Review of Human Subjects Research Regulation: Perspectives on the Future

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

From the review

:

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

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Patients Increasingly Influence The Direction Of Medical Research

NPR, November 28, 2016
by Richard Harris

[...] Often these explorations start when a parent notices something that seems not quite right...

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

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

Wednesday, November 9, 2016 at noo

n

Harvard Law School Room WCC 2036 Milstein East B/

C

1585 Massac...

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Cluster Randomized Trials: Ethics, Regulations, Statistics & Design

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

Descriptio

n

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

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

Deadline: October 31, 2016

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

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Social Media Use in Research Recruitment:

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

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

.

Imagine this scenario: you a...

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The morality of risks in research: reflections on Kumar

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

Abstract

:

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

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

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

>Note: The full article is behind a paywall

.

Abstract

:

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

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

Deadline: August 15, 2016

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

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IRB Administrator
Boston Children’s Hospital

Deadline: September 13, 2016

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

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Evaluating Offers of Payment to Research Participants

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

DFCI Ethics Grand Round

s

Evaluating Offers of Payment to Research Participant

s

Holly Fernandez Lyn...

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

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

From the article

:

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

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Correlations and Research Results:

EMR & EHR, May 26, 2016
by Andy Oram

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

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From Medical Experimentation to Non-Medical Experimentation:

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

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

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Research Project Coordinator
Johns Hopkins Berman Institute of Bioethics

Deadline: July 29, 2016

General Descriptio

n

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

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When Big Data Isn’t Big Enough

Ampersand, May 20, 2016
by Elise Davis

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

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Dead man’s sperm

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

Excerpt from article

:

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

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Promoting Healthcare Innovation on the Demand Side,

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

Abstract

:

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

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

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

From the article

:

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

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Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk

Institute of Medicine, 2015

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

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What is a biobank? Differing definitions among biobank stakeholders

Clinical Genetics, March 2014
by Shaw et al.

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

. Read More

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

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

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

e

Monday, Mar...

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Specimen Science: Ethics and Policy Implications

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

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

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

International Committee of Medical Journal Editors, Jan. 2016

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

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Biorepositories and Biospecimen Research Branch

National Cancer Institute

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

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NIH Data Sharing Policy

National Institutes of Health

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

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Characterizing biobank organizations in the U.S.

Genome Medicine, Jan. 2013
by Henderson et al.

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

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Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

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

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

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

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

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Clinical Trial Data Portal Gateway

EFPIA

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

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WMA Declaration on Ethical Considerations Regarding Health Databases and   Biobanks

World Medical Association, March 2015

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

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Therapeutic Misconception in ALS

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

Event Descriptio

n

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

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

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

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

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Research Repositories, Databases, and the HIPAA Privacy Rule

NIH, January 2004

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

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Sharing and Reporting the Results of Clinical Trials

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

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

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Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

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

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Preparing for Responsible Sharing of Clinical Trial Data

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

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

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New Journal of Law & Biosciences featuring Harvard student work

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

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

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A Tool to Help Address Key Ethical Issues in Research

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

From the article: 

;

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

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Technical and Policy Approaches to Balancing Patient Privacy and Data Sharing

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

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

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Yale University Open Data Access Project

Yale School of Medicine

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

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Data Sharing and Transparency Initiative

Multi-Regional Clinical Trials Center

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

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Fourth Annual Health Law Year in P/Review

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

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

:
  • Learn more about the presentations -...

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Incorporating ethical principles into clinical research protocols:

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

Abstract

:

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

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Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule

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

>Abstract

:

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

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Learning the wrong lesson on privacy from Henrietta Lacks

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

From the article

:

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

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

Deadline: March 04, 2016

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

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IRB Analyst I
The Children’s Hospital of Philadelphia

Deadline: March 04, 2016

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

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IRB Review Specialist
Massachusetts Eye and Ear Infirmary

Deadline: December 01, 2015

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

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

Deadline: November 02, 2015

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

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Regulations Governing (Most) Federally-Funded Human Subjects Research

Department of Health and Human Services

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

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

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

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

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

Food and Drug Administration

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

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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 pati...

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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 Petri...

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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...

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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 Na...

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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&nbs...

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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&nbs...

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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 o...

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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 (...

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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...

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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

:

&lsq...

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

Deadline: June 30, 2015

Job Descriptio

n

This is a newly created full-time position for a post-doctoral employee fellow in c...

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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

.

Abstrac...

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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 t...

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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 ...

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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 se...

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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 Obam...

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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 expe...

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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 la...

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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-doll...

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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.&... 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 t...

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ReSourcing Big Data

Harvard Catalyst, March 2015

March 23: Symposiu

m

9:00am-5:00p

m

Joseph B. Martin Conference Cente
r Harvard Medical Schoo
l
Extan...

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