scholarly journals International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials

2020 ◽  
Vol 132 (1) ◽  
pp. 44-54 ◽  
Author(s):  
Tanya J. Symons ◽  
Nikolajs Zeps ◽  
Paul S. Myles ◽  
Jonathan M. Morris ◽  
Daniel I. Sessler
Keyword(s):  
United States ◽  
The United States ◽  
Emergency Setting ◽  
Minimal Risk ◽  
Pragmatic Trials ◽  
Ethical Guidelines ◽  
Loss Of Autonomy ◽  
Policy Frameworks ◽  
Internal And External Validity ◽  
Intense Debate

Abstract There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise. This article examines whether international ethical guidelines and the policy frameworks in three countries—the United States, England, and Australia—permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible. The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.

Precautionary Schemes

2013 ◽  
Vol 4 (2) ◽  
pp. 293-296 ◽  
Author(s):  
Jane K. Winn
Keyword(s):  
United States ◽  
Precautionary Principle ◽  
The United States ◽  
Environmental Risks ◽  
Recent Book ◽  
The Precautionary Principle ◽  
Narrative Framework ◽  
Intense Debate

“And remember you’re in France: The customer is always wrong!”Many years ago, there was intense debate about what the Precautionary Principle (“PP”) is, or is not. More recently, as the battle lines in that debate have ossified, academic attention seems to have shifted to a focus on the somewhat more subtle question of how the term PP, whatever it may mean, is used by different actors in different contexts. David Vogel’s recent book, The Politics of Precaution: Regulating the Environmental Risks in Europe and the United States (2012) (hereafter “Politics”), is a good recent example of such commentary. Vogel's approach recognizes the diversity of relevant developments, he seeks to impose a coherent narrative framework on those developments.

scholarly journals Burden of Hand Maladies in US Emergency Departments

Hand ◽  
2017 ◽  
Vol 13 (2) ◽  
pp. 228-236 ◽  
Author(s):  
David L. Colen ◽  
Justin P. Fox ◽  
Benjamin Chang ◽  
Ines C. Lin
Keyword(s):  
United States ◽  
Health Care ◽  
Emergency Department ◽  
The United States ◽  
Health Care Resource ◽  
Emergency Setting ◽  
Health Care Resource Utilization ◽  
Final Sample ◽  
Common Etiology ◽  
National Emergency

Background: Hand conditions commonly present to the emergency department (ED), yet data are lacking regarding the magnitude of hand-related conditions in the emergency setting. The purpose of this study is to describe the burden and quantify the health care resource utilization of hand conditions seen in EDs across the United States. Methods: Using the National Emergency Department Sample, we identified all ED encounters by patients at least 18 years of age that were associated with a hand condition in 2009 to 2012. The primary outcomes were prevalence, etiology, and associated health care charges for specific categories of hand conditions. Results: The final sample included 34.4 million ED encounters associated with a common hand condition generating $180.4 billion in health care charges. The volume of hand-related presentations varied in a predictable and cyclical manner, peaking in July and waning in December of each year. Trauma was the most common etiology (77.5%) predominantly due to falls (26.2%) and lacerations (19.7%). Over 4 years, the volume of ED encounters rose (5% increase, P < .001) and as did the resulting health care charges (24.6% increase, P < .001). Conclusions: Our study confirms that hand-related conditions contribute significantly to ED volume and consume a growing quantity of health care resources in the United States. The volume of patients presenting to EDs with hand-related conditions fluctuates cyclically throughout the year. Open wounds are the most common cause of presentation and mostly occur in young adults, followed by joint pain, contusions, and fractures.

Low back pain in the United States: incidence and risk factors for presentation in the emergency setting

2012 ◽  
Vol 12 (1) ◽  
pp. 63-70 ◽  
Author(s):  
Brian R. Waterman ◽  
Philip J. Belmont ◽  
Andrew J. Schoenfeld
Keyword(s):  
United States ◽  
Risk Factors ◽  
Low Back Pain ◽  
Back Pain ◽  
The United States ◽  
Emergency Setting ◽  
Low Back

Power, Force and Diplomacy

1981 ◽  
Vol 43 (3) ◽  
pp. 410-435 ◽  
Author(s):  
Kenneth W. Thompson
Keyword(s):  
United States ◽  
Foreign Relations ◽  
The United States ◽  
Ability To Act ◽  
Human Ability ◽  
Political Philosopher ◽  
National Boundaries ◽  
The Individual ◽  
Domestic Affairs ◽  
Intense Debate

The present crisis has generated intense debate over the instruments of foreign policy the United States has at its disposal and controversy over their use in particular stages of a dispute or conflict. The debate has centered over the meaning and use of power and force. A little more than a decade ago, writing On Violence in an era when its primary manifestation was within national boundaries, the American political philosopher, the late Hannah Arendt, sought to distinguish between violence and power, saying: “… power always stands in need of numbers, whereas violence up to a point … relies on implements.” Writers differ on concepts such as power and violence. Power for some is conceived as the ability of the individual or the group to impose its will on others. Power for Arendt implied the human ability to act in concert —potestas in populo; without a people or group there is no power in politics. Power for individuals and groups is linked with prestige and authority. In politics, authority requires respect either for a person or an office; its enemy is contempt or laughter directed at the person or office. In both foreign relations and domestic affairs, “violence appears as a last resort to keep … power … intact against individual challengers — the foreign enemy, the native criminal …” or to overthrow authority. It would seem, therefore, that force and violence are the prerequisites of power and power nothing but a facade. In a violent world, it is force that counts not power which is dependent on force.

scholarly journals Pest Management Needs and Limitations for Corn Earworm (Lepidoptera: Noctuidae), an Emergent Key Pest of Hemp in the United States

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Kadie E Britt ◽  
Thomas P Kuhar ◽  
Whitney Cranshaw ◽  
Christopher T McCullough ◽  
Sally V Taylor ◽  
...  
Keyword(s):  
United States ◽  
World War Ii ◽  
Pest Management ◽  
Helicoverpa Zea ◽  
Cannabis Sativa ◽  
Insect Pest ◽  
The United States ◽  
Corn Earworm ◽  
Minimal Risk ◽  
Lepidoptera Noctuidae

Abstract Corn earworm, Helicoverpa zea (Boddie) (Lepidoptera: Noctuidae), has emerged as an injurious insect pest to hemp, Cannabis sativa L., a crop newly reintroduced to the United States. Growing hemp presents a potential alternative economic opportunity for farmers but can be challenging with a market that is unstable and just developing. One of the most notable production challenges is managing corn earworm, an insect pest that is particularly damaging when it feeds on flower buds produced in cannabinoid varieties, creating extensive bud tunneling and wounds that allow entry of pathogens that can aid development and presence of bud rot. Damage to seeds is of lesser concern in hemp cultivars grown for grain and minimal risk is associated with hemp grown for fiber. Our ability to research hemp has only recently been allowed as production was largely suspended following World War II and, as such, there has been limited opportunity to develop information for empirically-based pest management recommendations. Further complicating development of integrated pest management (IPM) strategies are regulatory challenges associated with providing registration support to add hemp to pesticide labels, as it was not formally recognized as a crop by U.S. regulatory agencies until late 2019. Research needs and challenges to develop effective IPM programs for corn earworm on hemp are discussed here.

scholarly journals State Authority and Lynching in Latin America

2021 ◽  
Vol 13 (3) ◽  
Author(s):  
Giovanni B. Corvino ◽  
Keyword(s):  
United States ◽  
Latin America ◽  
State Intervention ◽  
The United States ◽  
Social Scientists ◽  
State Legitimacy ◽  
Legal Violence ◽  
The Subject ◽  
Nineteenth And Twentieth Centuries ◽  
Intense Debate

Social scientists observed a significant increase in the number of lynchings in contemporary Latin America. The reasons for the rise are wide-ranging and conflicting. However, there are commonalities with the well-known cases of the United States of the nineteenth and twentieth centuries in which state legitimacy was the subject of intense debate. Therefore, this essay aims at observing why state intervention was deemed illegitimate in resolving local disputes that led to the vigilantes’ use of this form of extra-legal violence.

Improving the Sustainability of Road Freight Transport by Relaxing Truck Size and Weight Restrictions

2013 ◽  
pp. 1265-1278 ◽  
Author(s):  
Alan McKinnon
Keyword(s):  
United States ◽  
Environmental Impacts ◽  
Analytical Framework ◽  
The United States ◽  
Weight Restrictions ◽  
Legal Limits ◽  
Road Freight ◽  
Critical Issues ◽  
Truck Size And Weight ◽  
Intense Debate

Increasing legal limits on the size and weight of trucks allows companies to achieve a higher degree of load consolidation. This reduces the total number of vehicle-kilometres required to distribute a given quantity of goods, saving money and reducing environmental impacts. Proposals to legalise longer and heavier vehicles, (LHVs) have, nevertheless, generated intense debate, particularly in Europe where they are strongly resisted by railway and environmental organisations. This chapter reviews recent studies on this subject, presents an analytical framework and focuses on three critical issues: the extent to which loads can be consolidated in LHVs, their effect on the freight modal split and the possibility that the resulting reduction in road freight costs will stimulate additional traffic growth. Most of the recent studies support the development of LHVs, particularly those based on actual experience of their use in countries such as Australia, Sweden and the United States.

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