Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives

The New York Academy of Sciences, June 21, 2017
by Panel featuring Holly Fernandez Lynch (Executive Director), Amrit Ray, Matthew Rotelli, Steve Usdin, and Robert Walker

On June 21, 2017, Executive Director Holly Fernandez Lynch participated in a panel discussion on "We...

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Millions of dollars’ worth of research in limbo at NIH

Washington Post, June 4, 2017
by Lenny Bernstein

[...] The leadership at the National Institute on Deafness and Other Communication Disorders, where...

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Specimen Science

MIT Press, October 2017
by Edited by Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera

This edited volume stems from a ;conference in 2015 that brought together leading experts t...

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

USA Today, May 22, 2017
by Tom Pelissero, citing Petrie-Flom's report

From the article

:

A short-term injured reserve for players diagnosed with a concussion was among 76...

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

Forbes, May 16, 2017
by Lee Igel, citing Petrie-Flom's report

From the article

:

Were either or both Crosby and Harden suffering the effects of a head injury, yet...

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How does the NFL stack up with health care?

ESPN, May 22, 2017
by Michael McCann, citing Petrie-Flom's report

Sports Illustrated legal analyst Michael McCann joins OTL to discuss the NFL's health care for i...

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Babies from skin cells? New fertility technology raises ethical questions

The Current, May 19, 2017
by Lara O'Brien and Karin Marley, interviewing I. Glenn Cohen (Faculty Director)

From the article

:

Women producing sperm. Or, for that matter, men producing eggs. Those could,...

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Some Social Scientists Are Tired of Asking for Permission

New York Times, May 22, 2017
by Kate Murphy

If you took Psychology 101 in college, you probably had to enroll in an experiment to fulfill a cour...

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Texas leans into unproven stem cell treatments, to the dismay of scientists

STAT, May 16, 2017
by Andrew Joseph

He made the emotional plea to his colleagues: Pass this bill

.

“It might give somebody like my...

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Revised ‘Common Rule’ Shapes Protections For Research Participants

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

From the article

:

Research with human participants funded by most federal agencies is governed by a...

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Should We Study Human Embryos Beyond 14 Days?

NOVA Next, April 26, 2017
by Jenny Morber, quoting I. Glenn Cohen (Faculty Director)

From the article

:

[...] Some critics view calls to re-evaluate the 14-day rule as a pernicious movi...

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

Vox, April 24, 2017
by Julia Belluz, quoting Holly Fernandez Lynch (Executive Director)

From the article

:

[...;Holly Fernandez Lynch, executive director of the Petrie-Flom Center fo...

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Nonexceptionalism, Research Risks, and Social Media

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

We are grateful for the thoughtful commentaries on our target article “Using Social Media as a...

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Science Needs Your Cells

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

>Biospecimens are essential to medical progress, but just medical waste to patients. Let's promot... Read More

Institutions as an Ethical Locus of Research Prioritisation

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

>Introductio

n

Ensuring that clinical trials, once launched, successfully complete and generate usefu...

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

WBUR, March 21, 2017
by Paul C. McLean, quoting Holly Fernandez Lynch (Executive Director)

From the article

:

That’s why ethics review of human subject research matters. This NIH panel...

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Final Revisions to the Common Rule

U.S. Department of Health and Human Services

On January 19, 2017, federal regulators published the Final Rule to amend and update the Federal Pol...

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The ethics of recruiting study participants on social media

Medical Xpress , March 16, 2017
by Heather Zeiger, citing Luka Gelinas (Fellow in Clinical Research Ethics)

From the article: 

;

In the recent issue of the American Journal of Bioethics, the target...

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

The Hastings Center Blog, February 8, 2017
by By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer

From the blog post

:

On January 19, the day the final revisions to the Federal Policy for...

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A New Day For Oversight Of Human Subjects Research

HealthAffairs, February 6, 2017
by Holly Fernandez Lynch (Executive Director)

>Editor’s note: This post is part of a series stemming from the ;Fifth Annua... Read More

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

The Health Care Blog, February 2, 2017
by Andy Oram, on PFC's 5th Annual Health Law Year in P/Review Conference

From the article

;

Pharmaceutical drug costs impinge heavily on consumers’ consciousness, ofte...

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Fifth Annual Health Law Year in P/Review

Monday, January 23, 2017 8:30 AM - 5:00 PM
Conferences
2016-2017
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

>Couldn't make it to the event? Check out some of the speakers' slides as well as blog posts... Read More

When clinical trials compete: prioritising study recruitment

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

Abstrac

t

It is not uncommon for multiple clinical trials at the same institution to recruit concurr...

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

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

Abstract

:

At the federal level in the United States, development of regulations is governed by the...

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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...

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Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite

Forbes, December 15, 2016
by David Shaywitz

In a year characterized by the extremes of rhetoric, healthcare entrepreneurs have been blessed with...

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Review of Human Subjects Research Regulation: Perspectives on the Future

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

From the review

:

Overall, the editors present an intriguing look at the concerns currently facing h...

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EVENT POSTPONED: HLS Library Book Talk: Charles Fried on Medical Experimentation

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

Wednesday, November 9, 2016 at noo

n

Harvard Law School Room WCC 2036 Milstein East B/

C

1585 Massac...

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Cluster Randomized Trials: Ethics, Regulations, Statistics & Design

Harvard Catalyst, November 3, 2016, 1:00 - 4:00pm
by featuring Holly Fernandez Lynch (Executive Director)

Descriptio

n

Please join Harvard Catalyst for a free half-day symposium on the topic of Cluster Rand...

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

Deadline: October 31, 2016

The Petrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time res...

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Social Media Use in Research Recruitment

Petrie-Flom Center / Harvard Catalyst, September 21, 2016
by Luke Gelinas (Petrie-Flom/Harvard Catalyst Fellow in Clinical Research Ethics)

>Cross-posted at the Petrie-Flom Center's blog ;Bill of Health

.

Imagine this scenario: you a...

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The morality of risks in research: reflections on Kumar

Journal of Medical Ethics, September 19, 2016 (online first)
by Frances M. Kamm (Senior Fellow alumna)

Abstract

:

Reflecting on the contribution by Rahul Kumar to the symposium, I consider the following...

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Federal Government’s Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered

Biopreservation and Biobanking, September 2016
by Christopher T. Robertson and Jonathan D. Loe

>Note: The full article is behind a paywall

.

Abstract

:

In September, the U.S. Department of Health...

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Manager of Online Initiatives
Public Responsibility in Medicine and Research (PRIM&R)

Deadline: August 15, 2016

Overview: Public Responsibility in Medicine and Research (PRIM&R), a nonprofit organization base...

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IRB Administrator
Boston Children’s Hospital

Deadline: September 13, 2016

The Boston Children’s Hospital IRB is seeking new team member to fill the role of IRB Administ...

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Evaluating Offers of Payment to Research Participants

Dana Farber Cancer Institute Ethics Grand Rounds, June 15, 2016
by Holly Fernandez Lynch (Executive Director) & Emily Largent (Student Fellow alumna)

DFCI Ethics Grand Round

s

Evaluating Offers of Payment to Research Participant

s

Holly Fernandez Lyn...

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Preventing Mitochondrial DNA Diseases: One Step Forward, Two Steps Back

Journal of the American Medical Association, June 9, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the article

:

On February 3, 2016, the Institute of Medicine (IOM) released its Ethical an...

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Correlations and Research Results

EMR & EHR, May 26, 2016
by Andy Oram

Andy Oram, an editor specializing in open source, software engineering, and health IT, attended...

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From Medical Experimentation to Non-Medical Experimentation

Charles Fried, Medical Experimentation: Personal Integrity and Social Policy, New Edition (Oxford University Press), May 2016
by I. Glenn Cohen (Faculty Director) and D. James Greiner

First published in 1974, Charles Fried's ;Medical Experimentation ;is a classic statemen...

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Research Project Coordinator
Johns Hopkins Berman Institute of Bioethics

Deadline: July 29, 2016

General Descriptio

n

The Research Project Coordinator will provide research and administrative assis...

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When Big Data Isn’t Big Enough

Ampersand, May 20, 2016
by Elise Davis

Elise Davis of PRIM&R attended the Petrie-Flom Center's 2016 Annual Conference on "Big Data,...

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Dead man’s sperm

Mosaic: The Science of Life, April 26, 2016
by Jenny Morber, quoting I. Glenn Cohen (Faculty Director)

Excerpt from article

:

[...] Where a man has made his wishes clear, the rights of the dead almost al...

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Promoting Healthcare Innovation on the Demand Side

U of Michigan Law & Econ Research Paper No. 16-008; U of Michigan Public Law Research Paper No. 503
by Rebecca Eisenberg and W. Nicholson Price II (Academic Fellow Alumnus)

Abstract

:

Innovation policy often focuses on the incentives of firms that sell new products. But op...

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Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

Health Affairs Blog, March 9, 2016
by I. Glenn Cohen (Faculty Director)

From the article

:

[...] Planned Parenthood received US $528 million of government money i...

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Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk

Institute of Medicine, 2015

A report commissioned by NIH and other sponsors on promoting responsible access to participant...

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What is a biobank? Differing definitions among biobank stakeholders

Clinical Genetics, March 2014
by Shaw et al.

An article discussing areas of agreement and difference in determining what constitutes a bioba..

. Read More

Are You Ready? The New Frontier in Clinical Research and the Evolving Common Rule

Boston Bar Association, March 7, 2016
by Holly Fernandez Lynch (Executive Director), Speaker

>CLE - Are You Ready? The New Frontier in Clinical Research and the Evolving Common Rul

e

Monday, Mar...

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Specimen Science: Ethics and Policy Implications

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Many important advances in human health depend on the effective collection, storage, use, and sharin...

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Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editor

International Committee of Medical Journal Editors, Jan. 2016

A proposal from the editors of major medical journals across the world to make publication in t...

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Biorepositories and Biospecimen Research Branch

National Cancer Institute

Website for the BBRB, which provides leadership, tools, resources, and policies in biobanking f...

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NIH Data Sharing Policy

National Institutes of Health

This site includes the NIH Statement on Sharing Research Data (2003), Data Sharing Regulations...

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Characterizing biobank organizations in the U.S.

Genome Medicine, Jan. 2013
by Henderson et al.

Results from a national survey of U.S. biobanks, including information on location, reason for...

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Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the indust...

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Biobank resources for future patient care: developments, principles and concepts

Journal of Clinical Bioinformation, Sept. 2011
by Ákos Végvári et al

An overview of global biobank development, outlining the critical research role of biobanks and...

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Clinical Trial Data Portal Gateway

EFPIA

This site offers a published list of major pharmaceutical companies’ online portals aimed ...

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WMA Declaration on Ethical Considerations Regarding Health Databases and   Biobanks

World Medical Association, March 2015

A supplemental declaration to the Declaration of Helskini, which provides additional principles...

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Therapeutic Misconception in ALS

Thursday, March 03, 2016 4:30 - 6:00 PM
Lectures and Panels
2015-2016
Tosteson Medical Education Center, Room 209
Harvard Medical School, 260 Longwood Ave., Boston, MA

Event Descriptio

n

Some subjects who participate in trials of novel therapies mistakenly believe tha...

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Sharing of Clinical Trials Data: Benefits, Risks, and Uniform Principles

Annals of Internal Medicine, 2015
by Michael Rosenblatt et al.

This commentary discusses the benefits and risks of data sharing from the perspective of person...

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Research Repositories, Databases, and the HIPAA Privacy Rule

NIH, January 2004

Discusses the impact of the HIPAA privacy rule on the creation of research databases and reposi...

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Sharing and Reporting the Results of Clinical Trials

JAMA, Jan. 2015
by Kathy L. Hudson and Francis S. Collins

This article advocates for sharing the results of clinical trials as an important means for adv...

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Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

An extensive listing of biobanks, tissue banks, and biorepositories, with links to all institut...

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Preparing for Responsible Sharing of Clinical Trial Data

New England Journal of Medicine, Oct. 2013
by Michelle M. Mello et al.

As more patient data from clinical trials is shared by sponsors and investigators, this article...

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New Journal of Law & Biosciences featuring Harvard student work

Journal of Law and the Biosciences (JLB), Vol. 3, Issue 1 (April 2016)

The ;Journal of Law and the Biosciences, the open-access journal launched in 2014 by the Pe...

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A Tool to Help Address Key Ethical Issues in Research

Journal of Medical Ethics Blog, February 22, 2016
by Rebecca H. Li & Holly Fernandez Lynch (Executive Director)

From the article: 

;

One of the most important responsibilities of a clinical project lead at a...

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Technical and Policy Approaches to Balancing Patient Privacy and Data Sharing

Journal of Investigative Medicine, Jan. 2010
by Bradley Malin et al.

This paper reviews several aspects of the privacy-related problems associated with data sharing...

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Yale University Open Data Access Project

Yale School of Medicine

The YODA project has iteratively developed a model to make data available to researchers in a s...

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Data Sharing and Transparency Initiative

Multi-Regional Clinical Trials Center

A data sharing and transparency initiative aimed at facilitating broad stakeholder clinical tri...

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Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

>Couldn't attend in person? Learn more about the event

:
  • Learn more about the presentations -...

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Incorporating ethical principles into clinical research protocols

Journal of Medical Ethics, January 25, 2016 (online first)
by Holly Fernandez Lynch (Executive Director) et al.

Abstract

:

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a...

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Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule

Hastings Center Report, January/February 2016, Vol. 46, Issue 1
by By Holly F. Lynch (Executive Director), Barbara E. Bierer and I. Glenn Cohen (Faculty Director)

>Abstract

:

On September 8, 2015, the Department of Health and Human Services issued a Notice of Prop...

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Learning the wrong lesson on privacy from Henrietta Lacks

Washington Post, January 8, 2016
by Christopher Robertson (Student Fellow Alumnus) and Jonathan D. Loe

From the article

:

In her acclaimed 2010 book, “The Immortal Life of Henrietta Lacks,” R...

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Senior Regulatory Specialist
Partners HealthCare, Human Research Quality Improvement (QI) Program

Deadline: March 04, 2016

The goal of the Partners Human Research Quality Improvement (QI) Program is to help fulfill the inst...

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IRB Analyst I
The Children’s Hospital of Philadelphia

Deadline: March 04, 2016

Job Description:  The IRB Analyst I is responsible for staffing the Committee for the Protectio...

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IRB Review Specialist
Massachusetts Eye and Ear Infirmary

Deadline: December 01, 2015

>Requisition Number: ;15-007
6 Department: Research Administratio
n Hours: 4
0 Location: Boston... Read More

CALL FOR PAPERS: The Social Value of Research
Conflicts between science, society, and individuals, Journal of Bioethics Special Issue

Deadline: November 02, 2015

The Editors of Bioethics are pleased to announce a special issue in 2016 on the social value of rese...

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Regulations Governing (Most) Federally-Funded Human Subjects Research

Department of Health and Human Services

This set of regulations governs the protection of human subjects in research supported or conducted...

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Notice of Proposed Rulemaking to Amend the Federal Policy for the Protection of Human Subjects

by Department of Health and Human Services (and several other federal departments and agencies)

This Federal Register notice from September 2015 outlines proposed changes to the Common Rule. These...

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U.S. Food and Drug Administration Regulations Applicable to Human Subjects Research

Food and Drug Administration

FDA’s regulations governing clinical trials are found at different parts of Title 21 of the Co...

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