When clinical trials compete: prioritising study recruitment

Journal of Medical Ethics, January 20, 2017 (online)
Luke Gelinas (Clinical Research Ethics Fellow), Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, and I. Glenn Cohen (Faculty Director)

Abstract It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for…

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Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule

IRB: Ethics & Human Research, January-February 2017, Vol. 39, Issue 1
Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Barbara E. Bierer

Abstract: At the federal level in the United States, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies to develop rules with the force…

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Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
W. Nicholson Price II (Academic Fellow Alumnus)

Abstract: Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual…

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Promoting healthcare innovation on the demand side

Journal of Law and the Biosciences, January 16, 2017 (online first)
W. Nicholson Price II (Academic Fellow Alumnus) and Rebecca S. Eisenberg

Abstract: Innovation policy often focuses on fortifying the incentives of firms that develop and sell new products by offering them lucrative rights to exclude competitors from the market. Regulators also rely on these same firms—and on similar incentives—to develop information about the…

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Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)


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The Promise and Peril of Emerging Reproductive Technologies

Science Translational Medicine, January 11, 2017, Vol. 9, Issue 372
By I. Glenn Cohen (Faculty Director), George Q. Daley, and Eli Y. Adashi

Harvard scientists call for proactively addressing legal, ethical challenges before an experimental technique reaches the clinic At a glance: In-vitro gametogenesis…

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Behavioral science suggests that Obamacare may not change as much as Republicans claim

STAT, January 3, 2017
Christopher R. Robertson (Academic Fellow Alumnus), I. Glenn Cohen (Faculty Director), & Holly Fernandez Lynch (Executive Director)

From the article: In the waning days of his administration, President Obama encouraged Americans to take advantage of the opportunity to get health insurance in what may be the last open enrollment period under the Affordable Care Act. Given…

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How Donald Trump’s Health Secretary Pick Endangers Women

New York Times, December 28, 2016
Allison K. Hoffman (Academic Fellow Alumna) and Jill R. Horwitz

LOS ANGELES — With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health of American women. It is regrettable, but not surprising, that Mr. Trump has nominated…

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What’s Confusing Us About Mental Health Parity

HealthAffairs Blog, December 22, 2016
Nathaniel Counts (Student Fellow alumnus), Timothy Clement, Amanda Mauri, Paul Gionfriddo, and Garry Carneal

The Mental Health Parity and Addiction Equity Act (MHPAEA) has been law since 2008. MHPAEA provided that health plans could not limit mental health or substance use disorder benefits in a way that was more restrictive than how most medical/surgical benefits were limited. This sounds simple…

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The Legality of Biometric Screening of Professional Athletes

The American Journal of Bioethics , 2017, Vol. 17, Issue 1
Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate) & Holly Fernandez Lynch (Executive Direc

From the article: In their thoughtful article, “Tracking U.S. Professional Athletes: The Ethics of Biometric Technologies,” Katrina Karkazis and Jennifer Fishman do an excellent job of outlining the concerns associated with the widespread adoption of biometric…

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The Oxford Handbook of U.S. Healthcare Law

The Oxford Handbooks, July 2016 (online), January 2017 (print)
Edited by I. Glenn Cohen (Faculty Director), Allison K. Hoffman (Academic Fellow Alumna), and William M. Sage

Abstract: The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law through the words and insights of the best scholars in the field. The content is valuable to readers with no background in the field and to those who write, teach, practice, or make policy…

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What Health Reform Reveals about Health Law

In The Oxford Handbook of U.S. Healthcare Law, I. Glenn Cohen, Allison K. Hoffman, and William M. Sage, eds., July 2016 (online), January 2017 (print)
Allison K. Hoffmann (Academic Fellow Alumna)

Chapter Abstract: This chapter describes the arc of health reform in the U.S. over the Twentieth Century and explores how the most-recent major reform, the Patient Protection and Affordable Care Act, offers a window into the idiosyncrasies of U.S. health care law and the values…

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How Is It Even Possible For Sofía Vergara’s Embryos To Sue Her? A Harvard Law Prof Weighs In

Refinery29, December 8, 2016
I. Glenn Cohen

From the article: The already-unusual legal battleover Modern Family actress Sofía Vergara’s frozen embryos reached a surprising new chapter on Tuesday — when the embryos sued Vergara. Yes: Two unborn, un-gestated frozen pre-embryos…

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Review of Human Subjects Research Regulation: Perspectives on the Future: edited by I. Glenn Cohen (Faculty Director) and Holly Fernandez Lynch (Executive Director)

American Journal of Bioethics, Vol. 16, Issue 12 (2016)
Erin Phinney Johnson

From the review: Overall, the editors present an intriguing look at the concerns currently facing human subjects research regulation and provide a number of suggestions for how to go about solving some of these problems. While the majority of these concerns have not…

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Review of The Neuroethics of Biomarkers: by Matthew L. Baum (Student Fellow Alumnus)

American Journal of Bioethics, Vol. 16, Issue 12 (2016)
Ryan H. Nelson

Matthew L. Baum. The Neuroethics of Biomarkers: What the Development of Bioprediction Means for Moral Responsibility, Justice, and the Nature of Mental…

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The International Intellectual Property Law Podcast on blinding expert witnesses to reduce bias

JurisDiction, featuring Christopher Robertson (Academic Fellow alumnus)

Click here to listen to the podcast featuring Prof. Christopher Robertson of the University of Arizona on blinding expert witnesses to reduce bias: Bias in Litigation Science and Blind Expertise.

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“Sperm Donor Anonymity and Compensation: An Experiment with American Sperm Donors”: New Scholarship from Faculty Director I. Glenn Cohen

Journal of Law and the Biosciences (JLB), November 23, 2016
Glenn Cohen (Faculty Director), Travis Coan, Michelle Ottey, and Christina Boyd

Prohibiting Sperm Donor Anonymity Could Reduce the Number of Donors: A new study published in the Journal of Law and the Biosciences (JLB) suggests that prohibiting anonymous sperm donation would result in a decline in the number of donors,…

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Study: NFL should break ties between doctors, teams

ESPN, November 17, 2016
Quoting report by Petrie-Flom affiliates Christopher R. Deubert, I. Glenn Cohen, and Holly Fernandez Lynch

From the article: Medical personnel caring for NFL players should no longer report to team management or coaches, according to a Harvard Law School report published Thursday. The recommendation comes in a 493-page report following…

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NFL doctors should not report to teams, Harvard study recommends

Washington Post, November 17, 2016
Rick Maese, quoting new report by Petrie-Flom affiliates Christopher R. Deubert, I. Glenn Cohen, and Holly Fernandez Lynch

From the article: A new report from Harvard Law School proposes drastic changes in the way health care is administered in the NFL, urging the nation’s most popular sports league to upend its system of medicine and untangle the loyalties of the doctors and trainers…

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When NFL Calls the Doctor

Boston Globe, November 17, 2016
I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (Executive Director), and Christopher R. Deubert (Senior Law & Ethics Associate)

The Boston Globe limits non-subscribers to five free articles per month. Harvard affiliates may view the full text via Hollis+. From the article: FROM MAJOR media outlets to federal research funding to conversations…

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