Pre-order now and get 30% off! Specimen Science

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

Pre-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… Read More

A Cancer Conundrum

New York Times, August 18, 2017
by Gina Kolata

With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical… Read More

IRB Review Specialist
Harvard T.H. Chan School of Public Health

Deadline: Open until filled.

Job Code: 43326BR Duties & Responsibilities The Office of Regulatory Affairs & Research Compliance (ORARC) ensures the quality and integrity of research conducted at the Harvard T.H. Chan School… Read More

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

Senate Passes F.D.A. Funding and ‘Right to Try’ Drug Bills

New York Times, August 3, 2017
by Robert Pear and Sheila Kaplan

WASHINGTON — The Senate on Thursday gave final approval to legislation to finance the Food and Drug Administration, clearing the measure for President Trump and tapping drug manufacturers once… Read More

Latinos Left Out Of Clinical Trials … And Possible Cures

Kaiser Health News, July 19, 2017
by Paula Andalo

[...] Cabrera is one of a relatively small number of Hispanics who participate in clinical trials. “Only less than 8 percent of enrollees are Hispanic, even though Hispanics comprise 17 percent of… Read More

Unapproved stem-cell treatments touted on federal database ClinicalTrials.gov, study says

Washington Post, July 19, 2017
by Laurie McGinley

Stem cell clinics offering unapproved treatments for ailments from hip pains to autism to erectile dysfunction increasingly are using a federal clinical-trials database as a marketing tool — a strategy… Read More

Is Alcohol Good for You? An Industry-Backed Study Seeks Answers

New York Times, July 3, 2017
by Roni Caryn Rabin

It may be the most palatable advice you will ever get from a doctor: Have a glass of wine, a beer or a cocktail every day, and you just might prevent a heart attack and live longer. But the mantra that… 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

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 recommendations included in a Harvard Law School report — based on research funded by the NFL Players… Read More

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 seeing game action? Appearances can be deceiving. In addition to medical personnel assessing a player's… Read More

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 its players. Watch video here! Read More

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, in theory, be some of the results of a new reproductive technology that's looming on the horizon,… Read More

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 set of rules and procedures designed to protect study participants while enabling the advancement of… Read More

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 moving of the goalposts. How meaningful can they be, the line of reasoning goes, if scientists want to change… Read More

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 for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, emphasized that the benefits to… Read More

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 Research Recruitment Tool: Ethical Issues and Recommendations” (Gelinas et al. 2017),… Read More

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 promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine injustice: the… 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)

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… Read More

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 is an especially good model in both its composition — expertise in law, medicine, medical science,… Read More

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 Policy for the Protection of Human Subjects (“the Common Rule”).  Key provisions govern… Read More

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 article addresses the ethics of finding participants for clinical trials on social media sites. The authors,… Read More

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 the Protection of Human Subjects were published in the Federal Register, our essay “Public Engagement,… Read More

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 Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23rd, 2017. The… 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, often on a monthly basis, and have become such a stress on the public that they came up repeatedly among both… 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)

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 it often is,… Read More

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 Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies… Read More

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 February… Read More

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 a number of thoughtful commentaries representing the opposite extreme. The selections cited below are… 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

Faculty Director I. Glenn Cohen Joins National Academy of Sciences Committee

Petrie-Flom Center, September 26, 2016

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 for… 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

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 topics in relation to risks in research: (1) treating someone as a mere means; (2) aggregation; (3) different… Read More

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 and Human Services, together with other federal agencies, announced proposed changes to the rules governing… 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

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 based in Boston, is dedicated to advancing the highest ethical standards in the conduct of research. PRIM&R… 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

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 Rounds Evaluating Offers of Payment to Research Participants Holly Fernandez Lynch, JD, MBioethics Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics,… Read More

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 and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial… Read More

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 the Petrie-Flom Center's 2016 annual conference, "Big Data, Health Law, and Bioethics," on… Read More

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 statement of the moral relationship between doctor and patient, as expressed within the concept of personal care.… Read More

Research Project Coordinator
Johns Hopkins Berman Institute of Bioethics

Deadline: July 29, 2016

General Description The Research Project Coordinator will provide research and administrative assistance for two grant-funded projects at the Johns Hopkins Berman Institute of Bioethics.  The first… Read More

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, Health Law, and Bioethics" on May 6, 2016. From her review at PRIM&R's blog Ampersand: … Read More

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 always supplant the rights of the living. Why? Law professor Glenn Cohen says this question is almost as… 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

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 in 2014, much of it going to pay for services that include contraception and cancer screenings, which it… Read More

HHS Announces Proposal to Improve Rules Protecting Human Research Subjects

U.S. Department of Health and Human Services

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research. A… 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

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 biobank. 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 Rule Monday, March 7, 2016 4:00 PM to 7:00 PM Boston Bar Association - 16 Beacon Street, Boston, MA Description:… 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

Biorepositories and Biospecimen Research Branch

National Cancer Institute

Website for the BBRB, which provides leadership, tools, resources, and policies in biobanking for the global biomedical research community. 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

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 establishment, research focus, collections, and organizational structure. 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

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 their potential impact on patient care. 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

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 for the ethical use of human biological materials in biobanks, as well as the ethical use of data… 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

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 repositories, and research that uses identifiable health information in repositories and databases. 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

Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

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

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 Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has… Read More

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 biotech company or an academic research team is to generate clinical trial protocols. The protocol dictates… 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

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 multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital… Read More

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 Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the… Read More

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,” Rebecca Skloot tells the story of a poor black woman with cervical cancer who checked into Johns Hopkins… Read More

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 institution's responsibility for ensuring compliance with federal and state regulations governing human… Read More

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 Protection of Human Subjects (CPHS) and its Institutional Review Boards (IRB). They help ensure that the IRB’s… Read More

IRB Review Specialist
Massachusetts Eye and Ear Infirmary

Deadline: December 01, 2015

Requisition Number: 15-0076 Department: Research Administration Hours: 40 Location: Boston, MA Description Reporting to the Director of the Human Research Protections Program, this position… 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 research. Social value is widely accepted, but rarely questioned as a benchmark of ethical research. International… 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 subjects… 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

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 Consent) and 21 CFR Part… Read More

Longitudinal Drug Studies in People with Dementia:  Ethical Challenges in Assessing Capacity and Get
Harvard Research Ethics Consortium, Harvard Medical School

Deadline: September 18, 2015

"Longitudinal Drug Studies in People with Dementia: Ethical Challenges in Assessing Capacity and Getting Consent" Friday September 18, 2015 from 12:30 PM to 2:00 PM EDT Harvard Medical School, Countway… Read More

Call for Abstracts: 2016 Petrie-Flom Annual Conference: Big Data, Health Law, and Bioethics
Petrie-Flom Center, Harvard Law School

Deadline: December 01, 2015

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and… Read More

Call For Papers: Beyond IRBs - Designing Ethical Review Processes for Big Data Research
Future of Privacy Forum

Deadline: October 25, 2015

The Future of Privacy Forum is hosting an academic workshop supported by the National Science Foundation to discuss ethical, legal, and technical guidance for organizations conducting research… Read More

What’s Trust Got to Do With It? Trust and the Importance of the Research-Care Distinction

American Journal of Bioethics, September 2015, Vol. 15, No. 9
by Emily Largent (Student Fellow alumna)

From the article: In a learning health care system, knowledge is an intended by-product of the patient–physician encounter. The integration of research and care within such systems holds the potential… 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

Research, Regulation, and Ethics: Discussion of Human Subjects Research Regulation Book

Science for the People Podcast, July 2015, No. 327
by Desiree Schell

About the podcast: This week we're learning about the regulatory frameworks that try to balance scientific progress with the safety of research subjects. We'll speak to Holly Fernandez Lynch and… Read More

Review of Human Subjects Research Regulation: Perspectives on the Future

IRB: Ethics & Human Research, July-August 2015, Vol. 37, No. 4
by Christine Grady

Christine Grady, MSN, PhD, the chief of the Department of Bioethics in the Clinical Center of the National Institutes of Health, recently published a review of Faculty Director I. Glenn Cohen &… Read More

Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nature Biotechnology, July 2015, Vol. 33, No. 7
by W Nicholson Price II (Academic Fellow alumnus) & Timo Minssen (past Visiting Scholar)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, and past Visiting Scholar Timo Minnsen, Associate… Read More

Black Box Medicine

Harvard Journal of Law & Technology, Vol. 28, No. 2 Spring 2015
by W. Nicholson Price II (Academic Fellow alumnus)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, has recently published an article in the Harvard Journal… Read More

PAPER NOW AVAILABLE

Journal of Law & the Biosciences, July 6, 2015 (Published Online)
by Rachel Sachs (Academic Fellow) and Carolyn Edelstein

Academic Fellow Rachel E. Sachs has a new article on the regulatory challenges of fecal microbiota transplantation in the Journal of Law & the Biosciences:  Abstract:… Read More

More than meets the IRB: On human subjects research and regulation: perspectives on the future

More Than Meets the IRB Podcast , May 2015, No. 11
by Holly F. Lynch (Executive Director), I. Glenn Cohen (Faculty Director), Michael Leary

In this eleventh installment of “More Than Meets the IRB,” we talk with I. Glenn Cohen (JD, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center for Health… Read More

This is Your Brain on Human Rights: Moral Enhancement and Human Rights

Law and Ethics of Human Rights, Vol 9, Issue 1, pp. 1-41 (2015) Symposium, Human Rights and Human Minds, 2015
by I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen has authored a new paper on the use of moral enhacement to increase the respect for human rights. Abstract: It seems fair to say that human rights law takes the… Read More

Regulating Bodies Across Borders

Bodies Across Borders: The Global Circulation of Body Parts, Medical Tourists and Professionals (Bronwyn Parry, Beth Greenhough, Tim Brown and Isabel Dyck, eds. Ashgate 2015)
by I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen has authored a new chapter on medical tourism. Abstract: ‘Medical tourism’ (to use the most common term, though ‘cross-border health care’ or… 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

Mental Health Postdoctoral Research Fellowship Program
The Cecil G. Sheps Center for Health Services Research, University of North Carolina

Deadline: June 05, 2015

The Cecil G. Sheps Center for Health Services Research of the University of North Carolina at Chapel Hill, in partnership with the Department of Psychiatry and Behavioral Sciences at the Duke… Read More

Are All Abortions Equal?

Journal of Law, Medicine and Ethics, Vol. 43, No. 1, 2015
by I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen has a new article on the criminalization of abortions. Abstract:   There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot”… Read More

Review of Human subjects research regulation: perspectives on the future

Theoretical Medicine and Bioethics, Vol. 36, Issue 2, April 2015
by Lydia Stewart Ferreira (Visiting Scholar)

Petrie-Flom Visiting Scholar Lydia Stewart Ferreira, currently Adjunct Professor at the University of Toronto Faculty of Law and Osgoode Hall Law School, recently published a review… Read More

Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements

Iowa Law Review, Vol. 81, No. 4, 2016 Forthcoming
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

Founding Faculty Director Einer Elhauge and four co-authors have just posted a new article on the reverse-payment patent settlements that are often used for pharmaceuticals.  The article… Read More

Johns Hopkins Faces Lawsuit Over Global STD Research

The Kojo Nnamdi Show, April 7, 2015
by Kojo Nnamdi, interviewing Holly F. Lynch (Executive Director)

Between 1945 and 1956, American researchers knowingly exposed hundreds of Guatemalan villagers to sexually transmitted diseases without their knowledge. President Obama has formally apologized for the… Read More

Religious colleges seek contraception mandate exception like for-profit companies

Washington Times, April 6, 2015
by Tom Howell Jr., quoting Holly F. Lynch (Executive Director)

From the article: Corporations with religious objections have already been granted relief from Obamacare’s contraceptive mandate, but religious colleges and charities are still fighting the administration… Read More

Johns Hopkins Sued For $1 Billion Over Unethical STD Study

BuzzFeed News, April 2, 2015
by Azeen Ghorayshi, quoting I. Glenn Cohen (Faculty Director)

More than 780 people filed a $1 billion lawsuit Wednesday against Johns Hopkins University over experiments conducted in the 1940s that deliberately infected over a thousand Guatemalans with syphilis and… Read More

Johns Hopkins Sued for Guatemala Experiments

The Scientist, April 2, 2015
by Tracy Vence, quoting I. Glenn Cohen (Faculty Director) and Holly F. Lynch (Executive Director)

From the article: Johns Hopkins University and other institutions are facing an up-to-$1 billion lawsuit brought by nearly 800 research participants and their families regarding experiments conducted… Read More

Hopkins faces $1B lawsuit over role in government study that gave subjects STDs

The Baltimore Sun, April 1, 2015
by Scott Dance, quoting Holly F. Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

From the article:  Nearly 800 former research subjects and their families filed a billion-dollar lawsuit Wednesday against the Johns Hopkins University, blaming the institution for its role in… Read More

An Interview with I. Glenn Cohen on Selling Human Organs

Talks on Law, March 2015
by Joel Cohen interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen joins Joel Cohen from Talks on Law to discuss selling human organs. With millions of Americans waiting for life saving organ transplants, why are human organ sales… Read More

“My Body, My Bank”

Texas Law Review, Vol. 93, No. 4, 2015
by I. Glenn Cohen (Faculty Director)

Abstract:       This essay reviews Kara Swanson’s "Banking on the Body: The Market in Blood, Milk, and Sperm in Modern America" (Harvard University Press, 2014) and… 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

What Working Parents Really Want

Fast Company, March 3, 2015
by Stephanie Vozza, quoting I. Glenn Cohen (Faculty Director)

From the article: Last year, Apple and Facebook both announced that they would cover egg freezing as a benefit for female employees. If you’re a woman who is considering postponing… Read More

Identified Versus Statistical Lives: An Interdisciplinary Perspective

Social Science Research Network, February 27, 2015
by Edited by I. Glenn Cohen (Faculty Director), Norman Daniels, Nir Eyal

Identified Versus Statistical Lives: An Interdisciplinary Perspective (Oxford University Press, 2015) is an edited volume that addresses the identified lives effect, which describes the fact that… Read More

Effect of Patient and Therapist Factors on Suicide Risk Assessment

Death Stud, February 12, 2015
by Noah C. Berman PhD, Abigail Stark BA, Allison Cooperman BA, Sabine Wilhelm PhD, and I. Glenn Cohen JD (Faculty Director

Abstract: The present study examined how patient risk factors and clinician demographics predict the assessment of suicide risk. Clinicians (N = 333) read two vignettes, one of which manipulated… Read More

Third Annual Health Law Year in P/Review collaborative blogging with Health Affairs

Petrie-Flom, February 5, 2015

The Third Annual Health Law Year in P/Review was a big success!  Video will be posted on our website shortly, but our presenters will be posting on their respective topics in a collaborative blog… 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

Online Launch of Medical Travel Show

International Medical Travel Journal, January 7, 2015
by I. Glenn Cohen (Faculty Director)

The Medical Travel Show is a serial podcast of interviews with international medical and wellness tourism experts including Josef Woodman, Keith Pollard, Susie Ellis, Glenn Cohen, and Pramod Goel. … Read More

Regulating the Organ Market: Normative Foundations for Market Regulation

Social Science Research Network, November 03, 2014
by I. Glenn Cohen (Faculty Director)

Abstract:       Should organs for transplant be bought and sold? There is a developed literature providing various arguments against organ markets and/or refuting those arguments.… Read More

New Rules for Human-Subject Research Are Delayed and Debated

The Chronicle of Higher Education, November 3, 2014
by Christopher Shea, quoting I. Glenn Cohen (Faculty Director)

From the article:  When I. Glenn Cohen, a professor at Harvard Law School and director of a bioethics center there, helped to organize a conference in 2012 about the future of research on human subjects,… Read More

First Two Chapters of “Patients with Passports: Medical Tourism, Law, and Ethics” Available for Free

Social Science Research Network, October 19, 2014
by I. Glenn Cohen (Faculty Director)

Patients with Passports: Medical Tourism, Law, and Ethics (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both the legal… Read More

Organs Without Borders? Allocating Transplant Organs, Foreigners, and the Importance of the Natio…

Social Science Research Network, October 19, 2014
by I. Glenn Cohen (Faculty Director)

Abstract:       Most of the discussion of market or non-market forms of allocating and procuring organs takes as its unit of analysis the nation state, or, less commonly a… Read More

Student Contractor
Program in Human Research Ethics and Oversight (PHREO), U.S. Environmental Protection Agency

Deadline: October 31, 2014

The Program in Human Research Ethics and Oversight (PHREO) at the U.S. Environmental Protection Agency (EPA) oversees the ethics of all research involving human participants that is conducted by EPA scientists… Read More

U.S. Troops and Patients Were Used as Malaria Guinea Pigs: Book

NBC News, October 7, 2014
by Bill Briggs, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] “There are no easy answers,” agreed I. Glenn Cohen, a Harvard Law School professor specializing in medical ethics. "But in trying to reach an answer on a particular… 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

I. Glenn Cohen and Holly F. Lynch (eds.): Human subjects research regulation: perspectives on the…

Theoretical Medicine and Bioethics, September 26, 2014
by Lydia Stewart Ferreira (Visiting Scholar)

Human Subjects Research (HSR) is an annual $10 billion dollar global activity. While there is consensus that HSR is necessary, a number of egregious historical examples point to the need to regulate this… Read More

A Fuller Picture of Organ Markets

The American Journal of Bioethics, September 17, 2014
by I. Glenn Cohen (Faculty Director)

From the article:  [...] A different problem with the reliance on the Iranian data is that Iran is, to put it mildly, quite different from many other countries. It is not a true organ market,… Read More

Petrie-Flom Center Executive Director Appointed to SACHRP

Petrie-Flom Center, September 11, 2014
by Holly Fernandez Lynch

Holly Fernandez Lynch, J.D., M.Bioethics, Executive Director of the Petrie-Flom Center at Harvard Law School, has been appointed by Secretary of Health and Human Services Sylvia Burwell to a… Read More

An Interview with I. Glenn Cohen on Controversial Health Issues

PBS.org, September 9, 2014
by Tavis Smiley, interviewing I. Glenn Cohen (Faculty Director)

In an interview with PBS.org, Faculty Director I. Glenn Cohen, sat down with Tavis Smiley to discuss important health issues, such as experimental Ebola drugs and prescription opiate use in the… Read More

Harold T. Shapiro Postdoctoral Fellowship in Bioethics
The University Center for Human Values, Princeton University

Deadline: November 10, 2014

The University Center for Human Values of Princeton University invites applications for the Harold T. Shapiro Postdoctoral Fellowship in Bioethics (#1400502). Applicants must have completed all the requirements… Read More

QA/QI Specialist
Human Research Quality Improvement Program, Partners Healthcare

Deadline: October 01, 2014

The Partners Human Research Quality Improvement Program (QI Program) is recruiting a QA/QI Specialist to join their team. The specialist will be responsible for providing regulatory support and education… Read More

Frozen embryos: Who do they belong to?

Chicago Lawyer Magazine, September 3, 2014
by Roy Strom, quoting I. Glenn Cohen (Faculty Director)

From the article:  [...] Glenn Cohen, a Harvard Law School professor who has written academic papers on embryo disputes, does not believe constitutional cases answer whether a person has a right to… Read More

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 risk of certain… Read More

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 about blood.… Read More

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… Read More

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 voted… Read More

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 voted… Read More

Human Subjects Research Regulation

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

Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch, stems from… Read More

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… 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

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

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

Deadline: August 15, 2014

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… Read More

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… 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… 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 subjects… 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

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Resear

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 recommendations… 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… 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… 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… 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, informed… 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… 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 the trial,… 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… 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

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

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