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119-564: 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

238-519: A people 's right to form its own political entity, and internal self-determination is the right to representative government with full suffrage . Self-determination is a cardinal principle in modern international law , binding, as such, on the United Nations as an authoritative interpretation of the Charter 's norms. The principle does not state how the decision is to be made, nor what

357-731: A European power by the grant of a League of Nations mandate . One of the German objections to the Treaty of Versailles was a somewhat selective application of the principle of self-determination as the Republic of German-Austria , which included the Sudetenland , was seen as representing the will to join Germany in those regions, while the majority of people in Danzig wanted to remain within

476-650: A code of research ethics, the Declaration of Helsinki . It was based on the Nuremberg Code, focusing on medical research with therapeutic intent. Subsequently, medical professionals and researchers began requiring that research follows the principles outlined in the Declaration. This document was one of the milestones towards the implementation of the institutional review board (IRB) process. Many IRBs review ethical aspects of clinical researches based on

595-577: A free association of equal states. As India obtained its independence, multiple ethnic conflicts emerged in relation to the formation of a statehood during the Partition of India which resulted in Islamic Pakistan and Secular India. Before the advent of the British , no empire based in mainland India had controlled any part of what now makes up the country's Northeast, part of the reason for

714-414: A method of prevention for syphilis. Neisser first inserted serum obtained from a single patient who had begun exhibiting the early signs of syphilis under the skin of four female patients, similar to the procedure for smallpox inoculation. Neisser did not obtain consent from these patients, but none of them developed the disease. Neisser then conducted the second set of trials on four prostitutes. This time,

833-676: A minority can secede. In the United States Abraham Lincoln acknowledged that secession might be possible through amending the United States Constitution . The Supreme Court in Texas v. White held secession could occur "through revolution, or through consent of the States." The British Parliament in 1933 held that Western Australia only could secede from Australia upon vote of a majority of

952-492: A minority has long been contested in democracies with majority rule. For instance, in his first inaugural speech Abraham Lincoln argued that: Plainly the central idea of secession is the essence of anarchy. A majority held in restraint by constitutional checks and limitations, and always changing easily with deliberate changes of popular opinions and sentiments, is the only true sovereign of a free people. Whoever rejects it does of necessity fly to anarchy or to despotism. Unanimity

1071-462: A modified code that is associated with research into development of any food, drug, or medical devices. The code establishes what is required to be considered research activities, and for participants to be considered human subjects of research. The definitions are written as such to include situations where the human is the subject of the experiment, their environment is manipulated by the researchers, and data regarding their responses are collected. If

1190-476: A requirement for informed consent, and contains other additional similarities to the Guidelines – for instance, both require risk to be balanced out by potential benefits, and both discourage the use of human experimentation if other means of obtaining the desired results are available. While the two are similar, the Guidelines contain more clauses and requirements regarding human experimentation. For example,

1309-687: A result of the Germanisation process in the 19th century, 90% of the people in Danzig were German by 1919, which made the Allied leaders at the Paris peace conference compromise by creating the Free City of Danzig , a city-state in which Poland had certain special rights. Through the city of Danzig was 90% German and 10% Polish, the surrounding countryside around Danzig was overwhelmingly Polish, and

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1428-404: A separate people, but under current law cannot claim the right to self-determination. On the other hand, she finds that secession within a single state is a domestic matter not covered by international law. Thus, there are no on what groups may constitute a seceding people. A number of states have laid claim to territories, which they allege were removed from them as a result of colonialism. This

1547-412: A study, must do to ensure the rights of the participant are met are. Researchers must share the findings of their procedures regardless of them being good or bad results. Also in the case someone did not want to participate in research but would like treatment they cannot be turned away and must be treated with the same standard care. The Belmont Report both serves as a historical document and provides

1666-436: A territory subject to a historic territorial claim are prevented from exercising a right to self-determination. This interpretation is rejected by many states, who argue that Paragraph 2 of UN Resolution 1514(XV) states that "all peoples have the right to self-determination" and Paragraph 6 cannot be used to justify territorial claims. The original purpose of Paragraph 6 was "to ensure that acts of self-determination occur within

1785-512: Is a sizable minority group. In democratic societies, majority rule is often used to determine the outcome in electoral and voting processes. However, a major critique of majority rule is that it may result in the tyranny of the majority , especially in cases in which a simple majority is used in order to determine outcome. This flaw is particularly poignant when there is a large minority group whose interests are not being represented, and who may then seek to secede. The right to self-determination by

1904-428: Is defined as the entire population of the occupied territorial unit, no matter their other differences. Meanwhile, in cases where people lack representation by a state's government, the unrepresented become a defined as a separate people. Present international law does not recognize ethnic and other minorities as separate peoples, with the notable exception of cases in which such groups are systematically disenfranchised by

2023-515: Is freely participating in the research, to excluding the individual from harm. This principle, in short, emphasizes the maximization of benefits, and minimization of potential harms. Especially when dealing with those who require further protections, from the Respect for Persons principle. Scientific researchers are urged to consider, not just the immediate consequences, but also the long term consequences of their research. This principle deals with

2142-461: Is impossible. The rule of a minority, as a permanent arrangement, is wholly inadmissible; so that, rejecting the majority principle, anarchy or despotism in some form is all that is left. However, liberal proponents for the right to self-determination by minority groups contradict this notion by arguing that, in cases where the minority is not able to become the majority, and that minority is territorially concentrated and does not want to be governed by

2261-466: Is justified by reference to Paragraph 6 of UN Resolution 1514(XV), which states that any attempt "aimed at partial or total disruption of the national unity and the territorial integrity of a country is incompatible with the purposes and principles of the Charter". This, it is claimed, applies to situations where the territorial integrity of a state had been disrupted by colonisation, so that the people of

2380-467: Is no contradiction between the principles of self-determination and territorial integrity, with the latter taking precedence. Allen Buchanan , author of seven books on self-determination and secession, supports territorial integrity as a moral and legal aspect of constitutional democracy. However, he also advances a "Remedial Rights Only Theory" where a group has "a general right to secede if and only if it has suffered certain injustices, for which secession

2499-607: Is not a mere phrase; it is an imperative principle of action." During World War II , the principle was included in the Atlantic Charter , jointly declared on 14 August 1941 by Franklin D. Roosevelt , President of the United States, and Winston Churchill , Prime Minister of the United Kingdom, who pledged The Eight Principal points of the Charter. It was recognized as an international legal right after it

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2618-547: Is not a recognized legal definition of "peoples" in international law. Indeed, Ivor Jennings called Wilson's doctrine "ridiculous" because, though on the surface it seems reasonable to "let the people decide", in practice "the people cannot decide until someone decides who are the people". Reviewing various international judgements and UN resolutions, Vita Gudeleviciute of Vytautas Magnus University Law School finds that, in cases of non-self-governing peoples (colonized and/or indigenous) and foreign military occupation, "a people"

2737-466: Is occurring, it should be reviewed for the protection of those involved. This clause covers, three ethical principles; Respect for Persons , Beneficence , and Justice . This ethical principle describes individuals as autonomous agents. Stating that an autonomous agent is an individual capable of deliberation regarding their personal goals, and who is able to be guided by that deliberation. It acknowledges that while most individuals are capable of making

2856-419: Is the appropriate remedy of last resort." He also would recognize secession if the state grants, or the constitution includes, a right to secede. Vita Gudeleviciute holds that in cases of non-self-governing peoples and foreign military occupation the principle of self-determination trumps that of territorial integrity. In cases where people lack representation by a state's government, they also may be considered

2975-543: Is the will of the people that makes a state legitimate. This implies a people should be free to choose their own state and its territorial boundaries. However, there are far more self-identified nations than there are existing states and there is no legal process to redraw state boundaries according to the will of these peoples. According to the Helsinki Final Act of 1975, the UN, ICJ and international law experts, there

3094-462: The American and French revolutions, and the emergence of nationalism . The European revolutions of 1848 , the post-World War I settlement at Versailles , and the decolonization movement after World War II shaped and established the norm in international law. The American Revolution has been seen as the earliest assertion of the right of national and democratic self-determination, as well as

3213-672: The Atlantic Charter and accepted the principle of self-determination. In January 1942 twenty-six states signed the Declaration by United Nations , which accepted those principles. The ratification of the United Nations Charter in 1945 at the end of World War II placed the right of self-determination into the framework of international law and diplomacy. On 14 December 1960, the United Nations General Assembly adopted United Nations General Assembly Resolution 1514 (XV) subtitled " Declaration on

3332-443: The Belmont Report . Interviewees expressed concerns regarding the Belmont Report ' s ethical principles and interpretations as being one size fits all and advocated researchers to resist the tendency to rely on those principles systematically. It argues that the ethical analysis should be extended to take into account more appropriate factors, such as cultural, gender, ethnic and geographical considerations. Debate continues over

3451-717: The Chinese Civil War . The Korean War shifted the focus of the Cold War from Europe to Asia, where competing superpowers took advantage of decolonization to spread their influence. In 1947, India gained independence from the British Empire . The empire was in decline but adapted to these circumstances by creating the British Commonwealth —since 1949 the Commonwealth of Nations —which is

3570-607: The Empire of Japan renounced control over many of its former possessions including Korea , Sakhalin Island , and Taiwan . In none of these areas were the opinions of affected people consulted, or given significant priority. Korea was specifically granted independence but the receiver of various other areas was not stated in the Treaty of San Francisco , giving Taiwan de facto independence although its political status continues to be ambiguous. In 1941 Allies of World War II declared

3689-544: The Habsburg empire . However, this imposition of states where some nationalities (especially Poles , Czechs , and Serbs and Romanians ) were given power over nationalities who disliked and distrusted them was eventually used as a pretext for German aggression in World War II . Wilson publicly argued that the agreements made in the aftermath of the war would be a "readjustment of those great injustices which underlie

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3808-579: The Indian independence movement . And Italy, Japan and Germany all initiated new efforts to bring certain territories under their control, leading to World War II. In particular, the National Socialist Program invoked this right of nations in its first point (out of 25), as it was publicly proclaimed on 24 February 1920 by Adolf Hitler . In Asia, Japan became a rising power and gained more respect from Western powers after its victory in

3927-712: The Reich . However, the Allies ignored the German objections; Wilson's 14 Points had called for Polish independence to be restored and Poland to have "secure access to the sea", which would imply that the German city of Danzig (modern Gdańsk , Poland ), which occupied a strategic location where the Vistula River flowed into the Baltic Sea , be ceded to Poland. At the Paris Peace Conference in 1919,

4046-776: The Russo-Japanese War . Japan joined the Allied Powers in World War I and attacked German colonial possessions in the Far East , adding former German possessions to its own empire. In the 1930s, Japan gained significant influence in Inner Mongolia and Manchuria after it invaded Manchuria . It established Manchukuo , a puppet state in Manchuria and eastern Inner Mongolia . This was essentially

4165-480: The Soviet threat of seizing parts of Inner Mongolia induced China to recognize Outer Mongolia's independence , provided that a referendum was held. The referendum took place on October 20, 1945, with (according to official numbers) 100% of the electorate voting for independence. Many of East Asia 's current disputes to sovereignty and self-determination stem from unresolved disputes from World War II. After its fall,

4284-791: The Special Committee on Decolonization to ensure decolonization complete compliance with the principles of self-determination in General Assembly Resolution 1541 (XV). However, the charter and other resolutions did not insist on full independence as the best way of obtaining self-government , nor did they include an enforcement mechanism. Moreover, new states were recognized by the legal doctrine of uti possidetis juris , meaning that old administrative boundaries would become international boundaries upon independence if they had little relevance to linguistic, ethnic, and cultural boundaries. Nevertheless, justified by

4403-418: The rise of nationalism led to Greece , Hungary , Poland and Bulgaria all seeking or winning independence. Karl Marx and Friedrich Engels supported some of these nationalist movements, believing nationalism might be a "prior condition" to social reform and international alliances. In 1914 Vladimir Lenin wrote: "[It] would be wrong to interpret the right to self-determination as meaning anything but

4522-651: The " Common Rule ". The Office for Human Research Protections (OHRP) was also established within HHS. On January 19, 2017, the 'Revised Common Rule' was issued as a Final Rule, which came into effect on January 21, 2019, and included two changes, instituting the Belmont Report as part of the Protection of Human Subjects federal policy. Firstly, a Department/Agency head waiver clause, which previously allowed federal department or agency heads to waive parts or all of

4641-423: The 1979 creation and publishing of the Belmont Report. This report identifies respect for persons, beneficence, and justice as ethical principles which must underlie human subject research. The American Psychological Association (APA) has a documented ethics code pertaining to the practice of psychology and associated research. This document contains guidelines for the use of deception in research. For members of

4760-793: The 1990s Yugoslavia began a violent break up into 6 states. Macedonia became an independent nation and broke off from Yugoslavia peacefully. Kosovo , which was previously an autonomous unit of Serbia declared independence in 2008, but has received less international recognition. In December 1991, Gorbachev resigned as president and the Soviet Union dissolved relatively peacefully into fifteen sovereign republics , all of which rejected Communism and most of which adopted democratic reforms and free-market economies. Inside those new republics, four major areas have claimed their own independence, but not received widespread international recognition. After decades of civil war, Indonesia finally recognized

4879-464: The 19th century and came into prominent use in the 1860s, spreading rapidly thereafter. During and after World War I , the principle was encouraged by both Soviet Premier Vladimir Lenin and United States President Woodrow Wilson . Having announced his Fourteen Points on 8 January 1918, on 11 February 1918 Wilson stated: "National aspirations must be respected; people may now be dominated and governed only by their own consent. 'Self determination'

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4998-778: The 19th century. The French Revolution legitimatized the ideas of self-determination on that Old World continent. Nationalist sentiments emerged inside traditional empires: Pan-Slavism in Russia; Ottomanism , Kemalist ideology and Arab nationalism in the Ottoman Empire; State Shintoism and Japanese identity in Japan; and Han identity in juxtaposition to the Manchurian ruling class in China. Meanwhile, in Europe itself,

5117-845: The APA, these are hard requirements levied against their membership. They are also requirements for any research project conducted, funded, or managed by the APA. Title 45 Code of Federal Regulations, Part 46 (45 CFR 46) is the primary set of Federal regulations regarding the protection of human subjects in research and is often referred to as the Common Rule. It defines the laws, criteria for exemption, as well as definition and formulation of institutional review boards , though some agencies have established their own implementation of this code that supersedes portions or all of 45 CFR 46. The Department of Defense uses CFR 46 but has different exemption criteria. The Food and Drug Administration also applies

5236-641: The Belmont report is in the setting of standards. The APA establishes standards for all reputable members of the psychology community (particularly those members of the American Psychological Association). The association sets a code of conduct for all APA individuals, which, when violated, can result in termination of professional licensure or membership. In a 2006 study by Nancy Shore, community-based participatory researchers were interviewed for their interpretation and critique of

5355-598: The Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather,

5474-544: The Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving

5593-480: The Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation. The Belmont report itself consists of 3 clauses: A. Boundaries between Practice and Research, B. Basic Ethical Principles, C. Applications. This clause establishes the differences between biomedical and behavioral research, and that

5712-443: The Common Rule without restrictions, has since been restricted by the contours of the Belmont Report. The Revised Common Rule states: "Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy, provided the alternative procedures to be followed are consistent with

5831-527: The Declaration of Helsinki codes. The Tuskegee syphilis experiment was an experiment begun in 1932 by the United States Public Health Service . The design of the experiment involved recruiting 400 poor black people with syphilis and tracking their health. In the 1940s penicillin was identified as standard treatment for syphilis, but the purpose of the experiment was to track long-term syphilis and researchers did not inform

5950-649: The Granting of Independence to Colonial Countries and Peoples ", which supported the granting of independence to colonial countries and people by providing an inevitable legal linkage between self-determination and its goal of decolonisation. It postulated a new international law-based right of freedom to exercise economic self-determination. Article 5 states: Immediate steps shall be taken in Trust and Non-Self-Governing Territories , or all other territories which have not yet attained independence, to transfer all powers to

6069-466: The Guidelines also necessitate the creation of a report detailing the purpose and justification of the experiment. Ravindra Ghooi was critical of the Nuremberg Code, arguing that it bears too strong of a resemblance to the 1931 Guidelines to pass as coincidence, and that the 1931 Guidelines must have been used as reference in creating the Code. However, the Nuremberg Code does contain stipulations not found in

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6188-547: The Guidelines – the clause requiring subjects be given the freedom to leave the experiment at any time is one such example. The Guidelines for Human Experimentation remained in effect through the end of the Third Reich in 1945, and continued to exist in the law until 1948. Notably, Nazi human experimentation occurred under the existence of these laws. In the early 1940s in Germany doctors conducted Nazi human experimentation on unwilling test subjects; one way of describing

6307-645: The League of Nations to decide if Japan had committed aggression or not, stated the majority of people in Manchuria who were Han Chinese who did not wish to leave China. In 1912, the Republic of China officially succeeded the Qing Dynasty, while Outer Mongolia , Tibet and Tuva proclaimed their independence. Independence was not accepted by the government of China . By the Treaty of Kyakhta (1915) Outer Mongolia recognized China's sovereignty. However,

6426-671: The Ministry of the Interior formulated a list of 14 points detailing these ethical principles. The main points of the 1931 Guidelines for Human Experimentation are as follows: The Guidelines were formed under the context of reforming criminal law in Germany and in partial response to public criticism of human experimentation. They also outline specific definitions for both therapeutic and non-therapeutic research in human subjects (dubbed “innovative therapy” and “scientific experimentation”), and set forth detailed boundaries for both. However,

6545-528: 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, to future subjects who are not capable to make independent decisions. The Belmont report took its name from the Belmont Conference Center in Elkridge, Maryland , 10 miles south of Baltimore where the document

6664-518: The Nuremberg Code was published to be a set of guidelines to guide researchers who work with human subjects. Among the points of the code are the following concepts: participants must continually give their voluntary consent, the study must have the goal of producing good for society, and considerations must be taken to protect participants from even the remote possibility of injury. In 1964, the World Medical Association published

6783-528: The Polish delegation led by Roman Dmowski asked for Wilson to honor point 14 of the 14 points by transferring Danzig to Poland, arguing that the city was rightfully part of Poland because it was Polish until 1793, and that Poland would not be economically viable without it. During the First Partition of Poland in 1772, the inhabitants of Danzig fought fiercely for it to remain a part of Poland, but as

6902-552: The Protection of Human Subjects of Research , was released. It was published in the Federal Register on April 18, 1979. The Department of Health, Education and Welfare (HEW) revised and expanded its regulations for the protection of human subjects 45 CFR part 46 in the late 1970s and early 1980s. The Belmont Report explains the unifying ethical principles for using any human subjects for research which have formed

7021-625: The Prussian directive had any effect on human experimentation; however, these were still the first regulations regarding human medical experimentation in Western medicine. One of the earliest models for ethical human experimentation, preceding the Nuremberg Code, was established in 1931. In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt (translating roughly to National Health Service), under

7140-424: The Royal Disciplinary Court fined Neisser, ruling that he was negligent in obtaining consent from patients. In 1899, the Prussian minister for religious, academic, and medical affairs sought advice regarding the ethicality of Neisser's experiments in response to a request from the Prussian parliament to take measures regarding the scandal, and commissioned a report from the Scientific Medical Office of Health. In 1900,

7259-464: The Soviet Union acknowledged the right of secession for its constituent republics. This presented a challenge to Wilson's more limited demands. In January 1918 Wilson issued his Fourteen Points of January 1918 which, among other things, called for adjustment of colonial claims, insofar as the interests of colonial powers had equal weight with the claims of subject peoples. The Treaty of Brest-Litovsk in March 1918 led to Soviet Russia 's exit from

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7378-608: The Soviet Union violated principles of self-determination by suppressing the Hungarian revolution of 1956 and the Prague Spring Czechoslovak reforms of 1968. It invaded Afghanistan to support a communist government assailed by local tribal groups. However, Marxism–Leninism and its theory of imperialism were also strong influences in the national emancipation movements of Third World nations rebelling against colonial or puppet regimes. In many Third World countries, communism became an ideology that united groups to oppose imperialism or colonization. Soviet actions were contained by

7497-400: The United States which saw communism as a menace to its interests. Throughout the cold war, the United States created, supported, and sponsored regimes with various success that served their economic and political interests, among them anti-communist regimes such as that of Augusto Pinochet in Chile and Suharto in Indonesia . To achieve this, a variety of means was implemented, including

7616-440: The basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii)

7735-413: The basis for the National Commission's topic-specific reports and regulations. The three ethical principles are: The summary, from the top of the Report: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify

7854-422: The benefits should overweigh the risks. It should be of two types that are as follows : 1) Individual justice 2) Social justice Burdens & benefits are equally shared irrespective of a person's dignity, ability, rich, poor. The Belmont Report allows for the protection of participants in clinical trials and research studies. Seven things nurses, as primary caregivers for individuals participating in

7973-494: The clinical experiments he conducted, triggering a public outcry in which Neisser was accused of “maliciously inoculating innocent children with syphilis poison.” Neisser defended his actions, arguing that the prostitutes contracted syphilis from their line of work rather than his experiments, and had the general support of academic physicians. One notable exception was the German psychiatrist Albert Moll, who believed informed consent to be necessary in human trials. Later that year,

8092-399: The concepts of consent and sovereignty by the people governed These ideas were inspired particularly by John Locke 's writings of the previous century. Thomas Jefferson further promoted the notion that the will of the people was supreme, especially through authorship of the United States Declaration of Independence , which became an inspiration for European nationalist movements during

8211-462: The conclusion of the Irish War of Independence , as established in the Anglo-Irish Treaty , it was still included in the Statute of Westminster. This statute built on the Balfour Declaration of 1926 which recognized the autonomy of these British dominions, representing the first phase of the creation of the British Commonwealth of Nations . Egypt , Afghanistan , and Iraq also achieved independence from Britain. Other efforts were unsuccessful, like

8330-498: The cooperation of the U.S. President Ronald Reagan , Gorbachev wound down the size of the Soviet Armed Forces and reduced nuclear arms in Europe, while liberalizing the Soviet economy . In the revolutions of 1989–90 , the communist regimes of Soviet satellite states collapsed in rapid succession in Poland, Hungary, Czechoslovakia, East Germany, Bulgaria, Romania, and Mongolia. East and West Germany united, Czechoslovakia peacefully split into Czech Republic and Slovakia , while in

8449-424: The country as a whole; the previous two-thirds majority vote for secession via referendum in Western Australia was insufficient. The Chinese Communist Party followed the Soviet Union in including the right of secession in its 1931 constitution in order to entice ethnic nationalities and Tibet into joining. However, the Party eliminated the right to secession in later years and had anti-secession clause written into

8568-540: The creation of united Malaysia . The Netherlands retained its New Guinea part from the previous Dutch East Indies , but Indonesia threatened to invade and annex it. A vote was supposedly taken under the UN sponsored Act of Free Choice to allow West New Guineans to decide their fate, although many dispute its veracity. Later, Portugal relinquished control over East Timor in the aftermath of Carnation Revolution in 1975, at which time Indonesia promptly invaded and annexed it . In 1999, Indonesian president B. J. Habibie

8687-408: The decision, some groups of people require more protections. Some lose their capacity for self-determination due to illness, mental disabilities, or other circumstances. Children, and the groups just mentioned, are to be granted protections, either temporarily or permanently, until the individual is capable of self-determination. These protections range from ensuring that the individual understands and

8806-422: The different areas of research, require different protections for human participants. Examining the differences between "practice" and "research", practice is dealing with bettering the wellbeing of an individual or group, while research is testing a theory and potentially has an unknown ending. This difference, establishes that they require different protections for human participants, and when any amount of research

8925-484: The distribution of benefits and burdens of research. It puts forward 5 different formulations, on how to base the distribution, 1, all given an equal share, 2, based on need, 3, based on individual effort, 4, based on societal contribution, 5, based on merit. This principle described the circumstances of the Tuskegee Syphilis Study , and explains the importance of the participants getting recognition and

9044-869: The early 1990s, the legitimatization of the principle of national self-determination has led to an increase in the number of conflicts within states, as sub-groups seek greater self-determination and full secession, and as their conflicts for leadership within groups and with other groups and with the dominant state become violent. The international reaction to these new movements has been uneven and often dictated more by politics than principle. The 2000 United Nations Millennium Declaration failed to deal with these new demands, mentioning only "the right to self-determination of peoples which remain under colonial domination and foreign occupation." In an issue of Macquarie University Law Journal Associate Professor Aleksandar Pavkovic and Senior Lecturer Peter Radan outlined current legal and political issues in self-determination. There

9163-543: The established boundaries of colonies, rather than within sub-regions". Further, the use of the word attempt in Paragraph 6 denotes future action and cannot be construed to justify territorial redress for past action. An attempt sponsored by Spain and Argentina to qualify the right to self-determination in cases where there was a territorial dispute was rejected by the UN General Assembly, which re-iterated

9282-572: The ethical principles of the Belmont Report." [Revised Common Rule at 45 CFR 46.101(c)] In the field of psychology, the Belmont Report has been supplemented by the American Psychological Association 's (APA) Ethical Principles of Psychologists and Code of Conduct. As of 2018, the APA's guidelines include the basics provided in the originally published Belmont Report, but also enhance and reinforce those established principles. Another area where APA guidelines move beyond

9401-453: The ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted

9520-419: The ethics and regulations of research involving human subjects because of discrepancies over the meaning and priority of the Belmont Report ' s basic ethical principles: respect for persons, beneficence, and justice. Notably, the Belmont Report does not specify how its three ethical principles should be weighted or prioritized. According to Albert R. Jonsen, a member of the National Commission that composed

9639-567: The ethnically Polish rural areas included in the Free City of Danzig objected, arguing that they wanted to be part of Poland. Neither the Poles nor the Germans were happy with this compromise and the Danzig issue became a flash-point of German-Polish tension throughout the interwar period. During the 1920s and 1930s there were some successful movements for self-determination in the beginnings of

9758-419: The general good of society. Guidelines for human subject research Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations. In 1892, Albert Ludwig Sigesmund Neisser, a German physician who is credited with the discovery of Neisseria gonorrhoeae, performed two sets of clinical trials attempting to find

9877-403: The government of the state they live in. Other definitions offered are "peoples" as self-evident (from ethnicity, language, history, etc.) , or defined by "ties of mutual affection or sentiment" ("loyalty", or by mutual obligations among peoples). Professor Uriel Abulof suggests that self-determination entails the "moral double helix" of duality: 1. personal right to align with a people, and

9996-717: The independence of East Timor in 2002. In 1949, the Communist Party won the Chinese Civil War and established the People's Republic of China in Mainland China . The Kuomintang -led Republic of China government retreated to Taipei , its jurisdiction now limited to Taiwan and several outlying islands. Since then, the People's Republic of China has been involved in disputes with the ROC over issues of sovereignty and

10115-611: The information called for under Article 73e of the United Nations Charter in Article 3", which provided that "[t]he inadequacy of political, economic, social and educational preparedness should never serve as a pretext for delaying the right to self-determination and independence." To monitor the implementation of Resolution 1514, in 1961 the General Assembly created the Special Committee referred to popularly as

10234-519: The language of self-determination, between 1946 and 1960, thirty-seven new nations in Asia, Africa, and the Middle East gained independence from colonial powers. The territoriality issue inevitably would lead to more conflicts and independence movements within many states and challenges to the assumption that territorial integrity is as important as self-determination. Decolonization in the world

10353-447: The majority, it may serve the best interest of the state to allow the secession of this group. Most sovereign states do not recognize the right to self-determination through secession in their constitutions. Many expressly forbid it. However, there are several existing models of self-determination through greater autonomy and through secession. In liberal constitutional democracies the principle of majority rule has dictated whether

10472-485: The minister issued the “Instructions for the Directors of Clinics, Outpatient Clinics and Other Medical Facilities” for all medical directors regarding any medical procedure “other than for diagnosis, therapy, and immunization”. The instructions state that medical experimentation would be prohibited if: These instructions were not committed to law and as such were not legally binding. To this day, it remains unclear if

10591-629: The model Japan followed as it invaded other areas in Asia and established the Greater East Asia Co-Prosperity Sphere . Japan went to considerable trouble to argue that Manchukuo was justified by the principle of self-determination, claiming that people of Manchuria wanted to break away from China and asked the Kwantung Army to intervene on their behalf. However, the Lytton commission which had been appointed by

10710-494: The moral framework for understanding regulations in the United States on the use of humans in experimental methods. In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as

10829-681: The ongoing insurgency in Northeast India . In 1971 Bangladesh obtained independence from Pakistan. Burma also gained independence from the British Empire, but declined membership in the Commonwealth. Indonesia gained independence from the Dutch Empire in 1949 after the latter failed to restore colonial control. As mentioned above, Indonesia also wanted a powerful position in the region that could be lessened by

10948-664: The orchestration of coups, sponsoring of anti-communist countries and military interventions. Consequently, many self-determination movements, which spurned some type of anti-communist government, were accused of being Soviet-inspired or controlled. In Asia, the Soviet Union had already converted Mongolia into a satellite state but abandoned propping up the Second East Turkestan Republic and gave up its Manchurian claims to China. The new People's Republic of China had gained control of mainland China in

11067-408: The outcome should be (whether independence , federation , protection , some form of autonomy or full assimilation ), and the right of self-determination does not necessarily include a right to an independent state for every ethnic group within a former colonial territory. Further, no right to secession is recognized under international law. The concept emerged with the rise of nationalism in

11186-474: The participants that they could be cured. In 1972 press reported on the study to public outrage for disregard of the health of the participants. The study was influential in shaping public perceptions of research involving human subjects. After the press exposed the study, the US Congress appointed a panel that determined that the study should be stopped immediately and that the oversight of human research

11305-555: The participants, are not only given all the relevant information, but that the information is presented in an understandable and researchable way. Comprehension: The participants should be capable of understanding the information; if they aren't, the third party in-charge of their safety (part of the protections from the Basic Ethical Principles, the Beneficence section) should be given the information regarding

11424-573: The people of those territories, without any conditions or reservations, in accordance with their freely expressed will and desire, without any distinction as to race, creed or colour, in order to enable them to enjoy complete independence and freedom. On 15 December 1960 the United Nations General Assembly adopted United Nations General Assembly Resolution 1541 (XV) , subtitled "Principles which should guide members in determining whether or nor an obligation exists to transmit

11543-449: The people's right to determine their politics; and 2. and mutuality (the right is as much the other's as the self's). Thus, self-determination grants individuals the right to form "a people," which then has the right to establish an independent state, as long as they grant the same to all other individuals and peoples. National self-determination appears to challenge the principle of territorial integrity (or sovereignty ) of states as it

11662-500: The political status of Taiwan. As noted, self-determination movements remain strong in some areas of the world . Some areas possess de facto independence, such as Taiwan, North Cyprus , Kosovo , and South Ossetia , but their independence is disputed by one or more major states. Significant movements for self-determination also persist for locations that lack de facto independence, such as East Turkistan ("Xinjiang"), Kurdistan , Balochistan , Chechnya , and Palestine . Since

11781-485: The possible benefits of research. It also mentions the exploitation of unwilling prisoners, as research participants, in the Nazi concentration camps . This clause is broken down into three parts, informed consent , assessment of risks and benefits , and selection of human subjects in research . This section is further broken down into three parts, information, comprehension, and voluntariness. Information: Ensuring that

11900-409: The principles of the Belmont Report." [Revised Common Rule at 45 CFR 46.101(i)] Secondly, a Department/Agency head determinations clause, which previously provided Department/Agency heads with the power and discretion to decide, whether an activity qualifies as human research which is subject to the federal policy, has since required that "this judgment [determination] shall be exercised consistent with

12019-825: The procedures could be to call it medical torture . After the Allied Forces won World War II , United States authorities who held the Nuremberg Palace of Justice used that building to host the Doctors' Trial in which Nazi researchers were charged with crimes against humanity for unethical research practices. After the Subsequent Nuremberg Trials many people felt compelled to create laws to codify some research guidelines to protect research participants and define acceptable relationships between researchers and research participants. In 1949

12138-706: The process of decolonization . In the Statute of Westminster the United Kingdom granted independence to Canada , New Zealand , Newfoundland , the Commonwealth of Australia , and the Union of South Africa after the British parliament declared itself as incapable of passing laws over them without their consent. Although the Irish Free State had already gained internationally recognized independence at

12257-526: The project does not meet these definitions (or there is minimal risk to participants) then the project is exempt from IRB review and the requirements of informed consent . Generally this decision is made and documented by an IRB. The common rule also provides definitions regarding whether institutions are engaged in research, interaction between investigators and subjects, what an intervention is, and what information subjects can expect to remain private. Self-determination Self-determination refers to

12376-583: The report, the Institutional Review Board is charged with weighing these principles and deciding how they should be applied. Matters become controversial when deciding if the principles should be interpreted as more or less weighty depending upon the particular circumstances of the research in question, if the principles should be viewed as an obligation that society must undertake on behalf of its members, or if it should be viewed as giving absolute priority to respect for persons' autonomy over

12495-493: The research, and presented it in an understandable manner. Voluntariness: Participants shouldn't be under any unjustifiable pressures to participate in research. This can include coercion, undue influence by excessive or inappropriate reward, influence by a close relative, threatening to withdraw health services, and other comparable situations. Individuals should make the decision to participate without being pressured by any unwarranted sources. It should be correctly assessed that

12614-626: The right to existence as a separate state." Woodrow Wilson revived America's commitment to self-determination, at least for European states, during World War I. When the Bolsheviks came to power in Russia in the October Revolution , they called for Russia's immediate withdrawal as a member of the Allies of World War I . They also supported the right of all nations, including colonies, to self-determination." The 1918 Constitution of

12733-407: The right to self-determination was a universal right. In order to accommodate demands for minority rights and avoid secession and the creation of a separate new state, many states decentralize or devolve greater decision-making power to new or existing subunits or autonomous areas . Self-determination can be at odds with the principle of majority rule and equal rights, especially when there

12852-400: The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings. The Belmont Report attempts to summarize the basic ethical principles identified by

12971-411: The serums were injected intravenously and each serum was obtained from a different syphilis patient, each at various stages of the disease. The prostitutes from the second set of trials also neither consented nor were informed of the experimentation. Unlike the first set of trials, all four of the subjects developed syphilis at varying times after the injection. In 1898, Neisser published his results from

13090-434: The vast majority of the physicians discussing the regulations prior to their instantiation were concerned primarily with the proper advancement of medical science rather than the protection of vulnerable patients. The Guidelines shares similarities with the 1900 Prussian Instructions for the Directors in that both contain clauses for needing consent and for subjects who are underage. The Nuremberg Code would also later specify

13209-509: The war and the nominal independence of Armenia, Finland, Estonia, Latvia, Ukraine, Lithuania, Georgia and Poland, though in fact those territories were under German control. The end of the war led to the dissolution of the defeated Austro-Hungarian Empire and Czechoslovakia and the union of the State of Slovenes, Croats and Serbs and the Kingdom of Serbia as new states out of the wreckage of

13328-439: The whole structure of European and Asiatic society", which he attributed to the absence of democratic rule. The new order emerging in the postwar period would, according to Wilson, place governments "in the hands of the people and taken out of the hands of coteries and of sovereigns, who had no right to rule over the people." The League of Nations was established as the symbol of the emerging postwar order; one of its earliest tasks

13447-668: Was contrasted by the Soviet Union 's successful post-war expansionism. Tuva and several regional states in Eastern Europe , the Baltic , and Central Asia had been fully annexed by the Soviet Union during World War II. Now, it extended its influence by establishing the satellite states of Eastern Germany and the countries of Eastern Europe , along with support for revolutionary movements in China and North Korea . Although satellite states were independent and possessed sovereignty,

13566-524: Was divided into a series of work groups. Several people worked on issues of autonomy, others worked on issues of beneficence , or non-maleficence , or justice. The commission developed the Belmont Report over a four-year period from 1974 to 1978, including an intensive four-day period of discussions in February 1976 at the Belmont Conference Center. On September 30, 1978, the commission's report, Ethical Principles and Guidelines for

13685-1013: Was drafted in part. The Belmont Conference Center, once a part of the Smithsonian Institution , was operated by Howard Community College until the end of 2010. In 1974, prompted in part by the ethical problems emerging from the Tuskegee Syphilis Study (1932–1972), the National Research Act was signed into law. This created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978). It consisted of altogether 11 physicians, lawyers and scientists, 8 of them were men and three women, namely Kenneth John Ryan, Joseph V. Brady , Robert E. Cooke, Dorothy I. Height (the only African-American), Albert R. Jonsen , Patricia King , Karen Lebacqz, David W. Louisell, Donald W. Seldin , Eliot Stellar and Robert H. Turtle. It

13804-522: Was explicitly listed as a right in the UN Charter . Implementing the right to self-determination can be politically difficult, in part because there are multiple interpretations of what constitutes a people and which groups may legitimately claim the right to self-determination. As World Court judge Ivor Jennings put it: "the people cannot decide until somebody decides who are the people". The norm of self-determination can be originally traced to

13923-525: Was inadequate. The panel recommended that federal regulations be designed and implemented to protect human research subjects in the future. Subsequently, the National Research Act of 1974 led to the creation of the Common Rule , the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research , and the Office for Human Research Protections All of these reactions led to

14042-543: Was pressured by Australia and the United Nations to give East Timor independence. The people of former Indonesian East Timor were given a choice of either greater autonomy within Indonesia or independence . 78.5% of East Timorese voted for independence, rejecting Indonesia's special autonomy proposal. The Cold War began to wind down after Mikhail Gorbachev assumed power as Soviet General Secretary in March 1985. With

14161-405: Was to legitimize the territorial boundaries of the new nation-states created in the territories of the former Ottoman Empire , Asia, and Africa. The principle of self-determination did not extend so far as to end colonialism; under the reasoning that the local populations were not civilized enough the League of Nations was to assign each of the post-Ottoman, Asian and African states and colonies to

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