|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Foundations, Ethics, and Law Program|
Drawing from expertise throughout Harvard Catalyst's participating institutions, the Regulatory Foundations, Ethics, and Law Program facilitates the development and strengthening of QA/QI programs by educating the research community, enabling compliance, and collaborating around issues relating to regulatory compliance.
Quality Assurance/Quality Improvement (QA/QI) functions ensure investigator and institutional compliance with federal and state regulations governing human research. This is accomplished by providing ongoing support, education and study management tools, and best practice recommendations that go above and beyond mere compliance, with an emphasis on improving efficiency.
The Harvard Catalyst QA/QI Subcommittee includes recognized QA/QI leaders and IRB members from participating Harvard Catalyst institutions. The Subcommittee also engages those new to the regulatory compliance arena who offer fresh perspectives and novel approaches to a problem. Each member brings a range of experience and familiarity: from social behavioral to biomedical research, from single-site, local research to multi-center, international studies. Learn more on our How We Work page.
Sabune Winkler, JD
Director, Regulatory Affairs Operations
Regulatory Affairs Officer