The Regulation of Reproduction and Best Interests Analysis

Oxford Handbook of Children and the Law, March 12, 2019
I. Glenn Cohen (Faculty Director)

From the article: "In its 1972 decision in Eisenstadt v. Baird, the US Supreme Court announced that: “it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting…

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Differential payment to research participants in the same study: an ethical analysis

BMJ, March 7, 2019
by Govind Persad, Holly Fernandez Lynch (Former Executive Director), Emily Largent (Student Fellow Alumna)

From the abstract:  Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment…

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Preclinical Alzheimer Disease and the Dawn of the Pre-Caregiver

JAMA Neurology , March 11, 2019
by Emily A. Largent (Student Fellow Alumna) and Jason Karlawish

From the paper:  A couple recently came to our memory center for a research visit. The husband is a participant in a clinical trial evaluating the efficacy of a drug to prevent the onset of dementia in cognitively unimpaired persons with elevated…

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Medical AI and Contextual Bias

Harvard Journal of Law & Technology , Spring 2019
by W. Nicholson Price (Academic Fellow Alum)

From the abstract:  Artificial intelligence will transform medicine. One particularly attractive possibility is the democratization of medical expertise. If black-box medical algorithms can be trained to match the performance of high-level human…

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Patients as Research Partners: How to Value their Perceptions, Contribution and Labor?

Citizen Science: Theory and Practice, March 2019
Elise Smith, Jean-Christophe BĂ©lisle-Pipon (Visiting Scholar), David Resnik

From the abstract:  Citizen Science refers to the consultation, participation, engagement or involvement of the general public in research. Rationales for this interaction include increased public access and involvement of citizens in research,…

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Social Media and Pediatric Research Recruitment

Ethics and Research with Children: A Case Based Approach, 2019
by Luke Gelinas (Former Senior Researcher) and Jennifer Kesselheim

From the chapter: "Social media use has increased exponentially across all demographics. With social media’s widespread popularity comes an increased potential for research sponsors and investigators to use it as an effective tool for recruiting…

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The Orphan Drug Act Revisited

JAMA, February 15, 2019
by Shailin Thomas (Student Fellow Alumnus) and Arthur Caplan

From the article: "The Orphan Drug Act (ODA) was first passed in 1983 to address the concern that pharmaceutical manufacturers were not pursuing drug development for diseases that affect limited patient populations. The concern was in part that companies…

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Present-day posthumous reproduction and traditional levirate marriage: two types of interactions

Journal of Law and the Biosciences, February 9, 2019
by Avishalom Westreich (Former Visiting Scholar)

From the article: "The paper studies the position of Jewish law on posthumous reproduction and its mutual interaction with the legal and bioethical discussion of this issue. It examines two types of interactions: a direct, legal-positive interaction…

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Ethical Acceptability of Reducing the Legal Blood Alcohol Concentration Limit to 0.05,

American Journal of Public Health, February 21, 2019
by Stephanie Morain and Emily Largent (Student Fellow Alumna)

From the article: "Twenty-nine Americans die in alcohol-impaired driving crashes daily. The National Academies of Sciences, Engineering, and Medicine released a report that identified strategies to reduce alcohol-impaired driving deaths. One strategy…

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Evaluating New Rules on Transparency in Cancer Research and Drug Development

JAMA Oncology, February 21, 2019
by Thomas J. Hwang, Kerstin N. Vokinger, and Rachel E. Sachs (Academic Fellow Alumna)

From the article: "Transparency in the development of new medicines has the potential to improve the efficiency and quality of clinical research by allowing investigators and companies to learn from successes and failures of similar products. It also…

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Shadow health records meet new data privacy laws

Science, February 1, 2019
by W. Nicholson Price (Academic Fellow Alumnus), Margot E. Kaminski, Timo Minssen (Former Visiting Scholar), Kayte Spector-Bagdad

From the article: "Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information,…

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A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance

AI-Health Working Group White Paper, January, 2019
David Arney, Max Senges, Sara Gerke et al

From the abstract:   AI-enabled health technology holds significant promise for improving health outcomes and clinical workflows. However, it also generates challenges for health data governance and security. More specifically, apps that…

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Drugmakers Drag Feet as Congress Drills Into Prescription Prices

Bloomberg Government, January 31, 2019
By Alex Ruoff and Jeannie Baumann, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "'Pharmaceutical companies look at what happened to Martin Shkreli and Heather Bresch at Mylan and they don’t want their company to be the face of this year’s drug pricing scandal,' Rachel Sachs, a professor…

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Luxturna: FDA documents reveal the value of a costly gene therapy

Drug Discovery Today, January 31, 2019
by Jonathan J. Darrow (Student Fellow Alumnus)

From the article: "In 2017, the US Food and Drug Administration (FDA) approved voretigene neparvovec‐rzyl (Luxturna), a gene therapy used to treat a rare form of inherited blindness. Widely described as a curative treatment that ‘restores…

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Power, Politics and Knowledge Claims: Sexual and Reproductive Health and Rights in the SDG Era

Global Policy , January 28, 2019
by Alicia Ely Yamin (Senior Fellow for GHRP)

From the article: "The selection of Sustainable Development Goals (SDGs) , targets and indicators for sexual and reproductive health and rights (SRHR) can only be understood in the light of struggles to advance these rights amid a context of the growing…

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Association Between Financial Incentives and Participant Deception About Study Eligibility

JAMA, January 25, 2019
by Holly Fernandez Lynch (Former Executive Director) et al, and Emily Largent (Student Fellow Alumna)

From the article: "Question: Is payment associated with participant deception about research eligibility and, if so, is higher payment associated with more deception? Findings: In this randomized survey…

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The Lumbering Crawl Toward Human Germline Editing

Journal of Law, Medicine & Ethics, January 10, 2019
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article:  It is in the nature of novelty that consensus is hard to come by. Such is clearly the lot of groundbreaking biomedical advances. History is no stranger to this phenomenon. The prospect of human germ-line editing is no exception.…

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Privacy in the age of medical big data

Nature Medicine, January 7, 2019
by W. Nicholson Price (Academic Fellow Alumnus) and I. Glenn Cohen (Faculty Director)

From the article:  "Big data has come to medicine. Its advocates promise increased accountability, quality, efficiency, and innovation. Most recently, the rapid development of machine-learning techniques and artificial intelligence (AI) has promised…

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Prescription Drug Policy: The Year In Review, And The Year Ahead

Health Affairs blog, January 3, 2019
by Rachel Sachs (Academic Fellow Alumna)

From the article:  This past year was once again filled with health policy news. Unlike 2017's congressional efforts to repeal the Affordable Care Act (ACA), 2018's news focused more on executive actions around health…

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An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

Nature Biotechnology, January 3, 2019
Timo Minssen (Former Visiting Scholar), Aaron S. Kesselheim, and Jonathan Darrow (Student Fellow Alumnus)

From the article: "A new European Union policy could increase the supply of legitimate pharmaceuticals in developing countries and thereby minimize the problem of counterfeit medicines, but many challenges remain. In…

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