With nearly 15 years of experience as senior in-house counsel for clinical/human research matters at a large Boston academic health system, Emily Chi Fogler intricately understands the operational and business considerations, issue and risk prioritization, workload, and other factors that health care and research organizations contend with every day. Few health care lawyers who focus on clinical research work have the depth of experience and knowledge that Emily has.
Emily helps clients plan and conduct compliant and ethical clinical and data-driven research. Her clients include health care provider institutions (hospitals and health systems), universities, research organizations, life sciences companies (pharma and device companies), health data companies, and health insurers. She works with organizations at all experience levels, including those just starting to develop human research programs. A thorough, detail-oriented, and trusted advisor, Emily provides regulatory counseling, contract negotiation, and advice on policies and implementation issues to help clients understand and keep up with this often-changing and critical part of the health care industry.
Clients value Emily’s work on human subject protections; FDA-regulated clinical investigations; single, central, and other Institutional Review Board (IRB) reliance arrangements for multi-site research; and health and personal data privacy (including HIPAA and GDPR). They also rely on her to resolve challenging contracting issues between institutions and industry sponsors, to facilitate data-sharing collaborations for research and health care quality measurement, and to advise on issues associated with banking and using health data and human tissues/biospecimens for research. Emily’s experience includes advising on complex projects involving data commercialization, precision medicine, and other areas where a variety of regulatory and policy frameworks intersect. Additionally, Emily helps clients navigate state laws (including state research and privacy laws) that affect the conduct of clinical and data research. Her experience working with different types of organizations allows her to get quickly to the heart of an issue and identify solutions that bridge gaps between multiple stakeholders’ perspectives.
In a practice area where ethical codes underlie many of the relevant laws and regulations, and where the laws and regulations do not always dictate a particular outcome, clients also seek Emily’s assistance with policy development and implementation. She helps clients determine “the right thing to do” and “the best way to operationalize doing it.”
Emily 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 relating to human research.
Before joining the firm, Emily was a partner in the Health Care & Life Sciences Group of a New England regional law firm. Her prior senior 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 and a community health center within the system. Earlier in her legal career, Emily practiced at 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.