Children In Clinical Research
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Children In Clinical Research
In health care, a clinical trial is a comparison test of a medication or other medical treatment (such as a medical device), versus a placebo (inactive look-alike), other medications or devices, or the standard medical treatment for a patient's condition. To be ethical, researchers must obtain the full and voluntary informed consent of participating human subjects. If the subject is unable to consent for him/herself, researchers can seek consent from the subject's legally authorized representative. For a minor child this is typically a parent or guardian since as under the age of 18 cannot legally give consent to participate in a clinical trial. International standards According to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good clinical practice, all trials involving unapproved medical treatments are reviewed for ethics before the study begins. These approving groups are typically called Institutional Re ...
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Health Care
Health care or healthcare is the improvement of health via the prevention, diagnosis, treatment, amelioration or cure of disease, illness, injury, and other physical and mental impairments in people. Health care is delivered by health professionals and allied health fields. Medicine, dentistry, pharmacy, midwifery, nursing, optometry, audiology, psychology, occupational therapy, physical therapy, athletic training, and other health professions all constitute health care. It includes work done in providing primary care, secondary care, and tertiary care, as well as in public health. Access to health care may vary across countries, communities, and individuals, influenced by social and economic conditions as well as health policies. Providing health care services means "the timely use of personal health services to achieve the best possible health outcomes". Factors to consider in terms of health care access include financial limitations (such as insurance coverage), geo ...
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Reye's Syndrome
Reye syndrome is a rapidly worsening brain disease. Symptoms of Reye syndrome may include vomiting, personality changes, confusion, seizures, and loss of consciousness. While liver toxicity typically occurs in the syndrome, jaundice usually does not. Death occurs in 20–40% of those affected with Reye syndrome, and about a third of those who survive are left with a significant degree of brain damage. The cause of Reye syndrome is unknown. It usually begins shortly after recovery from a viral infection, such as influenza or chickenpox. About 90% of cases in children are associated with aspirin (salicylate) use. Inborn errors of metabolism are also a risk factor. The syndrome is associated with changes on blood tests such as a high blood ammonia level, low blood sugar level, and prolonged prothrombin time. Often, the liver is enlarged in the syndrome. Prevention is typically by avoiding the use of aspirin in children. When aspirin was withdrawn for use in children in t ...
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Pregnant Women In Clinical Research
Pregnant women have historically been excluded from clinical research due to ethical concerns about harming the fetus or the perception of increased risk to the woman. Excluding pregnant women from research has also been called unethical, as it results in a scarcity of data about how therapies affect pregnant women and their fetuses. Despite consensus from bioethicists, researchers, and regulators that pregnant women should be included in clinical research, up to 95% of Phase IV clinical trials that could have included pregnant women did not, according to a 2013 review. Ethical considerations There are several points of concern regarding clinical research with pregnant women. Some concern is related to the idea that the fetus cannot give consent to participate in the research. Some clinical research could also result in unexpected harm to the fetus. Other concerns are that pregnant women are potentially more vulnerable to negative side effects than other populations. It has also been ...
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Philosophy Of Healthcare
The philosophy of healthcare is the study of the ethics, processes, and people which constitute the maintenance of health for human beings. (Although veterinary concerns are worthy to note, the body of thought regarding their methodologies and practices is not addressed in this article.) For the most part, however, the philosophy of healthcare is best approached as an indelible component of human social structures. That is, the societal institution of healthcare can be seen as a necessary phenomenon of human civilization whereby an individual continually seeks to improve, mend, and alter the overall nature and quality of their life. This perennial concern is especially prominent in modern political liberalism, wherein health has been understood as the foundational good necessary for public life. The philosophy of healthcare is primarily concerned with the following elemental questions: *Who requires and/or deserves healthcare? Is healthcare a fundamental right of all people? *Wha ...
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Human Experimentation In The United States
Humans (''Homo sapiens'') are the most abundant and widespread species of primate, characterized by bipedalism and exceptional cognitive skills due to a large and complex brain. This has enabled the development of advanced tools, culture, and language. Humans are highly social and tend to live in complex social structures composed of many cooperating and competing groups, from families and kinship networks to political states. Social interactions between humans have established a wide variety of values, social norms, and rituals, which bolster human society. Its intelligence and its desire to understand and influence the environment and to explain and manipulate phenomena have motivated humanity's development of science, philosophy, mythology, religion, and other fields of study. Although some scientists equate the term ''humans'' with all members of the genus ''Homo'', in common usage, it generally refers to ''Homo sapiens'', the only extant member. Anatomically modern ...
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Ethics In Clinical Research
Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Governance Most directly a local institutional review board oversees the clinical research ethics of any given clinical trial. The institutional review board understands and acts according to local and national law. Each countries national law is guided by international principles, such as the Belmont Report's directive that all study participants have a right to "respect for persons", "beneficence", and "justice" when participating in clinical research. Study participant rights Participants in clinical research have rights which they should expect, including the following: *right to informed consent *shared decision-making *privacy for research participants *return of results *right to withdraw Vulnerable populations There is a range of autonomy which study participants ...
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Ethics
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns matters of value; these fields comprise the branch of philosophy called axiology. Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. As a field of intellectual inquiry, moral philosophy is related to the fields of moral psychology, descriptive ethics, and value theory. Three major areas of study within ethics recognized today are: # Meta-ethics, concerning the theoretical meaning and reference of moral propositions, and how their truth values (if any) can be determined; # Normative ethics, concerning the practical means of determining a moral course of action; # Applied ethics, concerning what a person is obligated (or permitted) to do ...
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Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ...
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Commission To Inquire Into Child Abuse
The Commission to Inquire into Child Abuse (CICA) was one of a range of measures introduced by the Irish Government to investigate the extent and effects of abuse on children from 1936 onwards. Commencing its work in 1999, it was commonly known in Ireland as the Laffoy Commission after its chair, Justice Mary Laffoy. Laffoy resigned as chair in 2003 and was succeeded by Justice Sean Ryan, with the commission becoming known as the Ryan Commission. It published its final public report, commonly referred to as the Ryan report, in 2009. The commission's remit was to investigate all forms of child abuse in Irish institutions for children; the majority of allegations it investigated related to the system of sixty residential "Reformatory and Industrial Schools" operated by Catholic Church orders, funded and supervised by the Irish Department of Education. The commission's report said testimony had demonstrated beyond a doubt that the entire system treated children more like prison in ...
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University College Dublin
University College Dublin (commonly referred to as UCD) ( ga, Coláiste na hOllscoile, Baile Átha Cliath) is a public research university in Dublin, Ireland, and a collegiate university, member institution of the National University of Ireland. With 33,284 students, it is Ireland's largest university, and amongst the most prestigious universities in the country. Five Nobel Laureates are among UCD's alumni and current and former staff. Additionally, four Irish Taoiseach (Prime Ministers) and three Irish Presidents have graduated from UCD, along with one President of India. UCD originates in a body founded in 1854, which opened as the Catholic University of Ireland on the feast of Saint Malachy, St. Malachy with John Henry Newman as its first rector; it re-formed in 1880 and chartered in its own right in 1908. The Universities Act, 1997 renamed the constituent university as the "National University of Ireland, Dublin", and a ministerial order of 1998 renamed the institution as "U ...
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Ireland
Ireland ( ; ga, Éire ; Ulster Scots dialect, Ulster-Scots: ) is an island in the Atlantic Ocean, North Atlantic Ocean, in Northwestern Europe, north-western Europe. It is separated from Great Britain to its east by the North Channel (Great Britain and Ireland), North Channel, the Irish Sea, and St George's Channel. Ireland is the List of islands of the British Isles, second-largest island of the British Isles, the List of European islands by area, third-largest in Europe, and the List of islands by area, twentieth-largest on Earth. Geopolitically, Ireland is divided between the Republic of Ireland (officially Names of the Irish state, named Ireland), which covers five-sixths of the island, and Northern Ireland, which is part of the United Kingdom. As of 2022, the Irish population analysis, population of the entire island is just over 7 million, with 5.1 million living in the Republic of Ireland and 1.9 million in Northern Ireland, ranking it the List of European islan ...
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Patent
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A patent is not the grant of a right to make or use or sell. It does not, directly or indirectly, imply any such right. It grants only the right to exclude others. The supposition that a right to make is created by the patent grant is obviously inconsistent with the established distinctions between generic and specific patents, and with the well-known fact that a very considerable portion of the patents granted are in a field covered by a former relatively generic or basic patent, are tributary to such earlier patent, and cannot be practiced unless by license thereunder." – ''Herman v. Youngstown Car Mfg. Co.'', 191 F. 579, 584–85, 112 CCA 185 (6th Cir. 1911) In most countries, patent rights fall under private law and the patent holder mus ...
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