Digital Commons Network^™

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

David S Caudill

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …