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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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

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

Read More

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…

Read More

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 presents a multidisciplinary symposium to examine potential solutions to institutional…

Read More

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…

Read More

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…

Read More

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. 

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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.

Read More

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.

Read More

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…

Read More

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…

Read More

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. 

Read More

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.

Read More

Conflict of Interest in Biomedical Research

The Hastings Center

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

Read More

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.

Read More

Scope and Impact of Financial Conflict of Interest in Biomedical Research

Journal of the American Medical Association
by Justin Bekelman, Yan Li & Cary Gross

This article, although now somewhat dated, provides a review of quantitative studies on the extent, impact, and management of financial conflicts of interest in biomedical research.

Read More

Responsible Research: A Systems Approach to Protecting Research Participants

Institute of Medicine

This 2002 report was commissioned by HHS following the death of Jesse Gelsinger in a gene therapy experiment at the University of Pennsylvania.  It covers ethics review of research protocols,…

Read More

Moral Science: Protecting Participants in Human Subjects Research

Presidential Commission for the Study of Bioethical Issues

This 2011 report is the result of a thorough review of current regulations and international standards to assess whether they adequately protect human participants in federally funded research, and offers…

Read More

Public Responsibility in Medicine & Research

This organization aims to advance the highest ethical standards in the conduct of biomedical and social science/behavioral research through education, membership services, professional certification, and public policy initiatives.Their website has…

Read More

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

by Ezekiel Emanuel et al.

This book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing…

Read More

The Oxford Textbook of Clinical Research Ethics

by Ezekiel Emanuel et al.

This book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings, including scientific validity, fair subject selection, risk benefit ratio, independent review, and…

Read More

International Ethical Guidelines for Biomedical Research Involving Human Subjects

Council for International Organizations of Medical Sciences

These guidelines are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects, applying ethical standards in local circumstances, and…

Read More

Declaration of Helsinki

World Medical Association

This Declaration is widely regarded as a cornerstone document of human research ethics, and sets forth a variety of standards for the conduct of ethical research, some of which are…

Read More

E6 Guideline for Good Clinical Practice

International Conference on Harmonisation

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard…

Read More

Office for Human Research Protections, International

This site provides a variety of resources regarding international human subjects research, including an up-to-date compilation of international standards applicable to human subjects research in 104 countries, as well as…

Read More

Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Research

Council of Europe

This treaty sets forth ethical principles with regard to biomedical research involving interventions on human beings.

Read More

Medicinal Products for Human Use: Clinical Trials

European Commission

This site provides information on the requirements for conducting clinical trials in the EU. 

Read More

Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries

National Bioethics Advisory Commission

This report makes recommendations to address the ethical issues that arise when clinical research that is subject to US regulation is sponsored or conducted in developing countries, with special attention…

Read More

Charles Fried on Evidence as a Public Good

Friday, March 01, 2013
Lectures and Panels
2012-2013
Langdell 225 (Vorenberg Classroom), Harvard Law School
Watch Event Recordings

We hear a lot about the conflict between use of an individual's information for the public good and that individual's…

Read More

What Makes Clinical Research in Developing Countries Ethical?

Journal of Infectious Diseases
by Ezekiel J. Emanuel et al.

This foundational article provides a framework for ethical research in developing countries, addressing standard of care, post-trial access, and informed consent.  

Read More