Biography

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.

Services/Industries

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

Bar Admissions

  • Massachusetts

Clerkships

  • U.S. District Court for the District of Massachusetts, Hon. Patti B. Saris

Firm Highlights

Publication/Podcast

OHRP Issues Guidance on the Conduct of Research During COVID-19 Public Health Emergency

The U.S. Department of Health & Human Services Office for Human Research Protections (“OHRP”) issued guidance , dated April 8, 2020, on the application of Common Rule requirements to research being conducted during the...

Publication/Podcast

Responsible Research During the COVID-19 Pandemic

Publication/Podcast

COVID-19 Expanded Access Template

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements...

Publication/Podcast

EU-U.S. Privacy Shield Invalidated: Does Your Company Have a Plan B?

On Thursday, July 16, 2020, the Court of Justice of the European Union (“CJEU”) invalidated the EU-U.S. Privacy Shield (“Privacy Shield”) in Data Protection Commissioner v. Facebook Ireland and Maximillian Schrems (Case C-311/18...

Publication/Podcast

FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency

On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and...

Publication/Podcast

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...