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Informed Assent
The term informed assent describes the process whereby Minor (law), minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms. Background In adult medical research, the term informed consent is used to describe a state whereby a competent individual, having been fully informed about the nature, benefits and risks of a clinical trial, agrees to their own participation. National authorities define certain populations as vulnerable and therefore unable to provide informed consent, such as those without the necessary cognitive, psychological, or social maturity to understand these benefits and risks. The oft-reported belief that minors (for the purposes of this discussion, read minors as persons under the age of 18 years) are considered a vulnerable population and therefore may not autonomously provide informed consent, is actually an oversimplification that does not always hold ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Minor (law)
In law, a minor is someone under a certain age, usually the age of majority, which demarcates an underage individual from legal adulthood. The age of majority depends upon Jurisdiction (area), jurisdiction and application, but it is commonly 18. ''Minor'' may also be used in contexts that are unconnected to the overall age of majority. For example, the smoking age, smoking and legal drinking age, drinking age in the United States is 21, and younger people below this age are sometimes called ''minors'' in the context of tobacco and alcohol law, even if they are at least 18. The terms underage or ''minor'' often refer to those under the age of majority, but may also refer to a person under other legal age limits, such as the age of consent, marriageable age, driving age, voting age, etc. Such age limits are often different from the age of majority. The concept of ''minor'' is not sharply defined in most jurisdictions. The age of criminal responsibility and consent, the age at whi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Emancipated Minor
Emancipation of minors is a legal mechanism by which a minor before attaining the age of majority is freed from control by their parents or guardians, and the parents or guardians are freed from responsibility for their child. Minors are normally considered legally incompetent to enter into contracts and to handle their own affairs. Emancipation overrides that presumption and allows emancipated children to legally make certain decisions on their own behalf. Depending on jurisdiction, a child may be emancipated by acts such as marriage, attaining economic self-sufficiency, obtaining an educational degree or diploma, or military service. In the United States, all states have some form of emancipation of minors. Even without a court proceeding, some jurisdictions will find a minor to be emancipated for purposes of making a decision in the absence of the minor's parents or guardians. For example, a child in most jurisdictions can enter into a binding contract to procure their o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Legal Terminology
Law is a set of rules that are created and are enforceable by social or governmental institutions to regulate behavior,Robertson, ''Crimes against humanity'', 90. with its precise definition a matter of longstanding debate. It has been variously described as a science and as the art of justice. State-enforced laws can be made by a group legislature or by a single legislator, resulting in statutes; by the executive through decrees and regulations; or established by judges through precedent, usually in common law jurisdictions. Private individuals may create legally binding contracts, including arbitration agreements that adopt alternative ways of resolving disputes to standard court litigation. The creation of laws themselves may be influenced by a constitution, written or tacit, and the rights encoded therein. The law shapes politics, economics, history and society in various ways and serves as a mediator of relations between people. Legal systems vary between jurisdictions, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Médecins Sans Frontières
(MSF; pronounced ), also known as Doctors Without Borders, is a humanitarian medical non-governmental organisation (NGO) or charity of French origin known for its projects in conflict zones and in countries affected by endemic diseases. Main areas of work include diabetes, drug-resistant infections, HIV/AIDS, hepatitis C, tropical and neglected diseases, tuberculosis, vaccines and COVID-19. In 2019, the charity was active in 70 countries with over 35,000 personnel; mostly local doctors, nurses and other medical professionals, logistical experts, water and sanitation engineers, and administrators. Private donors provide about 90% of the organisation's funding, while corporate donations provide the rest, giving MSF an annual budget of approximately US$1.63 billion. MSF was founded in 1971, in the aftermath of the Biafran famine of the Nigerian Civil War, by a small group of French doctors and journalists who sought to expand accessibility to medical care across nation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Declaration Of Helsinki
The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations. Its role was described by a Brazilian forum in 2000 in these words: "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity." Principles The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Trovafloxacin
Trovafloxacin (sold as Trovan by Pfizer and Turvel by Laboratorios Almirall) is a broad spectrum antibiotic that inhibits the uncoiling of supercoiled DNA in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV. It was withdrawn from the market due to the risk of hepatotoxicity. It had better Gram-positive bacterial coverage but less Gram-negative coverage than the previous fluoroquinolones. Adverse reactions Trovafloxacin use is significantly restricted due to its high potential for inducing serious and sometimes fatal liver damage. Currently, the drug is not approved for use in the U.S. or the European Union due to association with cases of acute liver failure and death. Manufacturing The key reaction in building the ring consists of 1,3-Dipolar cycloaddition of ethyl diazoacetate to N-Cbz- 3-pyrroline to afford the pyrrazolidine (3). Pyrolysis results in loss of nitrogen and formation of the cyclopropylpyrrolidine ring. The stereochemistry of the r ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
The Washington Post
''The Washington Post'' (also known as the ''Post'' and, informally, ''WaPo'') is an American daily newspaper published in Washington, D.C. It is the most widely circulated newspaper within the Washington metropolitan area and has a large national audience. Daily broadsheet editions are printed for D.C., Maryland, and Virginia. The ''Post'' was founded in 1877. In its early years, it went through several owners and struggled both financially and editorially. Financier Eugene Meyer purchased it out of bankruptcy in 1933 and revived its health and reputation, work continued by his successors Katharine and Phil Graham (Meyer's daughter and son-in-law), who bought out several rival publications. The ''Post'' 1971 printing of the Pentagon Papers helped spur opposition to the Vietnam War. Subsequently, in the best-known episode in the newspaper's history, reporters Bob Woodward and Carl Bernstein led the American press's investigation into what became known as the Watergate scandal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891). Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than billion in annual revenues. In 2020, 52% of the company's revenues came from the United States, 6% came from each of China and Japan, and 36% came from other countries. Pfizer was a component of the Dow Jones Industrial Average stock market index from 2004 to August 2020. The company ranks 64th on the Fortune 500 and 49th on the Forbes Global 2000. History 1849–1950: Early history Pfizer was founded in 1849 by Charles Pfizer and Charles F. Erhart, two cousins who had i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Washington Post
''The Washington Post'' (also known as the ''Post'' and, informally, ''WaPo'') is an American daily newspaper published in Washington, D.C. It is the most widely circulated newspaper within the Washington metropolitan area and has a large national audience. Daily broadsheet editions are printed for D.C., Maryland, and Virginia. The ''Post'' was founded in 1877. In its early years, it went through several owners and struggled both financially and editorially. Financier Eugene Meyer purchased it out of bankruptcy in 1933 and revived its health and reputation, work continued by his successors Katharine and Phil Graham (Meyer's daughter and son-in-law), who bought out several rival publications. The ''Post'' 1971 printing of the Pentagon Papers helped spur opposition to the Vietnam War. Subsequently, in the best-known episode in the newspaper's history, reporters Bob Woodward and Carl Bernstein led the American press's investigation into what became known as the Watergate scandal, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
