News, Resources, and Events Tagged "Holly Fernandez Lynch"
Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness
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: Views of IRB Chairpersons at U.S. Universities and Academic Medical Centers
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
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
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
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?
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)
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
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
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
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
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
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
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
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
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?
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
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
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
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
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
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
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
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…
Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic
A foundational requirement of ethical research is that persons provide informed consent. Yet, there are exceptions that promote valuable research without unduly compromising participants' interests. Applicable regulations for federally funded…
The role of community engagement in addressing bystander risks in research: The case of a Zika virus controlled human infection study
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
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: permissible but not obligatory
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
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
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…
Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2: Report and Recommendations
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
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…
Overcoming obstacles to experiments in legal practice
The importance of evidence-based policy rooted in experimental methods is increasingly recognized, from the Oregon Medicaid experiment to the efforts to address global poverty that were awarded a 2019 Nobel Prize.…
Lawmakers seek to loosen US FDA drug approval requirements to allow early access
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
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
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
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
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
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
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
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
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
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…
Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies
From the article: Offering remuneration to participants in cancer trials can promote recruitment and retention. Concerns about the impact of remuneration on consent have received substantial attention, but legal risks…
When is it ethical to pay clinical trial participants different amounts?
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
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
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
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
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
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
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
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
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
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
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…
Informed Consent and the Role of the Treating Physician
From the paper: In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine…
IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons
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?
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
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
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,…
On Scarcity and the Value of Clinical Trials
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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…
Science Needs Your Cells: New York Times Op-Ed by Executive Director Holly Fernandez Lynch
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
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
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
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.
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
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
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…
Returning Results to Research Participants: A Health Policy and Bioethics Consortium
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?
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
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
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…