Clinical Trials May Need a Backup Plan for U.S.–EU Data Sharing
The Supreme Court’s June 2026 ruling in Trump v. Slaughter may affect how U.S. clinical trial sponsors receive long-term safety data from Europe.
Clinical Research
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Read more: The Ethics of Junk Science: It’s Time for a Reboot The Ethics of Junk Science: It’s Time for a Reboot
Science is supposed to be self-correcting. That mechanism is broken.
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Read more: It’s Time to Safeguard Genomic Data It’s Time to Safeguard Genomic Data
On Jan. 24, 2026, the New York Times reported that DNA sequences contributed by children and families to support a federal effort to understand adolescent brain development were later co-opted by other researchers and used to publish “race science” claims about intelligence.
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Read more: South Africa’s Pragmatic Turn: Pseudonymized Data and the Future of Health Research South Africa’s Pragmatic Turn: Pseudonymized Data and the Future of Health Research
A recent South African court judgment on pseudonymized school examination results has quietly opened a new and unexpected front in global debates about data protection and health research.
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Read more: Rethinking Evidence for Psychedelics in Medicine Rethinking Evidence for Psychedelics in Medicine
According to popular accounts, the U.S. Drug Enforcement Administration’s (DEA) scheduling of LSD and other psychedelics in 1968 shut down promising research for decades.
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Read more: Predictive Persons: Privacy Law and Digital Twins Predictive Persons: Privacy Law and Digital Twins
Imagine a clinical trial where the control group never sets foot in a clinic – because they don’t need to, and they don’t have feet. These “participants” are digital twins: computational models of real patients, built from health data to forecast disease trajectories and treatment response.
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Read more: NIH’s Access Planning Policy for Patent Licenses: Part 2 NIH’s Access Planning Policy for Patent Licenses: Part 2
Beginning Oct. 1, 2025, all applicants for commercial licenses of patents owned by the U.S. National Institutes of Health (NIH) are required to submit an Access Plan outlining how they will promote patient access to the resulting products.
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Read more: NIH’s Access Planning Policy for Patent Licenses: Part 1 NIH’s Access Planning Policy for Patent Licenses: Part 1
Beginning Oct. 1, 2025, all applicants for commercial licenses of patents owned by the U.S. National Institutes of Health (NIH) are required to submit an Access Plan outlining how they will promote patient access to the resulting products.
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Read more: Human Subjects Research Regulation: Perspectives on the Future Human Subjects Research Regulation: Perspectives on the Future
Editors: I. Glenn Cohen and Holly Fernandez LynchPublisher: MIT PressPublication Date: August 2014 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 the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current…
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Read more: Harvard Catalyst Harvard Catalyst
Overview Since 2013 the Petrie-Flom Center has collaborated with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School to promote the ethical conduct of research with human beings. Harvard Catalyst was established in 2008 to improve human health by enabling collaboration and providing tools, training, and technologies…