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Extending the US Food and Drug Administration’s Postmarket Authorities image

Extending the US Food and Drug Administration’s Postmarket Authorities

Holly Fernandez Lynch, Rachel E. Sachs, and Sejin Lee
JAMA Health Forum

Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug’s benefit not only when it first enters the…

Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness image

Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness

Holly Fernandez Lynch, et al.
JAMA

Independent review and oversight have long been recognized as requirements for ethical research involving human participants, leading institutional review boards (IRBs) to become deeply entrenched in the research enterprise. Against…

Diversity in IRB Membership image

Diversity in IRB Membership: Views of IRB Chairpersons at U.S. Universities and Academic Medical Centers

Sydney Churchill, Emily A. Largent, Elizabeth Taggert, and Holly Fernandez Lynch (Former Executive Director)
American Journal of Bioethics

Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S.…

‘Is an Abortion Medically Necessary?’ Is Not a Question for Ethicists to Answer image

‘Is an Abortion Medically Necessary?’ Is Not a Question for Ethicists to Answer

Holly Fernandez Lynch (Former Executive Director) et al.
Statnews

Abortion raises many ethical questions. Determining whether an abortion is needed to save a pregnant person’s life or health is not among them. That’s a factual…

Aspiring to Reasonableness in Accelerated Approval: Anticipating and Avoiding the Next Aducanumab

Emily A. Largent (Former Student Fellow), Andrew Peterson, Jason Karlawish & Holly Fernandez Lynch (Former Executive Director)
Drugs & Aging

The US Food and Drug Administration’s decisions about drug approval—though guided by science, as well as relevant statutes, regulations, and guidance documents—reflect normative judgments…

Introduction: Health Law and Anti-Racism: Reckoning and Response image

Introduction: Health Law and Anti-Racism: Reckoning and Response

Michele Goodwin and Holly Fernandez Lynch (Former Executive Director)
Journal of Law, Medicine and Ethics

Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with…

Institutional Review Board Use of Outside Experts: What Do We Know? image

Institutional Review Board Use of Outside Experts: What Do We Know?

Kimberley Serpico, Vasiliki Rahimzadeh, Emily E. Anderson, Luke Gelinas, and Holly Fernandez Lynch (Former Executive Director)
Ethics and Human Research

Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There…

Call for Submissions: 2nd Annual Health Law and Anti-Racism Graduate Student Writing Competition, American Society of Law, Medicine, and Ethics (ASLME)

Deadline: June 01, 2022
Holly Fernandez Lynch

The American Society of Law, Medicine, and Ethics (ASLME) is pleased to announce its 2nd Annual Health Law and Anti-Racism Graduate Student Writing Competition with the goal of encouraging students…

Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill image

Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill

Holly Fernandez Lynch (Former Executive Director) and Keith Hamilton
STAT News

It’s easy to feel like we’re in a pandemic “Groundhog Day” loop as the U.S. faces yet another Covid-19 surge with overwhelmed hospitals,…

A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken image

A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken

Holly Fernandez Lynch (Former Executive Director) and Christopher T. Robertson (Former Academic Fellow)
The Washington Post

Whether it’s covid or cancer, when you’re a patient facing a life-threatening disease without good treatment options, your risk tolerance is bound to be pretty high.…

Curbside Consults in Clinical Medicine: Empirical and Liability Challenges image

Curbside Consults in Clinical Medicine: Empirical and Liability Challenges

Rachel L. Zacharias, Eric A. Feldman, Steven Joffe, and Holly Fernandez Lynch (Former Executive Director)
Journal of Law, Medicine & Ethics

Abstract In most U.S. jurisdictions, clinicians providing informal “curbside” consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship. A recent Minnesota…

Challenges in confirming drug effectiveness after early approval image

Challenges in confirming drug effectiveness after early approval

Holly Fernandez Lynch (Former Executive Director) and Christopher T. Robertson (Former Academic Fellow)
Science

It’s easy to understand the urge to make potentially beneficial drugs quickly available to patients in need. It’s also easy to go too far. Through its 2021…

“We measure what we can measure”: Struggles in defining and evaluating institutional review board quality image

“We measure what we can measure”: Struggles in defining and evaluating institutional review board quality

Holly Fernandez Lynch (Former Faculty Director), Whitney Eriksen, and Justin T. Clapp
Social Science and Medicine

There has been a persistent lack of clarity regarding how to define and measure the quality of Institutional Review Boards (IRBs). To address this challenge, we interviewed 43 individuals designated as…

Researchers, Bioethicists Discuss the Future of Psychedelic Therapy in Petrie-Flom Webinar image

Researchers, Bioethicists Discuss the Future of Psychedelic Therapy in Petrie-Flom Webinar

Brandon L. Kingdollar and Waseem S. Nabulsi, featuring Carmel Shachar (Executive Director) and Holly Fernandez Lynch (Former Executive Director)
The Harvard Crimson

Experts in the fields of psychedelics, health care, and bioethics gathered virtually to discuss the ethical implications of psychedelic-assisted therapy in a webinar held by Harvard Law School’s…

FDA Drug Approval and the Ethics of Desperation image

FDA Drug Approval and the Ethics of Desperation

Emily A. Largent, Andrew Peterson, and Holly Fernandez Lynch (Former Executive Director)
JAMA Internal Medicine

In justifying the accelerated approval of aducanumab (Aduhelm; Biogen), US Food and Drug Administration (FDA) officials emphasized that many patients with Alzheimer disease and their families “made it clear…

Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use image

Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use

Andrea Seykora, Carl Coleman, Stephen J. Rosenfeld, Barbara E. Bierer, and Holly Fernandez Lynch (Former Executive Director)
Ethics & Human Research

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect…

Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases? image

Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?

Holly Fernandez Lynch (Former Executive Director) et al.
American Journal of Bioethics

After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s…

A Snapshot of U.S. IRB Review of COVID-19 Research in the Early Pandemic image

A Snapshot of U.S. IRB Review of COVID-19 Research in the Early Pandemic

Holly A. Taylor, Kimberley Serpico Holly Fernandez Lynch (Former Executive Director), John Baumann and Emily E. Anderson
Journal of Clinical and Translational Science

Background/Objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating…

Is it OK to offer a shot at lottery money to get people vaccinated? As bioethicists, we say yes. Opinion image

Is it OK to offer a shot at lottery money to get people vaccinated? As bioethicists, we say yes. Opinion

Holly Fernandez Lynch (Former Executive Director) and Emily Largent (Former Student Fellow)
The Inquirer

As many Americans shed their masks, COVID-19 vaccination rates are waning, and those who remain unvaccinated will likely need additional encouragement to move the needle. Amidst debate about the desirability…

Plumbing the Depths of Ethical Payment for Research Participation image

Plumbing the Depths of Ethical Payment for Research Participation

Holly Fernandez Lynch, Thomas C. Darton, Jae Levy, et al.
The American Journal of Bioethics

Full author list: Holly Fernandez Lynch (Former Executive Director), Thomas C. Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth O. Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley, and…

Ethical Inclusion of Health Care Workers in Covid‐19 Research image

Ethical Inclusion of Health Care Workers in Covid‐19 Research

Holly Fernandez Lynch (Former Executive Director), Dawn Lundin, and Emma A. Meagher
Ethics & Human Research

Employees are often considered a vulnerable research population due to concerns about consent and confidentiality, but there is insufficient guidance regarding their ethical inclusion in research. In the context of…

Promoting Ethical Payment in Human Infection Challenge Studies image

Promoting Ethical Payment in Human Infection Challenge Studies

Holly Fernandez Lynch, T. Darton, J. Levy, F. McCormick, U. Ogbogu, R. Payne, A. Roth, A.J. Shah, T. Smiley, and Emily Largent
The American Journal of Bioethics

Full Author List: Holly Fernandez Lynch (Former Executive Director), Thomas Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth Payne, Alvin Roth, Akilah Jefferson Shah, Thomas Smiley, and Emily A. Largent …

An ethics framework for consolidating and prioritizing COVID-19 clinical trials image

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

Michelle Meyer, L. Gelinas, B. Bierer, S. C. Hull, S. Joffe, et al.
Clinical Trials

Full Author List: Michelle Meyer (Former Academic Fellow), Luke Gelinas, Barbara Bierer, Sara Chandros Hull, Steven Joffe, David Magnus, Seema Mohapatra, Richard Sharp, Kayte Spector-Bagdady, Jeremy Sugarman, Benjamin Wilfond, and…

The limits of acceptable political influence over the FDA image

The limits of acceptable political influence over the FDA

Holly Fernandez Lynch (Former Executive Director), Steven Joffe & Matthew S. McCoy
Nature Medicine

Extensive involvement of the White House in decision-making about the COVID-19 pandemic by the US Food and Drug Administration (FDA) has renewed attention to questions about the agency’s…

The role of community engagement in addressing bystander risks in research image

The role of community engagement in addressing bystander risks in research: The case of a Zika virus controlled human infection study

Seema K. Shah, Franklin Miller, and Holly Fernandez Lynch (Former Executive Director)
Bioethics

There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder…

Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research image

Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research

Holly Fernandez Lynch (Former Executive Director), Alison Bateman-House, and Steven Joffe
Annals of Internal Medicine

The U.S. Food and Drug Administration (FDA) recently granted an emergency use authorization (EUA) for convalescent plasma to treat patients with coronavirus disease 2019 (COVID-19) (1). Recognizing substantial evidentiary gaps, several…

Compensating for research risk image

Compensating for research risk: permissible but not obligatory

Holly Lynch Fernandez (Former Executive Director) and Emily A. Largent (Former Student Fellow)
Journal of Medical Ethics

When payment is offered for controlled human infection model (CHIM) research, ethical concerns may be heightened due to unfamiliarity with this study design as well as perceptions—and misperceptions…

A Bioethicist on Trump’s COVID-19 Treatment Plan image

A Bioethicist on Trump’s COVID-19 Treatment Plan

James D. Walsh, quoting Holly Fernandez Lynch (Former Executive Director)
Intelligencer

President Trump marked his return to the White House Monday night with a video imploring Americans not to let COVID-19 dominate their lives because the United States has “the…

No Easy Answers in Allocating Unapproved COVID-19 Drugs Outside Clinical Trials image

No Easy Answers in Allocating Unapproved COVID-19 Drugs Outside Clinical Trials

Jamie Webb, Lesha Shah, Holly Fernandez Lynch (Former Executive Director)
American Journal of Bioethics

In our Target Article, "Ethically Allocating COVID-19 Drugs via Pre-Approved Access and Emergency Use Authorization," we tackle unique allocation challenges at the intersection of research and clinical care, offering an…

Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization image

Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization

Jamie Webb, Lesha D. Shah, Holly Fernandez Lynch (Former Executive Director)
American Journal of Bioethics

Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research. In conditions of scarcity,…

Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2 image

Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2: Report and Recommendations

Holly Fernandez Lynch (Former Executive Director) et al.
SSRN

Complete author list: Holly Fernandez Lynch, Thomas Darton, Emily Largent, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley To prepare for potential…

 Ethics of Controlled Human Infection to Study COVID-19 image

Ethics of Controlled Human Infection to Study COVID-19

Seema K. Shah, Franklin G. Miller, Thomas C. Darton, Devan Duenas, Claudia Emerson, Holly Fernandez Lynch (Former Executive Director), and others
Science

From the abstract: Development of an effective vaccine is the clearest path to controlling the coronavirus disease 2019 (COVID-19) pandemic. To accelerate vaccine development, some researchers are pursuing, and thousands of…

Lawmakers seek to loosen US FDA drug approval requirements to allow early access image

Lawmakers seek to loosen US FDA drug approval requirements to allow early access

Donna Young, quoting Holly Fernandez Lynch (Former Executive Director)
S&P Global Market Intelligence

From the article: Making products available under a conditional approval may result in some companies having difficulty enrolling patients in well-controlled phase 3 trials, Holly Fernandez Lynch, assistant professor of medical…

NFL or ‘Not For Long’? Transitioning Out of the NFL image

NFL or ‘Not For Long’? Transitioning Out of the NFL

Sarah McGraw, Chris Deubert, Holly Fernandez Lynch (former Executive Director), Alixandra Nozzolillo, I. Glenn Cohen (Faculty Director)
Journal of Sport Behavior

From the abstract: Like many other elite athletes, National Football League (“NFL”) players typically have a short playing career, often leaving the league due to injury or lack…

Holly Fernandez Lynch Named Inaugural Recipient of Baruch A. Brody Award & Lecture in Bioethics image

Holly Fernandez Lynch Named Inaugural Recipient of Baruch A. Brody Award & Lecture in Bioethics

Penn Medical Ethics & Health Policy, featuring Holly Fernandez Lynch (Former Executive Director)
Penn Medical Ethics & Health Policy

From the announcement: Congratulations to Holly Fernandez Lynch, JD, MBE, who has won the 2019-2020 Baruch A. Brody Award & Lecture in Bioethics from the Baylor College of Medicine Center…

Opportunities to Influence Health and Science Policy Under U.S. Lobbying Law image

Opportunities to Influence Health and Science Policy Under U.S. Lobbying Law

Holly Fernandez Lynch (Executive Director), Alison Bateman-House, Suzanne Rivera
AAMC

From the article: Medical school faculty and their colleagues in schools of nursing, public health, social work, and elsewhere often research issues of critical importance to health and science policy.…

Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight image

Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight

by Holly Fernandez Lynch (former Executive Director), Steven Joffe
JAMA

From the article: Faced with the prospect of death or debilitating disease, patients and their families may be willing to try almost any treatment. A number of systems exist to…

Health Law Workshop: Holly Fernandez Lynch: Thinking about Bystanders to Research

September 16, 2019

Presentation Topic: "Thinking about Bystanders to Research" This paper is not available for download. About the Presenter Holly Fernandez Lynch is John Russell Dickson, MD Presidential Assistant Professor of Medical…

Book Launch: Transparency in Health and Health Care in the United States

September 16, 2019
Watch Videos

Description In June 2019, Cambridge University Press published Transparency in Health and Health Care in the United States. This volume, edited by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and…

Filthy Lucre or Fitting Offer? Understanding Worries About Payments to Research Participants

By Emily Largent (Student Fellow Alumna), Ezekiel J. Emanuel, and Holly Fernandez Lynch (Former Executive Director)
The American Journal of Bioethics

From the article: Offers of payment made in exchange for research participation are common. And yet they are often regarded as, at best, a “necessary evil.” This is…

Amid rising concern, pay-to-play clinical trials are drawing federal scrutiny

By Rebecca Robbins, quoting Holly Fernandez Lynch (Former Executive Director)
STAT

From the article: “The examples that we have, that get this kind of media attention, it’s obvious that people shouldn’t be asked to pay to…

Designing development programs for non-traditional antibacterial agents

John H. Rex, Holly Fernandez Lynch (Former Executive Director), I. Glenn Cohen (Faculty Director), Jonathan J. Darrow (Student Fellow Alumnus) & Kevin
Nature Communications

From the abstract: In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule…

When is it ethical to pay clinical trial participants different amounts?

Govind Persad, Holly Fernandez Lynch (Former Executive Director), and Emily A. Largent
Journal of Medical Ethics Blog

From the post: "This collaboration grew out of our shared experience as scholars studying research ethics and (for some of us) as institutional review board members. We witnessed debates over…

Differential payment to research participants in the same study: an ethical analysis

Govind Persad, Holly Fernandez Lynch (Former Executive Director), Emily Largent (Student Fellow Alumna)
BMJ

From the abstract: Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential…

Of Parachutes and Participant Protection:: Moving Beyond Quality to Advance Effective Research Ethics Oversight

Holly Fernandez Lynch (Former Executive Director), Stuart Nicholls, Michelle N. Meyer, and Holly A. Taylor
Journal of Empirical Research on Human Research Ethics

From the abstract: There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants,…

Transparency in Health and Health Care in the United States

Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and Barbara J. Evans (eds.)
Cambridge University Press

Read the full introduction online now! This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health…

Consortium Seeks to Evaluate, Enhance HRPP Effectiveness

AAHRPP featuring work by Holly Fernandez Lynch (Former Executive Director) and colleagues
AAHRPP Advance

From the article: What are the outcomes of an effective HRPP? Can they be empirically evaluated—and, if so, can that data help drive best practices? Those are just…

Advance notice of mysterious rule puts drug-pricing people on edge

Sarah Karlin-Smith, featuring Holly Fernandez Lynch (Former Executive Director)
Politico Prescription Pulse

From the article: Holly Fernandez Lynch, a medical ethicist at the University of Pennsylvania, wonders whether FDA will audit third-party invoices to make sure manufacturers aren’t profiting from…

Protecting Clinical Trial Participants and Study Integrity in the Age of Social Media

Holly Fernandez Lynch, Emily A. Largent, Steven Joffe, and Angela M. DeMichele
Cancer

From the article: Social media communication among clinical trial participants has the potential to pose risks to their safety and to trial integrity. The Social Media ADEPT framework may help…

Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel

Luke Gelinas (Senior Fellow), Joel S. Weissman, Holly Fernandez Lynch, Avni Gupta, Ronen Rozenblum, Emily A. Largent, I. Glenn Cohen (Faculty Director
Annals of Internal Medicine

From the abstract: A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of…

Listening to NFL Players On Mental Health: New report highlights key findings from interviews with players and family members

Sarah A. McGraw, Christopher R. Deubert, Holly Fernandez Lynch (Former Executive Director), Alixandra Nozzolillo, Lauren Taylor, I. Glenn Cohen (Facul
Journal of Clinical Sport Psychology

When it comes to their careers, current and former NFL players express satisfaction – and frustrations – about their lives both on and off the field. “Life on an…

Viewpoint: Promoting Patient Interests in Implementing the Federal Right to Try Act

Holly Fernandez Lynch (former Executive Director and Academic Fellow Alumna), Patricia J. Zettler, Ameet Sarpatwari
JAMA

Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article: On May 30, 2018, President Trump…

When clinical trials compete: prioritising study recruitment

Luke Gelinas, Holly Fernandez Lynch, Barbara E Bierer, I. Glenn Cohen (Faculty Director)
BMJ

From the 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…

IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons

Joel S. Weissman, Eric G. Campbell, I. Glenn Cohen, Holly Fernandez Lynch, Emily A. Largent, Avni Gupta, Ronen Rozenblum, Melissa Abraham, Karen Spike
Journal of Empirical Research on Human Research Ethics

From the abstract: Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to…

Do NFL Safety Concerns Mean Regulators Should Get in the Game?

Fatima Hussein, featuring report by the Law and Ethics Initiative of the Football Players Health Study at Harvard University
Bloomberg Environment

From the article: Concussions involving NFL players have been an increasing worry. Now a debate has resurfaced about whether federal safety regulators should be able to fine teams found guilty…

Addressing Financial Barriers to Enrollment in Clinical Trials

Emily A. Largent and Holly Fernandez Lynch (Former Executive Director)
JAMA Oncology

From the article: Shortfalls in clinical trial recruitment and retention constitute a major obstacle to scientific advancement. One means of increasing patient participation rates is to reduce associated financial burdens.…

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

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

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. The article,…

Bystander risk, social value, and ethics of human research

S. K. Shah, J. Kimmelman, A. D. Lyerly, H. F. Lynch (Former Executive Director), F. G. Miller, R. Palacios, C. A. Pardo, C. Zorrilla
Science

From the article: Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How…

On Scarcity and the Value of Clinical Trials

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

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,…

Mutual Obligations in Research and Withholding Payment From Deceptive Participants

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

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…

Big Data, Health Law, and Bioethics

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

Now available - order it online! From the book: When data from all aspects of our lives can be relevant to our health - from our habits at the grocery…

Payments to Study Participants: Experts Discuss Potential Framework

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

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 School today…

A Framework for Ethical Payment to Research Participants

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

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 School today…

Hundreds sign on to letter opposing ‘right to try’ drug bill

Rachel Roubein, reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)
The Hill

From the Article: Several hundred "right to try" critics sent a letter to House Energy and Commerce Committee leaders expressing their “strong opposition” to the bill President Trump…

Physicians, ethicists urge Congress not to pass ‘right-to-try’ legislation

Ike Swetlitz, reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)
Stat

From the article: Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks harming patients’…

PFC Spotlight: Academic Fellow Alumnus Matthew J. B. Lawrence

Petrie-Flom Center

Matthew J. B. Lawrence was an Academic Fellow from 2010-2013, during which time his research focused on health care reform and health insurance coverage decision-making. Today, he is Assistant Professor…

PFC Spotlight: Student Fellow Alumna Emily Largent

Petrie-Flom Center

Emily Largent, JD, PhD, RN, was Peter Barton Hutt Student Fellow during the 2014-2015 academic year, while a second-year law student at Harvard Law School. Then-Academic Fellow Matthew Lawrence and…

Book Launch: Specimen Science: Ethics and Policy Implications

November 9, 2017

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne…

Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial

Marisa Taylor, quoting Holly Fernandez Lynch (Former Executive Director, Academic Fellow Alumna)
Kaiser Health News

From the article: As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks. The lead U.S. researcher,…

Contraceptive Coverage and the Balance Between Conscience and Access

Ronit Y. Stahl and Holly Fernandez Lynch (Former Executive Director, Academic Fellow Alumna)
JAMA

From the article: When the Obama administration included contraception in the essential benefits package to be covered by employer-sponsored health insurance plans under the Affordable Care Act, it sought to…

Why Only The NFL Doesn’t Guarantee Contracts

Dom Cosentino, quoting Christopher Deubert (former Senior Law & Ethics Associate) and citing the PFC's FPHS Comparative League Analysis Report
Deadspin

From the article: [...] How does this all work? Chris Deubert, one of the Harvard study’s authors, told me that “the contract on its face is guaranteed.”…

The FDA May Move to Shorten That Grim List of Side Effects in Every Drug Ad: Advertising Execs Can’t Wait

Megan Thielking, quoting Holly Fernandez Lynch (Executive Director)
STAT News

From the article: Warning: Watching TV drug ads may put you to sleep. That’s no surprise to many of us who’ve heard about the countless ways…

Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives

Panel featuring Holly Fernandez Lynch (Executive Director), Amrit Ray, Matthew Rotelli, Steve Usdin, and Robert Walker
The New York Academy of Sciences

On June 21, 2017, Executive Director Holly Fernandez Lynch participated in a panel discussion on "Weighing the Risks of Randomized Controlled Trials and Alternatives," which was part of the conference "The Need…

Specimen Science: Ethics and Policy Implications

Edited by Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera
MIT Press

Order through MIT Press and receive 30% off using discount code MSPECIMEN30: Order now! This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical…

The Sean Pendergast Show with Dr. Glenn Cohen, Harvard Law Professor

Interviewing I. Glenn Cohen (Faculty Director)
The TJ Show, AMP Radio 103.3 FM

Harvard Law Professor [I. Glenn Cohen (Faculty Director)] joins Sean to discuss a study he and a Harvard group did on player safety in the NFL, how the game can…

Faculty Books in Brief—Spring 2017

Featuring book by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (Executive Director), & Christopher T. Robertson (Academic Fellow Alumnus)
Harvard Law Bulletin

From the article: Cohen, faculty director of the Petrie-Flom Center; Lynch, the center’s executive director; and Robertson, a professor at University of Arizona’s College of Law,…

Harvard Study Looks At Ways NFL Can Bolster Player Health

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

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…

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 – 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…

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

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

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…

ORDER NOW & GET 20% OFF! Law, Religion, and Health in the United States

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

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…

Revised ‘Common Rule’ Shapes Protections For Research Participants

By Barbara E. Bierer, Mark Barnes, and Holly Fernandez Lynch (Executive Director)
Health Affairs

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…

The new Oprah movie about Henrietta Lacks reopens a big scientific debate

Julia Belluz, quoting Holly Fernandez Lynch (Executive Director)
Vox

From the article: [...] Holly Fernandez Lynch, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, emphasized that the benefits to society in…

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

Luke Gelinas (Research Ethics Fellow), Robin Pierce, Sabune Winkler, Glenn Cohen (Faculty Dir), Holly Fernandez Lynch (Executive Dir) & Barbara Bierer
American Journal of Bioethics

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…

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

Holly Fernandez Lynch (Executive Director) and Steven Joffe
New York Times

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…

Institutions as an Ethical Locus of Research Prioritisation

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

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.…

In Pausing Human Research On Zika, Medical Ethicists Acknowledge A Dark Past

Paul C. McLean, quoting Holly Fernandez Lynch (Executive Director)
WBUR

From the article: That’s why ethics review of human subject research matters. This NIH panel is an especially good model in both its composition — expertise in law,…

NFL doctors are on the wrong team

Editorial Board, citing Football Players Health Study
Washington Post

From the article: So why did only 47 of 100 players who were surveyed by the Associated Press say they thought the league’s clubs, coaches and team doctors have the…

NFL’s medical structure puts profits before players’ health. That must change.

Sally Jenkins, citing Football Players Health Study
Washington Post

From the article: Just last month, a Harvard study concluded that “the intersection of club doctors’ dual obligations creates significant legal and ethical quandaries that can threaten player…

UPCOMING! Annual Health Law Conference: Between Complacency & Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases

Holly Fernandez Lynch (Executive Director)
Northeastern University School of Law

From the event: Emerging infectious diseases (EIDs) such as Ebola and the Zika virus pose potentially grave threats to human health. They can also incite overreations that lead to the…

Ethical Considerations for Zika Virus Human Challenge Trials: Report & Recommendations

Seema K. Shah, Jonathan Kimmelman, Anne Drapkin Lyerly, Holly Fernandez Lynch (Executive Director), et al.
National Institute of Allergy and Infectious Diseases (NIAID) at NIH and the Walter Reed Army Institute of Research (WRAIR)

From the report: Zika virus is an emerging infectious disease that was first identified in 1947, and that has more recently become a major public health threat around the world. Zika…

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

Luke Gelinas, Robin Pierce, Sabune Winkler, I. Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer
The American Journal of Bioethics

Part 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 School to…

Returning Results to Research Participants: A Health Policy and Bioethics Consortium

February 10, 2017
Watch Videos

Clinical investigators, public health advocates, and IRBs have been struggling to develop appropriate policies on how to return results to patients involved in research studies. These results may come in…

Common Rule Revisions: Impact of Public Comment, and What’s Next?

By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer
The Hastings Center Blog

From the blog post: On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay &ldquo…

A New Day For Oversight Of Human Subjects Research

Holly Fernandez Lynch (Executive Director)
HealthAffairs

Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday,…

What Experts in Law and Medicine Have to Say About the Cost of Drugs

Andy Oram, on PFC's 5th Annual Health Law Year in P/Review Conference
The Health Care Blog

From the article; Pharmaceutical drug costs impinge heavily on consumers’ consciousness, often on a monthly basis, and have become such a stress on the public that they came up…