Law Commons^™

Special Topic Introduction: Minerva At The Departure Gate, Robert N. Strassfeld

Faculty Publications

No abstract provided.

All For One And One For All: Informed Consent And Public Health, Jessica Wilen Berg

Faculty Publications

The concept of informed consent is well established in the field of bioethics, but its application is unclear in the area of public health. The increasing prevalence of public health interventions creates a need to analyze the scope of government power as it relates to individual choice. This Article explores three different types of public health measures in which individual choice has been limited: (1) environmental interventions; (2) classic public health interventions to prevent contagious disease; and (3) public health information reporting or use. The reasons for limiting informed consent vary depending on the context, and the implications for the …

Introduction - Symposium Issue On Health Data Security Systems, Sharona Hoffman

Faculty Publications

Introduction to the Health Data Security System symposium 2012 Huston, TX.

Professional Power And The Standard Of Care In Medicine, Maxwell J. Mehlman

Faculty Publications

Since before the founding of the Republic, American medicine has been fighting a war to control the standard of care that physicians are expected to provide to their patients. It has waged battles on two fronts: against internal disagreements within the profession over what constitutes proper care, and against attempts to delineate the standard of care by forces outside the profession, such as private health insurers, the government, and the judicial system.

Making All The Children Above Average: Ethical And Regulatory Concerns For Pediatricians In Pediatric Enhancement Research, Jessica W. Berg, Maxwell J. Mehlman, Daniel B. Rubin, Eric Kodish

Faculty Publications

Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer. Growing interest in pediatric enhancements is likely to stimulate the conduct of enhancement research involving children. However, guidelines for the protection of human subjects were developed for investigations of therapeutic modalities. To date, virtually no attention has been paid to whether these rules would be appropriate for investigations to establish the safety and efficacy of technologies intended for enhancement rather than therapeutic uses and, …

Racially-Tailored’ Medicine Unraveled, Sharona Hoffman

Faculty Publications

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical …

Regulating Clinical Research: Informed Consent, Privacy, And Irbs, Sharona Hoffman

Faculty Publications

During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task.

Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical …