Who’s Actually Using ‘Right-To-Try’ Laws?

RAPS, August 4, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow alumna)

'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… Read More

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 "Weighing the Risks of Randomized Controlled Trials and Alternatives," which was part of the conference… Read More

Quality Improvement/Assurance Manager
University of North Carolina at Chapel Hill

Deadline: Open until filled

General Description: The University of North Carolina at Chapel Hill is recruiting to fill the position of Quality Improvement/Assurance Manager. The Office of Human Research Ethics (OHRE) is responsible… Read More

IRB Local Context Coordinator
The Emmes Corporation

Deadline: Open until filled.

The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland.  EMMES is dedicated to providing statistical and epidemiological… Read More

Clinical Trialist
Dartmouth-Hitchcock - Norris Cotton Cancer Center

Deadline: Open until filled.

The Norris Cotton Cancer Center and the Geisel School of Medicine at Dartmouth are seeking exceptional physician clinical investigators with research interests in early phase clinical research. The successful… Read More

Four-year Post Doctoral Research Position
Institute of Ethics (Dublin City University)

Deadline: April 15, 2017

General Description The Institute of Ethics at Dublin City University is seeking a postdoctoral researcher for a 4-year fixed-term contract to work on the EnTIRE project and do research on issues… Read More

Assistant Professor of Bioethics and Medical Humanities
Center for Bioethics and Medical Humanities in the Institute for Health and Equity at the Medical College of Wisconsin

Deadline: May 01, 2017

The Center for Bioethics and Medical Humanities in the Institute for Health and Equity at the Medical College of Wisconsin invites applications for a full-time faculty member at the rank of Assistant Professor.… Read More

Ethicist
Trillium Health Partners

Deadline: March 17, 2017

Job Description: Position: Ethicist  Status: Full Time  Dept/Health System: Ethics  Site: Trillium Health Partners  Hours of Work/Shifts: Primarily Monday to… Read More

Project Manager - SMART IRB
The Harvard Clinical and Translational Science Center, Harvard Medical School

Deadline: Open until filled.

Job Description: Harvard Catalyst | The Harvard Clinical and Translational Science Center facilitates clinical and translational research throughout the 27 Harvard Schools and Academic Healthcare Centers… Read More

Summer Internship
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

Deadline: Open until filled.

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), located in Harvard Square, has an opening for a Harvard Law graduate student for a summer internship… Read More

Clinical Ethics Faculty (open rank)
The Center for Medical Ethics and Health Policy, Baylor College of Medicine

Deadline: February 17, 2017

Clinical Ethics Faculty Due to tremendous growth, the Center for Medical Ethics & Health Policy at Baylor College of Medicine is seeking an experienced candidate to join their faculty (rank and… Read More

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 human subjects research regulation and provide a number of suggestions for how to go about solving some… Read More

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 noon Harvard Law School Room WCC 2036 Milstein East B/C 1585 Massachusetts Ave., Cambridge Lunch will be provided.   More About Medical Experimentation: Personal… Read More

Cluster Randomized Trials: Ethics, Regulations, Statistics & Design

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

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… Read More

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 research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science… Read More

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 are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition.… Read More

Clinical Bioethics Position
University of Wisconsin-Madison

Deadline: December 2, 2016

General Description: The University of Wisconsin seeks applications for a tenure-track faculty position in the Department of Medical History and Bioethics at the rank of assistant or associate professor. … Read More

Project Coordinator and Research Associate
ELSI, Center for Medical Ethics and Health Policy, Baylor College of Medicine

Deadline: October 03, 2016

Our ELSI Research Program, led by Dr. Amy McGuire, is seeking a project coordinator and a research associate for a new project looking at the integration of genome sequencing into clinical care of military… Read More

CALL FOR ABSTRACTS: 2017 Petrie-Flom Center Annual Conference
Harvard Law School

Deadline: Due no later than December 2, 2016

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: “Transparency in Health and… Read More

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 Administrator. Candidates with IRB experience will be given preference. The IRB Administrator will work as part… Read More

Regulatory Specialist
Partners HealthCare

Deadline: June 05, 2016

As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham… Read More

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 optimal use of healthcare products also requires good information about the likely effects of products in… Read More

Assistant or Associate Professor
Center for Medical Ethics & Health Policy at Baylor College of Medicine

Deadline: April 15, 2015

Assistant or Associate Professor Due to tremendous growth, the Center for Medical Ethics & Health Policy at Baylor College of Medicine is seeking an experienced  candidate to join their faculty… Read More

Director of Clinical Ethics at Cleveland
Department of Bioethics, Cleveland Clinic

Deadline: May 01, 2016

The Department of Bioethics at the Cleveland Clinic invites applications for the Director of Clinical Ethics. The successful candidate will be a member of the Professional Staff (faculty) and will be eligible… Read More

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 level data. Read More

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 sharing of biological specimens and their associated data.  However, recent controversies involving… Read More

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 their journals contingent on sharing de-identified, individual-level participant data from clinical… Read More

NIH Data Sharing Policy

National Institutes of Health

This site includes the NIH Statement on Sharing Research Data (2003), Data Sharing Regulations for NIH Awards, and other information on the NIH data sharing policy. Read More

Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the industry’s commitment to responsible data sharing. Read More

Clinical Trial Data Portal Gateway

EFPIA

This site offers a published list of major pharmaceutical companies’ online portals aimed at advancing responsible clinical trial data sharing. Read More

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 persons with experience in academic medicine, government, and medical publishing, as well as the pharmaceutical… Read More

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 advancing medical knowledge and promoting health. Read More

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 provides a suggested framework for broad sharing of participant-level data from clinical trials… Read More

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 for clinical research from technical and policy perspectives. Read More

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 sustainable way; the project currently has 123 trials available to request. Read More

Data Sharing and Transparency Initiative

Multi-Regional Clinical Trials Center

A data sharing and transparency initiative aimed at facilitating broad stakeholder clinical trials data sharing. Read More

Symposium on “Ethical Risk Assessment in Biomedical Big Data”

Organised by the Oxford Internet Institute, University of Oxford, in association with the Brocher Foundation., March 14-15, 2016
by Featuring I. Glenn Cohen (Faculty Director)

Please register via the event website. Description In biomedical research, the analysis of large datasets (Big Data) has become a major driver of innovation and success. ‘Biomedical Big Data’… Read More

Clinical Ethicist Position (Alberta, Canada)
Alberta Health Services

Deadline: December 29, 2015

The Clinical Ethicist provides support in addressing, analyzing, and resolving complex ethical issues arising in the delivery and planning of health care. As part of the Clinical Ethics Service, the Clinical… Read More

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 proposals are not yet final. Read More

Special Section: Moving Forward in Animal Research Ethics

Cambridge Journals, October 2015

The articles in this special section address a range of issues relating to animal research, law, and bioethics. Read More

Petrie-Flom Welcomes New Harvard Catalyst Fellow in Clinical Research Ethics

Petrie-Flom Center, August 17, 2015

We are pleased to announce our newest addition, Luke Gelinas, who will be serving as the first Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics. Luke earned his PhD in Philosophy… Read More

Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics
Petrie-Flom Center, Harvard Law School

Deadline: June 30, 2015

Job Description This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration… Read More

ReSourcing Big Data

Harvard Catalyst, March 2015

March 23: Symposium 9:00am-5:00pm Joseph B. Martin Conference Center Harvard Medical School Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus… Read More

Call for Participants: Making Sense of Clinical Translation: Ethical, Regulatory & Policy Challenges
Brocher Foundation, Geneva, Switzerland

Deadline: February 27, 2015

We hereby invite early career researchers to participate in a workshop on the ethical, regulatory and policy challenges for clinical translation on May 18-19, 2015. Ever more frequently, innovation policies… Read More

Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,

Petrie-Flom Center, February 5, 2015

On January 19 - 21, 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst |… Read More

Program Manager
Harvard Multi-Regional Clinical Trials Center

Deadline: February 20, 2015

The mission of the MRCT Center at Harvard is to improve the design, conduct, and oversight of multi-regional clinical trials, especially trials sited in or involving the developing world; to simplify research… Read More

Bioethics Funding Opportunity: Making a Difference in Real-World Bioethics Dilemmas
The Greenwall Foundation

Deadline: January 12, 2015

New Bioethics Program, Spring 2015 Making a Difference in Real-World Bioethics Dilemmas The Greenwall Foundation will fund a bioethics grants program, Making a Difference in Real-World Bioethics Dilemmas to… Read More

Two Full-Time Faculty Positions
Treuman Katz Center for Pediatric Bioethics, University of Washington Seattle

Deadline: December 15, 2014

The Treuman Katz Center for Pediatric Bioethics, Seattle Children’ Research Institute and the Division of Bioethics, Department of Pediatrics, University of Washington School of Medicine invite applications… Read More

Introduction to Translational Medicine

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

Introduction to Translational Medicine September 29 – October 1, 2014 Sheraton Commander Hotel, Cambridge, MA Course themes: Preclinical Discovery Clinical and Experimental Pharmacology Conflicts… Read More

Director of IRB Administration
Committee on the Use of Human Subjects, Faculty of Arts & Sciences, Harvard University

Deadline: September 20, 2014

Duties & Responsibilities:  Reporting to the FAS Associate Dean for Research Administration, the Director is responsible for leadership of the human subjects research protection program and oversight… Read More

Clinical Trials and the Right to Remain Silent

JAMA, July 21, 2014
by Michelle Mello, JD, PhD, MPhil and I. Glenn Cohen, JD (Faculty Director)

I. Glenn Cohen has coauthored a new Invited Commentary piece in JAMA on access to clinical trial data. From the article: In this issue of JAMA Internal Medicine, Kernan et al chronicle Yale University’s… Read More

Stem Cell Therapies

Institute of Medicine and the National Academy of Sciences, 2014
by Adam C. Berger, Sarah H. Beachy, and Steve Olson, featuring I. Glenn Cohen (Faculty Director)

Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells… Read More

Public Workshop: Strategies for Responsible Sharing of Clinical Trial Data

Institute of Medicine, National Academies, May 5, 2014
by Featuring a presentation by I. Glenn Cohen (Faculty Director)

Petrie-Flom Center Faculty Director I. Glenn Cohen will participate in a session on "Operational Principles for the Governance for Sharing Clinical Trial Data" on Monday, May 5, at 1:30pm. From… Read More

Michelle N. Meyer Named to Board of Directors of PersonalGenomes.org

Petrie-Flom, May 1, 2014

Academic Fellow alumna Michelle Meyer, J.D., Ph.D., currently Assistant Professor and Director of Bioethics Policy in the Union Graduate College-Icahn School of Medicine at Mt. Siniar Bioethics Program,… Read More

Special Issue: Rethinking the Ethics of Research Involving Non-Human Animals

Tom Beauchamp, Hope R. Ferdowsian, John P. Gluck, Issue Eds., April 2014

The articles in this issue assess how moral argument and empirical studies stand to guide animal research policies and practices into the future. Read More

The Use of Nonhuman Animals in Biomedical Research

Paper presented at the 17th Annual Thomas A. Pitts Memorial Lectureship, Medical University of South Carolina, October 29-30, 2010
by Dario L. Ringach

One scientist's response to key objections against animal research, and an argument that the responsible use of animals in biomedical research with the goal of advancing medical knowledge, science… Read More

The First Issue of Journal of Law and Biosciences Is Now Available!

Petrie-Flom Center, February 27, 2014

We are pleased to announce that the first issue of Journal of Law and the Biosciences (JLB) is now available online. The articles are: Knoppers, Bartha M., Edward S. Dove, & Ma'n H. Zawati.… Read More

Are We Willing to Fight for Our Research?

14 Ann. Rev. of Neuroscience, 1991
by David H. Hubel

Neuroscientist David H. Hubel's 1991 argument that scientists need to advocate for and educate the public about the importance of animal research not only in their own work but in advancing medicine… Read More

‘What Makes Clinical Research Ethical?’

Journal of American Medical Association , 24/31 (2000): 2701-11
by Ezekiel Emanuel, Christine Grady, David Wendler

In this influential article the authors aim to widen the focus of research ethics beyond informed consent, suggesting that there are seven conditions that research with humans must meet to be ethical. Read More

2015 Proposed Revisions

by Council for International Organizations of Medical Sciences

These are revisions to the existing CIOMS International Guidelines, proposed in September 2015.  These proposals are not yet final. Read More

The Ethical Challenges of Human Research

Oxford University Press, 2012
by Franklin G. Miller

This collection of essays covers several key debates in contemporary research ethics, including the ethics of trial design, deception, the placebo effect, and the therapeutic obligations of researchers. Read More

The Nuremberg Code

This early and historically significant statement, crafted in response to the abuses of Nazi experimentation with humans during World War II, outlines the principles of research ethics. Read More

Ethical Aspects of Clinical Research in Developing Countries

The European Group on Ethics in Science and New Technologies, 2003

This guidance document places particular emphasis on the ethical issues surrounding pharmaceutical drug development in developing nations. Read More