Biography

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.

Services/Industries

Education

  • 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

Bar Admissions

  • Massachusetts
  • New York

Honors

  • 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.

Clerkships

  • U.S. Court of Appeals for the Second Circuit, Hon. Dennis Jacobs

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

Updated FDA COVID-19 Guidance for Conduct of Clinical Trials

On March 27, 2020, the U.S. Food & Drug Administration (“FDA”) updated its prior guidance on the “ Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic ,” with an appendix adding a...

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

Two Proposed Rules Aim to Increase Organ Donation in the U.S.

News

38 Verrill Attorneys, Across Four Offices, Recognized in 2020 Chambers & Partners Guide

(April 27, 2020) – Verrill has been rated as a Leading Firm in a total of ten categories and subcategories as evaluated by London-based Chambers & Partners , one of the world's most respected...

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

COVID-19: FDA Clinical Trial Guidance

On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic...

Publication/Podcast

Responsible Research During the COVID-19 Pandemic