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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…

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…

“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…

Effect of Targeted Behavioral Science Messages on COVID-19 Vaccination Registration Among Employees of a Large Health System image

Effect of Targeted Behavioral Science Messages on COVID-19 Vaccination Registration Among Employees of a Large Health System: A Randomized Trial

Henri C. Santos, Amir Goren, Christopher F. Chabris, Michelle N. Meyer (Academic Fellow Alumnus)
JAMA

During the 3-day study period, an individual email nudge caused more than twice as many HCWs to register for a COVID-19 vaccination compared with HCWs in the control condition, with…

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 …

The Lost Decade: Clinical Trials Data Access After Seife v HHS image

The Lost Decade: Clinical Trials Data Access After Seife v HHS

Y. Tony Yang and Emily A. Largent (Former Student Fellow)
American Journal of Managed Care

Realization of the full value of data from clinical trials requires that the data be accessible to the broader research community, not just to the investigators who conducted and the…

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,…

Right to Try image

Right to Try: A ‘well-intentioned’ but ‘misguided’ law

Quoting Holly Fernandez Lynch (former Executive Director)
HemOnc Today

[...] “On its face, it seems as though Right to Try would streamline the process and make it easier for patients, but actually, the FDA approves almost all the requests…

The ‘Nudgability’ Model for More Ethical Clinical Research image

The ‘Nudgability’ Model for More Ethical Clinical Research

February 19, 2020

The concept of “nudging,” has been thoroughly discussed and debated in the context of health care, and particularly in the public health domain. The use of nudging in…

Economic vulnerability and payment for research participation image

Economic vulnerability and payment for research participation

Luke Gelinas (Former Senior Researcher), Sarah White, Barbara Bierer
Journal of the Society for Clinical Trials

Abstract: There has been significant analysis of the ethical and regulatory issues involved with paying research participants, but less attention has been focused specifically on paying economically vulnerable individuals and…

Continuing Education: Ethics of Research with Human Subjects, University of Pennsylvania Medical Ethics & Health Policy

Deadline: No deadline.
Holly Fernandez Lynch

From the course description: Program Overview The goal of this activity is to provide learners with basic knowledge and skills on how to make ethical evaluations on research protocols, including…

Biomarkers in Cancer Drug Approvals: New Opportunities and Challenges image

Biomarkers in Cancer Drug Approvals: New Opportunities and Challenges: A Health Policy and Bioethics Consortium

November 15, 2019

The FDA recently approved Keytruda and Vitrakvi, two cancer drugs targeting biomarkers without reference to the site of the disease. Defining cancer in terms of biomarkers alone may require us…

Health Law Workshop: Alex John London: Is There a Moral Dilemma at the Heart of Research with Humans?

October 7, 2019

Presentation Topic: “Is There a Moral Dilemma at the Heart of Research with Humans?” This paper is not available for download. About the Presenter Alex John London is…

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
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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…

Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations

Luke Gelinas (Former Senior Researcher), Brian Crawford, Ariella Kelman, Barbara E. Bierer
Contemporary Clinical Trials

From the abstract: Clinical trials for investigational new products to treat rare and ultra-rare diseases typically involve a limited number of research sites recruiting from a small pool of patients…

You No Longer Own Your Face

by Sidney Fussell, quoting Michelle Meyer (Academic Fellow Alumna)
The Atlantic

From the article: “It’s just not what [the IRB] was designed to do,” says Michelle Meyer, a bioethicist who chairs the IRB Leadership Committee at Geisinger,…

Our Aversion to A/B Testing on Humans Is Dangerous

by Scott Koenig, quoting Michelle Meyer (Academic Fellow Alumna), et al
Nautilus

From the article: Meyer and her team found that in nearly every situation they tested, the decision to conduct an A/B test was deemed least appropriate by a considerable…

Objecting to experiments that compare two unobjectionable policies or treatments

by Michelle N. Meyer (Academic Fellow Alumna), et al.
Proceedings of the National Academy of Sciences

From the abstract: Randomized experiments have enormous potential to improve human welfare in many domains, including healthcare, education, finance, and public policy. However, such “A/B tests” are…

A shocking share of the public thinks randomized trials are immoral

by Kelsey Piper, featuring work by Michelle Meyer (Academic Fellow Alumna), et al
Vox

From the article: Randomized trials are one of the best tools scientists have for learning about the effects of new policies. There’s just one problem — the public…

People Have A Hard-To-Explain Bias Against Experimental Testing of Policies And Interventions, Prefe

by Jesse Singal, featuring work by Michelle Meyer (Academic Fellow Alumna), et al
The British Psychological Society Research Digest

From the article: To anyone who believes in evidence-based decision making, medicine and policy, randomised tests make sense. But as a team led by Michelle N. Meyer at the Center…

Scientific Merit Predicates Ethical Review of Clinical Research

Barbara E. Bierer and Luke Gelinas
Ethics and Human Research

From the article: In the United States, federal regulations codified by the Department of Health and Human Services in the “Common Rule”1 address the conduct and oversight of…

You Don’t Want to Be a Human Guinea Pig? That’s Unfortunate

by Cass R. Sunstein, quoting Michelle Meyer (Academic Fellow Alumna), et al
Bloomberg

From the article: In other words, people who thought that A was fine, and also that B was fine, thought that it was unethical to test A and B to…

Why Do Experiments Make People Uneasy?

by Alex Tabarrok, featuring work by Michelle Meyer (Academic Fellow Alumna), et al
Marginal Revolution

From the article: People were outraged in 2014 when Facebook revealed that it had run “psychological experiments” on its users. Yet Facebook changes the way it operates on a…

People Really Hate the Idea of Experimenting on People

by Kevin Drum, featuring work from Michelle Meyer (Academic Fellow Alumna)
Mother Jones

From the article: There are various other parts to the paper designed to test whether people were upset about lack of informed consent, didn’t understand the reason for…

Recruitment and Trial-Finding Apps—Time for Rules of the Road

Stephanie R. Morain and Emily A. Largent (Student Fellow Alumna)
JNCI: Journal of the National Cancer Institute

From the abstract: The problem of insufficient recruitment to clinical oncology trials is well-known. Some stakeholders view mobile apps as a solution with the potential to make recruitment more efficient,…

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…

Preclinical Alzheimer Disease and the Dawn of the Pre-Caregiver

Emily A. Largent (Student Fellow Alumna) and Jason Karlawish
JAMA Neurology

From the paper: A couple recently came to our memory center for a research visit. The husband is a participant in a clinical trial evaluating the efficacy of a drug…

Patients as Research Partners: How to Value their Perceptions, Contribution and Labor?

Elise Smith, Jean-Christophe Bélisle-Pipon (Visiting Scholar), David Resnik
Citizen Science: Theory and Practice

From the abstract: Citizen Science refers to the consultation, participation, engagement or involvement of the general public in research. Rationales for this interaction include increased public access and involvement of…

Social Media and Pediatric Research Recruitment

Luke Gelinas (Former Senior Researcher) and Jennifer Kesselheim
In Ethics and Research with Children: A Case Based Approach, edited by Eric Kodish and Robert M. Nelson

From the chapter: "Social media use has increased exponentially across all demographics. With social media’s widespread popularity comes an increased potential for research sponsors and investigators to use…

Association Between Financial Incentives and Participant Deception About Study Eligibility

by Holly Fernandez Lynch (Former Executive Director) et al, and Emily Largent (Student Fellow Alumna)
JAMA

From the article: "Question: Is payment associated with participant deception about research eligibility and, if so, is higher payment associated with more deception? Findings: In this randomized survey experiment of…

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,…

The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area

Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
JAMA

From the article: Editing the genome of human gametes or embryos is a disruptive unactualized technology and continues to be the subject of a wide range of concerns. The chief…

Simulation and Deliberation to Prepare for Clinical Trials in Infectious Disease Emergencies: Digital Health @ Harvard Series

November 27, 2018
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Description Infectious disease emergencies are opportunities to test the efficacy of newly developed interventions (e.g. drugs, vaccines and treatment regimens), yet they raise many intertwined challenges of politics, logistics,…

On Repugnance, Distribution, and the Global Kidney Exchange: Comment

I. Glenn Cohen (Faculty Director)
Journal of Institutional and Theoretical Economics (JITE)

From the article: Krawiec opens the article by quoting Alvin Roth’s framing of repugnance as a “distaste for certain kinds of transactions [that] can be a real…

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…

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…

Ethical Investment in Global Public Health Security: A Health Policy and Bioethics Consortium

October 12, 2018

Description Health emergencies around the world in recent years have included SARS, MERS, Ebola, and influenza. These epidemics have caused substantial mortality, destabilized governments, and served as significant risks to…

Patient‐Engaged Research: Choosing the “Right” Patients to Avoid Pitfalls

Emily A. Largent, Holly Fernandez Lynch, Matthew S. McCoy
Hastings Center Report

From the article: To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in…

Early career researchers’ perspectives and roles in patient-oriented research

Geneviève Rouleau, Jean-Christophe Bélisle-Pipon (Visiting Researcher), et al.
Research Involvement and Engagement

Complete author list: Geneviève Rouleau, Jean-Christophe Bélisle-Pipon, Stanislav Birko, Philippe Karazivan, Nicolas Fernandez, Karine Bilodeau, Yi-Sheng Chao, Alexandra de Pokomandy, Véronique Foley, Bruno Gagnon,…

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…

A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests

Margot Sanger-Katz, featuring Michael Frakes (Academic Fellow Alumnus)
The New York Times

From the article: Mr. Gruber and Michael D. Frakes, a Duke economist and lawyer, looked at the health care system for active-duty members of the military. Under longstanding law, such…

Defensive Medicine: Evidence from Military Immunity

Michael D. Frakes (Former Academic Fellow) and Jonathan Gruber
National Bureau of Economic Research Working Paper Series

From the abstract: We estimate the extent of defensive medicine by physicians, embracing the no-liability counterfactual made possible by the structure of liability rules in the Military Heath System. Active-duty…

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…

Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight

June 29, 2018
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Description Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun…

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…

Criticism of ‘right to try’ law for experimental drugs after it passes in US

Anthony King, quoting Jonathan J. Darrow (Student Fellow Alumnus)
Chemistry World

From the article: The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law…

Parenting of the future: Many embryos, each with DNA profile

Malcolm Ritter, quoting I. Glenn Cohen (Faculty Director)
The Washington Post

From the article: Once the genetic profile is done, could it come back to haunt a child if, say, a life insurer or nursing home demanded to see it to…

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…

House passes right-to-try on second try

Sarah Karlin-Smith, quoting Christopher T. Robertson (Academic Fellow alumnus)
Politico

From the Article: The House of Representatives passed on party lines Wednesday evening a bill designed to let very sick patients request access to experimental medicines without government oversight. The…

National Institutes of Health IRB Internship Program Fall 2018, University of Bergen

Deadline: April 22, 2018
Reidar K. Lie

Renee Goodman

>Read full call

General Description: Members of Institutional Review Boards (IRBs), IRB administrators, research ethics committees, tribal governance bodies, and others who are currently employed in positions related to research participant protections are…

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…

Patient-Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight Issues

Emily A. Largent (Student Fellow Alumna), Joel S. Weissman, Avni Gupta, Melissa Abraham, Ronen Rozenblum, Holly Fernandez Lynch (Academic Fellow Alumn
The Hastings Center

Abstract: The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods project, the Patient Centered Outcomes Research…

Sixth Annual Health Law Year in P/Review

December 12, 2017
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Couldn't join us? Check out the conversation on Twitter: @PetrieFlom #healthlawpreview2018 and some of our speakers' slide presentations below! Description The Sixth Annual Health Law Year in P/Review…

Big Data, Health Law, and Bioethics

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

This edited volume stems from the Petrie-Flom Center’s 2016 annual conference, which brought together leading experts to identify the various ways in which law and ethics intersect with the…

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…

Research with Biospecimens: Balancing Individual Interests and Social Goods

October 21, 2017

This panel at the annual meeting of the American Society for Bioethics and Humanities examined issues addressed at Petrie-Flom's 2015 conference "Specimen Science: Ethics and Policy Implications," and the edited…

Who’s Actually Using ‘Right-To-Try’ Laws?: A Texas Oncologist Explains his Experience

Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow alumna)
RAPS

'The record with state-level right-to-try laws also suggests lackluster interest from industry. "It's telling that although 37 states have adopted these laws, when asked to provide examples of success stories,…

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…

Roster exemptions for players with concussions could draw vote from NFL owners

Tom Pelissero, citing Petrie-Flom's report
USA Today

From the article: A short-term injured reserve for players diagnosed with a concussion was among 76 recommendations included in a Harvard Law School report — based on research funded by the…

Why Successful Post-Season Runs Make People Lose Their Minds About Concussions

Lee Igel, citing Petrie-Flom's report
Forbes

From the article: Were either or both Crosby and Harden suffering the effects of a head injury, yet seeing game action? Appearances can be deceiving. In addition to medical personnel…

How does the NFL stack up with health care?

Michael McCann, citing Petrie-Flom's report
ESPN

Sports Illustrated legal analyst Michael McCann joins OTL to discuss the NFL's health care for its players. Watch video here!

Babies from skin cells? New fertility technology raises ethical questions

Lara O'Brien and Karin Marley, interviewing I. Glenn Cohen (Faculty Director)
The Current

From the article: Women producing sperm. Or, for that matter, men producing eggs. Those could, in theory, be some of the results of a new reproductive technology that's looming…

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…

2017 Petrie-Flom Center Annual Conference: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits

April 28, 2017
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Couldn't attend in person? You can still check out the conversation on Twitter: @PetrieFlom #transparencyinhealth! And check out many of the speakers' slide presentations below! Description Transparency is a…

Should We Study Human Embryos Beyond 14 Days?

Jenny Morber, quoting I. Glenn Cohen (Faculty Director)
NOVA Next

From the article: [...] Some critics view calls to re-evaluate the 14-day rule as a pernicious moving of the goalposts. How meaningful can they be, the line of reasoning goes, if…

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,…

The ethics of recruiting study participants on social media

Heather Zeiger, citing Luka Gelinas (Fellow in Clinical Research Ethics)
Medical Xpress

From the article: In the recent issue of the American Journal of Bioethics, the target article addresses the ethics of finding participants for clinical trials on social media sites. The…

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

February 10, 2017
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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…

Fifth Annual Health Law Year in P/Review

January 23, 2017
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Couldn't make it to the event? Check out some of the speakers' slides as well as the Health Affairs blog symposium! Description The Fifth Annual Health Law Year in…

When clinical trials compete: prioritising study recruitment

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

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…

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

Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Barbara E. Bierer
IRB: Ethics & Human Research

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…

Mid-Atlantic Health Law Works-in-Progress Retreat, Seton Hall Law School

Deadline: February 03, 2017

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is pleased to announce the inaugural Mid-Atlantic Health Law Works-in-Progress Retreat, which will be held on…

Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite: Healthcare Commentaries of 2016!

David Shaywitz
Forbes

In a year characterized by the extremes of rhetoric, healthcare entrepreneurs have been blessed with a number of thoughtful commentaries representing the opposite extreme. The selections cited below are measured,…

Paying Research Participants: Ethical and Regulatory Parameters

December 9, 2016
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Couldn't make it to the event? Check out some of the speakers' slide presentations below! Description This symposium brought together a variety of experts to discuss key ethical and…

Clinical Trial Data Sharing and Reproducibility: A Health Policy and Bioethics Consortium

December 7, 2016

In January, the International Committee of Medical Journal Editors proposed requiring that investigators make de-identified trial data available six months after publication as a precondition of consideration. Many data scientists…

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

Erin Phinney Johnson
American Journal of Bioethics

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…

EVENT POSTPONED: HLS Library Book Talk: Charles Fried on Medical Experimentation: Personal Integrity and Social Policy - New Edition

featuring I. Glenn Cohen (Faculty Director)
Harvard Law School

Wednesday, November 9, 2016 at noon Harvard Law School Room WCC 2036 Milstein East B/C 1585 Massachusetts Ave., Cambridge Lunch will be provided. More About Medical Experimentation: Personal Integrity and Social Policy: New…

Cluster Randomized Trials: Ethics, Regulations, Statistics & Design: Harvard Catalyst Regulatory Symposium

featuring Holly Fernandez Lynch (Executive Director)
Harvard Catalyst

Description Please join Harvard Catalyst for a free half-day symposium on the topic of Cluster Randomized Trials: Ethics, Regulations, Statistics & Design. We will provide a general overview of Cluster…

Faculty Director I. Glenn Cohen Joins National Academy of Sciences Committee: Cohen and HMS Center for Bioethics Director Robert Truog to Advise on Issues in Organ Donor Intervention Research

Petrie-Flom Center

I. Glenn Cohen, Faculty Director of Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and Robert Truog, Director of the Harvard Medical School Center…

Petrie-Flom seeks RA for project on human subjects research, Petrie-Flom Center, Harvard Law School

Deadline: October 31, 2016
Luke Gelinas, PhD

>Learn more about Petrie-Flom's collaboration with Harvard Catalyst!

The Petrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science Center)…

Social Media Use in Research Recruitment: A New Guidance Document from Petrie-Flom and Harvard Catalyst

Luke Gelinas (Petrie-Flom/Harvard Catalyst Fellow in Clinical Research Ethics)
Petrie-Flom Center / Harvard Catalyst

Cross-posted at the Petrie-Flom Center's blog Bill of Health. Imagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious…