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Topic: Declaration of Helsinki

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	Bioline International Official Site (site up-dated regularly)
		The Declaration of Helsinki was adopted in June 1964 in Finland.
		The Declaration of Helsinki stresses that the design and performance of the study should be clearly formulated in an experimental protocol.
		Also, a clarification of the Declaration of Helsinki issued in October 2001 states that a placebo control may be ethically acceptable when there is a scientifically sound methodological reason or the study involves a minor condition with no additional risk of serious harm.
	www.bioline.org.br /request?dv03019 (1560 words)

	The Declaration of Helsinki (Site not responding. Last check: 2007-10-21)
		The original version of the Declaration was adopted by the 18th General Assembly, meeting in Helsinki in June 1964 after an intense debate lasting 12 years.
		Between 1964 and 2000 the Declaration was revised, in some cases in a relatively minor manner, on four occasions, in 1975, 1983, 1989 and 1996.
		The Declaration, frequently described as the 'cornerstone' of contemporary research ethics, is precisely that.
	www.samedanltd.com /members/archives/EPC/Spring2003/DelonHuman.htm (1634 words)

	Declaration of Helsinki - Wikipedia, the free encyclopedia
		The Declaration of Helsinki, developed by the World Medical Association, is a set of ethical principles for the medical community regarding human experimentation.
		Like the Nuremberg Code, the Declaration made informed consent a central requirement for ethical research while allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor.
		The Declaration also states that research with these groups should be conducted only when the research is necessary to promote the health of the population represented and when this research cannot be performed on legally competent persons.
	en.wikipedia.org /wiki/Declaration_of_Helsinki (344 words)

	Ovid: Brennan: N Engl J Med, Volume 341(7).August 12, 1999.527-531
		The heterogeneous foundations of research ethics are the result of revulsion: globally, at the horror of the Nazi experiments, which gave rise to the Nuremberg Code in 1947 [10] and the Declaration of Helsinki in 1964, and nationally, at the revelations of abuses in the Tuskegee and Willowbrook studies.
		The proposed changes in the Declaration of Helsinki are subtle, so much so that some consider them only a slight dilution of the existing document.
		In summary, the proposed revisions to the Declaration of Helsinki weaken the principle of the researcher's moral commitment to the research subject and provide diminished protection of the rights of research subjects.
	www.hsph.harvard.edu /bioethics/uae/BrennanNEJM1999.html (3261 words)

	Declaration of Helsinki (1964)
		In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results.
		Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
		The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present declaration are complied with.
	www.cirp.org /library/ethics/helsinki (1204 words)

	Helsinki Declaration revisions
		These different responses are not necessarily an indication of less or greater concern for research subjects in these different countries and cultures; they are indicative of different approaches to and understanding of the Declaration of Helsinki.
		The revised version of the Declaration includes a note on post-trial availability of drugs to the trial subjects:At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.
		The standards of current research ethics, as set by the Declaration of Helsinki, are better than what was expected when the first drafts were circulated.
	www.issuesinmedicalethics.org /091re029.htm (770 words)

	THE REVISED DECLARATION OF HELSINKI (EDINBURGH (2000) BY THE WORLD MEDICAL ORGANISATION
		The World Medical Association gave the task of drafting the new Declaration of Helsinki to a committee of three members who were presidents of their respective medical associations.
		Second, rule 9 concerns itself with the relation of the Declaration of Helsinki to the local law.
		The Declaration of Helsinki, promulgated in the year 2000 in Edinburgh, Scotland, is a compromise.
	www.utoronto.ca /cip/Global3.htm (3501 words)

	AMA (Virtual Mentor) Historical Postmortem January 2001 (Site not responding. Last check: 2007-10-21)
		The Declaration of Helsinki emerged in the aftermath of World War II as one of the guidelines of biomedical ethical conduct.
		At the heart of the controversy is paragraph 29 of the Helsinki Declaration, which states that "the benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods.
		This most recent revision in the Declaration (the document was previously revised in 1975, 1983, 1989, and 1996) is aimed at making the document relevant to today's field of medical research.
	www.ama-assn.org /ama/pub/category/3787.html (588 words)

	WMA - Policy
		All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.
		The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care.
		The Declaration of Helsinki (Document 17.C) is an official policy document of the World Medical Association, the global representative body for physicians.
	www.wma.net /e/policy/b3.htm (1881 words)

	Doctors revise Declaration of Helsinki -- Christie 321 (7266): 913 -- BMJ
		This is the fifth revision of the Declaration of Helsinki, which was first drawn up in response to the atrocities of the second
		The full text of the revised Declaration of Helsinki can be found on the WMA's website (www.wma.net).
		The Declaration of Helsinki was drawn up to prevent such crimes.
	bmj.bmjjournals.com /cgi/content/full/321/7266/913 (720 words)

	Public Citizen \| Publications - US exceptionalism comes to research ethics - Comment by Peter Lurie in The Lancet (HRG ...
		Seeking an expansive vision for his second term, the President declared that "There is only one force of history that can break the reign of hatred and resentment, and expose the pretensions of tyrants, and reward the hopes of the decent and tolerant, and that is the force of human freedom".
		Ironically, the FDA has already deftly evaded the 2000 modifications to the Declaration of Helsinki by declaring in 2001 that the reference to the declaration in FDA regulations was not actually to the current version, but rather to the weaker, now defunct 1989 version.
		For placebo use, the FDA complained that the language in the 2000 Declaration of Helsinki precludes the use of placebos in studies of minor conditions.
	www.citizen.org /publications/release.cfm?ID=7373 (1253 words)

	The Euro-Mediterranean Partnership - Declaration of the Euro-Mediterranean Ministerial Conference on the environment
		The Euro-Mediterranean Conference which was held in Barcelona in November 1995 adopted a Declaration establishing a new Partnership between the European Union and 12 Southern and Eastern Mediterranean Partners.
		The Commission was entrusted in the Barcelona Declaration with the coordination of the preparation of a Short and Medium-term Priority Environmental Action Programme (SMAP).
		As foreseen by the Barcelona Declaration, the Euro-Mediterranean Partners undertake to establish a short and medium-term priority action programme, including in connection with combatting desertification, and to concentrate appropriate technical and financial support on those actions.
	ec.europa.eu /comm/external_relations/euromed/conf/sect/env.htm (9053 words)

	WMA - Ethics Unit - Declaration of Helsinki
		The Declaration of Helsinki is the WMA's best-known policy statement.
		Documentation for the Preparation of Note of Clarification on Paragraph 30 of the Revised Declaration of Helsinki
		The International Response to Helsinki VI - The WMA's Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, as adopted by the 52nd WMA General Assembly, Edinburgh, October 2000
	www.wma.net /e/ethicsunit/helsinki.htm (161 words)

	World Leaders sign Helsinki Declaration
		KO: In the afternoon of 11 September, the 6th ASEM Summit was concluded in Helsinki, capital of Finland.
		The Helsinki Declaration contains guidelines and practical recommendations for developing cooperation between the countries in issues such as politics, economics, culture and education.
		The Declaration on Climate Change, based on the Kyoto Protocol sends a strong signal to the world that ASEM intends to tackle the threat that climate change poses to sustainable development.
	www.ntdtv.com /xtr/en/2006/09/13/a_46660.html (322 words)

	Rising concerns about placebos - Declaration of Helsinki amended to call for testing new drugs against current best ...
		In such cases, informed consent from a volunteer--saying he or she understands and accepts the risks of participating in a clinical trial--may be ethically meaningless.
		The Helsinki amendment suggests that "the rights of the individual patient [to the best available treatment] take precedence over the rights of science and society in genera," Rothman concludes.
		In July 2000, before the Helsinki declaration was amended, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use released a guidance document explicitly stating that placebo use is, in general, ethically acceptable.
	www.findarticles.com /p/articles/mi_m1200/is_5_159/ai_71352470 (637 words)

	The Center for Bioethics and Culture Network :. Article Display
		The Declaration of Helsinki is one of the 20th century’s most remarkable texts.
		Yet, with the 5th and most recent amendment in October 2000, the Declaration of Helsinki finds itself in the midst of a storm of controversy.
		Two of the new paragraphs in particular, i.e., paragraphs 29 and 30, are at the centre of the controversy.
	www.thecbc.org /redesigned/research_display.php?id=146 (1477 words)

	Declaration of Helsinki should be strengthened - Letter to the Editor British Medical Journal - Find Articles
		Declaration of Helsinki should be strengthened - Letter to the Editor
		EDITOR--The debate over changes to the Declaration of Helsinki is disappointing.[1] It has in many ways muddied the waters instead of clearing the way to improving international research ethics standards.
		What we see at the moment is a clear fault line between the American and British medical associations--both of which support lower standards of care for people living in developing countries--and continental European, Latin American, and some Asian medical associations, which reject such a double standard.
	www.findarticles.com /p/articles/mi_m0999/is_7281_322/ai_71186056 (787 words)

	Some Helsinki Guidelines on Human Medical Research
		The Declaration of Helsinki : revising ethical research guidelines for the 21st century
		Article I.9 of the current Declaration states that a physician should "obtain a patient's freely-given informed consent, preferably in writing".
		Article 24 of the Proposed Revision introduces a waiver of written consent "when the research involves only slight risk or when the procedures to be used are customarily used in the practice of medicine without documentation of consent".
	www.circulatorboot.com /literature/MEthics.html (347 words)

	The standard of care debate: the Declaration of Helsinki versus the international consensus opinion -- Lie et al. 30 ...
		The standard of care debate: the Declaration of Helsinki versus the international consensus opinion -- Lie et al.
		The standard of care debate: the Declaration of Helsinki versus the international consensus opinion
		Declaration of Helsinki and the allowance of exceptions by other
	jme.bmjjournals.com /cgi/content/full/30/2/190 (2137 words)

	The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia -- Carpenter et ...
		The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia -- Carpenter et al.
		The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia
		Helsinki 2000 of placebo substitution for a standard treatment.
	ajp.psychiatryonline.org /cgi/content/full/160/2/356 (4349 words)

	Helsinki Declaration on Action for Environment and Health in Europe - Health, Declarations, Resolutions, Charters, ... (Site not responding. Last check: 2007-10-21)
		Helsinki Declaration on Action for Environment and Health in Europe - Health, Declarations, Resolutions, Charters, Programmes, Platforms, UN - Healthy Documents
		In implementing this Declaration, we will follow the recommendations of the 1992 report of the WHO Commission on Health and Environment, which emphasized that there is complementarity, not conflict, in the promotion of health and the protection of the environment.
		The WHO Commission’s concept has been endorsed by the Commission on Sustainable Development, which has stressed the need to integrate health, environment and development goals and activities: we will be guided by its decisions as these relate to environment and health in Europe.
	www.healthydocuments.info /development/doc27.html (3799 words)

	Declaration of Helsinki (1964) -- 313 (7070): 1448 -- BMJ
		Declaration of Helsinki (1964) -- 313 (7070): 1448 -- BMJ
		laid down in this Declaration should not be accepted for publication.
		the principles enunciated in the present declaration are complied
	bmj.bmjjournals.com /cgi/content/full/313/7070/1448/a (1019 words)

	World Medical Association Declaration Of Helsinki
		The Declaration of Geneva of the World Medical Assembly binds the physician with the words.
		"The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient’s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."
		The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.
	biotech.law.lsu.edu /research/reports/Helsink.htm (1155 words)

	NEJM -- The Need to Revise the Declaration of Helsinki
		Carpenter, W. Jr., Appelbaum, P. S., Levine, R. The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia.
		Morens, D. M., Kopp, V. J., Senn, S., Macpherson, C. C., O'Ryan, M., Misbin, R. I., Levine, R. Should the Declaration of Helsinki Be Revised?.
		Rothman, K. J, Michels, K. B, Baum, M. For and against: Declaration of Helsinki should be strengthened FOR AGAINST Rothman and Michels' riposte.
	content.nejm.org /cgi/content/short/341/7/531 (539 words)

	Dismantling the Helsinki Declaration -- 169 (10): 997 -- Canadian Medical Association Journal
		of the Declaration were made in 2000 in response to new ethical
		The World Medical Association's Declaration of Helsinki: Historical and Contemporary Perspectives, 5th draft.
		In: Comments on the Workgroup Report on the Revision of Paragraph 30 of the Declaration of Helsinki.
	www.cmaj.ca /cgi/content/full/169/10/997 (706 words)

	JAMA -- Perspectives on the Fifth Revision of the Declaration of Helsinki, December 20, 2000, Riis 284 (23): 3045 (Site not responding. Last check: 2007-10-21)
		JAMA -- Perspectives on the Fifth Revision of the Declaration of Helsinki, December 20, 2000, Riis 284 (23): 3045
		Perspectives on the Fifth Revision of the Declaration of Helsinki
		Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.
	jama.ama-assn.org /cgi/content/extract/284/23/3045 (181 words)

	Office of Research and Compliance - The Helsinki Declaration (Site not responding. Last check: 2007-10-21)
		Office of Research and Compliance - The Helsinki Declaration
		Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended by the 29th World Medical Assembly Tokyo, Japan, October 1975, 35th World Medical Assembly, Venice, Italy, October 1983 and the 41st World Medical Assembly, Hong Kong, September 1989.
		In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject.
	www.southalabama.edu /com/research/humansubjects/helsinki.shtml (1152 words)

	Helsinki Accords - Wikipedia, the free encyclopedia
		For the set of principles on human experimentation, see Declaration of Helsinki.
		However, the civil rights portion of the agreement provided the basis for the work of the Moscow Helsinki Group, an independent non-governmental organization created to monitor compliance to the Helsinki Accords (which evolved into several regional committees, eventually forming the International Helsinki Federation and Human Rights Watch).
		While these provisions applied to all signatories, the focus of attention was on their application to the Soviet Union and its Warsaw Pact allies, including Bulgaria, Czechoslovakia, East Germany, Hungary, Poland, and Romania.
	en.wikipedia.org /wiki/Helsinki_Accords (185 words)

	index
		ICH (which is the main topic of your course) International Conference on Harmonization, international organization, met for the first time in 60-s and issued declaration on harmonization in Helsinki.
		They set on international principles of clinical research in humans.
		The only country that has technical/marketing advantage may take a leadership of the discussion and control of the resultant standards.
	www.krctraining.com /faq/faq20.htm (243 words)

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