Lauren Hartsmith, JD, CIP, is a seasoned human subjects protection professional with over 15 years of experience in research compliance, IRB oversight, and regulatory affairs. Lauren has a strong background in the practical development and implementation of regulatory strategies at a variety of academic, private, and independent IRBs/human research protection programs, and has been instrumental in drafting federal research policies, guiding IRB compliance strategies, and implementing risk-based monitoring programs. She played a significant role in revising the Common Rule (subpart A of 45 CFR part 46), analyzing thousands of public comments and developing regulatory guidance documents used nationwide.
Emphasizing the integration of technology into compliance solutions, Lauren has created automated tools for IRB processes, data tracking, and policy implementation, improving efficiency and regulatory adherence. She regularly presents at national conferences, authors policy documents, and trains research professionals on evolving regulatory landscapes. Lauren holds a Juris Doctor from Wake Forest University School of Law and a Bachelor’s degree in Geography from Vassar College. She is a Certified IRB Professional (CIP), a practicing attorney (Maryland), an active member of research ethics and other oversight organizations, and is deeply committed to helping research professionals conduct meaningful, ethical research.
