scholarly journals Recommendations for Ethical Review of Veterinary Clinical Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Jessica A. Bertout ◽  
Philippe J. R. Baneux ◽  
Carol K. Robertson-Plouch
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Best Practices ◽  
United States Of America ◽  
Clinical Studies ◽  
Animal Studies ◽  
The United States ◽  
Animal Research ◽  
Laboratory Animals ◽  
Ethical Review

Ethical review of both human and animal research is critical to ensuring that studies are conducted with due regard to the welfare and safety of enrolled subjects and to the integrity of the data. However, differences exist in laws, policies, and best practices between human and animal studies. Ethical review is required for most human studies. While the laws and standards are clear for humans and for laboratory animals, the laws and standards for clinical research for client-owned animals are not as well-defined. Here, we discuss gaps in ethical review of clinical animal research in the United States of America and propose expanded functions for veterinary clinical studies committees as a solution.

scholarly journals Best Practices for Conducting Clinical Trials With Indigenous Children in the United States

2021 ◽  
Vol 111 (9) ◽  
pp. 1645-1653
Author(s):  
Jennifer L. Shaw ◽  
Erin Semmens ◽  
May Okihiro ◽  
Johnnye L. Lewis ◽  
Matthew Hirschfeld ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Best Practices ◽  
Health Outcomes ◽  
Alaska Native ◽  
Institutional Development ◽  
The United States ◽  
Indigenous Research ◽  
Case Examples ◽  
Indigenous Children

We provide guidance for conducting clinical trials with Indigenous children in the United States. We drew on extant literature and our experience to describe 3 best practices for the ethical and effective conduct of clinical trials with Indigenous children. Case examples of pediatric research conducted with American Indian, Alaska Native, and Native Hawaiian communities are provided to illustrate these practices. Ethical and effective clinical trials with Indigenous children require early and sustained community engagement, building capacity for Indigenous research, and supporting community oversight and ownership of research. Effective engagement requires equity, trust, shared interests, and mutual benefit among partners over time. Capacity building should prioritize developing Indigenous researchers. Supporting community oversight and ownership of research means that investigators should plan for data-sharing agreements, return or destruction of data, and multiple regulatory approvals. Indigenous children must be included in clinical trials to reduce health disparities and improve health outcomes in these pediatric populations. Establishment of the Environmental Influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network (ECHO ISPCTN) in 2016 creates a unique and timely opportunity to increase Indigenous children’s participation in state-of-the-art clinical trials.

scholarly journals Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database

2015 ◽  
Vol 25 (S2) ◽  
pp. 172-180 ◽  
Author(s):  
Kevin D. Hill ◽  
Heather T. Henderson ◽  
Christoph P. Hornik ◽  
Jennifer S. Li
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Optimal Design ◽  
Drug Administration ◽  
United States Of America ◽  
Capital Investment ◽  
Food And Drug Administration ◽  
The United States ◽  
Pediatric Drug ◽  
The Impact

AbstractRecent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.

Thinking About Scots Law

1996 ◽  
Vol 1 (1) ◽  
pp. 3-24 ◽  
Author(s):  
Alan Rodger
Keyword(s):  
United States ◽  
Nineteenth Century ◽  
British Empire ◽  
United States Of America ◽  
Case Law ◽  
The United States ◽  
Memorial Lecture ◽  
University Of Edinburgh ◽  
The University

This article is the revised text of the first W A Wilson Memorial Lecture, given in the Playfair Library, Old College, in the University of Edinburgh, on 17 May 1995. It considers various visions of Scots law as a whole, arguing that it is now a system based as much upon case law and precedent as upon principle, and that its departure from the Civilian tradition in the nineteenth century was part of a general European trend. An additional factor shaping the attitudes of Scots lawyers from the later nineteenth century on was a tendency to see themselves as part of a larger Englishspeaking family of lawyers within the British Empire and the United States of America.

Off to a bad start: John Adams’s tussle over titles

2008 ◽  
Vol 4 ◽  
Author(s):  
James C Alexander
Keyword(s):  
United States ◽  
United States Of America ◽  
Vice President ◽  
The United States ◽  
John Adams ◽  
The Press ◽  
First Session

From the first days, of the first session, of the first Congress of the United States, the Senate was consumed by an issue that would do immense and lasting political harm to the sitting vice president, John Adams. The issue was a seemingly unimportant one: titles. Adams had strong opinions on what constituted a proper title for important officers of government and, either because he was unconcerned or unaware of the damage it would cause, placed himself in the middle of the brewing dispute. Adams hoped the president would be referred to as, “His highness, the President of the United States of America, and Protector of the Rights of the Same.” The suggestion enraged many, amused some, and was supported by few. He lost the fight over titles and made fast enemies with several of the Senators he was constitutionally obligated to preside over. Adams was savaged in the press, derided in the Senate and denounced by one of his oldest and closest friends. Not simply an isolated incident of political tone-deafness, this event set the stage for the campaign against Adams as a monarchist and provided further proof of his being woefully out of touch.

Armed Violence in the Ideology of Contemporary Islamic Fundamentalism - Study models

2019 ◽  
Vol 2 (4) ◽  
pp. 237
Author(s):  
Laith Mzahim Khudair Kazem
Keyword(s):  
United States ◽  
United States Of America ◽  
The United States ◽  
The Other ◽  
Islamic Fundamentalism ◽  
Islamic Movements ◽  
Important Means ◽  
Armed Violence ◽  
Goals And Objectives ◽  
At Home

The armed violence of many radical Islamic movements is one of the most important means to achieve the goals and objectives of these movements. These movements have legitimized and legitimized these violent practices and constructed justification ideologies in order to justify their use for them both at home against governments or against the other Religiously, intellectually and even culturally, or abroad against countries that call them the term "unbelievers", especially the United States of America.

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