New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University, April 17, 2018
Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility. …

Read More

On Scarcity and the Value of Clinical Trials

The American Journal of Bioethics, 2018, Issue 4, Volume 18
Luke Gelinas (Senior Researcher), Holly Fernandez Lynch (Former Executive Director), Barbara E. Bierer, & I. Glenn Cohen (Faculty Director)

From the artice: Allocation of scarce goods and resources is a common concern in the health care context, from intensive care unit (ICU) beds, to extracorporeal membrane oxygenation (ECMO) machines, to vaccines, to organs for transplant. Problems raised by scarcity…

Read More

Mutual Obligations in Research and Withholding Payment From Deceptive Participants

The American Journal of Bioethics, 2018, Issue 4, Volume 18
Holly Fernandez Lynch (Former Executive Director), Luke Gelinas (Senior Researcher), & Emily A. Largent

From the article: Paying research participants can be ethically charged, both when payment is offered and—as demonstrated in this case—when it is withheld. When individuals undergoing screening intentionally deceive investigators as to their eligibility,…

Read More

Assisted Reproduction in Israel: Law, Religion, and Culture

Brill Research Perspectives, March 20, 2018
Avishalom Westreich

From the article: The theme of this composition is the right to procreate in the Israeli context. Our discussion of this right includes the implementation of the right to procreate, restrictions on the right (due to societal, legal, or religious concerns), and the…

Read More

NOW AVAILABLE! Big Data, Health Law, and Bioethics

Cambridge University Press, March 2018
I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena

Now available - order it online!  From the book: When data from…

Read More

Drug Approval in a Learning Health System

Minnesota Law Review, Forthcoming, March 29, 2018
W. Nicholson Price (Academic Fellow Alumnus)

From the article: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn…

Read More

Prevalence of Publicly Available Expanded Access Policies

Clinical Pharmacology & Therapeutics, March 23, 2018
Emily Jung (Petrie-Flom Student Intern), Patricia J. Zettler, Aaron S. Kesselheim

From the Article: The Food and Drug Administration's expanded access program allows patients with serious or immediately life‐threatening conditions to seek access to experimental drugs and treatments from their manufacturers. The 21st Century Cures Act…

Read More

Price Insensitivity. Guest, Rachel Sachs

The Week in Health Law, Episode 132, March 22, 2018
Nicolas Terry and Frank Pasquale, interviewing Rachel Sachs (Academic Fellow Alumna)

From the podcast: This week’s episode features a welcome return from Rachel Sachs, Associate Professor of Law at the Washington University in St. Louis School of Law. Rachel’s primary research interests lie at the intersection…

Read More

Can Rationing through Inconvenience Be Ethical?

Hasting Center Report, Volume 48, Issue 1
Nir Eyal, Paul L. Romain, and Christopher T. Robertson (Academic Fellow alumnus)

From the Article: In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a nonfinancial burden (the…

Read More

The Legal and Ethical Environment of Business, Second Edition

Wolters Kluwer, New York , 2018
Gerald R. Ferrera, Mystica M. Alexander, William P. Wiggins, Cheryl Kirschner, Jonathan Darrow (Student Fellow Alumnus)

Summary of the text: Focusing on ethics in every aspect of the business environment, The Legal and Ethical Environment of Business, Second Edition, prepares students to work within current industry norms, practices, and legislation. Ethics coverage is integrated…

Read More

Promoting Competition To Address Pharmaceutical Prices

Health Affairs, March 15, 2018
Jonathan Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the article Under ideal market conditions, competition among producers of a commercial good can drive down prices. The market for pharmaceuticals, however, is inefficient in many ways, leading to rapid price increases in recent years, even for some drugs without…

Read More

Harvard Law School Program of Study: Law, Science, & Technology Student Advisory Lunch

Moderated by Carmel Shachar (Executive Director)

Thursday March 22, 2018 12:00-1:00pm Langdell 225 North classroom, Harvard Law School   This advisory lunch will provide information about courses and experiential opportunities for students interested in careers in health law policy, biotechnology, and bioethics. 

Read More

Brain Scans in the Courts: Prosecutor’s Dream or Civil Rights Nightmare?

Inside Science, March 14, 2018
James Gaines, quoting Francis Shen (Senior Fellow in Law and Applied Neuroscience)

From the article:  One of the foundations of the U.S. legal system is the Bill of Rights, which enshrines the idea that there are certain individual liberties and inalienable freedoms that governments and the courts cannot infringe upon, including the freedom…

Read More

Risk and Resilience in Health Data Infrastructure

Colorado Technology Law Journal, Volume 16, Issue 1 (2017)
W. Nicholson Price II (Academic Fellow Alumnus)

From the journal article: Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting, and using those data. In the easy cases of coordinated care and…

Read More

Lawmakers file a bill to block maneuvers like Allergan’s patent deal with Mohawks

STAT, March 7, 2018
Ed Silverman quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Angered by a controversial Allergan (AGN1 ) patent maneuver, a handful of lawmakers introduced a bill that would prohibit tribal sovereign immunity from being used to block…

Read More

Early-career researchers’ views on ethical dimensions of patient engagement in research

BMC Medical Ethics BMC series, 2018 19:21
Jean-Christophe Bélisle-Pipon (Visiting Researcher) Geneviève Rouleau and Stanislav Birko

From the Article: Increasing attention and efforts are being put towards engaging patients in health research, and some have even argued that patient engagement in research (PER) is an ethical imperative. Yet there is relatively little empirical data on ethical issues…

Read More

Payments to Study Participants: Experts Discuss Potential Framework

RAPS, February 27, 2018
Michael Mezher, featuring NEJM article produced as part of the Harvard Catalyst Project

Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical…

Read More

A Framework for Ethical Payment to Research Participants

NEJM, February 22, 2018
Luke Gelinas (Clinical Research Ethics Fellow), Emily A. Largent (Student Fellow Alumna), I. Glenn Cohen (Faculty Director), Susan Kornetsky, Barbara

Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard…

Read More

Preventing Mitochondrial Disease: A Path Forward

Obstetrics & Gynecology, March 2018 - Volume 131 - Issue 3
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

Abstract: In a possible first, the heritable transmission of a fatal mitochondrial DNA disease (Leigh syndrome) may have been prevented by replacing the mutation-bearing mitochondria of oocytes with donated mutation-free counterparts. The procedure, carried out by a U.S.-led…

Read More

Delinking Reimbursement

Minnesota Law Review, Forthcoming, February 14, 2018
Rachel Sachs (Academic Fellow Alumna)

From the article: Over the past few years, calls for the Food and Drug Administration (FDA) to approve pharmaceuticals more speedily have grown louder. At the same time, many have argued that America’s drug pricing problems can be solved if only Congress were…

Read More