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Office For Human Research Protections
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH). The office's primary duty is the implementation of , a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection of Human Subjects, which is also known as the "Common Rule". Institutions that conduct DHHS-sponsored research must have a "Federal-Wide Assurance" (FWA), an agreement with OHRP regarding ethical oversight. OHRP also provides education for IRBs, gives guidance on research ...
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United States Department Of Health And Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the US federal government created to protect the health of the US people and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW). HHS is administered by the secretary of health and human services, who is appointed by the president with the advice and consent of the United States Senate. The United States Public Health Service Commissioned Corps, the uniformed service of the PHS, is led by the surgeon general who is responsible for addressing matters concerning public health as authorized by the secretary or by the assistant secretary for health in addition to his or her primary mission of administering the Commissioned Corps. History Federal Security Agency ...
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National Bioethics Advisory Commission
The National Bioethics Advisory Commission was the name of a United States governmental organization which existed from 1996–2001. It was replaced by The President's Council on Bioethics. __TOC__ Reports In 1999 the NBAC issued a report containing 23 recommendations on the governance of biobanks. Other work during its existence was the creation of 120 recommendations on bioethics issues human cloning, research involving mental vulnerable persons, research with human biological specimens, stem cell research, clinical trials in developing countries but sponsored by the United States, and privacy for research participants Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Some typical scenarios this would apply to include, or example, a surveyor .... Here are the titles of the reports published by the commission: * ''Ethical and Policy Issues in Research Invol ...
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Belmont Report
The ''Belmont Report'' is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the ''Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research''. The ''Belmont Report'' summarizes ethical principles and guidelines for human subject research. Three core principles are identified: respect for persons, Beneficence, and Justice. The three primary areas of application were stated as informed consent, assessment of risks and benefits, and selection of human subjects in research. It was named the ''Belmont Report'', for the Belmont Conference Center, where the National Commission met when first drafting the report. According to Vollmer and Howard, the ''Belmont Report'' allows for a positive solution, which at times may be difficult to find, t ...
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The Office Of Human Research Protections Organization Graph
''The'' is a grammatical article in English, denoting nouns that are already or about to be mentioned, under discussion, implied or otherwise presumed familiar to listeners, readers, or speakers. It is the definite article in English. ''The'' is the most frequently used word in the English language; studies and analyses of texts have found it to account for seven percent of all printed English-language words. It is derived from gendered articles in Old English which combined in Middle English and now has a single form used with nouns of any gender. The word can be used with both singular and plural nouns, and with a noun that starts with any letter. This is different from many other languages, which have different forms of the definite article for different genders or numbers. Pronunciation In most dialects, "the" is pronounced as (with the voiced dental fricative followed by a schwa) when followed by a consonant sound, and as (homophone of the archaic pronoun ''thee'' ...
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Informed Consent
Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their Right to refuse medical treatment, right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research, to disclose a person's medical information, or to participate in high risk sporting and recreational activities. Within the United States, definitions of informed consent vary, and the standard required is generally determined by the state. As of 2016, nearly half of the states adopted a reasonable patient standard, in which the informed consent process is viewed from the patient's perspective. These standards ...
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Hexamethonium
Hexamethonium is a non-depolarising ganglionic blocker, a neuronal nicotinic ( nAChR) receptor antagonist that acts in autonomic ganglia by binding mostly in or on the nAChR receptor, and not the acetylcholine binding site itself. It does not have any effect on the muscarinic acetylcholine receptors ( mAChR) located on target organs of the parasympathetic nervous system, nor on the nicotinic receptors at the skeletal neuromuscular junction, but acts as antagonist at the nicotinic acetylcholine receptors located in sympathetic and parasympathetic ganglia ( nAChR). Pharmacology By blocking the neuronal nicotinic receptors in autonomic ganglia, which are necessary for transmission in all autonomic ganglia, both the sympathetic and parasympathetic nervous systems are inhibited. Its action on the neuronal nicotinic receptors is primarily through the block of the ion pore, rather than through competition with the binding site for acetylcholine. Postganglionic sympathetic system ...
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Johns Hopkins University
The Johns Hopkins University (often abbreviated as Johns Hopkins, Hopkins, or JHU) is a private university, private research university in Baltimore, Maryland, United States. Founded in 1876 based on the European research institution model, Johns Hopkins is considered to be the first research university in the U.S. The university was named for its first benefactor, the American entrepreneur and Quakers, Quaker philanthropist Johns Hopkins. Hopkins's $7 million bequest (equivalent to $ in ) to establish the university was the largest Philanthropy, philanthropic gift in U.S. history up to that time. Daniel Coit Gilman, who was inaugurated as :Presidents of Johns Hopkins University, Johns Hopkins's first president on February 22, 1876, led the university to revolutionize higher education in the U.S. by integrating teaching and research. In 1900, Johns Hopkins became a founding member of the Association of American Universities. The university has led all Higher education in the U ...
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Human Subject Research
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. (A specific, and especially heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and medical devices are evaluated.) On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, ...
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David Satcher
David Satcher (born March 2, 1941) is an American physician, and public health administrator. He is a four-star admiral in the United States Public Health Service Commissioned Corps and served as the 11th Assistant Secretary for Health, and the 16th Surgeon General of the United States. Biography Early years Satcher was born in Anniston, Alabama. At the age of two, he contracted whooping cough. A Black doctor, Dr. Jackson, came to his parents' farm, and told his parents he didn't expect David to live, but nonetheless spent the day with him and told his parents how to give him the best chance he could. Satcher said that he grew up hearing that story, and that inspired him to be a doctor. While in college, Satcher was active in the Civil Rights Movement and was arrested on multiple occasions. Satcher graduated from Morehouse College in Atlanta in 1963 and was elected to Phi Beta Kappa. He received his MD and a PhD in cell biology from Case Western Reserve University in 1970 ...
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United States Assistant Secretary For Health
The assistant secretary for health (ASH) is a senior U.S. government official within the U.S. Department of Health and Human Services (HHS) who serves as the primary advisor to the secretary of health and human services on matters involving the nation's public health, and provides strategic and policy direction to the Public Health Service agencies and Commissioned Corps. The position is a statutory Senate-confirmed presidential appointment (), who may be a civilian, or a uniformed four-star admiral of the PHS Commissioned Corps and is nominated for appointment by the president. The president may also nominate a civilian appointee to also be appointed a direct commission in the commissioned corps if the nominee so chooses. The assistant secretary's office and its staff make up the Office of the Assistant Secretary for Health (OASH). History The Office of the Assistant Secretary for Health and Scientific Affairs was established on January 1, 1967, following Reorganizatio ...
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Office Of Public Health And Science
An office is a space where the employees of an organization perform administrative work in order to support and realize the various goals of the organization. The word "office" may also denote a position within an organization with specific duties attached to it (see officer or official); the latter is an earlier usage, as "office" originally referred to the location of one's duty. In its adjective form, the term "office" may refer to business-related tasks. In law, a company or organization has offices in any place where it has an official presence, even if that presence consists of a storage silo. For example, instead of a more traditional establishment with a desk and chair, an office is also an architectural and design phenomenon, including small offices, such as a bench in the corner of a small business or a room in someone's home (see small office/home office), entire floors of buildings, and massive buildings dedicated entirely to one company. In modern terms, an office i ...
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Donna Shalala
Donna Edna Shalala ( ; born February 14, 1941) is an American politician and academic who served in the Carter and Clinton administrations, as well as in the U.S. House of Representatives from 2019 to 2021. Shalala is a recipient of the Presidential Medal of Freedom, which she was awarded in 2008. Shalala earned a bachelor's degree from Western College for Women in 1962 and served in the Peace Corps. In 1970, she earned a PhD from the Maxwell School of Citizenship and Public Affairs at Syracuse University. Shalala later worked as a professor at Baruch College and at Teachers College, Columbia University and was appointed as assistant secretary for policy development and research at the U.S. Department of Housing and Urban Development by President Jimmy Carter. Shalala became the president of Hunter College in 1980, serving until 1988 when she became chancellor of the University of Wisconsin–Madison. From 1993 to 2001, Shalala served as the 18th United States Secretary of He ...
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