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Honest Broker
An honest broker is an entity that keeps sets of private information but distributes parts of those sets to other entities who should not have access to the entire set. Honest brokers often work in clinical research with biological specimens; in that case, donors of specimens allow researchers to do research on those specimens, but typically want their specimen de-identified by having protected health information separated from it. The honest broker would keep both the specimen and associated protected health information, but only allow researchers to have access to the specimen without the protected health information. Characteristics Honest brokers are typically appointed to a research project by an institutional review board. They provide data from clinical and research sources for research use only and in accordance with policies that prohibit re-identification. Organizations conducting breast cancer research have identified access to biological specimens as a top priority, a ...
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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 ...
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Biological Specimens
A biological specimen (also called a biospecimen) is a biological laboratory specimen held by a biorepository for research. Such a specimen would be taken by sampling so as to be representative of any other specimen taken from the source of the specimen. When biological specimens are stored, ideally they remain equivalent to freshly-collected specimens for the purposes of research. Human biological specimens are stored in a type of biorepository called a biobank, and the science of preserving biological specimens is most active in the field of biobanking. Quality control Setting broad standards for quality of biological specimens was initially an underdeveloped aspect of biobank growth. There is currently discussion on what standards should be in place and who should manage those standards. Since many organizations set their own standards and since biobanks are necessarily used by multiple organizations and typically are driven towards expansion, the harmonization of standard ...
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De-identification
De-identification is the process used to prevent someone's personal identity from being revealed. For example, data produced during human subject research might be de-identified to preserve the privacy of research participants. Biological data may be de-identified in order to comply with HIPAA regulations that define and stipulate patient privacy laws. When applied to metadata or general data about identification, the process is also known as data anonymization. Common strategies include deleting or masking personal identifiers, such as personal name, and suppressing or generalizing quasi-identifiers, such as date of birth. The reverse process of using de-identified data to identify individuals is known as data re-identification. Successful re-identifications cast doubt on de-identification's effectiveness. A systematic review of fourteen distinct re-identification attacks found "a high re-identification rate €¦dominated by small-scale studies on data that was not de-iden ...
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Institutional Review Board
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes. A key goal of IRBs is to protect human subjects ...
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Breast Cancer
Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a red or scaly patch of skin. In those with distant spread of the disease, there may be bone pain, swollen lymph nodes, shortness of breath, or yellow skin. Risk factors for developing breast cancer include obesity, a lack of physical exercise, alcoholism, hormone replacement therapy during menopause, ionizing radiation, an early age at first menstruation, having children late in life or not at all, older age, having a prior history of breast cancer, and a family history of breast cancer. About 5–10% of cases are the result of a genetic predisposition inherited from a person's parents, including BRCA1 and BRCA2 among others. Breast cancer most commonly develops in cells from the lining of milk ducts and the lobules that supply these ...
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Diplomacy
Diplomacy comprises spoken or written communication by representatives of states (such as leaders and diplomats) intended to influence events in the international system.Ronald Peter Barston, ''Modern diplomacy'', Pearson Education, 2006, p. 1 Diplomacy is the main instrument of foreign policy which represents the broader goals and strategies that guide a state's interactions with the rest of the world. International treaties, agreements, alliances, and other manifestations of international relations are usually the result of diplomatic negotiations and processes. Diplomats may also help to shape a state by advising government officials. Modern diplomatic methods, practices, and principles originated largely from 17th-century European custom. Beginning in the early 20th century, diplomacy became professionalized; the 1961 Vienna Convention on Diplomatic Relations, ratified by most of the world's sovereign states, provides a framework for diplomatic procedures, methods, and co ...
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Otto Von Bismarck
Otto, Prince of Bismarck, Count of Bismarck-Schönhausen, Duke of Lauenburg (, ; 1 April 1815 – 30 July 1898), born Otto Eduard Leopold von Bismarck, was a conservative German statesman and diplomat. From his origins in the upper class of Junker landowners, Bismarck rose rapidly in Prussian politics, and from 1862 to 1890 he was the Minister President of Prussia, minister president and List of foreign ministers of Prussia, foreign minister of Prussia. Before his rise to the Executive (government), executive, he was the Prussian ambassador to Russian Empire, Russia and Second French Empire, France and served in both houses of the Landtag of Prussia, Prussian Parliament. He masterminded the unification of Germany in 1871 and served as the first Chancellor of Germany#Under the Emperor (1871–1918), Chancellor of the German Empire until 1890, in which capacity he dominated European affairs. He had served as the chancellor of the North German Confederation from 1867 to 1871, alon ...
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Congress Of Berlin
The Congress of Berlin (13 June – 13 July 1878) was a diplomatic conference to reorganise the states in the Balkan Peninsula after the Russo-Turkish War of 1877–78, which had been won by Russia against the Ottoman Empire. Represented at the meeting were Europe's then six great powers: Russia, Great Britain, France, Austria-Hungary, Italy and Germany; the Ottomans; and four Balkan states: Greece, Serbia, Romania and Montenegro. The congress concluded with the signing of the Treaty of Berlin, replacing the preliminary Treaty of San Stefano that had been signed three months earlier. The leader of the congress, German Chancellor Otto von Bismarck, sought to stabilise the Balkans, reduce the role of the defeated Ottoman Empire in the region, and balance the distinct interests of Britain, Russia and Austria-Hungary. He also wanted to avoid domination of the Balkans by Russia or the formation of a Greater Bulgaria, and to keep Constantinople in Ottoman hands. Finally Bismarck ...
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Diplomacy
Diplomacy comprises spoken or written communication by representatives of states (such as leaders and diplomats) intended to influence events in the international system.Ronald Peter Barston, ''Modern diplomacy'', Pearson Education, 2006, p. 1 Diplomacy is the main instrument of foreign policy which represents the broader goals and strategies that guide a state's interactions with the rest of the world. International treaties, agreements, alliances, and other manifestations of international relations are usually the result of diplomatic negotiations and processes. Diplomats may also help to shape a state by advising government officials. Modern diplomatic methods, practices, and principles originated largely from 17th-century European custom. Beginning in the early 20th century, diplomacy became professionalized; the 1961 Vienna Convention on Diplomatic Relations, ratified by most of the world's sovereign states, provides a framework for diplomatic procedures, methods, and co ...
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Medical Ethics
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment. There are several codes of conduct. ...
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Research Ethics
Research is " creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to controlling sources of bias and error. These activities are characterized by accounting and controlling for biases. A research project may be an expansion on past work in the field. To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole. The primary purposes of basic research (as opposed to applied research) are documentation, discovery, interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge. Approaches to research depend on epistemologies, which vary considerably both within and between humanities and sciences. There are several forms of research: scientific, humanities, artistic, econ ...
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