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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 Hu ...
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United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., federal district, five major unincorporated territories, nine United States Minor Outlying Islands, Minor Outlying Islands, and 326 Indian reservations. The United States is also in Compact of Free Association, free association with three Oceania, Pacific Island Sovereign state, sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Palau, Republic of Palau. It is the world's List of countries and dependencies by area, third-largest country by both land and total area. It shares land borders Canada–United States border, with Canada to its north and Mexico–United States border, with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the List of ...
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The President's Council On Bioethics
The President's Council on Bioethics (PCBE) was a group of individuals appointed by United States President George W. Bush to advise his administration on bioethics. Established on November 28, 2001, by Executive Order 13237, the council was directed to "advise the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology". Executive Order 13237 - ''Creation of the President's Council on Bioethics'', November 28, 2001, Vol. 66, No. 231,  It succeeded and largely replaced the National Bioethics Advisory Commission, appointed by President Bill Clinton in 1996, which expired in 2001. The members of the council were appointed directly by the President; the President also chose the chairperson of the council (last appointed Chair was Edmund D. Pellegrino). Council members, totaling no more than 18, were appointed for a two-year term, after which time they could be reappointed by the President. Individuals ...
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Biobanks
A biobank is a type of biorepository that stores biological samples (usually human) for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalized medicine. Biobanks can give researchers access to data representing a large number of people. Samples in biobanks and the data derived from those samples can often be used by multiple researchers for cross purpose research studies. For example, many diseases are associated with single-nucleotide polymorphisms. Genome-wide association studies using data from tens or hundreds of thousands of individuals can identify these genetic associations as potential disease biomarkers. Many researchers struggled to acquire sufficient samples prior to the advent of biobanks. Biobanks have provoked questions on privacy, research ethics, and medical ethics. Viewpoints on what constitutes appropriate biobank ethics diverge. However, a consensus has been ...
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Bioethics
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine ( "the ethics of the ordinary"), ethical education in science, animal, and environmental ethics, and public health. Etymology The term ''Bioethics'' (Greek , life; , behavior) was coined in 1927 by Fritz Jahr in an article about a ...
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Human Cloning
Human cloning is the creation of a genetically identical copy (or clone) of a human. The term is generally used to refer to artificial human cloning, which is the reproduction of human cells and tissue. It does not refer to the natural conception and delivery of identical twins. The possibility of human cloning has raised controversies. These ethical concerns have prompted several nations to pass laws regarding human cloning. Two commonly discussed types of human cloning are ''therapeutic cloning'' and ''reproductive cloning''. Therapeutic cloning would involve cloning cells from a human for use in medicine and transplants. It is an active area of research, but is not in medical practice anywhere in the world, as of . Two common methods of therapeutic cloning that are being researched are somatic-cell nuclear transfer and (more recently) pluripotent stem cell induction. Reproductive cloning would involve making an entire cloned human, instead of just specific cells or tis ...
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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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Stem Cell Research
In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of cell in a cell lineage. They are found in both embryonic and adult organisms, but they have slightly different properties in each. They are usually distinguished from progenitor cells, which cannot divide indefinitely, and precursor or blast cells, which are usually committed to differentiating into one cell type. In mammals, roughly 50–150 cells make up the inner cell mass during the blastocyst stage of embryonic development, around days 5–14. These have stem-cell capability. ''In vivo'', they eventually differentiate into all of the body's cell types (making them pluripotent). This process starts with the differentiation into the three germ layers – the ectoderm, mesoderm and endoderm – at the gastrulation stage. However, when ...
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Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, 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 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 studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ...
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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 doing social research conducts an interview with a participant, or a medical researcher in a clinical trial asks for a blood sample from a participant to see if there is a relationship between something which can be measured in blood and a person's health. In both cases, the ideal outcome is that any participant can join the study and neither the researcher nor the study design nor the publication of the study results would ever identify any participant in the study. Thus, the privacy rights of these individuals can be preserved. Privacy for medical research participants is protected by several procedures such as informed consent, compliance with medical privacy laws, and transparency in how patient data is accumulated and analyzed. ...
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Bioethics Research Organizations
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine ( "the ethics of the ordinary"), ethical education in science, animal, and environmental ethics, and public health. Etymology The term ''Bioethics'' ( Greek , life; , behavior) was coined in 1927 by Fritz Jahr in an articl ...
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Biobank Organizations
A biobank is a type of biorepository that stores biological samples (usually human) for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalized medicine. Biobanks can give researchers access to data representing a large number of people. Samples in biobanks and the data derived from those samples can often be used by multiple researchers for cross purpose research studies. For example, many diseases are associated with single-nucleotide polymorphisms. Genome-wide association studies using data from tens or hundreds of thousands of individuals can identify these genetic associations as potential disease biomarkers. Many researchers struggled to acquire sufficient samples prior to the advent of biobanks. Biobanks have provoked questions on privacy, research ethics, and medical ethics. Viewpoints on what constitutes appropriate biobank ethics diverge. However, a consensus ha ...
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