Law Commons^™

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 …

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.

Responding, 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.

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Biomedical Research And The Law:--Embryonic Stem Cells, Clones And Genes: Science, Law, Politics, And Values, 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.

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research (Aug. Draft), Michael J. Malinowski

Michael J. Malinowski

This article addresses the proliferation of race and ethnicity-based genetics research, which has become increasingly prevalent with the utilization of population genetics to make medical sense out of the map of the human genome. The article challenges the work of several law scholars with arguments based in bioethics, research pragmatism, and genetic science to propose that recognition of race and ethnicity is preferred in population genetics. The article concludes that proposals to stretch U.S. antidiscrimination jurisprudence to regulate away race and ethnicity in genetics research are misguided at best.

Dealing With The Reality Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research , Michael J. Malinowski

Michael J. Malinowski

This article challenges proposals to apply law to greatly constrain if not wholly prohibit race-based genetics research with arguments based in bioethics, research pragmatism, and genetic science. The article concludes that proposals to stretch U.S. antidiscrimination jurisprudence to regulate away race and ethnicity in genetics research are misguided at best.