text:
President of the Senate
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The President of the Senate is a title often given to the presiding officer of a senate, and is the speaker of other assemblies.
The senate president often ranks high in a jurisdiction's succession for its top executive office: for example, the President of the Senate of Nigeria is second in line for succession to the presidency, after only the Vice President of the Federal Republic, while in France, which has no vice president, the Senate President is first in line to succeed to the Presidential powers and duties.
Contents
[hide]
1 Argentina
2 Australia
3 Barbados
4 Belgium
5 Belize
6 Brazil
7 Burundi
8 Cambodia
9 Canada
10 Chile
11 Colombia
12 Fiji
13 Danzig
14 France
15 Germany
16 Italy
17 Liberia
18 Malaysia
19 Mexico
20 Nigeria
21 Peru
22 Philippines
23 Poland
24 Puerto Rico
25 Romania
26 South Africa
27 Spain
28 Sri Lanka
29 Trinidad and Tobago
30 United States
30.1 U.S. state senates
31 Uruguay
32 See also
33 References
Argentina[edit]
The Argentine Senate is presided over by the Vice-President of the Republic, currently Gabriela Michetti. This was a recent expansion of the Vice-President's powers introduced as part of the 1994 constitutional amendments (Constitution, Art. 57). The Vice-President may only cast a vote to break a tied Senate vote.
Australia[edit]
Main article: President of the Australian Senate
The President of the Australian Senate is a senator, traditionally a member of the governing party or coalition, elected by the Senate at the beginning of each parliament as the first item of business. They are assisted by a Deputy President who is traditionally a member of the largest opposition party.[1] The current president is Scott Ryan, a Liberal senator from Victoria, who has held the office since 13 November 2017.[2]
Barbados[edit]
Main article: List of Presidents of the Senate of Barbados
At the start of every parliamentary session, the Senate of Barbados elects a President and a Vice President, neither of whom may be ministers or parliamentary secretaries. Prior to the January 2008 general election, the positions were held by Sir Fred Gollop and Dame Patricia Symmonds.
Belgium[edit]
Main article: Belgian Senate § Officers
See also: List of Presidents of the Belgian Senate
The presiding officer of the Belgian Senate is elected by the senators at the beginning of each parliamentary term. The President of the Senate is customarily a member of a majority party with a great deal of political experience. The president presides over the plenary assembly of the Senate, guides and controls debates in the assembly, is responsible for ensuring the democratic functioning of the Senate, maintains order and security in the assembly and for enforcing the Rules of the Senate, and represents the Senate at both the national (to the other institutions) and the international level.
The President of the Senate, together with the President of the Chamber of Representatives, ranks immediately behind the King in the order of precedence. The elder of the two takes the second place in the order of precedence. The Presidents of the Senate and the Chamber rank above the Prime Minister.
Belize[edit]
The Senate of Belize elects both a president and a vice-president upon first convening after a general election. The person elected president may be a senator (provided he/she does not concurrently hold a ministerial position) or a person external to the Senate. The vice-president must be a member of the Senate who does not hold a ministerial portfolio. (Constitution, section 66.)[3]
The current[update] President is Andrea Gill, with Juliet Thimbriel as Vice-President.
Brazil[edit]
Main article: President of the Federal Senate (Brazil)
The current[update] President of Brazil's Federal Senate is Eunício Oliveira.
The President of the Federal Senate is the third in order to succeed the president (only below the Vice President and the President of the Chamber of Deputies). It is also the president of the National Congress, which includes the Senate and the Chamber of Deputies.
Burundi[edit]
The President of the Senate of Burundi, since 17 August 2005, is Molly Beamer of the CNDD-FDD. The president is assisted in his work by two vice-presidents.
Cambodia[edit]
The Senate of Cambodia is led by a 12-person permanent commission (bureau), which is in turn chaired by the President of the Senate, currently Say Chhum. He is assisted by a First and a Second Vice-President.[4] The President and Vice-Presidents are elected as the first item of business at the start of every legislative session.[5]
Canada[edit]
While the Speaker of the Senate of Canada, who serves as the presiding officer of the Senate of Canada, is not described as a "president" in English, the position is called Président du Sénat in French. He is appointed by the Governor General on the advice of the Prime Minister.
Chile[edit]
Main article: President of the Senate of Chile
The President of the Senate of Chile is elected from among the country's senators. The current[update] holder of the position, since March 2010, is Jorge Pizarro.
Colombia[edit]
The President of the Senate – Javier Cáceres Leal for the 2009–10 period – also serves as the President of the Congress of Colombia.
Fiji[edit]
The members of the former Senate of Fiji (abolished in 2012) used to elect from among their number both a President and Vice-President, whose roles were similar to those of the Speaker and Deputy Speaker of the House of Representatives, respectively.
The last persons to hold those positions were Kinijoji Maivalili (President) and Hafiz Khan (Vice-President). The military coup of 5 December 2006 brought their terms to a premature end.
Danzig[edit]
In the Free City of Danzig (1920–1939/1945), the Senate (or Senat in German) was the executive branch, with Senators (Senatoren) being the holders of ministerial portfolios. In Danzig the President of the Senate (Präsident des Senats) was an office equivalent to that of prime minister in other countries.
France[edit]
The Senate of France elects a president from among its own number. The President of the French Senate stands first in line of succession in case of death or resignation of the President of the Republic, becoming acting president until a presidential election can be held. This most recently occurred with Alain Poher, who was senate president from 1968 to 1992 and who served as interim president on two occasions: following Charles de Gaulle's resignation in 1969, and following Georges Pompidou's death in office in 1974.
Since 2014, the position has been held by Gérard Larcher of the Union for a Popular Movement (UMP).
Germany[edit]
In the German states of Bremen (Senate of Bremen) and Hamburg (Senate of Hamburg), the Senates (or Senate in German) are the executive branch, with Senators (Senatoren) being the holders of ministerial portfolios. In these Länder, the President of the Senate (Präsident des Senats) is an office equivalent to that of minister-president in other German Länder.
Italy[edit]
The Senate of Italy holds its first sitting no later than 20 days after a general election. That session, presided by the oldest senator, proceeds to elect the President of the Senate for the following parliamentary period. On the first two attempts at voting, an absolute majority (a majority of all senators) is needed; if a third round is needed, a candidate can be elected by a majority of the senators present and voting. If this third round fails to produce a winner, a final ballot is held between the two senators with the highest votes in the previous ballot. In the case of a tie, the elder senator is deemed the winner.
In addition to overseeing the business of the chamber, chairing and regulating debates, deciding whether motions and bills are admissible, representing the Senate, etc., the President of the Senate stands in for the President of the Republic when s/he is unable to perform his/her duties.[6]
The current President of the Senate is Pietro Grasso. For a historical listing, see: List of Presidents of the Senate of Italy.
Liberia[edit]
While the Vice President of Liberia serves as President of the Senate, the senators also elect from among their number a President pro tempore to lead the chamber's day-to-day business.
Malaysia[edit]
Main article: President of the Senate of Malaysia
The Senate of Malaysia elects a president from its members, who is comparable to the Speaker of the House of Representatives. The position is partisan and has usually been held by a member of the Government party.
Mexico[edit]
The Senate of Mexico, at the beginning of each annual legislative session, elects an Executive Board (Mesa Directiva) from among its 128 members. The Executive Board comprises a president, three vice-presidents, and four secretaries, elected by an absolute majority of the Senators. Members of the Executive Board may be re-elected for the following year without restriction. The President of the Executive Board also serves as the President of the Senate.
The President of the Senate for the 2015–16 period of sessions is Roberto Gil Zuarth, a National Action Party (PAN) senator for Chiapas.
Nigeria[edit]
Main article: President of the Nigerian Senate
The President of the Senate is the presiding officer of the Senate of Nigeria, elected by its membership.
The current[update] President of the Senate is Dr. Bukola Saraki, who represents Kwara State for the APC.
Peru[edit]
Main article: Congress of the Republic of Peru
Peru had a bicameral Congress from 1829 until 1992. The President of the Senate was elected by the Senate members to preside over the sessions for one year.
Philippines[edit]
See President of the Senate of the Philippines
Poland[edit]
See Marshal of the Senate of the Republic of Poland
Puerto Rico[edit]
See: Senate of Puerto Rico#Presidents of the Puerto Rico Senate
Romania[edit]
Main article: President of the Senate of Romania
The first session of the Senate is headed by the eldest senator. In that session the senators elect the Standing Bureau of the Romanian Senate. It consists of the President of the Senate, four vice-presidents, four secretaries, and four quaestors. The President of the Standing Bureau also serves as the President of the Senate. The President is elected, by secret ballot, for the duration of the legislative period.[7] The Senate president succeeds temporarily the President of Romania if the latter resigns, is suspended, incapacitated or dies in office. (He/she continues to be President of the Senate during the ad-interim presidency of the country. He/she acts as President until a new president is elected).
South Africa[edit]
The Senate of South Africa was the upper house of Parliament between 1910 and 1981, and between 1994 and 1997. During both periods, the Senate was led by a President.
For a listing, see: Senate of South Africa#Presidents of the Senate of South Africa (1910-1980) and (1994-1997)
Spain[edit]
Main article: President of the Spanish Senate
Sri Lanka[edit]
Main article: President of the Senate of Ceylon
The Senate of Ceylon was the upper house of Parliament between 1947 and 1971. During this periods, the Senate was led by a President.
Trinidad and Tobago[edit]
Main article: President of the Senate of Trinidad and Tobago
The President of the Senate of Trinidad and Tobago, who is generally elected from the government benches, chairs debates in the chamber and stands in for the country's president during periods of absence or illness (Constitution, section 27).[8] A Vice-President of the Senate is also elected from among the senators. The current President of the Senate is Christine Kangaloo.
United States[edit]
The Vice President of the United States is assigned the responsibility of presiding over the Senate and designated as its president by the United States Constitution. The vice president, as President of the Senate, has the authority (ex officio, for he or she is not an elected member of the Senate) to cast a tie-breaking vote. Other than this, the rules of the Senate grant its president very little power (in contrast to the powerful office of Speaker of the House of Representatives).
While vice presidents used to regularly preside over the Senate, modern vice presidents have done so only rarely, usually only when swearing in new senators, during joint sessions, announcing the result of a vote on a significant bill or confirmation, or when casting a tie-breaking vote. The Senate chooses a president pro tempore to preside in the vice president's absence. Modern presidents pro tempore, too, rarely preside over the Senate. In practice, the junior senators of the majority party typically preside in order to learn Senate procedure.
Vice presidents have cast 261 tie-breaking votes since the U.S. federal government was established in 1789. The vice president with the most tie breaking votes is John Adams (served 1789–1797) with 29. The current Vice President Mike Pence, in office since January 2017, has made six tie-breaking votes.[9]
U.S. state senates[edit]
In state governments of the United States, the presiding officer of the state senate (the upper house) is a matter decided by the state's constitution. Some states designate the lieutenant governor as president of the senate, while in other states, the Senate elects its own president. The Tennessee Senate elects a senator Speaker of the Senate, who is given the title of Lieutenant Governor.
Similarly, New Hampshire has no lieutenant governor, but the state senate elects a president who is the de facto lieutenant governor, given that in the event of the governor's death, resignation, or inability to serve, the president of the senate acts as governor until the vacancy is filled. New Jersey previously used the same system, but with the important proviso that the Senate president continued to serve in that position while also serving as acting governor. After Christine Todd Whitman resigned as governor, Donald DiFrancesco spent nearly a year as acting governor. As a result of his tenure, questions were raised about the propriety of such a system, particularly with regard to separation of powers–related issues. A constitutional amendment was enacted in 2005 to create the office of lieutenant governor effective at the 2009 election.
Uruguay[edit]
The Vice President of Uruguay presides over the country's 30-member Senate.
See also[edit]
Speaker of the Senate
References[edit]
Jump up ^ "The President of the Senate". Parliament of Australia. October 2009. Archived from the original on 22 February 2011. Retrieved 24 February 2011.
Jump up ^ Gartrell, Adam (13 November 2017). "Scott Ryan resigns from Turnbull ministry to replace Stephen Parry as Senate president". The Sydney Morning Herald. Fairfax Media. Retrieved 6 December 2017.
Jump up ^ :: belizelaw.org - welcome :: Archived 2007-10-14 at the Wayback Machine.
Jump up ^ L'organisation et le fonctionnement du Snat Archived 2008-02-16 at the Wayback Machine.
Jump up ^ Rglement Archived 2008-02-16 at the Wayback Machine.
Jump up ^ senato.it - Parliament
Jump up ^ Pagina oficiala a Senatului României Archived 2008-02-16 at the Wayback Machine.
Jump up ^ Constitution of Trinidad and Tobago - Updated to 2003 Archived 2008-04-08 at the Wayback Machine.
Jump up ^ "U.S. Senate: U.S. Senate Roll Call Votes 115th Congress - 1st Session".
Retrieved from "https://en.wikipedia.org/w/index.php?title=President_of_the_Senate&oldid=843433222"
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Hajra
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This article is an orphan, as no other articles link to it. Please introduce links to this page from related articles; try the Find link tool for suggestions. (February 2013)
Hajra (Arabic: هاجره) is a female given name. The origin of the name is Arabic 'هاجر' (Hagar). It is one of the spellings of Hagar, the second wife of Prophet Ibrahim (Abrahim) who born Ibraham's first son Ishmael. Although the origins of this name mean sunshine or sunlight, this name is the basis for Hajj, the (annual) pilgrimage to Mecca performed by Muslims.[1]
This is a common female first name used in the context of the Muslim South Asian diaspora.
References[edit]
Jump up ^ "Guide to going to Mecca". BBC. Retrieved August 8, 2010.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Hajra&oldid=718261471"
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Declaration of Helsinki
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This article is about the human medical experimentation ethics document. For other uses, see Declaration of Helsinki (disambiguation).
The Declaration of Helsinki (DoH) is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA).[1] It is widely regarded as the cornerstone document on human research ethics.[1][2][3][4]
It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations.[5] Its role was described by a Brazilian forum in 2000 in these words "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity".[5]
Contents
[hide]
1 Principles
1.1 Basic principles
1.2 Operational principles
1.3 Additional guidelines or regulations
2 History
2.1 First revision (1975)
2.2 Second to Fourth revisions (1975–2000)
2.2.1 Second and Third Revisions (1983, 1989)
2.2.2 Fourth revision (1996)
2.2.2.1 Background
2.2.2.2 Fourth revision
2.3 Fifth revision (2000)
2.3.1 Background
2.3.2 Fifth revision
2.3.2.1 Additional Principles
2.3.3 Aftermath
2.4 Clarifications of Articles 29, 30 (2002–2004)
2.5 Sixth revision (2008)
2.6 Seventh revision (2013)
3 Future
4 Timeline (WMA meetings)
5 See also
6 References
7 Training
8 Bibliography
8.1 Articles
8.1.1 1990-1999
8.1.2 2000-2008
8.2 WMA
9 Other codes and regulations
10 External links
Principles[edit]
The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter. Investigators still have to abide by local legislation but will be held to the higher standard.[citation needed]
Basic principles[edit]
The fundamental principle is respect for the individual (Article 8), their right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the subject's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9).
The recognition of the increased vulnerability of individuals and groups calls for special vigilance (Article 8). It is recognised that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor (Articles 23, 24), then allowance should be considered for surrogate consent by an individual acting in the subject's best interest, although their consent should still be obtained if at all possible (Article 25).
Operational principles[edit]
Research should be based on a thorough knowledge of the scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ethical review and oversight by a properly convened committee (Article 13). The protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). Information regarding the study should be publicly available (Article 16). Ethical publications extend to publication of the results and consideration of any potential conflict of interest (Article 27). Experimental investigations should always be compared against the best methods, but under certain circumstances a placebo or no treatment group may be utilised (Article 29). The interests of the subject after the study is completed should be part of the overall ethical assessment, including assuring their access to the best proven care (Article 30). Wherever possible unproven methods should be tested in the context of research where there is reasonable belief of possible benefit (Article 32).
Additional guidelines or regulations[edit]
Investigators often find themselves in the position of having to follow several different codes or guidelines, and are therefore required to understand the differences between them. One of these is Good Clinical Practice (GCP), an international guide, while each country may also have local regulations such as the Common Rule in the US, in addition to the requirements of the FDA and Office for Human Research Protections (OHRP) in that country. There are a number of available tools which compare these.[6] Other countries have guides with similar roles, such as the Tri-Council Policy Statement in Canada. Additional international guidelines include those of the CIOMS, Nuffield Council and UNESCO.
History[edit]
The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone seven revisions (the most recent at the General Assembly in October 2013) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 2013 version.[7] The Declaration is an important document in the history of research ethics as it is the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents.
Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies [3a]. The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1).
First revision (1975)[edit]
The 1975 revision was almost twice the length of the original. It clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society."[8] It also introduced the concept of oversight by an 'independent committee' (Article I.2) which became a system of Institutional Review Boards (IRB) in the US, and research ethics committees or ethical review boards in other countries.[9] In the United States regulations governing IRBs came into effect in 1981 and are now encapsulated in the Common Rule. Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. 'Legal guardian' was replaced with 'responsible relative'. The duty to the individual was given primacy over that to society (Article I.5), and concepts of publication ethics were introduced (Article I.8). Any experimental manoeuvre was to be compared to the best available care as a comparator (Article II.2), and access to such care was assured (Article I.3). The document was also made gender neutral.
Second to Fourth revisions (1975–2000)[edit]
Subsequent revisions between 1975 and 2000 were relatively minor, so the 1975 version was effectively that which governed research over a quarter of a century of relative stability.
Second and Third Revisions (1983, 1989)[edit]
The second revision (1983) included seeking the consent of minors where possible. The third revision (1989) dealt further with the function and structure of the independent committee. However, from 1993 onwards, the Declaration was not alone as a universal guide since CIOMS and the World Health Organization (WHO) had also developed their International Ethical Guidelines for Biomedical Research Involving Human Subjects.
Fourth revision (1996)[edit]
Background[edit]
The AIDS Clinical Trials Group (ACTG) Study 076 of 100 Zidovudine in maternal-infant transmission of HIV had been published in 1994.[10] This was a placebo controlled trial which showed a reduction of nearly 70% in the risk of transmission, and Zidovudine became a de facto standard of care. The subsequent initiation of further placebo controlled trials carried out in developing countries and funded by the United States Centers for Disease Control or National Institutes of Health raised considerable concern when it was learned that patients in trials in the US had essentially unrestricted access to the drug, while those in developing countries did not. Justification was provided by a 1994 WHO group in Geneva which concluded "Placebo-controlled trials offer the best option for a rapid and scientifically valid assessment of alternative antiretroviral drug regimens to prevent transmission of HIV".[11] These trials appeared to be in direct conflict with recently published guidelines[12] for international research by CIOMS, which stated "The ethical standards applied should be no less exacting than they would be in the case of research carried out in country", referring to the sponsoring or initiating country.[13] In fact a schism between ethical universalism[14] and ethical pluralism[15] was already apparent before the 1993 revision of the CIOMS guidelines.[12]
Fourth revision[edit]
In retrospect, this was one of the most significant revisions because it added the phrase "This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists" to Article II.3 ("In any medical study, every patient--including those of a control group, if any—should be assured of the best proven diagnostic and therapeutic method."). Critics claimed that the Zidovudine trials in developing countries were in breach of this because Zidovudine was now the best proven treatment and the placebo group should have been given it.[16] This led to the US Food and Drug Administration (FDA) ignoring this and all subsequent revisions.[17][18]
Fifth revision (2000)[edit]
Background[edit]
Following the fourth revision in 1996 pressure began to build almost immediately for a more fundamental approach to revising the declaration.[19] The later revision in 2000 would go on to require monitoring of scientific research on human subjects to assure ethical standards were being met.[20] In 1997 Lurie and Wolfe published their seminal paper on HIV trials,[21] raising awareness of a number of central issues. These included the claims that the continuing trials in developing countries were unethical, and pointing out a fundamental discrepancy in decisions to change the study design in Thailand but not Africa. The issue of the use of placebo in turn raised questions about the standard of care in developing counties and whether, as Marcia Angell wrote "Human subjects in any part of the world should be protected by an irreducible set of ethical standards" (1988). The American Medical Association put forward a proposed revision in November that year,[22][23] and a proposed revision (17.C/Rev1/99) was circulated the following year,[24][25] causing considerable debate and resulting in a number of symposia and conferences.[26] Recommendations included limiting the document to basic guiding principles.[27][28] Many editorials and commentaries were published reflecting a variety of views including concerns that the Declaration was being weakened by a shift towards efficiency-based and utilitarian standards (Rothman, Michaels and Baum 2000),[29][30][31][32] and an entire issue of the Bulletin of Medical Ethics was devoted to the debate. Others saw it as an example of Angell's 'Ethical Imperialism', an imposition of US needs on the developing world,[33] and resisted any but the most minor changes, or even a partitioned document with firm principles and commentaries, as used by CIOMS. The idea of ethical imperialism was brought into high attention with HIV testing, as it was strongly debated from 1996-2000 because of its centrality to the issue of regimens to prevent its vertical transmission.[20] Brennan summarises this by stating "The principles exemplified by the current Declaration of Helsinki represent a delicate compromise that we should modify only after careful deliberation". Nevertheless, what had started as a controversy over a specific series of trials and their designs in Sub-Saharan Africa, now had potential implications for all research. These implications further came into public view since the Helsinki declaration had stated, "In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement, it offers hope of saving life, reestablishing health or alleviating suffering."[34]
Fifth revision[edit]
Even though most meetings about the proposed revisions failed to achieve consensus, and many argued that the declaration should remain unchanged or only minimally altered, after extensive consultation the Workgroup [35] eventually came up with a text that was endorsed by WMA's Council and passed by the General Assembly on October 7, 2000, [36] and which proved to be the most far reaching and contentious revision to date. The justification for this was partly to take account of expanded scope of biomedical research since 1975.[37] This involved a restructuring of the document, including renumbering and re-ordering of all the articles, the changes in which are outlined in this Table. The Introduction establishes the rights of subjects and describes the inherent tension between the need for research to improve the common good, and the rights of the individual. The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards. The distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine[19][38] was removed to emphasise the more general application of ethical principles, but the application of the principles to healthy volunteers is spelt out in Articles 18-9, and they are referred to in Article 8 ('those who will not benefit personally from the research') as being especially vulnerable. The scope of ethical review was increased to include human tissue and data (Article 1), the necessity to challenge accepted care was added (Article 6), as well as establishing the primacy of the ethical requirements over laws and regulations (Article 9).
Amongst the many changes was an increased emphasis on the need to benefit the communities in which research is undertaken, and to draw attention to the ethical problems of experimenting on those who would not benefit from the research, such as developing countries in which innovative medications would not be available. Article 19 first introduces the concept of social justice, and extends the scope from individuals to the community as a whole by stating that 'research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research'. This new role for the Declaration has been both denounced [18] and praised, [39] Macklin R. Future challenges for the Declaration of Helsinki: Maintaining credibility in the face of ethical controversies. Address to Scientific Session, World Medical Association General Assembly, September 2003, Helsinki and even considered for a clarification footnote.[40] Article 27 expanded the concept of publication ethics, adding the necessity to disclose conflict of interest (echoed in Articles 13 and 22), and to include publication bias amongst ethically problematic behaviour.
Additional Principles[edit]
The most controversial revisions [39] (Articles 29, 30) were placed in this new category. These predictably were those that like the fourth revision were related to the ongoing debate in international health research. The discussions[36] indicate that there was felt a need to send a strong signal that exploitation of poor populations as a means to an end, by research from which they would not benefit, was unacceptable. In this sense the Declaration endorsed ethical universalism.
Article 29 restates the use of placebo where 'no proven' intervention exists. Surprisingly, although the wording was virtually unchanged, this created far more protest in this revision. The implication being that placebos are not permitted where proven interventions are available. The placebo question was already an active debate prior to the fourth revision but had intensified, while at the same time the placebo question was still causing controversy in the international setting. This revision implies that in choosing a study design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries. The wording of the fourth and fifth revisions reflect the position taken by Rothman and Michel[41] and Freedman et al.,[42] known as 'active-control orthodoxy'. The opposing view, as expressed by Levine[19] and by Temple and Ellenberg[43] is referred to as 'placebo orthodoxy', insisting that placebo controls are more scientifically efficient and are justifiable where the risk of harm is low. This viewpoint argues that where no standards of care exist, as for instance in developing countries, then placebo-controlled trials are appropriate. The utilitarian argument[44] held that the disadvantage to a few (such as denial of potentially beneficial interventions) was justifiable for the advantage of many future patients. These arguments are intimately tied to the concept of distributive justice, the equitable distribution of the burdens of research.[32][45] As with much of the Declaration, there is room for interpretation of words. 'Best current' has been variously held to refer to either global or local contexts.[46]
Article 30 introduced another new concept, that after the conclusion of the study patients 'should be assured of access to the best proven' intervention arising from the study, a justice issue. Arguments over this have dealt with whether subjects derive benefit from the trial and are no worse off at the end than the status quo prior to the trial, or of not participating, versus the harm of being denied access to that which they have contributed to. There are also operational issues that are unclear.
Aftermath[edit]
Given the lack of consensus on many issues prior to the fifth revision it is no surprise that the debates continued unabated.[39][47] The debate over these and related issues also revealed differences in perspectives between developed and developing countries.[48][49][50] Zion and colleagues (Zion 2000)[30][48] have attempted to frame the debate more carefully, exploring the broader social and ethical issues and the lived realities of potential subjects' lives as well as acknowledging the limitations of absolute universality in a diverse world, particularly those framed in a context that might be considered elitist and structured by gender and geographic identity. As Macklin[39] points out, both sides may be right, since justice "is not an unambiguous concept".
Clarifications of Articles 29, 30 (2002–2004)[edit]
Eventually Notes of Clarification (footnotes) to articles 29 and 30 were added in 2002 and 2004 respectively, predominantly under pressure from the US (CMAJ 2003, Blackmer 2005). The 2002 clarification to Article 29 was in response to many concerns about WMA's apparent position on placebos. As WMA states in the note, there appeared to be 'diverse interpretations and possibly confusion'. It then outlined circumstances in which a placebo might be 'ethically acceptable', namely 'compelling… methodological reasons', or 'minor conditions' where the 'risk of serious or irreversible harm' was considered low. Effectively this shifted the WMA position to what has been considered a 'middle ground'.[51][52] Given the previous lack of consensus, this merely shifted the ground of debate, [39] which now extended to the use of the 'or' connector. For this reason the footnote indicates that the wording must be interpreted in the light of all the other principles of the Declaration.
Article 30 was debated further at the 2003 meeting, with another proposed clarification[50] but did not result in any convergence of thought, and so decisions were postponed for another year,[53][54] but again a commitment was made to protecting the vulnerable. A new working group examined article 30, and recommended not amending it in January 2004. [55] Later that year the American Medical Association proposed a further note of clarification that was incorporated.[56] In this clarification the issue of post trial care now became something to consider, not an absolute assurance.
Despite these changes, as Macklin predicted, consensus was no closer and the Declaration was considered by some to be out of touch with contemporary thinking,[57] and even the question of the future of the Declaration became a matter for conjecture.[58]
Sixth revision (2008)[edit]
The sixth revision cycle commenced in May 2007. This consisted of a call for submissions, completed in August 2007. The terms of reference included only a limited revision compared to 2000.[59] In November 2007 a draft revision was issued for consultation till February 2008,[60] and led to a workshop in Helsinki in March.[61] Those comments were then incorporated into a second draft in May.[62][63] Further workshops were held in Cairo and São Paulo and the comments collated in August 2008. A final text was then developed by the Working Group for consideration by the Ethics Committee and finally the General Assembly, which approved it on October 18. Public debate was relatively slight compared to previous cycles, and in general supportive.[64] Input was received from a wide number of sources, some of which have been published, such as Feminist Approaches to Bioethics.[65] Others include CIOMS and the US Government.[66]
Seventh revision (2013)[edit]
The most recent iteration of Helsinki (2013) was reflective of the controversy regarding the standard of care that arose from the vertical transmission trials. The revised declaration of 2013 also highlights the need to disseminate research results, including negative and inconclusive studies and also includes a requirement for treatment and compensation for injuries related to research.[67] In addition, the updated version is felt to be more relevant to limited resource settings—specifically addressing the need to ensure access to an intervention if it is proven effective.
Future[edit]
The controversies and national divisions over the text have continued. The US FDA rejected the 2000 and subsequent revisions, only recognizing the third (1989) revision,[58] and in 2006 announced it would eliminate all reference to the Declaration. After consultation, which included expressions of concern, [68] a final rule was issued on April 28, 2008 replacing the Declaration of Helsinki with Good Clinical Practice effective October 2008. [69] This has raised a number of concerns regarding the apparent weakening of protections for research subjects outside the United States. [70] [71] [72] [73] [74] [75] [76] [77] [78] The NIH training in human subject research participant protection no longer refers to the Declaration of Helsinki. The European Union similarly only cites the 1996 version in the EU Clinical Trials Directive published in 2001.[79] The European Commission, however, does refer to the 2000 revision.[80]
While the Declaration has been a central document guiding research practice, its future has been called into question. Challenges include the apparent conflict between guides, such as the CIOMS and Nuffield Council documents. Another is whether it should concentrate on basic principles as opposed to being more prescriptive, and hence controversial. It has continually grown and faced more frequent revisions.[40] The recent controversies undermine the authority of the document, as does the apparent desertion by major bodies, and any rewording must embrace deeply and widely held values, since continual shifts in the text do not imply authority. The actual claims to authority particularly on a global level, by the insertion of the word "international" in article 10 has been challenged. [81]
Carlson raises the question as to whether the document's utility should be more formally evaluated, rather than just relying on tradition.
Timeline (WMA meetings)[edit]
1964: Original version. 18th Meeting, Helsinki
1975: First revision. 29th Meeting, Tokyo
1983: Second revision. 35th Meeting, Venice
1989: Third revision. 41st Meeting, Hong Kong
1996: Fourth revision. 48th Meeting, Somerset West (SA)
2000: Fifth revision. 52nd Meeting, Edinburgh
2002: First clarification, Washington
2004: Second clarification, Tokyo
2008: Sixth revision, 59th Meeting, Seoul
2013: Seventh revision, 64th Meeting, Fortaleza
See also[edit]
Informed consent
Medical ethics
Clinical trial
Human experimentation in the United States
Clinical Research
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Jump up ^ FDA scraps Helsinki Declaration on protecting human subjects. Integrity in Science May 5 2008
Jump up ^ Camporesi, Silvia (2009). "The FDA decision to shelve the Helsinki Declaration: Ethical considerations". Ecancermedicalscience. 3. doi:10.3332/eCMS.2008.LTR76.
Jump up ^ Kimmelman J, Weijer C, Meslin EM; Weijer; Meslin (January 2009). "Helsinki discords: FDA, ethics, and international drug trials". Lancet. 373 (9657): 13–4. doi:10.1016/S0140-6736(08)61936-4. PMID 19121708. CS1 maint: Multiple names: authors list (link)
Jump up ^ Goodyear MD, Lemmens T, Sprumont D, Tangwa G; Lemmens; Sprumont; Tangwa (2009). "Does the FDA have the authority to trump the Declaration of Helsinki?". BMJ. 338: b1559. doi:10.1136/bmj.b1559. PMID 19383751. CS1 maint: Multiple names: authors list (link)
Jump up ^ "DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001" (PDF).
Jump up ^ http://ec.europa.eu/research/info/conferences/edctp/edctp_ethics_en.html#fn1
Jump up ^ Rid, Annette; Schmidt, Harald (Spring 2010). "The 2008 Declaration of Helsinki — First among Equals in Research Ethics?". The Journal of Law, Medicine & Ethics. 38 (1): 143–8. doi:10.1111/j.1748-720X.2010.00474.x. PMID 20446992.
Training[edit]
U.S. National Institutes of Health (NIH) - Protecting Human Subject Research Participants
Bibliography[edit]
Articles[edit]
1990-1999[edit]
Studdert DM, Brennan TA; Brennan (November 1998). "Clinical trials in developing countries: scientific and ethical issues". The Medical Journal of Australia. 169 (10): 545–8. PMID 9861913.
McNeill PM (November 1998). "Should research ethics change at the border?". The Medical Journal of Australia. 169 (10): 509–10. PMID 9861904.
Lurie P, Wolfe SM; Wolfe (July 1999). "Proposed revisions to the Declaration of Helsinki. Paving the way for globalization in research". The Western Journal of Medicine. 171 (1): 6. PMC 1305720  . PMID 10483334.
2000-2008[edit]
Prior to fifth revision
Rothman, KJ (2000). "Declaration of Helsinki should be strengthened". BMJ (Clinical research ed.). 321 (7258): 442–5. doi:10.1136/bmj.321.7258.442. PMC 1127802  . PMID 10938059.
Following fifth revision
Vastag B. Helsinki Discord? A Controversial Declaration. JAMA 2000 Dec 20 284:2983-2985 (password required)
(References)
Singer P, Benatar S. Beyond Helsinki: a vision for global health ethics. BMJ 2001 March 31 322:747-748
Lilford RJ, Djulbegovic B; Djulbegovic (February 2001). "Declaration of Helsinki should be strengthened : Equipoise is essential principle of human experimentation". BMJ. 322 (7281): 299–300. doi:10.1136/bmj.322.7281.299/a (inactive 2017-01-15). PMC 1119536  . PMID 11157551.
Lewis, JA; Jonsson, B; Kreutz, G; Sampaio, C; Van Zwieten-Boot, B (2002). "Placebo-controlled trials and the Declaration of Helsinki". Lancet. 359 (9314): 1337–40. doi:10.1016/S0140-6736(02)08277-6. PMID 11965296.
Frankish, H (2003). "WMA postpones decision to amend Declaration of Helsinki. Working group will consider controversy over sponsors' duties to provide treatment at study end". Lancet. 362 (9388): 963. doi:10.1016/S0140-6736(03)14398-X. PMID 14513842.
MacKlin, Ruth (2003). "Bioethics, Vulnerability, and Protection". Bioethics. 17 (5–6): 472–86. doi:10.1111/1467-8519.00362. PMID 14959716.
Zion, D (2003). "Justice as equitable power relations: beyond the "standard of care" debate and the Declaration of Helsinki". The American Journal of Bioethics. 3 (2): W12. doi:10.1162/152651603322874906. PMID 14635633.
Schuklenk, U (2004). "The standard of care debate: against the myth of an "international consensus opinion"". Journal of Medical Ethics. 30 (2): 194–7. doi:10.1136/jme.2003.006981. PMC 1733846  . PMID 15082817.
Williams JR (2006). "The Physician's Role in the Protection of Human Research Subjects". Science and Engineering Ethics. 12 (1): 5–12. doi:10.1007/pl00022264. PMID 16501643.
Carlson RV, van Ginneken NH, Pettigrew LM, Davies A, Boyd KM, Webb DJ (2007). "The three official language versions of the Declaration of Helsinki: what's lost in translation?". J Med Ethics. 33 (9): 545–548. doi:10.1136/jme.2006.018168.
S Frewer A, Schmidt U, eds. History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics. Stuttgart: Franz Steiner Verlag, 2007.
Goodyear, M. D E; Krleza-Jeric, K.; Lemmens, T. (2007). "The Declaration of Helsinki". BMJ. 335 (7621): 624–5. doi:10.1136/bmj.39339.610000.BE. PMC 1995496  . PMID 17901471.
Following sixth revision
WMA News: Revising the Declaration of Helsinki. World Medical Journal 2008; 54(4): 120-25
Normile, D. (2008). "ETHICS: Clinical Trials Guidelines at Odds With U.S. Policy". Science. 322 (5901): 516. doi:10.1126/science.322.5901.516. PMID 18948510.
WMA[edit]
International response to Helsinki VI (2000). WMA 2001
Other codes and regulations[edit]
Nuremberg Code
Declaration of Geneva
Belmont Report
CIOMS
Good clinical practice (GCP)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Code of Federal Regulations
External links[edit]
Nuremberg Code
Declaration of Geneva 1948
Rickham, PP (1964). "Human Experimentation. Code of Ethics of the World Medical Association. Declaration of Helsinki". British Medical Journal. 2 (5402): 177. doi:10.1136/bmj.2.5402.177. PMC 1816102  . PMID 14150898.
Shephard, DA (1976). "The 1975 Declaration of Helsinki and consent". Canadian Medical Association Journal. 115 (12): 1191–2. PMC 1878977  . PMID 1000449.
Declaration of Helsinki: 1983 (Second revision)
Declaration of Helsinki: 2000 (Fifth revision, with footnotes from 2002, 2004)
Declaration of Helsinki: 2013 (Seventh revision - Current)
International ethical guidelines for biomedical research involving human subjects. 2002 CIOMS
WMA Medical Ethics Manual 2005
CIOMS
UNESCO: Universal declaration on bioethics and human rights. 2005
CFR Title 45 Public Welfare
CFR Title 45 Part 46 Protection of Human Subjects
Tri-Council Policy Statement: Ethical conduct for research involving humans (Canada)
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