedin.