Belmont Principles
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Belmont Principles
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 area ...
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National Commission For The Protection Of Human Subjects Of Biomedical And Behavioral Research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States. Formed in the aftermath of the Tuskegee Study of Untreated Syphilis in the Negro Male, Tuskegee Experiment scandal, the Commission was created in 1974 as Title II of the National Research Act. It was part of the United States Department of Health, Education, and Welfare (DHEW) until 1978. Goals The Commission had four goals that it needed to analyze: 1) the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were 2) assessing the risks and benefits of the appropriateness of research involving human subjects 3) determining appropriate guidelines for how human subjects can be chosen for the participation in such research 4) defining what informed consent is in each research setting. Work The Commission also had the task of making recommendat ...
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Justice (ethics)
In research ethics, justice is the fair selection of research participants. Justice is the ideal distribution of risks and benefits when scientists conducting clinical research are recruiting volunteer research participants to participate in clinical trials. The concept gives guidelines on how scientific objectives and not membership in either a privileged or vulnerable population should determine which members of which communities should meet inclusion criteria to participate in research in order to most equitably share the risks and benefits of the research. Defining research justice The most commonly recognized source for drawing attention to the importance of justice is the 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 ..., which used the term "justice" to describ ...
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Ethics Literature
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 in a sp ...
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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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Menlo Report
The Menlo Report is a report published by the U.S. Department of Homeland Security Science and Technology Directorate, Cyber Security Division that outlines an ethical framework for research involving Information and Communications Technologies (ICT). The 17-page report was published on August 3, 2012. The following year, the Department of Homeland Security published a 33-page companion reportD. Dittrich, E. Kenneally, and M. Bailey. "Applying Ethical Principles to Information and Communication Technology Research: A Companion to the Menlo Report", Tech. Report., U.S. Department of Homeland Security, Oct 2013. https://www.dhs.gov/sites/default/files/publications/CSD-MenloPrinciplesCOMPANION-20120103-r731_1.pdf, https://www.impactcybertrust.org/link_docs/Menlo-Report-Companion.pdf that includes case studies that illustrate how the principles can be applied. The Menlo Report adapted the original Belmont Report principles (Respect for Persons, Beneficence, and Justice) to the co ...
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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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Clinical Trial
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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Human Experimentation In The United States
Humans (''Homo sapiens'') are the most abundant and widespread species of primate, characterized by bipedalism and exceptional cognitive skills due to a large and complex brain. This has enabled the development of advanced tools, culture, and language. Humans are highly social and tend to live in complex social structures composed of many cooperating and competing groups, from families and kinship networks to political states. Social interactions between humans have established a wide variety of values, social norms, and rituals, which bolster human society. Its intelligence and its desire to understand and influence the environment and to explain and manipulate phenomena have motivated humanity's development of science, philosophy, mythology, religion, and other fields of study. Although some scientists equate the term ''humans'' with all members of the genus ''Homo'', in common usage, it generally refers to ''Homo sapiens'', the only extant member. Anatomically modern ...
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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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Common Rule
The Common Rule is a 1981 rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018. It governed Institutional Review Boards for oversight of human research and followed the 1975 revision of the Declaration of Helsinki; it is encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A. The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding. Background The Common Rule is a 1981 rule of ethics (revised in 2018) regarding biomedical and behavioral research involving human subjects in the United States. The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declara ...
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Nazi Concentration Camps
From 1933 to 1945, Nazi Germany operated more than a thousand concentration camps, (officially) or (more commonly). The Nazi concentration camps are distinguished from other types of Nazi camps such as forced-labor camps, as well as concentration camps operated by Germany's allies. on its own territory and in parts of German-occupied Europe. The first camps were established in March 1933 immediately after Adolf Hitler became Chancellor of Germany. Following the 1934 purge of the SA, the concentration camps were run exclusively by the SS via the Concentration Camps Inspectorate and later the SS Main Economic and Administrative Office. Initially, most prisoners were members of the Communist Party of Germany, but as time went on different groups were arrested, including "habitual criminals", "asocials", and Jews. After the beginning of World War II, people from German-occupied Europe were imprisoned in the concentration camps. Following Allied military victories, the ...
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