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Author Details

Holly Fernandez Lynch
University of Pennsylvania Perelman School of Medicine.
2007
107
16
Vardit Ravitsky (CM4AI)
PMIDPaper TitleJournal TitlePublished Year
36219208Bioethics and the Moral Authority of Experience.Am J Bioeth2023
37769066Ethically cleared to launch?Science2023
35731960How Do Accredited Organizations Evaluate the Quality and Effectiveness of Their Human Research Protection Programs?AJOB Empir Bioeth2023
37351871Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness.JAMA2023
37290781Considering tomorrow's patients in today's drug approvals.BMJ2023
37104606Pressing regulatory challenges for psychedelic medicine.Science2023
37272596Inclusive, engaged, and accountable institutional review boards.Account Res2023
37294583Extending the US Food and Drug Administration's Postmarket Authorities.JAMA Health Forum2023
37226759Devil in the Details: Physician Duties and Expanded Access.J Law Med Ethics2023
36476106Journeying to Ixtlan: Ethics of Psychedelic Medicine and Research for Alzheimer's Disease and Related Dementias.AJOB Neurosci2023
36912848The Ethics of Expanded Access Research.JAMA2023
36800184Navigating the Expanded Access Pathway to Investigational Drugs as an Academic Oncologist.JAMA Netw Open2023
34908169Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies.Hastings Cent Rep2022
35696021Aspiring to Reasonableness in Accelerated Approval: Anticipating and Avoiding the Next Aducanumab.Drugs Aging2022
35716691Access to investigational drugs for patients with amyotrophic lateral sclerosis in the USA.Lancet Neurol2022
35748820Institutional Review Board Use of Outside Experts: A National Survey.AJOB Empir Bioeth2022
36480185Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs.JAMA2022
36069985Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II.JAMA Netw Open2022
35993964Diversity in IRB Membership: Views of IRB Chairpersons at U.S. Universities and Academic Medical Centers.AJOB Empir Bioeth2022
36260335Estimated Clinical Trial Capacity of Sites Participating in the COVID-19 Convalescent Plasma Expanded Access Program.JAMA Netw Open2022
36318206Perspectives of Academic Oncologists About Offering Expanded Access to Investigational Drugs.JAMA Netw Open2022
35102412Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.Pediatrics2022
34861569"We measure what we can measure": Struggles in defining and evaluating institutional review board quality.Soc Sci Med2022
35218600Institutional Review Board Use of Outside Experts: What Do We Know?Ethics Hum Res2022
35243994INTRODUCTION Health Law and Anti-Racism: Reckoning and Response.J Law Med Ethics2022
33472432Reopening schools safely in the face of COVID-19: Can cluster randomized trials help?Clin Trials2021
33541252Promoting Ethical Payment in Human Infection Challenge Studies.Am J Bioeth2021
33565280Ethical Inclusion of Health Care Workers in Covid-19 Research.Ethics Hum Res2021
33530721An ethics framework for consolidating and prioritizing COVID-19 clinical trials.Clin Trials2021
33689566Plumbing the Depths of Ethical Payment for Research Participation.Am J Bioeth2021
34855490Challenges in confirming drug effectiveness after early approval.Science2021
35006047Curbside Consults in Clinical Medicine: Empirical and Liability Challenges.J Law Med Ethics2021
34956653A snapshot of U.S. IRB review of COVID-19 research in the early pandemic.J Clin Transl Sci2021
34665689Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?Am J Bioeth2021
34694325FDA Drug Approval and the Ethics of Desperation.JAMA Intern Med2021
34676693Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use.Ethics Hum Res2021
33462449The limits of acceptable political influence over the FDA.Nat Med2021
33315470Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic.Ann Intern Med2021
33136427Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research.Ann Intern Med2021
31199697Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies.J Clin Oncol2020
31920143Offering Payment in Clinical Research: Enrolling Individuals With or at Risk for Opioid Use Disorder.J Empir Res Hum Res Ethics2020
31976568The right to withdraw from controlled human infection studies: Justifications and avoidance.Bioethics2020
32091138Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants.Bioethics2020
33141451The role of community engagement in addressing bystander risks in research: The case of a Zika virus controlled human infection study.Bioethics2020
33051381Compensating for research risk: permissible but not obligatory.J Med Ethics2020
32687743Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research.Ann Intern Med2020
32631197Facilitating Both Evidence and Access: Improving FDA's Accelerated Approval and Expanded Access Pathways.J Law Med Ethics2020
32908674Regulatory flexibility for COVID-19 research.J Law Biosci2020
32821021Evaluating the Quality of Research Ethics Review and Oversight: A Systematic Analysis of Quality Assessment Instruments.AJOB Empir Bioeth2020
32646992Unnecessary hesitancy on human vaccine tests-Response.Science2020
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Collaborators

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Petrie-Flom Center for Health Law Policy, Harvard University
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Medical Ethics and Health Policy, University of Pennsylvania
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McGill University
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Benjamin S Wilfond
University of Washington School of Medicine.
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Nancy S Jecker
University of Washington School of Medicine
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Ameet Sarpatwari
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
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Richard R Sharp
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Emmanuel Urquieta
Translational Research Institute for Space Health
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Jessica L Roberts
Health Law & Policy Institute, University of Houston Law Center
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Joseph S Ross
Yale School of Medicine
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Tara Ruttley
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Vardit Ravitsky (CM4AI)
The Hastings Center
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Dorit Donoviel
Translational Research Institute for Space Health
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Jessica Candia
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Henry T Greely
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