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Biobank Ethics
Biobank ethics refers to the ethics pertaining to all aspects of biobanks. The issues examined in the field of biobank ethics are special cases of clinical research ethics. Overview of issues The following table shows many of the leading controversial issues related to biobanking. The table names an issue, then describes a point on which there is consensus and an aspect of that same point for which there is no consensus. Privacy for research participants There is broad consensus that when a person donates a specimen for research then that person has a right to privacy thereafter. To this end, researchers balance the need for specimens to be Anonymity, anonymous or de-identified from protected health information with the need to have access to data about the specimen so that researchers can use the sample without knowing the identity of the donor. In the United States, for example, the Office for Human Research Protections often promotes a traditional system wherein data which co ...
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Ethics
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns matters of value; these fields comprise the branch of philosophy called axiology. Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. As a field of intellectual inquiry, moral philosophy is related to the fields of moral psychology, descriptive ethics, and value theory. Three major areas of study within ethics recognized today are: # Meta-ethics, concerning the theoretical meaning and reference of moral propositions, and how their truth values (if any) can be determined; # Normative ethics, concerning the practical means of determining a moral course of action; # Applied ethics, concerning what a person is obligated (or permitted) to do ...
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Anonymity
Anonymity describes situations where the acting person's identity is unknown. Some writers have argued that namelessness, though technically correct, does not capture what is more centrally at stake in contexts of anonymity. The important idea here is that a person be non-identifiable, unreachable, or untrackable. Anonymity is seen as a technique, or a way of realizing, a certain other values, such as privacy, or liberty. Over the past few years, anonymity tools used on the dark web by criminals and malicious users have drastically altered the ability of law enforcement to use conventional surveillance techniques. An important example for anonymity being not only protected, but enforced by law is the vote in free elections. In many other situations (like conversation between strangers, buying some product or service in a shop), anonymity is traditionally accepted as natural. There are also various situations in which a person might choose to withhold their identity. Acts of cha ...
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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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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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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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Biological Patent
A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate. Biological patents in different jurisdictions Australia In February 2013, Judge Justice John Nicholas ruled in the Federal Court of Australia in favour of a Myriad Genetics patent on the BRCA1 gene. This was a landmark ruling, affirming the validity of patents on naturally occurring DNA sequences. However, the U.S. Supreme Court came to the opposite conclusion only a few months later. The Australian ruling has been appealed to the Full Bench of the Federal Court; submis ...
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Single Nucleotide Polymorphisms
In genetics, a single-nucleotide polymorphism (SNP ; plural SNPs ) is a germline substitution of a single nucleotide at a specific position in the genome. Although certain definitions require the substitution to be present in a sufficiently large fraction of the population (e.g. 1% or more), many publications do not apply such a frequency threshold. For example, at a specific base position in the human genome, the Guanine, G nucleotide may appear in most individuals, but in a minority of individuals, the position is occupied by an Adenine, A. This means that there is a SNP at this specific position, and the two possible nucleotide variations – G or A – are said to be the alleles for this specific position. SNPs pinpoint differences in our susceptibility to a wide range of diseases, for example age-related macular degeneration (a common SNP in the Factor H, CFH gene is associated with increased risk of the disease) or nonalcoholic fatty liver disease (a SNP in the PNPLA3 gene ...
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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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Right To Privacy
The right to privacy is an element of various legal traditions that intends to restrain governmental and private actions that threaten the privacy of individuals. Over 150 national constitutions mention the right to privacy. On 10 December 1948, the United Nations General Assembly adopted the Universal Declaration of Human Rights (UDHR), originally written to guarantee individual rights of everyone everywhere; while ''right to privacy'' does not appear in the document, many interpret this through Article 12, which states: "No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks." Since the global surveillance disclosures (2013–present), global surveillance disclosures of 2013, initiated by ex-NSA employee Edward Snowden, the right to privacy has been a subject of international debate. Government ag ...
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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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Public Consultation
Public consultation (Commonwealth countries and European Union), public comment (US), or simply consultation, is a regulatory process by which the public's input on matters affecting them is sought. Its main goals are in improving the efficiency, transparencyBackground Document on Public Consultation
(from the Code, 10-Mar-2006)
and public involvement in large-scale projects or laws and policies. It usually involves ''notification'' (to publicise the matter to be consulted on), ''consultation'' (a two-way flow of information and opinion exchange) as well as ''participation'' (involving interest groups in the drafting of policy or legislation). A frequently used tool for understanding ...
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