|
Clinical Equipoise
Clinical equipoise, also known as the principle of equipoise, provides the ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial. The term was proposed by Benjamin Freedman in 1987 in response to "controversy in the clinical community" to define an ethical situation of “genuine uncertainty within the expert medical community… about the preferred treatment.” This applies also for off-label treatments performed before or during their required clinical trials. An ethical dilemma arises in a clinical trial when the investigator(s) begin to believe that the treatment or intervention administered in one arm of the trial is significantly outperforming the other arms. A trial should begin with a null hypothesis, and there should exist no decisive Empirical evidence, evidence that the intervention or drug being tested will be superior to existing treatments, or that it will be completely ineffective. As the trial progresses, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bracketing (phenomenology)
Bracketing (; also called phenomenological reduction, transcendental reduction or phenomenological ''epoché'') means looking at a situation and refraining from judgement and biased opinions to wholly understand an experience. The preliminary step in the philosophical movement of phenomenology is to suspend judgment (''i.e.'', epoché) about the natural world and instead, to focus on analysis of experience. Suspending judgement involves stripping away every connotation and assumption made about an object. Its earliest conception can be traced back to Immanuel Kant who argued that the only reality that one can know is the one each individual experiences in their mind (or Phenomena). Edmund Husserl, building on Kant’s ideas, first proposed bracketing in 1913, to help better understand another’s phenomena. Overview Immanuel Kant Though it was formally developed by Edmund Husserl (1859–1938), phenomenology can be understood as an outgrowth of the influential ideas of Immanuel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ethical Principles
Ethics is the philosophical study of moral phenomena. Also called moral philosophy, it investigates normative questions about what people ought to do or which behavior is morally right. Its main branches include normative ethics, applied ethics, and metaethics. Normative ethics aims to find general principles that govern how people should act. Applied ethics examines concrete ethical problems in real-life situations, such as abortion, treatment of animals, and business practices. Metaethics explores the underlying assumptions and concepts of ethics. It asks whether there are objective moral facts, how moral knowledge is possible, and how moral judgments motivate people. Influential normative theories are consequentialism, deontology, and virtue ethics. According to consequentialists, an act is right if it leads to the best consequences. Deontologists focus on acts themselves, saying that they must adhere to duties, like telling the truth and keeping promises. Virtue ethics ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Edward Jenner
Edward Jenner (17 May 1749 – 26 January 1823) was an English physician and scientist who pioneered the concept of vaccines and created the smallpox vaccine, the world's first vaccine. The terms ''vaccine'' and ''vaccination'' are derived from ''Variolae vaccinae'' ('pustules of the cow'), the term devised by Jenner to denote cowpox. He used it in 1798 in the title of his ''Inquiry into the Variolae vaccinae known as the Cow Pox'', in which he described the protective effect of cowpox against smallpox. Jenner is often called "the father of immunology", and his work is said to have saved "more lives than any other man". In Jenner's time, smallpox killed around 10% of the global population, with the number as high as 20% in towns and cities where infection spread more easily. In 1821, he was appointed physician to King George IV, and was also made mayor of Berkeley and justice of the peace. He was a member of the Royal Society. In the field of zoology, he was among the firs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Suspension Of Judgment
Suspended judgment is a cognitive process and a rational state of mind in which one withholds judgments, particularly on the drawing of moral or ethical conclusions. The opposite of suspension of judgment is ''premature judgement'', usually shortened to ''prejudice''. While prejudgment involves drawing a conclusion or making a judgment before having the information relevant to such a judgment, suspension of judgment involves waiting for all the facts before making a decision. Law Suspension of judgment is used in civil law to indicate a court's decision to nullify a civil judgment. Motions to set aside judgments entered in civil cases in the United States district courts are governed by Rule 60 of the Federal Rules of Civil Procedure which opens with the statement, "On motion and just terms, the court may relieve a party or its legal representative from a final judgment, order, or proceeding...". The rule is quite straightforward and court room application is mostly as stated. In ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Principle Of Indifference
The principle of indifference (also called principle of insufficient reason) is a rule for assigning epistemic probabilities. The principle of indifference states that in the absence of any relevant evidence, agents should distribute their credence (or "degrees of belief") equally among all the possible outcomes under consideration. In Bayesian probability, this is the simplest non-informative prior. Examples The textbook examples for the application of the principle of indifference are coins, dice, and cards. In a macroscopic system, at least, it must be assumed that the physical laws that govern the system are not known well enough to predict the outcome. As observed some centuries ago by John Arbuthnot (in the preface of ''Of the Laws of Chance'', 1692), :It is impossible for a Die, with such determin'd force and direction, not to fall on such determin'd side, only I don't know the force and direction which makes it fall on such determin'd side, and therefore I call it ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Precautionary Principle
The precautionary principle (or precautionary approach) is a broad epistemological, philosophical and legal approach to innovations with potential for causing harm when extensive scientific knowledge on the matter is lacking. It emphasizes caution, pausing and review before leaping into new innovations that may prove disastrous. Critics argue that it is vague, self-cancelling, unscientific and an obstacle to progress. In an engineering context, the precautionary principle manifests itself as the factor of safety. It was apparently suggested, in civil engineering, by Belidorde Bélidor, Bernard Forest, La science des ingénieurs, dans la conduite des travaux de fortification et d'architecture civile, Paris: Chez Claude Jombert 1729 in 1729. Interrelation between safety factor and reliability is extensively studied by engineers and philosophers. The principle is often used by policy makers in situations where there is the possibility of harm from making a certain decision (e.g. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cartesian Doubt
Cartesian doubt is a form of methodological skepticism associated with the writings and methodology of René Descartes (March 31, 1596February 11, 1650). Cartesian doubt is also known as Cartesian skepticism, methodic doubt, methodological skepticism, universal doubt, systematic doubt, or hyperbolic doubt. Cartesian doubt is a systematic process of being skeptical about (or doubting) the truth of one's beliefs, which has become a characteristic method in philosophy. Additionally, Descartes' method has been seen by many as the root of the modern scientific method. This method of doubt was largely popularized in Western philosophy by René Descartes, who sought to doubt the truth of all beliefs in order to determine which he could be certain were true. It is the basis for Descartes' statement, "''Cogito ergo sum''" (I think, therefore I am). A fuller version of his phrase: "''dubito ergo cogito, cogito ergo sum''" translates to "I doubt therefore I think, I think therefore I exist." ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Therapeutic Misconception
Therapeutic misconception is a common ethical problem encountered in human subjects research. It was originally described in 1982 by Paul Appelbaum and colleagues. The idea was introduced to the bioethics community in 1987. The formulation given by Appelbaum ''et al.'' in 1987 was the following: “To maintain a therapeutic misconception is to deny the possibility that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself.” Context and definitions Therapeutic misconception did not receive great attention until the early 2000s, when references to the concept expanded significantly. Originally only used in the context of randomized controlled trials, the term is now commonly used among sociologists, neuroscientists, and clinical investigators. Therapeutic misconception Therapeutic misconception is detrimental to a subject's understanding of a study, which is crucial for an autonomous decision. Certain facto ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patient Recruitment
Patient recruitment is the process of finding and enrolling suitable participants for clinical trials. It is a crucial aspect of drug development and medical research, as it affects the validity, reliability, and generalizability of the results. Patient recruitment can also be challenging, time-consuming, and costly, involving various ethical, regulatory, and logistical issues. Many factors influence patient recruitment, such as the design and complexity of the trial, the availability and accessibility of the target population, the awareness and motivation of the potential participants, and the competition and collaboration among different stakeholders. To overcome these challenges, patient recruitment service providers offer various solutions, such as public education, patient outreach, site support, and data analytics. These services aim to increase the enrollment rate, reduce the dropout rate, and improve the quality and diversity of the trial participants. Patient recruitmen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Surgical
Surgery is a medical specialty that uses manual and instrumental techniques to diagnose or treat pathological conditions (e.g., trauma, disease, injury, malignancy), to alter bodily functions (e.g., malabsorption created by bariatric surgery such as gastric bypass), to reconstruct or alter aesthetics and appearance ( cosmetic surgery), or to remove unwanted tissues (body fat, glands, scars or skin tags) or foreign bodies. The act of performing surgery may be called a surgical procedure or surgical operation, or simply "surgery" or "operation". In this context, the verb "operate" means to perform surgery. The adjective surgical means pertaining to surgery; e.g. surgical instruments, surgical facility or surgical nurse. Most surgical procedures are performed by a pair of operators: a surgeon who is the main operator performing the surgery, and a surgical assistant who provides in-procedure manual assistance during surgery. Modern surgical operations typically require a surgi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
