Petrie-Flom Seeks Research Assistant

Petrie-Flom Seeks Research Assistant
Petrie-Flom Center, Harvard Law School

Deadline: Open until filled.

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

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SAVE THE DATE: Third Annual Health Law Year in P/Review

Friday, January 30, 2015 9:00 AM - 5:00 PM
Conferences
2014-2015

At our Third Annual Health Law Year in P/Review, we will welcome experts discussing major developments during 2014 and what to watch…

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Book Launch: Human Subjects Research Regulation: Perspectives on the Future

Wednesday, October 22, 2014 12:00 PM
Lectures and Panels
2014-2015
Harvard Law School Library, Langdell Hall, Caspersen Room
1557 Massachusetts Ave., 4th floor, Cambridge, MA

MIT Press recently published Human Subjects Research Regulation: Perspectives on the Future (2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive…

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A Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM
Lectures and Panels
2014-2015
Wasserstein Hall, Room 3018
1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services…

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The Danger in Losing Sight of Ebola Victims’ Humanity

The Atlantic, August 22, 2014
by Raphael Frankfurter

[...] Responding to Ebola requires putting patients and families into inescapably horrific situations. Being diagnosed with the disease means confronting and accepting the absolute terror of a likely-terminal condition—I am…

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West Africa’s Ebola Epidemic Spreads

On Point , August 18, 2014
by Jane Clayson

More than one thousand people dead, more than two thousand infected. Ebola continues to spread across West Africa: Liberia, Sierra Leone, Guinea and Nigeria. The worst outbreak in history.  And still not…

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Gay Teen’s Eyes Rejected for Donation Due to FDA Policy

Newsmax TV, August 15, 2014
by Wanda Carruthers, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] The FDA rule goes back to when HIV and AIDS epidemic started in the United States. The FDA maintained the policy was necessary due to "documented increased…

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After suicide, gay teen’s eye donation rejected

Washington Post, August 14, 2014
by Ryan Weber, quoting I. Glenn Cohen (Faculty Director)

From the article: In the Journal of the American Medical Association, Glenn Cohen, a bioethics law professor at the Harvard Law School, wrote that the United States should repeal the rules…

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Ethical issues over experimental Ebola drug

CCTV America, August 13, 2014
by Asieh Namdar, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV America to discuss ethical questions about who is receiving an experimental drug to treat Ebola. From the interview: [...] Usually when we think about what's ethical,…

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Ethical to use untested Ebola drugs, says WHO:

BBC News, August 12, 2014

The WHO said it was ethical in light of the scale of the outbreak and high number of deaths - more than 1,000 people have died in West Africa. The…

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Medical ethicists to meet on use of experimental Ebola drugs:

Al Jazeera America, August 8, 2014
by Courtney Brooks

Medical ethicists will meet next week to discuss the use of experimental medicines in the West Africa Ebola outbreak. The World Health Organization (WHO) announced the talks in the wake…

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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article: One of the largest big-data experiments in health care has set its first research target. The leaders of the Patient-Centered Outcomes Research Institute (PCORI) in Washington DC…

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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article: One of the largest big-data experiments in health care has set its first research target. The leaders of the Patient-Centered Outcomes Research Institute (PCORI) in Washington DC…

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Clinical Ethicist

Clinical Ethicist
Office of Ethics at Boston Children’s Hospital

Deadline: Immediate Opening.

The Office of Ethics at Boston Children’s Hospital has an immediate opening for a clinical ethicist.  Applications are being accepted online, at www.childrenshospital.jobs.   To locate the position on the website, enter “32902BR” in the…

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The Recovering Americans and the ‘Top Secret’ Ebola Treatment:

Atlantic, August 4, 2014
by James Hamblin

Because Kent Brantly is a physician who has watched people die of Ebola, there was an especially chilling prescience to his assessmentlast week, between labored breaths: "I am going to die."…

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Why Psychologists’ Food Fight Matters

Slate, July 31, 3014
by Michelle N. Meyer (Academic Fellow alumna) and Christopher Chabris

From the article: Psychologists are up in arms over, of all things, the editorial process that led to the recent publication of a special issue of the journal Social Psychology. This may seem like…

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Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

MIT Press, August 2014
by I. Glenn Cohen (Faculty Director) and Holly Fernandez Lynch (Executive Director), eds.

The Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive…

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Misjudgements will drive social trials underground:

Nature, July 16, 2014
by Michelle Meyer (Academic Fellow Alumna) et al.

Former Petrie-Flom Academic Fellow Michelle N. Meyer has joined with a group of other scholars to defend the recently publicized social contagion experiment conducted by Facebook, arguing that the experiment…

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Introduction to Translational Medicine

Harvard Catalyst, September 29 – October 1, 2014
by Featuring Holly Fernandez Lynch (Executive Director)

Introduction to Translational MedicineSeptember 29 – October 1, 2014 Sheraton Commander Hotel, Cambridge, MA Course themes: Preclinical Discovery Clinical and Experimental Pharmacology Conflicts of Interest Leadership and Team Dynamics in…

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Mississippi Child Thought Cured Of HIV Shows Signs Of Infection

NPR, July 10, 2014
by Richard Harris

A baby who generated great excitement last year because it appeared she had been cured of HIV is infected with the virus after all, health officials say. This discovery is…

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A Cholera Vaccine Halts New Cases In A Guinea Epidemic

NPR, May 28, 2014
by Richard Knox

There's new evidence that an oral cholera vaccine might help stop an epidemic in its tracks. That's the encouraging message from a study that tested a two-dose vaccine during a…

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Health Science Administrator (Deputy Director, OHRP)

Health Science Administrator (Deputy Director, OHRP)
Office of the Secretary, Office of the Asst. Secretary for Health (OASH), Office for Human Research Protections (OHRP)

Deadline: June 13, 2014

The Office for Human Research Protections (OHRP) is pleased to announce the following job vacancy within the Office of the Assistant Secretary for Health (OASH). OHRP is actively seeking to fill a vacancy for its…

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Streamlining Review by Accepting Equivalence

American Journal of Bioethics, Vol. 14, Issue 5, 2014
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

In their target article, Barchi, Singleton, and Merz (2014) identify several challenges to the review of international research, including regulatory frameworks and review criteria that may overlap or compete across…

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Once in limbo, promising Duchenne muscular dystrophy drug back on track toward approval

Washington Post, April 21, 2014
by Brady Dennis

For much of last fall and winter and into this spring, scientists at the Food and Drug Administration wavered over what to do about a potential new drug to slow the progression…

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Idea of New Attention Disorder Spurs Research, and Debate

New York Times, April 11, 2014
by Alan Schwarz

With more than six million American children having received a diagnosis of attention deficit hyperactivity disorder, concern has been rising that the condition is being significantly misdiagnosed and overtreated with…

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Hot Topics at the Presidential Commission for the Study of Bioethical Issues:
Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014 12:00 PM
Lectures and Panels
2013-2014
Pound Hall 100
1563 Massachusetts Ave., Cambridge, MA

This event featured an update from the Presidential Commission for the Study of Bioethical Issues delivered by Michelle Groman (HLS '05), Associate Director at the…

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Health Law Year in P/Review

Friday, January 31, 2014 8:30 AM - 5:00 PM
Conferences
2013-2014
Wasserstein Hall, Milstein East B & C
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

Video of this conference is now available at online! (See below for links to specific panels.) At our second Annual Health…

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Harvard Scientists Say Research Subjects Should See Data

Bloomberg Technology, January 23, 2014
by John Lauerman

People who give blood or other tissues for research should be able to track their use through the scientific process to see the data their activities or samples generate, Harvard…

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Clots Tied to Heart Pump Open Debate on Risks Patients Face in Trials

New York Times, December 9, 2013
by Barry Meier

A new report showing an increase in blood clots associated with a popular heart device is dividing experts over whether a clinical trial of the implant is potentially too risky…

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Alzheimer’s risk before symptoms:

CNN, November 9, 2013
by Elizabeth Landau

[...] to set up human experiments aimed at prevention, researchers need to identify a whole new category of patient: Those in the "preclinical" stage of Alzheimer's. By performing brain scans…

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Harvard Reception at the PRIM&R Annual Conference

Wednesday, November 06, 2013 6:00 PM
Lectures and Panels
2013-2014
Hynes Convention Center, Room 200
900 Boylston St., Boston, MA

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Division of Medical Ethics at Harvard Medical…

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Massive DNA volunteer hunt begins

BBC News, November 6, 2013
by James Gallagher

The UK Personal Genome Project could provide a massive free tool for scientists to further understanding of disease and human genetics. Participants will get an analysis of their DNA, but so will…

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When Less Information is Better:
Blinding as a Solution to Institutional Corruption

Friday, November 01, 2013 8:00 AM - 6:00 PM
Conferences
2013-2014
Harvard Law School, Wasserstein Hall, Milstein West B
1585 Massachusetts Ave., Cambridge, MA

The Edmond J. Safra Center for Ethics at Harvard University presented a multidisciplinary symposium that examined potential solutions to institutional corruption that…

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Decades Later, Condemnation for a Skid Row Cancer Study

New York TImes, October 17, 2013
by Gina Kolata

A medical researcher from Columbia University, Dr. Perry Hudson, made the skid row alcoholics in Lower Manhattan an offer: If they agreed to surgical biopsies of their prostates, they would…

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The Future of Human Subjects Research Regulation:

This conference brought together a variety of experts on human subjects research to discuss the 2011 Advanced Notice of Proposed Rulemaking and offer suggestions for how to best regulate human…

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US Government Clinical Trial Registry

U.S. National Institutes of Health

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. 

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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 by HHS, as well as several other federal agencies.  It covers basic protections for all…

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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 Code of Federal Regulations. Use the link to search for 21 CFR Part 50 (Informed…

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The Belmont Report:

U.S. Department of Health & Human Services

The Belmont Report is the foundational document on which current human subjects research regulations are based. It set forth the principles of respect for persons, beneficence, and justice to make…

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Grants and Funding: Research Involving Human Subjects

National Institutes of Health, Office of Extramural Research

This site provides HHS and NIH requirements and resources for the extramural community involved in human subjects research in their roles as Applicants/Grantees, Offerors/Contractors, Peer Reviewers, and Institutional Officials.  It…

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Bioethics Resources on the Web

National Institutes of Health

This excellent website provides links to a variety of resources related to human subjects research, including major ethics codes and standards (such as the Declaration of Helsinki, Nuremberg Code, Belmont…

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HHS Office of the Inspector General, Office of Evaluations and Inspections

US Department of Health and Human Services

This site includes a variety of government reports related to human subjects research and the agencies responsible for oversight.

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Ethical and Policy Issues in Research Involving Human Participants

National Bioethics Advisory Commission

This 2001 report offers several suggestions for improving the federal oversight system for protecting the rights and welfare of human research participants.

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs

Institute of Medicine

This report examines the possible roles of accreditation in strengthening accountability and oversight of programs responsible for protecting human subjects. One such accrediting organization now in existence is the Association…

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Conflict of Interest in Medical Research, Education, and Practice

Institute of Medicine, 2009

This report provides detailed information of the problem of conflict of interest in medicine. It reviews evidence on industry relationships with medical professionals and evaluates policies geared towards relieving conflicts…

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Protecting Patients, Preserving Integrity, Advancing Health:

by Association of American Medical Colleges & Association of American Universities

This is a link to a joint report by the AAMC and AAU that provides recommendations for universities in crafting their conflicts of interest policies. 

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Conflict of Interest in Biomedical Research: FASEB Guidelines

Journal of the Federation of American Societies for Experimental Biology
by Laura Brockway & Leo Furch

This article suggests conflict of interest guidelines for individual biomedical investigators to address the challenges faced when financial relationships exist with industry.

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Conflict of Interest in Biomedical Research

The Hastings Center

This link provides a brief overview of the issues arising due to conflict of interest.

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Conflicts of Interest in Biomedical Research

Journal of the American Medical Association
by David Korn

This article provides reasons why financial conflicts of interest should be a focus of attention for the academic medical community.

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