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Kate Gallin Heffernan

Kate Gallin Heffernan



  • Academic & Clinical Research
  • Health Care
  • Life Sciences
  • Health Care & Life Sciences

WSG Practice Industries


WSG Leadership

WSG Coronavirus Task Force Group

Massachusetts, U.S.A.


Kate advises academic medical centers, hospitals, research institutes, universities, and other research organizations and stakeholders on issues related to:

  • Human subjects protection
  • Research compliance and misconduct
  • Research affiliations and contracting
  • Investigator and institutional conflicts of interest
  • The creation of data, genomic, and tissue research repositories and downstream uses of stored materials
  • FDA requirements for clinical investigations
  • Treatment with investigational products pursuant to FDA's expanded access program and "right to try" laws
  • Research involving human embryonic stem cells and induced pluripotent cells
  • Multi-site global trials
  • The privacy of research subjects' information

Kate also advises clients on general patient care issues including legal issues related to assisted reproductive technologies, clinical informed consent, and the protection of sensitive health information, as well as on organ donation and transplantation.

Kate's prior experience advising from both outside and within the institutional setting has given her an appreciation of the hurdles health care organizations face not only in analyzing and understanding the complex regulatory scheme in which they pursue their mission, but also in developing and implementing solutions that work.

Kate is a frequent speaker and author on many issues related to the legal and ethical issues raised by academic and clinical research, and her writings have appeared in, among other places, the Journal of Clinical Oncology, the Journal of Medical Ethics, Transplantation, the Journal of the American Medical Association, Cell Stem Cell, The Hastings Center Report, IRB: Ethics and Human Research, BNA Medical Research Law & Policy Report, and Bloomberg Law's Pharmaceutical and Life Sciences News, where she serves on the Editorial Advisory Board.

Kate is involved with policy and thought development on the national and international scene. Serving on an expert panel appointed to advise the Health Resources and Services Administration, Kate contributed to a proposed ethical framework for the conduct and oversight of organ donor intervention trials; the framework was subsequently endorsed in The National Academies of Medicine's report Opportunities for Organ Donor Intervention Research: Saving Lives by Improving the Quality and Quantity of Organs for Transplantation, for which Kate served as an invited reviewer. The Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the Secretary of the United States Department of Health and Human Services on challenging issues related to human subjects research, invited Kate to present to SACHRP on this topic in July 2019.

Kate serves as a member of the planning committee for the Advancing Ethical Research Conference, an internationally attended conference jointly sponsored by Public Responsibility in Medicine & Research (PRIM&R) and Boston University, at which she is a regular faculty member. She also has served as a member of several working groups of the Multi-Regional Clinical Trials Center at Harvard University's Global Health Institute, an interdisciplinary group of academics, health care providers, and industry convened to recommend concrete solutions for challenging ethical issues in international research. Kate has an enduring interest in bioethics, pursuing advanced study in June 2009 through a fellowship in medical ethics at Harvard Medical School, Division of Medical Ethics. She served on the Institutional Review Board of South Shore Hospital in Weymouth, Massachusetts, for several years.

Prior to joining Verrill, Kate operated her own practice as the founder of KGH Advisors LLC, after having worked in the Research and Technology division of the Office of the General Counsel at Partners HealthCare System, which encompasses Massachusetts General Hospital and Brigham and Women's Hospital, among others. Prior to that, she practiced in the health care group of Ropes & Gray LLP.

Bar Admissions

  • Massachusetts
  • New York


  • New York University School of Law  (J.D., magna cum laude)
    • Order of the Coif
  • Georgetown University  (B.A., magna cum laude)
    • Phi Beta Kappa
Areas of Practice

Academic & Clinical Research | Health Care | Health Care & Life Sciences | Life Sciences | Privacy & Security | Strategic Counseling & Transactions

Professional Career

Professional Activities and Experience

  • Recognized in Chambers USA: America's Leading Lawyers for Business under Health Care
  • Selected by peers for inclusion in New England Super Lawyers© under Health Care

To learn more about third-party ratings and rankings, and the selection processes used for inclusion, click here.


Responsible Research During the COVID-19 Pandemic
Verrill, March 2020

The world has been thrown off its stride by the 2019 novel coronavirus SARS-CoV-2 and the resulting disease, “COVID-19.” At the time of this Alert, the full impact of SARS-CoV-2 and COVID-19 is still unknown...

Additional Articles

Co-Authored Community Research Partnerships: Underappreciated Challenges, Unrealized Opportunities, in JAMA, Vol. 309, No. 6 (February 13, 2013)

"HITECH's Proposed Changes to HIPAA's Research Authorization Provisions: Progress with Continued Pitfalls," in BNA's Medical Research Law & Policy Report (November 2010)

Co-Authored "Centralized Banks for Human Embryonic Stem Cells: A Worthwhile Challenge," in Cell Stem Cell (April 2008)

Co-Authored "Establishing Institutional Oversight for Human Embryonic Stem Cell Research: Creating an ESCRO Committee," in BNA's Medical Research Law & Policy Report (August 2007)

Co-Authored The "'Future Uses' Dilemma: Secondary Uses of Data and Materials by Researchers and Commercial Research Sponsors," in BNA's Medical Research Law & Policy Report (June 2004)

Co-Authored "Auditing for Human Subjects Research Compliance: Informed Consent," in Journal of the Association of Healthcare Internal Auditors (Spring 2004)

Co-Authored "Recent Developments in Research Compliance" in Journal of the Association of Healthcare Internal Auditors, Inc., including a discussion of the ARDS Network trial and issues of surrogate consent in research, and the impact of Greenberg v. Miami Children's Hospital on consent for future uses of research data and materials (Fall 2003)

Co-Authored article in IRB: Ethics & Human Research on new federal draft guidance on conflicts of interest in research (September-October 2003)

Co-Authored article in IRB: Ethics & Human Research on how HIPAA affects research exempt under the Common Rule (July-August 2003)

Co-Authored "HIPAA and Human Subjects Research: A Question & Answer Reference Guide" (Barnett International, March 2003)

Co-Authored "In re Shulman et. al," Letter to the Editor, 348 New Engl. J. Med. 2003; 348: 476-478 (discussing disconnect between informed consent process and terms of clinical trial agreements and the impact on research subjects' privacy) (January 30, 2003)

Co-Authored "The HIPAA Privacy Rule: A Guide to Conducting State Law Preemption Analysis," 11 BNA Health Law Reporter 659 (May 2, 2002)

WSG's members are independent firms and are not affiliated in the joint practice of professional services. Each member exercises its own individual judgments on all client matters.

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