Office For Human Research Protections
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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 e ...
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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 U.S. federal government created to protect the health of all Americans 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 position is currently held by Xavier Becerra. 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 Commission ...
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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. 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 surveyo .... Here are the titles of the reports published by the commission: * ''Ethical and Policy Issues in Research Involving Hum ...
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Belmont Report
The ''Belmont Report'' is a 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 report was issued on September 30, 1978 and published in the Federal Register on April 18, 1979. The report took its name from the Belmont Conference Center where the document was drafted in part. The Belmont Conference Center, once a part of the Smithsonian Institution, is in Elkridge, Maryland, 10 miles south of Baltimore, and until the end of 2010 was operated by Howard Community College. The ''Belmont Report'' summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Three primary areas ...
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The Office Of Human Research Protections Organization Graph
''The'' () is a grammatical article in English, denoting persons or things already 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 pronouns 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 pronoun ''thee'') when followed by a v ...
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Informed Consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their 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 and to disclosing a person's medical information. Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning an ...
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Hexamethonium
Hexamethonium is a non-depolarising ganglionic blocker, a 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 but acts as antagonist at the nicotinic acetylcholine receptors located in sympathetic and parasympathetic ganglia ( nAChR). Pharmacology It can act on receptors at pre-ganglionic sites in both the sympathetic and parasympathetic nervous systems, which are both regulated by nicotinic ligand-gated ionotropic acetylcholine receptors. Postganglionic sympathetic systems are usually regulated by norepinephrine (noradrenaline) (adrenergic receptors), whereas parasympathetic systems are acetylcholine-based, and instead rely on muscarinic receptors (some post-ganglionic sympathetic neurons, such as those stimulating sweat ...
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Johns Hopkins University
Johns Hopkins University (Johns Hopkins, Hopkins, or JHU) is a private university, private research university in Baltimore, Maryland. Founded in 1876, Johns Hopkins is the oldest research university in the United States and in the western hemisphere. It consistently ranks among the most prestigious universities in the United States and the world. The university was named for its first benefactor, the American entrepreneur and Quaker philanthropist Johns Hopkins. Hopkins' $7 million bequest 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 American Association of Universities. The university has led all Higher education in the U ...
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David Satcher
David Satcher, (born March 2, 1941) is an American physician, and public health administrator. He was a four-star admiral in the United States Public Health Service Commissioned Corps and served as the 10th 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 197 ...
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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 United States Department of Health and Human Services (HHS). The position is a statutory office () and the holder of the office serves as the United States Secretary of Health and Human Services's primary advisor on matters involving the nation's public health. The assistant secretary oversees all matters pertaining to the United States Public Health Service (PHS), the main division of the Department of Health and Human Services, for the secretary, and provides strategic and policy direction. The Public Health Service comprises almost all of the agency divisions of the Department of Health and Human Services including the United States Public Health Service Commissioned Corps, one of the eight federal uniformed services, comprising more than 6,500 uniformed health professionals who serve with the Department of Health and Human Services, or are assigned to work within other federal agencies ...
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Office Of Public Health And Science
The Office of the Assistant Secretary for Health (OASH) is an operating agency of the United States Department of Health and Human Services and the managing personnel body for the United States Public Health Service. The office is under the direction of the Assistant Secretary for Health, who serves as the senior advisor on public health and science issues to the Department Secretary. The Office serves as the focal point for leadership and coordination across the Department in public health and science, provides direction to program offices within OASH, and provides advice and counsel on public health and science issues to the Secretary. Prior to 2010, the Office was known as the Office of Public Health and Science (OPHS). Organization As of 2018, OASH oversees 12 core public health offices, 10 regional health offices, and 10 presidential and secretarial advisory committees. The core offices are: * National Vaccine Program Office * Office of Adolescent Health * Office of Diseas ...
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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 Ph.D. from the Maxwell School of Citizenship and Public Affairs. 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 Health and Human Ser ...
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