Regulating Research with Biospecimens under the Revised Common Rule

The Hastings Center Report, May/June 2017
Holly Fernandez Lynch (Executive Director) and Michelle N. Meyer (Academic Fellow Alumna)

From the paper: Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent…

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FDA User Fee Reauthorization Clears Hurdle In Senate With Bipartisan Support

Health Affairs Blog, May 15, 2017
Rachel Sachs (Academic Fellow Alumna)

From the article: On Thursday, May 11, the Senate Committee on Health, Education, Labor and Pensions marked up the proposed Food and Drug Administration (FDA) user fee reauthorization bill and voted 21-2 to advance it to the full Senate. The bill would reauthorize…

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Medical Tourism, Medical Migration, and Global Justice: Implications for Biosecurity in a Globalized

Medical Law Review, April 11, 2017
I. Glenn Cohen (Faculty Director)

From the paper: We live in the age of globalization. In medicine, that globalization has brought many benefits such as the diffusion of technology and the spread of health care training, but it has also brought threats to biosecurity. This article examines how medical…

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Babies From Skin Cells? Prospect Is Unsettling to Some Experts

New York Times, May 16, 2017
Tamar Lewin, citing I. Glenn Cohen (Faculty Director)

From the article: Three prominent academics in medicine and law sounded an alarm about the possible consequences in a paper published this year. “I.V.G. may raise the specter of ‘embryo farming’ on a scale currently…

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Harvard Study Looks At Ways NFL Can Bolster Player Health

Law360, May 16, 2017
Fola Akinnibi, quoting I. Glenn Cohen (Faculty Director) and citing Petrie-Flom's report

Law360, New York (May 16, 2017, 6:03 PM EDT) -- Harvard Law School published a report Monday exploring the National Football League’s health policies and practices, noting that the professional football league has done a good job with player safety and suggesting areas of improvement using…

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New Report from the Law & Ethics Initiative of the Football Players Health Study: Harvard Report Compares NFL’s Health Policies and Practices to Those of Other Professional Sports Leagues

Petrie-Flom Center and Football Players Health Study at Harvard University, May 15, 2017

May 15, 2017 – While the NFL’s player health policies and practices are robust in some areas, there are opportunities for improvement in others, according to the findings of a newly released report by researchers at The…

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Harvard study: NFL should offer treatment for performance-enhancing drug users

Boston Globe, May 15, 2017
Travis Anderson, citing Petrie-Flom's report

From the Boston Globe:  The National Football League should consider providing treatment to any player caught using performance-enhancing drugs, according to a new Harvard University study. The recommendation was one…

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Special Issue: Comparing Health Related Policies and Practices in Sports: The NFL and Other Professional Leagues

Journal of Sports Law and Entertainment, May 2017

The Journal of Sports and Entertainment Law at Harvard Law School published a Special Edition in May 2017, which prints in full the new report from the Petrie-Flom Center's Law & Ethics Initiative, part…

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Promoting demand-side innovation: prizes for payers

Journal of Law and the Biosciences, May 5, 2017
Rachel E. Sachs (Academic Fellow Alumna)

From the paper: Promoting Healthcare Innovation on the Demand Side,1 the recent article by Professors Rebecca Eisenberg and Nicholson Price, is a thoughtful, detailed look at an issue that has gone almost entirely unexplored in the innovation policy…

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Innovative Contracting for Pharmaceuticals and Medicaid’s Best-Price Rule

Journal of Health Politics, Policy and Law, Forthcoming
Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius N. Lakdawalla

From the abstract: In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have…

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Law, Religion, and Health in the United States

Cambridge University Press, July 2017
Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Elizabeth Sepper

About the Book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion,…

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Revised ‘Common Rule’ Shapes Protections For Research Participants

Health Affairs, May 2017, Vol. 36, No. 5
By Barbara E. Bierer, Mark Barnes and Holly Fernandez Lynch (Executive Director)

From the article: Research with human participants funded by most federal agencies is governed by a set of rules and procedures designed to protect study participants while enabling the advancement of important biomedical…

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Second Chance Kids

Frontline, PBS, May 2, 2017
Featuring Robert Kinscherff (Senior Fellow in Law and Applied Neuroscience)

On May 2, 2017, PBS's Frontline aired "Second Chance Kids," an exploration of the fight over the fate of juveniles in prison for murder, following a landmark Supreme Court ruling. Robert…

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Value-Based Pricing For Pharmaceuticals In The Trump Administration

Health Affairs Blog, April 27, 2017
Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius Lakdawalla

From the article: Everyone seems to agree: Drug prices are too damn high. Scandalous prices for new drugs and enormous price hikes on old drugs have focused public ire on the pharmaceutical industry. A bipartisan consensus has emerged that something must be done to tackle…

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Prize fund for new antibiotics could mean true innovation

STAT News, April 25, 2017
Rachel E. Sachs (Academic Fellow Alumna)

A few weeks ago, a group of Democrats in both houses of Congress introduced the Improving Access to Affordable Prescription Drugs Act, a 129-page bill designed to lower drug prices while increasing innovation and cracking down on pharmaceutical company abuses (my thoughts on the bill are here). …

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Nonexceptionalism, Research Risks, and Social Media: Response to Open Peer Commentaries on “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations”

American Journal of Bioethics, 17(5):W1-W3, 2017 (Published online April 21, 2017)
Luke Gelinas (Research Ethics Fellow), Robin Pierce, Sabune Winkler, Glenn Cohen (Faculty Dir), Holly Fernandez Lynch (Executive Dir) & Barbara Bierer

We are grateful for the thoughtful commentaries on our target article “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations” (Gelinas et al. 2017), commentaries that in many cases further clarify and expand upon our recommendations. For the most…

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Science Needs Your Cells: New York Times Op-Ed by Executive Director Holly Fernandez Lynch

New York Times, April 21, 2017
Holly Fernandez Lynch (Executive Director) and Steven Joffe

Biospecimens are essential to medical progress, but just medical waste to patients. Let's promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine injustice: the racism that characterized the…

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Institutions as an Ethical Locus of Research Prioritisation

Journal of Medical Ethics, April 11, 2017 (Online)
Luke Gelinas (Fellow in Clinical Research Ethics), Holly Fernandez Lynch (Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director)

Introduction Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants.…

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Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

Health Affairs Blog, April 7, 2017
Rachel E. Sachs (Academic Fellow Alumna)

From the post: On Wednesday morning, the United States Senate Committee on Health, Energy, Labor, and Pensions conducted the confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee to be the next Commissioner of the Food & Drug Administration…

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Prohibiting sperm donor anonymity in the US and possible effects on recruitment and compensation

BioNews, April 3, 2017
Andrew Hellman and I. Glenn Cohen (Faculty Director)

From the article: Many children conceived using donor sperm or eggs want to know their biological parents. In the US, some clinics make the identity of the sperm donor available to a donor-conceived child at age 18. Most intending parents,…

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