The Journal of Law, Medicine and Ethics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Law as a Tool in “The War on Obesity”: Useful Interventions, Maybe, But, First, What's the Problem?
This article explores the effectiveness of legal interventions to promote healthier eating/drinking and exercise in responding to obesity. Undue emphasis on weight loss and prevention of excess gain have largely been failures and have fueled prejudice against fat people. A major challenge lies in shifting norms: away from stigmatization of the obese and towards more nutritious eating/drinking and increased activity with acceptance of bodies in all shapes and sizes. Part of the enormity of this challenge lies in the complex effects of law and its relationship with norms, including unintended consequences of regulation. To i...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: W. A. Bogart Source Type: research

Tackling the Global NCD Crisis: Innovations in Law and Governance
35 million people die annually of non‐communicable diseases (NCDs), 80% of them in low‐ and middle‐income countries — representing a marked epidemiological transition from infectious to chronic diseases and from richer to poorer countries. The total number of NCDs is projected to rise by 17% over the coming decade, absent significant interventions. The NCD epidemic poses unique governance challenges: the causes are multifactorial, the affected populations diffuse, and effective responses require sustained multi‐sectorial cooperation. The authors propose a range of regulatory options available at the domestic leve...
Source: The Journal of Law, Medicine and Ethics - April 12, 2013 Category: Medical Law Authors: Bryan Thomas, Lawrence O. Gostin Source Type: research

INTRODUCTION: Global Health Challenges and the Role of Law
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - March 1, 2013 Category: Medical Law Authors: Colleen M. Flood, Trudo Lemmens Source Type: research

Currents in Contemporary Bioethics
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Amy L. McGuire, Melody J. Wang, Frank J. Probst Source Type: research

Public Health and the Law
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: James G. Hodge Source Type: research

Medication Information for Patients with Limited English Proficiency: Lessons from the European Union
Misuse or misunderstanding of medication information is a common and costly problem in the U.S. The risks of misunderstanding medication information are compounded for the large and growing population of individuals with limited English proficiency that often lacks access to this information in their own language. This paper examines practices related to translation of medication information in the European Union that may serve as a model for future U.S. policy efforts to improve the quality and availability of medication information for individuals with limited English proficiency. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Marsha Regenstein, Ellie Andres, Dylan Nelson, Stephanie David, Ruth Lopert, Richard Katz Source Type: research

What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011
Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an a...
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Gail E. Henderson, Eric T. Juengst, Nancy M. P. King, Kristine Kuczynski, Marsha Michie Source Type: research

Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB
A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not‐for‐profit Institutional Review Board (IRB). (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: David Perlman Source Type: research

More Than Cheating: Deception, IRB Shopping, and the Normative Legitimacy of IRBs
Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deepe...
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Ryan Spellecy, Thomas May Source Type: research

In Plain Sight: A Solution to a Fundamental Challenge in Human Research
The physician‐researcher conflict of interest has thus far eluded satisfactory solution. Most attempts to deal with it focus on improving informed consent. But those attempts are not successful and may even make things worse. Research subjects are already voluntarily undertaking the risks of research — we should not ask them to go it alone — to undergo medical “treatment” without medical “care.” The only effective solution is that in much clinical research, each research subject should have a doctor independent from the research study. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Lois Shepherd, Margaret Foster Riley Source Type: research

IRB Decision‐Making with Imperfect Knowledge: A Framework for Evidence‐Based Research Ethics Review
Here we describe the five steps of evidence‐based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo‐controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision‐making. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Emily E. Anderson, James M. DuBois Source Type: research

Questions Concerning the Clinical Translation of Cell‐Based Interventions under an Innovation Pathway
Stem cell‐based innovation is one pathway to clinical translation that stands in contrast to clinical research and medical treatment. After reviewing recently issued guidelines for responsible innovation, this article examines the potential benefits and harms of using this pathway as well as practical barriers and conceptual concerns regarding it. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Jeremy Sugarman Source Type: research

A Non‐Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review
This paper offers a non‐paternalistic justification for prospective research review as providing a credible social assurance that the institutions of scientific advancement respect and affirm the moral equality of all community members and as creating a “market” in which stakeholders working to advance diverse ends also advance the common good. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Alex John London Source Type: research

Revolution or Reform in Human Subjects Research Oversight
The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review‐and‐comment, to the current review‐and‐approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Steven Joffe Source Type: research

Alive and Well: The Research Imperative
Many features of the existing biomedical research enterprise rest on questionable judgments about the value of research. Policymakers and research ethicists make assumptions about research value that aren't necessarily warranted. A more balanced view of research value could contribute to more defensible decisions about research policy and practice. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - January 3, 2013 Category: Medical Law Authors: Rebecca Dresser Source Type: research