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Verrill

Emily Chi Fogler

Emily Chi Fogler

Partner

Verrill
Massachusetts, U.S.A.

tel: (617) 309 2600
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Local Time: Tue. 02:13

Profile

Emily assists academic medical centers, hospitals, universities, Institutional Review Boards (IRBs), pharmaceutical 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

Emily'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.

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 pertaining to human research.

Emily's prior in-house counsel role was at Partners HealthCare System, which includes Massachusetts General Hospital and Brigham and Women's Hospital. While at Partners, she was also the staff attorney in charge of managing legal affairs for the Newton-Wellesley Hospital, a nationally recognized community hospital within the system. Prior to her work at Partners, Emily practiced in the litigation and labor and employment groups of Ropes & Gray LLP.

Bar Admissions

  • Massachusetts

Education

  • Harvard Law School  (J.D., cum laude)
    • Harvard Law Review (Executive Editor)
  • Williams College  (B.S., summa cum laude)
    • Highest Honors
    • Phi Beta Kappa
Areas of Practice
Professional Career

Professional Associations

    Boston Bar Association, Health Law Section

Seminars

  • "The Nuts and Bolts of IRB Reliance Agreements: What Institutions and IRBs Need to Address for a Successful Relationship," 2014 PRIM&R Annual Conference on Advancing Ethical Research Conference
  • "Central IRBs: Models, Logistics, and Implications," PRIM&R Webinar, 4/15/2014
  • "When it Rains it Pours: Best Practices for Managing Parallel Internal Investigations of Research-Related Misconduct or Noncompliance," American Health Lawyers Association Annual Conference, 1/24/2014
  • "Taking the Ominous Out of the Omnibus Rule: Implications of the Final Health Insurance Portability and Accountability Act (HIPAA) Changes for Research," PRIM&R Advancing Ethical Research Conference, 11/7-9/2013
  • "Getting There: Reliance Agreements," PRIM&R Advancing Ethical Research Conference, 11/6/2013
  • "Primer on the HIPAA/HITECH Act Omnibus Final Rule," PRIM&R Webinar, 3/4/2013
  • "Who Does What: Division of Responsibilities in a Central IRB System," PRIM&R Annual Conference on Advancing Ethical Research, 12/4-6/2012
  • "Questions and Challenges for a Central IRB," 2012 Conference on the Future of Human Subjects Research Regulation, 5/18-19/2012
  • "When is the Ball in My Court? Distinguishing Between Institutional Decisions and IRB Decisions," PRIM&R Advancing Ethical Research Conference, 12/8/2010
  • "How Institutions and Sponsors Can Understand Each Other's Needs and Reach Agreement," PRIM&R Advancing Ethical Research Conference, 11/17/2008
  • The ABCs of Clinical Trial Agreements for IRBs and Institutional Officials: Regulatory Requirements and AAHRPP Considerations," PRIM&R Human Research Protection Programs in an Evolving Research Landscape Conference, 12/2/2007

Articles

Co-author, "Biomedical Research," a chapter from Massachusetts Health and Hospital Law Manual, 2014


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