EMILY CHI FOGLER is a Member of the Firm in the Health Care and Life Sciences practice, in the Boston office of Epstein Becker Green. She assists academic medical centers, hospitals, universities, Institutional Review Boards (IRBs), pharmaceutical and device companies, insurance providers, and other health care and research organizations with matters related to:
- Human subjects protection
- Single, central, and other IRB reliance arrangements for multi-site research
- Sponsored research and other collaborative research agreements
- Compliance with HIPAA and other federal, state, and international privacy frameworks, including the EU General Data Protection Regulation
- Research and clinical data-sharing agreements
- Tissue and data repositories
- FDA requirements for clinical investigations
- Expanded access to investigational products
- Research compliance
- International research collaborations
Ms. Fogler's extensive prior experience as senior in-house counsel for human research matters for a large Boston health system gives her a deep "insider's" understanding of the challenges faced by health care and research organizations, as well as a practical perspective in providing advice. She enjoys working with clients and other stakeholders to consider the legal, operational, and policy implications of various responses to a problem in order to identify the best approach.
Ms. Fogler has contributed significantly to national efforts to implement IRB reliance arrangements for multi-site research and is regarded as a thought leader in this area. She is a regular speaker at national and local conferences and on webinars on IRB reliance and many other topics pertaining to human research.
Before joining Epstein Becker Green, Ms. Fogler was a Partner in the Health Care & Life Sciences Group of a New England regional law firm. Her prior in-house counsel role was at a health system renowned for medical research, where she was also the staff attorney in charge of managing legal affairs for a nationally recognized community hospital within the system. Earlier in her legal career, Ms. Fogler practiced in the litigation and labor and employment groups of an international law firm and served as a Law Clerk for the Honorable Patti B. Saris of the U.S. District Court for the District of Massachusetts.
- Harvard Law School (J.D., cum laude)
- Executive Editor, Harvard Law Review
- Williams College (B.S., summa cum laude)
- Highest Honors
- Phi Beta Kappa