ARTIGO MoralImperialismMulti Centric

7/29/2019 ARTIGO MoralImperialismMulti Centric

1/8

Cad. Sade Pblica, Rio de Janeiro, 24(10):2219-2226, out, 2008

2219

Moral imperialism and multi-centric clinicaltrials in peripheral countries

Imperialismo moral e ensaios clnicosmulticntricos em pases perifricos

1 Ctedra UNESCO de

Biotica, Universidade de

Braslia, Braslia, Brasil.

2Universidade Federal da

Bahia, Salvador, Brasil.

Correspondence

V. Garrafa

Ctedra UNESCO de Biotica,

Universidade de Braslia.

C. P. 04451, Bras lia, DF

70904-970, Brasil.

[email protected]

Volnei Garrafa 1

Claudio Lorenzo2

Abstract

Moral imperialism is expressed in attempts to

impose moral standards from one particular

culture, geopolitical region or culture onto other

cultures, regions or countries. Examples of Direct

Moral Imperialism can be seen in various recur-

rent events involving multi-centric clinical tri-

als promoted by developed (central) countries inpoor and developing (peripheral) countries, par-

ticularly projects related to the theory of double

standards in research. After the WMA General

Assembly refused to change theHelsinki Declara-tion which would have given moral recognitionto the above mentioned theory the USA aban-

doned the declaration and began to promote re-

gional seminars in peripheral countries with the

aim of training researchers on ethical perspec-

tives that reflect Americas best interests. Individ-

uals who received such training became trans-

mitters of these central countries ideas across

the peripheral countries, representing a form ofIndirect Moral Imperialism. The paper proposes

the establishment of regulatory and social con-

trol systems for clinical trials implemented in

peripheral countries, through the formulation of

ethical norms that reflect the specific contexts of

these countries, along with the drawing up and

validation of their own national norms.

Bioethics; Human Experimentation; Clinical

Trial

Introduction

Bioethics has become an increasingly impor-tant issue in the 21st Century. Through the recentadoption of the Universal Declaration on Bioeth-ics and Human Rights, unanimously approvedby the 191 countries present at the 33rd Sectionof the General Conference of the United Nations

Educational, Scientific and Cultural Organiza-tion (UNESCO), held in Paris in October 2005,bioethics has also widened its coverage: in ad-dition to the issues of biomedicine and biotech-nology already considered to be within its remit,health, social and environmental issues havebeen added.

Scientific research, including clinical trials,has evolved from being an amateur activity in the18th Century, and a university practice in the 19thCentury, to an industrial activity in the 20th Cen-tury1. The acceleration of the process of marketglobalization in recent years has made clinical

trials more international and influenced theirmeans of financing as well as the development ofresearch practices 2.

The globalization of the world economy,rather than leading to a reduction in the gap be-tween rich and poor across the world has furthersharpened contradictions and reinforced exist-ing problems. The majority of the populationsin poor and developing (or peripheral) countriesstill struggle to guarantee the minimum condi-tions necessary for their survival and dignity. In

ARTIGO ARTICLE


2/8

Garrafa V, Lorenzo C2220


Latin America, for example, the quality of publichealth services is generally low3, and investmentsin the promotion of access to pharmacotherapieson the part of underprivileged populations are al-most non-existent, meaning that individuals areresponsible for almost 70% of all medical-relatedexpenses in these countries 4. In addition, socialsecurity fails to cover approximately 40% of thepopulations, representing 218 million people 5.

However, people in the upper social strata ofperipheral countries make up an important con-sumer market of global goods and they are ableto access sophisticated medical technologies.

Without the means to determine their re-search priorities or to make substantial in-roadsin the field of public health, peripheral countriesoften find themselves hostages to foreign financ-ing. This assertion is supported by data from the

Word Health Organization (WHO), according towhich 87% of the US$ 2 trillion spent annually onhealth care across the globe benefits just 16% of

the worlds population, while 10% of the globalburden of disease is responsible for as much as90% of global expenditure on health research 6. Itis common for research performed in developingcountries to be guided exclusively by the logicof the market, with the aim of developing medi-cines which may not be available in local publichealth systems in the future. In spite of criticismsof these kinds of clinical trials, many scholars, in-cluding bioethicists in developed countries, havestrived to justify these views 7,8,9.

In this context, one of the most important de-bates has focused on placebo controlled trials.

The Helsinki Declaration, the main internationalnormative document on biomedical research,claims that the potential benefits and discomfortof a new diagnostic or therapeutic method shouldbe compared to the benefits of current method(s)and prohibits the use of placebo groups if othereffective methods already exist. However, thisstatement is now under strong pressure from autilitarian rationale which places cost/benefitcalculations and scientific arguments ahead ofuniversal ethical concerns. Several authors, uni-versities and national institutions, like the UnitedStates Food and Drug Administration, defend the

morality of performing placebo controlled tri-als when a methodological justification exists orwhen there are no medicines available to devel-oping countries populations 10.

Therefore, it is no surprise to note that in re-cent years, expressions such as bioethics colo-nialism 11 and moral imperialism 12,13 startedto appear in scientific magazines specialized inethics and bioethics. During the final decades ofthe 20th Century encouraged by certain theo-retical currents in bioethics ethics started to be

used in many instances as a horizontal and asep-tic tool, to the service of a neutral understandingand interpretation of the collective conflicts thatoccur within populations that have themselvesbeen marginalized and socially excluded fromtheir societys development process.

Taking as a starting point an analysis of theexpression moral imperialism, the objective ofthis study is to critically apply the term to multi-centric clinical trials that have received foreignsupport and been performed in several periph-eral countries in the Southern Hemisphere in re-cent years.

Moral Imperialism

Moral Imperialism, applied to the field of bio-ethics, is the aim of imposing, through differentforms of coercion, moral standards from specificcultures, geopolitical regions and countries on

other cultures, regions, or countries 14. The is-sue of imperialism is a very broad one. In spitethe fact that it is a relatively recent expression(in use since around 1870), a historical retro-spective study would have to discuss categoriessuch as: colonialism, neo-colonialism and un-derdevelopment (as established by Marxist theo-ries on imperialism); militarism and surplus, anew concept that substitutes more-worth (frommonopolistic capitalism theory); market (socialdemocratic theory); capitalism (liberal theory);anarchism, hegemony and State power (reasonof State theory). As a general rule, in terms of

political theory, imperialism means the violentexpansion of a State to submit other territories toits influence or direct power and even to forms ofeconomic exploitation, to the detriment of thosesubjugated States or peoples 15.

With regard to the issues of neocolonialismand underdevelopment both of which are di-rectly relevant to this discussion and specificallyto the peripheral countries in the world it isimportant to State that uncontrolled capitalismtends to maintain and strengthen unbalanceddifferences between rich and poor countries,

which may only be overcome by the introduction

of instruments that guarantee effective regionalprogramming and concrete regional policieswith worldwide dimensions. For the field of clini-cal trials, the overall recommendation should bethe same, an issue that will be addressed towardsthe end of this study.

Taking into account economic interests, par-ticularly those of the pharmaceutical industriesin developed countries, it is worth consideringthe problem of imposing TRIPS-Plus provisions(provisions that exceed the obligations under the


3/8

MORAL IMPERIALISM AND MULTI-CENTRIC CLINICAL TRIALS 2221


TRIPS Agreement) into Free Trade Agreementsproposed by the United States of America to pe-ripheral countries. These provisions can signifi-cantly reduce the capacity of these countries toprovide adequate access to medicines for theirpoorest citizens. Furthermore, strict intellectualproperty rules can jeopardize the development ofproduction from the autonomous biomedical in-dustry and erase the rights granted by the TRIPS

Agreement under the World Trade Organization(WTO) 16.

Free Trade Agreements or FTAAs have beencriticized by constituency groups in the USA andin peripheral countries and risk creating tensionsand antagonisms between governments and civilsociety in these countries. Economic and politicalpressures for the acceptance of such provisionsbroaden the gap between both sides in termsof development and health protection which isclearly a sign of moral imperialism.

This text considers imperialism as an instru-

ment for the imposition of the cultural standardsof one nation upon another, of a strong coun-try upon more fragile ones 17. Among the fun-damental principles of International Law, thereare those related to the non-interference of onecountry into the internal affairs of another, andrespect for the particular political and culturalnorms of each country, with very specific excep-tions. According to this line of thought and inrecognition of the original meaning of the Latin

word mores meaning way of being or way ofproceeding, habits of a people or a nation andupon which Roman Law was established the

moral plurality of different cultures should berespected. What is now happening is that somehegemonic cultures are using their economicclout and mass communication to manipulateand invade other cultures, especially in poor anddeveloping countries, imposing their own unilat-eral visions of the world. This moral imperialismtransforms citizens into subjects; and the subjectis a vassal, whose autonomy is very fragie or non-existent and who is always under the control ofsomeone stronger 17.

We can classify moral imperialism in the fieldof bioethics as being direct or indirect. An exam-

ple of Direct Moral Imperialism is the increasingpressure of some developed (or central) countriesto impose their moral visions on others. A proofof this tendency is the recent actions (up to 2004)of the USA in imposing changes to the originalcontent of the Helsinki Declaration on researchinvolving human beings, with regard to the qua-si-requirement of accepting as ethically correctthe use of different methodological standards fordifferent countries. That would mean the defini-tive acceptance that the methodological design

for clinical trials (of new antiretroviral medicine,for example) should have one standard for poorcountries and another for rich ones, tearing apartthe theorem that held sway in the 20th Century,recognizing the equality of all individuals 17. Italso goes against Kants historical affirmationthat human beings are an end in themselves. Thisdistortion, defined by many scientists as diver-sity of ethical criteria 18 has been labeled doublestandards that is, double standards in terms ofthe actions of researchers and double standardsin the protection of research subjects, which isincompatible with the idea of human rights, andtherefore, unacceptable by peripheral countries.

Indirect Moral Imperialism, in turn, is similarto active Moral Imperialism in the way that it isapplied to peripheral countries but works in adifferent way. It is undertaken through prelimi-nary educative actions aimed at convincing andco-opting people in more vulnerable countries,

which in the medium- and long-term may be-

come members of ethics committees and gov-ernment bodies that make decisions about thefield of clinical trials.

Clinical multi-centric trials in peripheralcountries and their implications

Direct Moral Imperialism

Some cases from recent world literature are con-sidered here in order to contextualize the issue. Atthe end of 1997, Lurie & Wolf 19 issued an article

denouncing 15 clinical trials designed to studythe prevention of vertical transmission of HIVbetween pregnant women and their babies in socalled developing countries, using a placebo fortreating the control group 19. The chief editor ofthe magazine, in which the article was published The New England Journal of Medicine (N EnglJ Med) wrote an editorial supporting the au-thors position, and comparing these trials to the

well known Tuskegee case 20. This analogy wasmade on the grounds that the HIV trials deniedantiretroviral medicines to a group of women

who participated in the research in the same way

that the Tuskegee study denied penicillin to thesubjects, even after the acknowledged proof ofits efficacy. The criticism was based on the factthat these studies violated informed consent, ex-ceeded the grounds of placebo use and took ad-vantage of poor and misinformed populations.

Directors of the National Institutes of Health(NIH) and the Centers for Disease Control andPrevention (CDC), both American governmentagencies which financed the HIV research, im-mediately defended the ethics of this trial, saying


4/8



that these situations were correct, and allegingthat the scientific, social and economic complex-ity of each trial should be considered 7. This issuehas later highlighted on the pages of magazinesand newspapers with broad circulations, such asthe New York Times.

The most surprising aspect was that severalresearchers strongly defended the adoption ofdifferent ethical criteria for trials performed indeveloped countries and those undertaken inpoor or developing countries. The argument wasbased on the relativity of each situation: Ethi-cal standards for trials involving human beings

are universal, but not absolute: there are some

principles that may be applied to all cases of tri-

als involving human beings, but their applica-

tion should also consider factors inherent to the

particular situations(...) which vary according tothe social and economic context, besides the trial

scientific conditions 8 (p. 288).In other words, this argument contextual-

izes the issue by putting it out of context. Theemerging question within the internationalacademic community was then whether theadoption of different standards for trials andparticipants would be ethically justifiable. How-ever, well-timed statements contested such ar-guments, maintaining that they went entirelyagainst the improvements achieved previously,in relation to universal political and civil rights21,22,23. Almost two years after this event, anothertrial on HIV performed in poor countries has giv-en rise to similar inquiries. This research project

was developed in rural areas of Uganda, with the

aim of determining risk factors associated withthe transmission of HIV (type 1) among hetero-sexuals, trying to establish whether other sexu-ally transmitted diseases could increase the riskof HIV infection 24 and to verify the relation be-tween viral load and heterosexual transmission ofHIV-1 25. For this trial, hundreds of people withHIV were observed for 30 months, but receivedno treatment and were provided with impreciseand incomplete information 26. The perplexityraised by this trial resulted from the fact that aproject of this nature would never receive ap-proval in the USA (the country that financed

the research), or any other developed country,where patients with HIV or other sexually trans-mitted diseases would receive prior informa-tion and treatment. It was clear that differentethical standards had been adopted for Uganda.

What is even more serious is that many trialsdeveloped in peripheral countries began to belimited to observing subjects and confirmingavoidable harm as, for example, in the case ofthe HIV positive pregnant women who weretreated with a placebo. In this case, the problem

was aggravated by the fact that the studies hadbeen approved by ethical revision committees,in both the country in which they were to beimplemented and in the country that financedthem, an issue that will be discussed later.

What is also surprising is the fact that someEditorial Boards of scientific publications suchas the N Engl J Med and The Lancet, traditionaland prestigious international publications inthe biomedical sciences accepted to publisharticles with the above mentioned distortions19,24,25. Regarding the N Engl J Med, the problemhas been the subject of two editorials by Angell20,26, who was Chief Editor of the journal at thetime, both of which are critical of the decisionthat was taken by the board and not approvedby her. She admitted that she found herself in aminority but was nevertheless unsatisfied. Soonafter this affair, she left (or was forced out of) theposition that she had occupied for many years.The Lancet reviewed its position through an edi-

torial published in 2003 with the notable title ofOne Standard, Not Two 27. But as long as thoseissues raised in this present article are not con-sidered within the context of the scientific pub-lications themselves, including the decision torefuse publication under certain circumstanc-es, these practices that are so negative towardsmore vulnerable members of society will remainin place.

Subsequent to the events mentioned abovethe USA, with support from many developedcountries tried every means available to changethe content of articles 19, 29 and 30 of the Helsinki

Declaration, which refers to the double standardsfor research involving human beings includingthe obligation to continue to provide treatmentto subjects after the research has ended. In spiteof having obtained some favorable changes fol-lowing their proposals to revise the 2002 CIOMSGuidelines at the World Health Assembly in To-kyo in 2004 28, in the official discussion forumfor changing the declaration, the USAs inten-tions were comprehensively buried by a major-ity of representatives from other countries. Theimmediate reaction of the USA was to refuse torecognize officially the Helsinki Declaration as a

reference tool for clinical trials involving humanbeings.More recently, at the end of 2005, the Brazil-

ian Health Council was informed of the use of hu-man subjects as research guinea pigs in the Stateof Amap, near Brazils northern border with Ven-ezuela. Public investigations showed that a groupof people were each paid between US$ 6 and US$10 a day to capture mosquitoes and to exposethemselves to 100 bites from these mosquitoesthat were infected by malaria at a rate of 3.5%.


5/8



The research was promoted by a North AmericanUniversity with cooperation from important Bra-zilian research institutions and the support of theNIH. The blood feeding of captured mosquitoeson human beings was described in the protocolapproved by the Institutional Review Board ofthe University (this protocol is available with theauthors).

The capture of mosquitoes using the humanbait method consists of exposure of parts of thebody to attract the mosquitoes and capture thembefore they can bite. It is a routine method em-ployed in research as well as for entomologicalsurveillance. According to Forattini 29 the safetyof the method depends on the ability of thoseresponsible for capturing each mosquito beforeit can start to bite.

The procedure, when performed by skilledtechnicians or researchers, seems not to presenthigher risks than natural exposure, although nostudies have ever corroborated this. The prob-

lem of this specific research was that membersof the community itself were used to capture themosquitoes; no criteria had been determined toselect the individuals involved and their trainingbegan only a few weeks before capture started.Therefore, the level of safety involved in the pro-cedures performed by the human subjects couldnever be compared to those performed by expe-rienced technicians. Nonetheless, the expressionguinea pigsis not appropriate when applied here,and the sensationalist exploitation by the presshas hampered the approval of research initiativesthat apply the procedure correctly.

The human feeding of mosquitoes capturedin nature has not been described in other articles,although it has been used in previous studies30,31,32. Depending on the level of infection andthe number of mosquitoes being fed, there areclearly significant risks involved in such a pro-cedure, including hyper-infection, mixed infec-tion, and other zoonotic diseases. Consideringthe risks involved, this procedure is totally differ-ent from other forms of research such as plasmo-dium inoculation for vaccine research, in whichknowledge of the viral load and infection ratesare far greater.

In the particular study under discussionhere, it was established that individuals wouldallow themselves to be bitten by 100 mosqui-toes, twice a year. There is no mention of thenumber of days during which this procedure

would be undertaken. The researcher in chargeof field activities admitted openly that the pe-riod of exposure was planned to be four nightsbut that the procedure was performed only onceand then cancelled. Notwithstanding, accordingto members of the riverside community where

the research was conducted, exposure lasted forfour nights at a time.

At two different stages in the original pro-tocol, blood feeding by mosquitoes on humanbeings is mentioned clearly. The chapter that de-scribes the methodology to be employed statesthat: Mosquitoes captured from human landingcounts will be blood-fed on team member volun-

teers who have taken the recommended Ministry

of Health malaria prophylaxis for the region (p.37) and in the description of the participation ofthe individuals, it states: The team volunteerswho blood feed the mosquitoes during the mark-

recapture experiments will be provided with the

current Ministry of Health recommendation for

chemoprophylaxis in this region (p. 43). The doc-ument of informed consent signed by researchsubjects also includes a clear description of theprocedure in its item 6: you will be requestedto feed 100 mosquitoes from your arm or leg for

studies of marking-recapture. That will happen

twice a year (informed consent attached to theprotocol; p. 2). It is clear that the reasoning usedby the International Review Board to accept sucha high degree of risk was based on double stan-dards.

The public presentation by the BrazilianHealth Council of the investigators report in April2006, showed that the blood feeding procedureand the capture of mosquitoes through exposureof members of the local communities were omit-ted in the Portuguese translation of the protocol,and were also omitted in the consent documentreceived by the National Commission on Ethics

in Research (CONEP). As the English original ver-sion cannot be examined without translation bya Brazilian Commission, the protocol was alsoapproved in Brazil and the research began. Theacknowledgement of these facts caused the im-mediate suspension of the research by the Bra-zilian Health Council and the publication of itsresults was forbidden.

Indirect Moral Imperialism

A paradigmatic text written by Emanuel &Grady33 and published in January 2007, proposes

a historical classification of four different phasesrelating to the development of clinical trials: (1)the researcher paternalism phase from 1940 tothe beginning of the 1970s labeled utilitarian-ism; (2) between the start of the 1970s and themid-1980s, a phase known as principalism;(3) the participant access phase, between themid-1980s and the mid-1990s, referring to basicindividual rights and informed consent; and (4)the community partnership phase, from themid-1990s to the present, represented by com-


6/8



munitarian actions in the form of cooperationbetween institutions, people and countries.

This chronology is consistent with the line ofaction proposed by the NIH in relation to periph-eral countries, starting with the USAs rejectionof the Helsinki Declaration in December 2004.The USA formally declared to the world that fromthat moment on, their researchers and the trialsfinanced by their companies should follow theirown guidelines, based on the ICH-GCP guide-lines (International Conference on the Harmo-nization Good Clinical Practices). These guide-lines reflect the tripartite agreement made in1997 between America, Japan and Europe, whichare the worlds three leading medicine produc-ers. As mentioned previously, the 2002 CIOMSversion also includes changes that reflect thesepressures.

More recently, USA changed its strategy toavoid international confrontation. It now pro-motes frequent academic meetings in different

countries with the support of the Fogarty Inter-national Center, an institute of the NIH, with theaim of instructing researchers from peripheralcountries in their particular way of interpretingthe ethics of clinical trials, independently of theviews of the governments of the countries from

which these researchers hail 34. In Latin Amer-ica, for example, many activities of this kindhave been developed in Argentina, Chile and

Venezuela over the last three years. The strategyimplies that once these researchers have beenappropriately drilled, they should start partici-pating in Research Ethics Committees in their

own countries, and in bodies that regulate suchissues within their national governments. In this

way, in just a few years, Emanuel & Gradys 33paradigmatic proposal may become reality,since decisions related to ethics in clinical trialsin different countries would be taken concretelyand coherently by societies and communities.It thus represents a more subtle form of ethicalimperialism. Tealdi 34 reports that in 10 years it

would be possible to instruct 3,600 people inLatin America alone, changing some of the corereferences for ethics in clinical trials up to 2010,

when the next revision of the Helsinki Declara-

tion is due.

Regulation and control of trials inperiphery countries

At this point in the text we present a proposalfor the development of systems for the regula-tion and social auditing of research in peripheralcountries. These systems could be crucially im-portant in guaranteeing significant changes in

the current situation, and be to the benefit of vul-nerable populations. This proposal has been pre-sented to the Latin American and Caribbean Bio-ethics Network of UNESCO (Redbiotica) and

was also included in its first course on ethics intrials involving human beings in the program fordistance learning and permanent education 2.

The development of a system for the regula-tion and social auditing of research in poor anddeveloping countries that is capable of promot-ing cooperation in international research, andlimiting moral imperialism and exploitation ininternational research would, in this proposal,involve reform along two main lines: (1) thedrawing up of strict norms that are relevant tothe socioeconomic and cultural contexts of thesecountries, involving the three axes of protectionin research ethics (obtaining consent, minimiza-tion of risks and maximization of benefits); (2) re-form of the socio-political component, throughthe creation of normative regulatory instruments

in the form of laws and ethical norms in researchand the opening up of democratic spaces forsocial auditing, embodied in institutional or re-gional committees and national commissions forclinical trials.

With regard to proposal 1 the design ofnorms that are relevant to the socioeconomicand cultural contexts of peripheral countries there are three components to be considered:(a) improve the processes for obtaining informedconsent, by giving less importance to the con-tractual neo-liberal approach and more impor-tance to a communitarian vision of autonomy

for populations with low levels of education; (b)improve procedures aimed at minimizing risksto ensure equality for all subjects who participatein clinical trials; (c) improve procedures aimed atmaximizing benefits, for this same reason.

In relation to proposal 2 the creation andvalidation of national norms there are also threecomponents to be considered: (a) stimulate so-ciopolitical participation in the production ofdocuments through independent and inter-disciplinary discussion forums, with the aim ofobtaining a national consensus on ethical limitsin research; (b) create national or institutional

spaces for the evaluation of the ethical aspectsof research protocols, with independent deci-sion-making capacities and ethical overview ofresearch; (c) build the capacities of members ofethics committees and commissions in the fol-lowing areas: knowledge development of ethicalnorms for trials and their interpretation, with rel-evance to the local context; knowledge develop-ment about the degree of risk of human partici-pation depending on the main methodologicaltechniques of research (here scientific issues can


7/8



be simplified in order to make them accessible toindividuals who are not themselves researchersin the area of health); training on communica-tion, developing arguments and on the criticalanalysis of certain arguments, to support deci-sion-making processes.

Final considerations

The partnership society proposed by Emanuel& Grady33 may come about as a result of actionsby the USA which seek to promote the passiveacceptance of research projects as a result of rich(central) countries interests in peripheral coun-tries. In such a scenario, many of those who par-ticipate in the decision-making process in poorand developing countries would receive the ap-propriate drilling on the new/old ways of think-ing, and assume that supposedly universal, butimperialist ethics are in fact appropriate ethics

for their populations. This could be considered tobe an example of the ideology ofdouble standards

or the persuasion of researchers through specialmethods of instruction on research ethics.

Nonetheless, it is important to highlight theresistance of some countries in the SouthernHemisphere to attempts to import bioethicalcolonialism and to acknowledge the benefits ofethical imperialism. Redbiotica, a network cre-ated with the support of the Regional UNESCOBureau in Mexico, is proof of such resistanceand is critical of importing ethical packagesinto different contexts and cultures.

Redbiotica is fully open to bilateral ex-changes with other institutions, countries andregions of the world, aimed at sharing experi-ence and best practice. In recent years, someLatin American countries have provided con-crete responses to ethical invasions, throughimproving legislation and academic programsfor clinical researchers and bioethicists, whichare more critical and concerned with the socio-politic feedback of their trials, thus creating a

new culture of public participation, citizenshipand social responsibility.

Resumo

Imperialismo moral a inteno de impor padres

morais de determinadas culturas, regies geopol-

ticas e pases a outras culturas, regies ou pases. O

Imperialismo Moral Direto pode ser exemplificado

com diversos episdios recorrentes de ensaios clnicos

multicntricos promovidos por pases desenvolvidos

(centrais) em pases pobres e em desenvolvimento (pe-

rifricos), especialmente projetos relacionados com a

teoria do double standard de pesquisas. Com a recu-sa da Assemblia Geral da Associao Mdica Mundial

em alterar a Declarao de Helsinki, que significariao reconhecimento moral da referida teoria, os Estados

Unidos abandonaram a declarao, passando a pro-

mover seminrios regionais em pases perifricos com

objetivo de treinar investigadores nas vises ticas

dos interesses estadunidenses. Estes passam a ser du-plicadores das idias centrais, em diferentes instncias

das naes perifricas, caracterizando uma forma de

Imperialismo Moral Indireto. O estudo prope a cons-

truo de sistemas de regulao e de controle social

para os ensaios clnicos a serem implementados nos

pases perifricos, por meio da formulao de normas

ticas adequadas s caractersticas contextuais destes

pases, conjuntamente com a criao e validao de

documentos normativos nacionais prprios.

Biotica; Experimentao Humana; Ensaio Clnico

Contributors

Both authors worked on all phases of the research, in-cluding design, literature review and writing up the finalarticle.


8/8



References

1. Ravetz J. Scientific knowledgement and its socialproblems. Oxford: Oxford University Press; 1971.

2. Garrafa V, Lorenzo C. tica e investigacin clnicaen los pases en desarrollo aspectos conceptua-les, tcnicos y sociales. Crdoba: Red Latino-Ame-ricana y del Caribe de Biotica de UNESCO; 2006.

3. Rosemberg H, Pea M. Dimensions of exclusionfrom social protection in health in Latin Americaand the Caribbean. Washington DC: Pan AmericanHealth Organization; 2000.

4. Vieira C. Globalizacin, comercio internacional yequidad en materia de salud. Rev Panam Salud P-blica 2002; 11:425-9.

5. Rosemberg H, Andersson B. Repensar la protec-cin social en salud en Amrica Latina y el Caribe.Rev Panam Salud Pblica 2000; 8:118-25.

6. Singer P, Benatar S. Beyond Helsinki: a vision forglobal health ethics. BMJ 2001; 322:747-8.

7. Varmus H, Satcher D. Ethical complexities of con-ducting research in developing countries. N Engl JMed 1997; 337:1000-5.

8. Resnik DB. The ethics of HIV research in develop-

ing nations. Bioethics 1998; 12:286-306.9. Capron A. Power and injustice in research involv-

ing human subjects. In: Annals of the Sixth WorldCongress of Bioethics. Braslia: International Asso-ciation of Bioethics/Sociedade Brasileira de Bio-tica; 2002. p. 83.

10. Rothman K, Michels K, Baum M. Declarationof Helsinki should be strengthened. BMJ 2000;321:442-5.

11. Chadwick R, Schklenk U. Bioethical colonialism?[Editorial]. Bioethics 2004; 18:iii-iv.

12. Benatar SR. Imperialism, research ethics and glob-al health. J Med Ethics 1998; 24:221-2.

13. Dawson A, Garrard E. In defense of moral imperi-alism: four equal and universal prima facie prin-

ciples. J Med Ethics 2006; 32:200-4.14. Garrafa V. Imperialismo tico (verbete). In: TealdiJC, editor. Diccionrio latino-americano de bio-tica. Bogot: Unibiblos/Organizacin de las Na-ciones Unidas para la Educacin, la Ciencia y laCultura; in press.

15. Bobbio N, Matteucci N, Pasquino G. Dicionrio depoltica. Braslia: Editora da Universidade de Bras-lia; 2004.

16. World Trade Organization. Trade related aspects ofintellectual property rights. http://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm (ac-cessed on 05/Sep/2007).

17. Garrafa V, Prado MM. Mudanas na Declarao deHelsinki: fundamentalismo econmico, imperia-lismo tico e controle social. Cad Sade Pblica2001; 17:1489-96.

18. Lie RK, Emanuel E, Grady C, Wendler D. The stan-dard of care debate: the Declaration of Helsinkiversus the international consensus opinion. J MedEthics 2004; 30:190-3.

19. Lurie P, Wolfe S. Unethical trials of inter ventionsto reduce perinatal transmission of the humanimmunodeficiency virus in developing countries.N Engl J Med 1997; 337:853-6.

20. Angell M. The ethics of clinical research in thirdworld [Editorial]. N Engl J Med 1997; 337:847-9.

21. Schklenk U. Unethical perinatal HIV transmis-sion trials establish bad precedent. Bioethics 1998;12:312-8.

22. Thomas J. Ethical challenges of HIV clinical trialsin developing countries. Bioethics 1998; 12:320-7.

23. Greco D. A cure at any cost? New Sci 2001; 167:42-3.

24. Wawer MJ, Sewankambo NK, Serwadda D, QuinnTC, Paxton LA, Kiwanuka N, et al. Control of sexu-ally transmitted diseases for AIDS prevention inUganda: a randomised community trial. RakaiProject Study Group. Lancet 1999; 353:525-35.

25. Quinn TC, Wawer MJ, Sewankambo N, SerwaddaD, Li C, Wabwire-Mangen F, et al. Viral load andheterosexual transmission of human immunode-ficiency virus type 1. Rakai Project Study Group.

N Engl J Med 2000; 342:921-9.26. Angell M. Investigators responsibilities for human

subjects in developing countries [Editorial]. N EnglJ Med 2000; 342:967-9.

27. Carlson R, Boyd K, Webb D. One standard, not two[Editorial]. Lancet 2003; 362:1761.

28. Regional Office for the Western Pacific, WorldHealth Organization. Regional committee for the

Western Pacific fifty-third session. Report of the re-gional committee summary records of the plenarymeetings. Manila: Regional Office for the WesternPacific, World Health Organization; 2002.

29. Forattini OP. Coulicidologia mdica. v. 2. So Pau-lo: Edusp; 1997.

30. Roberts DR, Alecrim WD, Tavares AM, McNeill

KM. Field observations on the gonotrophic cycleofAnapheles darlingi (Diptera: Culicidae). J MedEntomol 1983; 20:189-92.

31. Charlwood JD, Alecrim WA. Capture-recapturestudies with the South American malaria vector

Anopheles darlingi. Ann Trop Med Parasitol 1989;83:569-76.

32. Santos R, Forattini O, Burattini M. Laboratory andfield observations on duration of gonotrophic cy-cle ofAnopheles albitarsis (Diptera: Culicidae) inSouthern Brazil. J Med Entomol 2002; 39:926-30.

33. Emanuel EJ, Grady C. Four paradigms of clinicalresearch and research oversight. Camb Q HealthcEthics 2007; 16:82-96.

34. Tealdi JC. Historia y significado de las normasticas internacionales sobre investigaciones bio-mdicas. In: Keyeux G, Penchaszadeh V, Saada A,editores. Investigacin en seres humanos y polti-cas de salud pblica. Bogot: Universidad Nacio-nal de Colombia/Red Latino-Americana y del Ca-ribe de Biotica de UNESCO; 2006. p. 33-62.

Submitted on 03/Jul/2007Final version resubmitted on 04/Oct/2007

Approved on 25/Oct/2007

ARTIGO MoralImperialismMulti Centric

Documents

Transcript of ARTIGO MoralImperialismMulti Centric