Legal Ethics and Professional Responsibility 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. …

Template Policy Re: Access To Medical Assistance In Dying In Publicly-Funded Institutions, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Patients are being denied access to assessments for, and provision of, medical assistance in dying (MAiD) in publicly-funded institutions in Canada. Health authorities should implement policies that prohibit forced transfer for MAiD (assessments and provision) unless it can be achieved without undue delay or harm to the patient (as determined by the MAiD Program, not the institution). This is a template policy that health authorities could adopt to ensure access to a legal health service in all publicly-funded institutions (including faith-based institutions) under their authority.

An Alternative To Medical Assistance In Dying? The Legal Status Of Voluntary Stopping Eating And Drinking (Vsed), Jocelyn Downie

Articles, Book Chapters, & Popular Press

Medical assistance in dying (MAiD) has received considerable attention from many in the field of bioethics. Philosophers, theologians, lawyers, and clinicians of all sorts have engaged with many challenging aspects of this issue. Public debate, public policy, and the law have been enhanced by the varied disciplinary analyses. With the legalization of MAiD in Canada, some attention is now being turned to issues that have historically been overshadowed by the debate about whether to permit MAiD. One such issue is voluntary stopping eating and drinking (VSED) as an alternative to MAiD. In this paper, I will apply a legal lens …

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 …

The House Edge: On Gambling And Professional Discipline, Stacey A. Tovino

Scholarly Works

On March 26, 2014, the Iowa Supreme Court revoked the license to practice law of Cedar Rapids attorney Susan Hense. Admitted to the Iowa Bar in 1996, Hense subsequently misappropriated $837,000 in client trust funds to feed her addiction to casino gambling. This Article assesses how attorneys like Hense who are addicted to gambling are treated in professional disciplinary actions, including license suspension, revocation, and reinstatement proceedings. Themes that emerge include public misunderstanding of gambling disorder, stigma against individuals with gambling disorder, statutory recognition of substance addictions but not behavioral addictions, and mandatory attendance at religion based fellowship meetings as …

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, …

Substitute Decision Making About Research: Identifying The Legally Authorized Representative In Four Canadian Provinces, Sheila Wildeman, Gina Bravo, Marie-France Dubois, Carole Cohen, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

When an adult is legally incapable of deciding whether to participate in health research, who (if anyone) has the legal authority to make that decision? Furthermore, how well do Canadians with a stake in health research, such as older adults, informal caregivers of older persons with cognitive impairments, researchers in aging, and members of research ethics boards (“REBs”), understand the state of the law on this question? These two interrelated matters are addressed by our study.

We find that the laws of the four provinces we target are frequently unclear as to whether, or in what circumstances, a guardian, proxy …

The Convention On The Rights Of Persons With Disabilities: Beginning To Examine The Implications For Canadian Lawyers' Professional Responsiblities, H Archibald Kaiser

Articles, Book Chapters, & Popular Press

The United Nations Convention on the Rights of Persons with Disabilities (hereafter the CRPD or the Convention) should herald a new epoch in the way persons with disabilities are treated throughout the world community. The entire panoply of ramifications of this Convention, the purpose of which is “to promote, protect and ensure the full enjoyment of all human rights and fundamental freedoms by all persons with disabilities, and to promote respect for their inherent dignity”, (Article 1) is as yet unascertainable. However, States Parties must “take all appropriate measures to eliminate discrimination by any person, organization or private enterprise” (Article …

A Conflict By Any Other Name Would Smell As Foul: A Comment On The Appointment Of A Vice-President Of Pfizer To The Cihr Governing Council, Jocelyn Downie

Articles, Book Chapters, & Popular Press

If one had to pick the pharmaceutical company most associated with unethical and illegal conduct this past year, it would likely be Pfizer. So it seems reasonable to respond with disbelief and outrage to the federal government’s October 5, 2009 appointment of Dr. Bernard Prigent – Vice President, Medical Director and registered lobbyist for Pfizer Canada – to the Canadian Institutes of Health Research Governing Council (CIHR GC). This is the body that sets the strategic direction for most federally funded health research in Canada. A senior executive from a for-profit pharmaceutical company should not be given a seat at …

Mapping The Issues: Public Health, Law And Ethics, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The field of public health is typically regarded as a positivistic pursuit and, undoubtedly, our understanding of the etiology and response to disease is heavily influenced by scientific inquiry. Public health policies, however, are shaped not only by science but also by ethical values, legal norms, and political oversight. Public Health Law and Ethics: A Reader (expanded and updated 2nd ed., 2010) probes and seeks to illuminate this complex interplay, through a careful selection of government reports, scholarly articles, and court cases together with discussion and analysis of critical problems at the interface of law, ethics, and public health. The …

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 …

Relational Theory And Health Law And Policy, Jennifer Llewellyn, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Relational theory starts from an understanding of human selves as relational. This theory informs some significant current developments in the areas of philosophy, ethics and legal theory that re-envision key concepts including autonomy, equality, rights, justice, memory, trust, judgment and identity. In this paper we introduce relational theory and begin to explore some of its implications for health law and policy. In doing so, we hope to show the relevance of each field to the other and to persuade those interested in health law and policy to take up the challenge to pursue the transformative potential of relational theory through …

A Comprehensive Analysis Of Mri Research Risks: In Support Of Full Disclosure, Jennifer Marshall, Toby Martin, Jocelyn Downie, Krisztina Malisza

Articles, Book Chapters, & Popular Press

Magnetic resonance imaging (MRI) procedures have been used for over 20 years. This modality is considered relatively safe and holds great promise. Yet, MRI has a number of risks. In order for MRI research to meet the Canadian standard of disclosure, the investigator must communicate and make note of all risks in their research protocols and consent forms. Those creating and reviewing research protocols and consent forms must take notice of the different circumstances under which MRI poses a risk. First, this paper will describe the current standard of disclosure in Canada for research participants. Second, the paper will provide …

Watch Out For Whistleblowers, Leslie C. Griffin

Scholarly Works

No abstract provided.

Protecting Human Research Subjects: A Jurisdictional Analysis, Jennifer Llewellyn, Jocelyn Downie, Robert Holmes

Articles, Book Chapters, & Popular Press

The most recent speech from the throne contained a pledge from the federal government to "work with provinces to implement a national system for the governance of research involving humans, including national research ethics and standards." This commitment signals a desire on the part of the federal government to address concerns about the inadequacies of the current governance of health research involving humans (RIH). To this end, Health Canada's Ethics Division is currently exploring the ways in which such a national governance system for RIH might be implemented. It is important for the federal government, as it moves toward making …

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 …