Health Law and Policy Commons^™

Genome Editing 2020: Ethics And Human Rights In Germline Editing In Humans And Gene Drives In Mosquitoes, George J. Annas

Faculty Scholarship

The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and …

“Unusual Care”: Groupthink And Willful Blindness In The Support Study, George J. Annas, Catherine L. Annas

Faculty Scholarship

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. …

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

Crowdsourcing Public Health Experiments: A Response To Jonathan Darrow's Crowdsourcing Clinical Trials, Ameet Sarpatwari, Christopher Robertson, David Yokum, Keith Joiner

Faculty Scholarship

We are pleased to have this opportunity to respond to Jonathan Darrow's article, Crowdsourcing Clinical Trials (CCT).' We seek to highlight its important contributions and to commence debate over some of its arguments. In particular, we qualify the ethical arguments that characterize early clinical use of drugs as if they were research, and suggest instead that, in either domain, the ethical (and legal) analysis should remain focused on whether all material information is provided so patients may make informed decisions. We also highlight the limits of what can be gleaned from the observational data collection efforts envisioned by CCT.

Ultimately, …

Enhancing The Fighting Force: Medical Research On American Soldiers, Catherine L. Annas, George J. Annas

Faculty Scholarship

During President Barack Obama's first primetime press conference, reporters asked primarily about the state of the economy and terrorism. Wedged between questions on these two vital issues was a query from the Washington Post's Michael Fletcher:

Question: What is your reaction to Alex Rodriguez's admission that he used steroids as a member of the Texas Rangers?

Obama: You know, I think it's depressing news.... And if you're a fan of Major League Baseball, I think it - it tarnishes an entire era, to some degree. And it's unfortunate, because I think there are a lot of ballplayers who played it …

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

Informed Consent In The Post-Modern Era, Wendy K. Mariner

Faculty Scholarship

The doctrine of informed consent' is intended to get physicians to talk to their patients so that patients can make reasonably knowledgeable choices about whether to undergo particular forms of medical care. Although the law has long prohibited treatment without the patient's consent,² physicians have resisted the idea that treatment decisions ultimately are for the patient to make. Only recently have physicians been willing to disclose information about the benefits and risks of recommended therapies. ³ Even with the best of intentions, however, the discussions that do take place are often far from the law's ideal of reasonable disclosure …

Made In The U.S.A.: Legal And Ethical Issues In Artificial Heart Experimentation, George J. Annas

Faculty Scholarship

The death of William Schroeder in Louisville, Kentucky, on August 6, 1986, brought to a close a remarkable chapter in public human experimentation. Artificial heart implants represent the most public experiments in the history of the world. The manner in which they are conducted is a matter of utmost public and professional concern, since it graphically portrays the seriousness with which we take our laws and ethical rules regarding the protection of the rights and welfare of human subjects. Unfortunately, the brief history of artificial heart implants is neither a happy nor a proud one. Begun with high hopes and …