When clinical trials compete: prioritising study recruitment

BMJ, January 20, 2017
Luke Gelinas, Holly Fernandez Lynch, Barbara E Bierer, I. Glenn Cohen (Faculty Director)

From the 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, trials essentially compete for participants. There…

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Personhood Seeking New Life with Republican Control

Indiana Law Journal, April 2017
Jonathan F. Will, I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the abstract:  Just three days prior to the inauguration of Donald J. Trump as president of the United States, Rep. Jody B. Hice (R-GA) introduced the Sanctity of Human Life Act (H.R. 586), which, if enacted, would provide that the rights associated with…

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Moratoria and Innovation in the Reproductive Sciences: Of Pretext, Permanence, Transparency, and Timelimits

Journal of Health & Biomedical Law, 2018
Russell Spivak, I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the abstract:  As progress in the biosciences soldiers forth, new breakthroughs can often be swept up in a common narrative, that is, the narrative of science as a disruptive threat. Responding to perceived threats, policymakers the world over have frequently…

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“What Is PER?” Patient Engagement in Research as a Hit

Canadian Journal of Bioethics / Revue canadienne de bioéthique, July 6, 2018, Vol 1, Issue 2
By Jean-Christophe Bélisle-Pipon (Visiting Researcher), Claudio Del Grande, and Geneviève Rouleau

From the paper: Engaging patients in research conduct and agenda setting is increasingly considered as an ethical imperative, and a way to transcend views of patients as passive subjects by fostering their empowerment. However, patient engagement in research (PER)…

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Informed Consent and the Role of the Treating Physician

New England Journal of Medicine, June 21, 2018
By Holly Fernandez Lynch (Former Executive Director), Steven Joffe, and Eric A. Feldman

From the paper: In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,”1 informed consent has become a central feature…

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Regulation of Stem Cell Therapy Travel

Current Stem Cell Reports, July 2018
I. Glenn Cohen and Shelly Simana

From the abstract: Purpose of Review Stem cell therapies (hereinafter: SCT) hold tremendous promise for the treatment of a variety of diseases. Yet, alongside the medical potential, they pose significant risks. This…

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IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons

Journal of Empirical Research on Human Research Ethics, June 14, 2018
Joel S. Weissman, Eric G. Campbell, I. Glenn Cohen, Holly Fernandez Lynch, Emily A. Largent, Avni Gupta, Ronen Rozenblum, Melissa Abraham, Karen Spike

From the abstract:  Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and…

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A Method for Approximating Future Entry of Generic Drugs

Value in Health Journal, June 11, 2018
Jonathan J. Darrow, SJD, JD, MBA, (Student fellow alumnus) Aaron S. Kesselheim, MD, JD, MPH, Reed F. Beall, PhD

From the abstract:  Objectives To develop and test a method for approximating generic entry of top-selling drugs. Methods The…

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Building Capacity for a Global Genome Editing Observatory: Institutional Design

Trends in Biotechnology, June, 2018
Krishanu Saha, J. Benjamin Hurlbut,Sheila Jasanoff,Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet [...] I. Glenn Cohen (Faculty Director)[...]

Complete author list: Krishanu Saha, J. Benjamin Hurlbut, Sheila Jasanoff, Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet,  Françoise Baylis, Gaymon Bennett, George Church, I. Glenn Cohen, George Daley, Kevin Finneran, William Hurlbut, Rudolf Jaenisch, Laurence Lwoff,…

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On the Human Right to Health: Statistical Lives, Contingent Persons, and Other Difficult Questions

Human Rights, Democracy, and Legitimacy in a World of Disorder , 2018
I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen has written a chapter in the fortchoming book "Human Rights, Democracy, and Legitimacy in a World of Disorder," (Cambridge University Press, edited by Silja Voeneky and Gerald Neuman) that engages with the philosophical concept of a human right…

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Health Insurance’s Secondary Cost Problem: Market and Mandatory Solutions to Balance Billing and Other Symptoms

Harvard Law & Policy Review, Forthcoming
Matthew J.B. Lawrence (Academic Fellow Alumnus)

From the abstract: This Article identifies a fundamental problem with health insurance and, so, contemporary American health care. While competition pushes health insurers to minimize the primary costs of their plans—monthly premiums and periodic out-of-pocket…

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HIPAA and Protecting Health Information in the 21st Century

JAMA, May 24, 2018
I. Glenn Cohen (Faculty Director) and Michelle M. Mello

Faculty Director I. Glenn Cohen has co-authored a new opinion piece in JAMA that addresses the adequacy of HIPAA in protecting electronic health data in light of the launch of the Trump administration's…

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Circumvention Medical Tourism and Cutting Edge Medicine: The Case of Mitochondrial Replacement Therapy

Indiana Journal of Global Legal Studies, May 12, 2018
I. Glenn Cohen (Faculty Director)

From the article: “Medical Tourism” is the travel of patients from a home country to a destination country for the primary purpose of receiving health care. “Circumvention Tourism” is a sub-type of such travel where the motivation is circumventing…

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The Ethics of Medicaid’s Work Requirements and Other Personal Responsibility Policies

JAMA, May 7, 2018
Harald Schmidt and Allison K. Hoffman (Academic Fellow Alumna)

From the paper:  Breaking controversial new ground, the Centers for Medicare & Medicaid Services (CMS) recently invited states to consider establishing work requirements as a condition of receiving Medicaid benefits. Noncompliant beneficiaries may lose some…

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Grants

Berkeley Technology Law Journal, May 10, 2018
W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: Innovation is a primary source of economic growth, and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government’s arsenal of tools to promote innovation, but legal academic studies of…

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Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines

Health Affairs , May 2018
Lisette Pregelj, Thomas J. Hwang, Damian C. Hine, Evan B. Siegel, Ross T. Barnard, Jonathan J. Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the article: Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient populations. The potential for more immediate signals of efficacy during clinical trials suggests such medicines will reach…

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Addressing Financial Barriers to Enrollment in Clinical Trials

JAMA Oncology, April 19, 2018
Emily A. Largent and Holly Fernandez Lynch (Former Executive Director)

From the article: Shortfalls in clinical trial recruitment and retention constitute a major obstacle to scientific advancement. One means of increasing patient participation rates is to reduce associated financial burdens. In several states, efforts are under way…

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Preventing Mitochondrial Diseases: Embryo-Sparing Donor-Independent Options

Trends in Molecular Medicine, Volume 24, Issue 5 (May 2018)
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

Abstract Mutant mitochondrial DNA gives rise to a broad range of incurable inborn maladies. Prevention may now be possible by replacing the mutation-carrying mitochondria of zygotes or oocytes at risk with donated unaffected counterparts. However, mitochondrial…

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REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Harvard University Embryonic Stem Cell Research Oversight (“ESCRO”) Committee, April 2018

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD…

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Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough an

Journal of Clinical Oncology , April 24, 2018
Thomas J. Hwang, Jessica M. Franklin, Julie C. Lauffenburger, Bishal Gyawali, Aaron S. Kesselheim, and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non–breakthrough-designated cancer…

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