Perspect Biol Med
December 2018
The origins and aspirations of institutional review boards (IRBs), the American oversight system for research with human subjects, are well known, and their failures have been documented and disputed for decades. Contention about IRBs is often ideological and unsatisfying, but their shortcomings are real. A new wave of attention to the promise and problems of this oversight system has coincided with the years-long effort to update the federal "Common Rule.
View Article and Find Full Text PDFTissue engineering research is a complex process that requires investigators to focus on the relationship between their research and anticipated gains in both knowledge and treatment improvements. The ethical considerations arising from tissue engineering research are similarly complex when addressing the translational progression from bench to bedside, and investigators in the field of tissue engineering act as moral agents at each step of their research along the translational pathway, from early benchwork and preclinical studies to clinical research. This review highlights the ethical considerations and challenges at each stage of research, by comparing issues surrounding two translational tissue engineering technologies: the bioartificial pancreas and a tissue engineered skeletal muscle construct.
View Article and Find Full Text PDFThe recent explosion of publicity about the dangers of concussion in contact sports - particularly in football - represents the unraveling of a disinformation campaign by the NFL amid growing public and professional concern about the game's long-term risks of harm. The persistence of controversy and denial reflects a cultural view of football players as serving the needs of the team, a resulting evidentiary skepticism, and resistance to rule changes as excessive or unenforceable. This article considers the cultural context of informed decision making by parents of youth football players and suggests that policy changes designed to lower (although they cannot eliminate) risks of brain injury have the potential to change both the culture of football and the way the benefits and harms of the game are regarded for its players, without loss of its essential excitement and appeal.
View Article and Find Full Text PDFRapid progress in biotechnology has introduced a host of pressing ethical and policy issues pertaining to stem cell research. In this review, we provide an overview of the most significant issues with which the stem cell research community should be familiar. We draw on a sample of the bioethics and scientific literatures to address issues that are specific to stem cell research and therapy, as well as issues that are important for stem cell research and therapy but also for translational research in related fields, and issues that apply to all clinical research and therapy.
View Article and Find Full Text PDFBackground: Population ancestry-based differences exist in genetic risk for many kidney diseases. Substantial debate remains regarding returning genetic test results to participants. African-Americans (AAs) and European-Americans (EAs) at risk for end-stage kidney disease were queried for views on the value and use of genetic testing in research.
View Article and Find Full Text PDFDrug resistance occurs through a series of subtle changes that maintain substrate recognition but no longer permit inhibitor binding. In HIV-1 protease, mutations at I50 are associated with such subtle changes that confer differential resistance to specific inhibitors. Residue I50 is located at the protease flap tips, closing the active site upon ligand binding.
View Article and Find Full Text PDFResearch 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 analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers.
View Article and Find Full Text PDFJ Law Med Ethics
January 2014
Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.
View Article and Find Full Text PDFThe nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted.
View Article and Find Full Text PDFIn a recent article in The Journal of Clinical Ethics, David Wendler argues that worries about the therapeutic misconception (TM) are not only misconceived, but detract from the larger agenda of a proper informed consent for subjects involved in clinical research.1 By contrast, we argue that Wendler mischaracterizes those who support TM research, and that his arguments are fragmentary, often illogical, and neglect a critical difference between clinical care and clinical research. A clear explanation about the chief aim of research is, in fact, what gives the other elements in a consent process their meaning.
View Article and Find Full Text PDFThe development of HIV-1 protease inhibitors has been the historic paradigm of rational structure-based drug design, where structural and thermodynamic analyses have assisted in the discovery of novel inhibitors. While the total enthalpy and entropy change upon binding determine the affinity, often the thermodynamics are considered in terms of inhibitor properties only. In the current study, profound changes are observed in the binding thermodynamics of a drug-resistant variant compared to wild-type HIV-1 protease, irrespective of the inhibitor bound.
View Article and Find Full Text PDFKennedy Inst Ethics J
September 2011
Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease and suffering arising from the natural outbreak or intentional deployment of some of the world's most dreaded pathogens. Research to develop medical countermeasures to these diseases faces a difficult challenge since the products usually cannot be tested for efficacy in human beings. The U.
View Article and Find Full Text PDFHIV-1 protease is one of the major antiviral targets in the treatment of patients infected with HIV-1. The nine FDA approved HIV-1 protease inhibitors were developed with extensive use of structure-based drug design, thus the atomic details of how the inhibitors bind are well characterized. From this structural understanding the molecular basis for drug resistance in HIV-1 protease can be elucidated.
View Article and Find Full Text PDFAt the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding.
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