International Collaboration for Global Public Health

© The Author(s) 2016 241
D.H. Barrett et al. (eds.), Public Health Ethics: Cases Spanning the Globe,
Public Health Ethics Analysis 3, DOI 10.1007/978-3-319-23847-0_8
Chapter 8
International Collaboration for Global Public
Health
Eric M. Meslin and Ibrahim Garba
8.1 Introduction
There is a long tradition of global collaboration in biomedicine and public health.
Examples range from medical outposts in rural communities run by foreign missionaries (Good 1991 ) to the early infectious disease programs of the Rockefeller
Foundation (Fosdick 1989 ) and from medical services and training programs for
indigenous populations set up by colonial authorities (Marks 1997 ) to the Pan
American Health Organization (PAHO) established by a collective of sovereign
governments (Cueto 2007 ).
Two complementary sets of factors provide context for understanding collaboration in global public health : fi rst, the factors that inform globalization generally and
global health specifi cally; second, the factors that shape ethical standards for global
health programs generally and global health research specifi cally. Good examples
of both factors are refl ected in this chapter’s case studies.
The opinions, fi ndings, and conclusions of the authors do not necessarily refl ect the offi cial
position, views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions.
E. M. Meslin , PhD (*)
Indiana University Center for Bioethics , Indianapolis , IN , USA
e-mail: [email protected]
I. Garba , MA, JD, LLM
Indiana University Center for Bioethics , Indianapolis , IN , USA
Public Health Law Program, Offi ce of State, Tribal, Local, and Territorial Support ,
Centers for Disease Control and Prevention , Atlanta , GA , USA
242
8.2 The Rise of Globalization and Global Health
Collaboration in global health, as we know it today, began taking shape after World
War II when new laws and institutions were established to govern relations among
countries. The war’s end was marked by efforts to establish a body that would
facilitate peaceful relations among member countries. In 1945, the United Nations
(U.N.) was established “to save succeeding generations from the scourge of war”
and to “promote social progress and better standards of life” (U.N. 1945 ). Various
U.N. agencies were set up to realize these goals—most prominently the World
Health Organization (WHO) , founded in 1948 “to act as the directing and
coordinating authority on international health work” (WHO 1948 ). 1
Yet even as
these institutions were being established, their ability to encourage international
collaboration was hampered in two ways.
First , most low- and middle-income countries (LMICs) , which bear the bulk of
today’s global disease burden , were under colonial rule for the fi rst decade of the
U.N.’s existence. Hence, these countries were unrepresented in the new organization. In later years, the principle of self-determination (i.e., the right of “peoples” to
govern themselves and choose their developmental priorities) and the efforts of
nationalist movements secured political independence and membership in the international community. In effect, the governments of these countries were authorized
under international law to represent their populations in relations with other governments, thereby enabling equitable partnerships, even in matters of health.
Second, the escalation of the Cold War in the founding years of the U.N. introduced ideological rivalries into its workings. These rivalries often impeded coordinated actions involving health. For example, the 1950s and 1960s were marked by
the superpowers’ competitive attempts to eradicate specifi c (often communicable)
diseases (e.g., the United States targeted malaria while the Soviet Union focused on
smallpox) (WHO 2008b ). This selective, disease-specifi c vertical approach confl icted with the realization in the 1970s that primary health care was a vital component of a national health system. The latter approach defi ned “health” broadly,
recognizing it as a right and acknowledging the impact of socioeconomic factors on
wellness (WHO 1978 ). The emphasis on primary health care became critical for
governments of newly independent countries faced with the task of expanding
health systems that under colonial rule had catered to a narrow, privileged segment
of the population (WHO 2008a ). However, ideological disputes over government’s
role in society and the policies of the International Monetary Fund (IMF) , which
favored privatization of certain public services (Stuckler and Basu 2009 ), neglected
the primary health care approach (WHO 2008b ). The Cold War also infl uenced patterns of global health collaboration , particularly among members of feuding coalitions that continued to support ideologic allies (Feldbaum et al. 2010 ).
1
Other U.N.-affi liated agencies not directly related to health but infl uencing collaboration in public
health include the International Monetary Fund , World Bank , and World Trade Organization.
E.M. Meslin and I. Garba
243
The fall of the Berlin Wall in 1989 and the collapse of the Soviet Union shortly
thereafter marked the end of the Cold War . These events led more countries to adopt
liberal and capitalist principles . Other developments—advances in communications
(most notably, the Internet) and greater trade and travel across borders—intensifi ed
exchanges among national communities. Collectively referred to as the process of
globalization ,
2
these changes altered the global context for public health
collaboration .
On the one hand, the absence of a drawn-out ideological battle led to constructive
deliberation and global action in public health. For example, in 2000, all members
of the U.N. General Assembly declared their commitment to achieving eight objectives (the Millennium Development Goals) by 2015—half of which pertained to
health. Also signifi cant were widespread efforts to address the HIV/AIDS epidemic
through such mechanisms as the Joint United Nations Programme on HIV/AIDS
(UNAIDS) 3
and the more recently established Global Fund to Fight AIDS,
Tuberculosis and Malaria. 4
On the other hand , the growing infl uence of liberal and capitalist principles in the
global environment of the 1990s affected the extent to which governments (especially those of LMICs ) were involved and able to collaborate in public health. These
changes included
… an increasing reliance upon the free market; a signifi cant growth in the infl uence of
international fi nancial markets and institutions in determining national policies ; cutbacks in
public sector spending; the privatization of functions previously considered to be the exclusive domain of the state; and the deregulation of a range of activities with a view to facilitating investment and rewarding entrepreneurial initiative. These trends serve to reduce the
role of the state in economic affairs, and at the same time increase the role and responsibilities of private (non-state) actors, especially those in corporate business, but also those in
civil society…. (WHO 2002 )
Generally associated with neoliberal principles , the changes discussed above
have reduced governments ’ public policy role. These developments notwithstanding, there remain compelling arguments for deliberate and sustained engagement by
governments in the interest of global public health . Three are discussed below.
8.2.1 Collective Health
The fi rst argument is that even with their reduced profi le in national health systems,
governments continue to bear primary responsibility for population health .
Individual citizens can take responsibility for personal health, but certain health
2
Defi nitions of globalization vary by disciplinary focus. Richard Labonté ( 2004 ) describes globalization as “a process by which nations, businesses, and people are becoming more connected and
interdependent across the globe through increased economic integration and communication
exchange, cultural diffusion (especially of Western culture), and travel.”
3
See http://www.unaids.org/en/
4
See http://www.theglobalfund.org/en/
8 International Collaboration for Global Public Health
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benefi ts (e.g., clean air, safe roads, potable water) can be secured only through organized, collective efforts generally involving the exercise of public authority. As
such, in the interest of global health , a country’s public health institutions should be
robust—equipped to protect population health , reduce disease, and administer programs that save money and lives (Frieden and Koplan 2010 ). This case needs to be
made for LMICs especially; otherwise, neoliberal principles guiding globalization
may further weaken emergent, poorly governed, or underfunded health systems.
Indeed, the exercise (or failure) of public authority infl uence all ethical issues
presented by the cases in this chapter. In Jensen and Gaie’s case, an LMIC government has neither passed legislation nor provided support that would effectively prevent discrimination against citizens seeking HIV services. In Zinner’s case, an
international aid worker must make diffi cult decisions about who gets preventive
HIV/AIDS treatment in an African community characterized by a neglected, poorly
funded health system. In Timms’ case, a physician encounters an ethical challenge
brought about by the underdeveloped health infrastructure in India , the government’s lax enforcement of research regulations , and the substantial infl uence of
large foreign pharmaceutical companies on national policy . In List and Boyd’s case,
a foreign researcher must decide whether there is an ethical obligation to expose an
African government’s avoidable failure to prevent a TB medication stock-out .
Under question in Millum’s case is the degree to which both the U.N. (as a collective body of governments carrying out a humanitarian intervention) and the Haitian
government (as the provider of health infrastructure for its citizens) can be held
morally or legally liable for a cholera outbreak. In Al-Faisal, Hussain, and Sen’s
case, a public health expert testifying before a U.N. Commission must weigh in on
the extent to which (1) foreign governments are obliged to minimize harm to the
health of Syrians and Iraqis when applying sanctions and (2) Syrian and Iraqi governments are obliged to conduct a foreign policy that does not jeopardize the health
of their citizens. A U.S.-based researcher grapples in Lee, Kleinfeld, and Glassford’s
case with the question of whether she can ethically justify publishing a paper based
on data obtained from two African countries whose governments have neither institutional review boards nor national research guidelines .
8.2.2 Coordination
The second argument favoring active engagement of governments in national health
systems is their longstanding ability to enter binding legal agreements with each
other and other stakeholders . A government’s continued involvement is indispensable to shaping broad-based and sustainable solutions to the challenges of global
public health . The broad scope of a government’s responsibilities (and authority
associated with performing these responsibilities) enables it to coordinate public
health efforts involving public, private, and civic institutions. The importance of
governmental involvement was crystallized in the words of former WHO Director
General, Gro Harlem Brundtland, as the 2003 WHO Framework Convention on
E.M. Meslin and I. Garba
245
Tobacco Control was being drafted: “Tobacco control cannot succeed solely through
the efforts of individual governments , national NGOs (nongovernmental organizations) , and media advocates. We need an international response to an international
problem” (Bodansky 1999 ). Tackling one of the world’s leading causes of preventable death (i.e., smoking ), the Framework Convention adopts a comprehensive
strategy that has been signed by the governments of 168 countries. 5
With completion of the human genome and development of various technologies
to use it, interest in DNA repositories has surged (Kaye et al. 2009 ). The development and increasing use of biorepositories of DNA, tissues, and other biological
materials in institutions worldwide present far-reaching ethical challenges. Some
challenges, such as those resulting from the collection and use of dried blood spots
(Hendrix et al. 2013 ) or from regular surveillance like the U.S. Centers for Disease
Control and Prevention (CDC) HIV surveillance projects, are recurrent and familiar. 6
When specimens must be shared in the context of collaborative public health
emergency response and planning, the challenges can take on greater urgency. Such
emergency collaborative sharing has occurred with virus strains for pandemic infl uenza planning 7
and with the sequencing of the SARS coronavirus jointly undertaken
by researchers from Canada, Hong Kong, Taipei, the United States , and Vietnam
during the global outbreak (Tong et al. 2004 ). Similarly, the sharing of data and
health information has long been a source of ethical and legal commentary and is
widely viewed as desirable ethical behavior with demonstrable scientifi c benefi t
(Committee on National Statistics 1985 ; Benkler and Nissenbaum 2006 ).
8.2.3 Accountability
The third argument supporting government engagement in global public health is
based on democratic theory. Put simply, a country’s citizens can hold their governments accountable for failure to meet health commitments. In contrast to governments that are accountable to their entire populations , NGO stakeholders in global
health answer to narrower constituencies (i.e., corporations to their stockholders,
NGOs to their funders, and foreign health organizations to their home governments). Because public health is of general concern, a level of accountability is
essential for the entire health system to function properly. The involvement of governments is, therefore, critical both to ensure the widest participation possible in
formulating health policies and to sustain such policies despite shifting interests or
diminishing profi ts of partners.
Setting aside the issue of relative advantages or demerits, the diminished role of
governments in global public health —especially governments of LMICs —creates
5
See http://www.who.int/fctc/signatories_parties/en/index.html
6
See http://www.cdph.ca.gov/programs/aids/Pages/TOASurv.aspx
7
See http://www.ip-watch.org/2013/05/27/world-health-assembly-pandemic-fl u-frameworkclears-committee/
8 International Collaboration for Global Public Health
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room for others to enter the fi eld. Entrants include public institutions (e.g., international intergovernmental bodies , governments of emerging economies); NGOs
(e.g., development and relief agencies, academic health partnerships, faith-based
initiatives); private entities (e.g., corporations, philanthropies, individuals); and
hybrid entities that pool resources and expertise from public, nongovernmental, and
private stakeholders (e.g., The Global Fund to Fight AIDS, Tuberculosis and
Malaria). Each entrant to the global health environment plays a unique role. Some
take direct action by providing care, some facilitate and leverage the work of others,
and some effect change in policies to cultivate better and closer collaboration . All
undertake some form of partnership activity.
Essentially, rather than being merely an instrument of foreign policy and diplomacy or a means to technical aid between governments, collaboration in health has
grown into a global endeavor involving many actors and stakeholders (Elmendorf
2010 ). The declining role of governments in public policy presents special challenges for global public health , and the proliferation of stakeholders makes the formation of partnerships more demanding and critical. As such , effective ethical
frameworks that can serve as guides for planning and also as arbiters between competing values are indispensable.
8.3 Ethics Frameworks for Global Health
Complementing this political history has been an equally comprehensive set of
approaches, each of which provides a moral foundation for defending actions, policies , and decisions in global health. Foremost among these are principle-based
approaches, human-rights frameworks, and social determinants of health (SDH) ,
although other approaches have been suggested (Ruger 2009 ).
8.3.1 Principles and Benchmarks
The debate arising from the 1997 AIDS Clinical Trial Group Study 076 (ACTG076) to reduce maternal–fetal transmission of HIV served many purposes. Among
the most useful was the attention focused on how ethical arguments are applied to
substantive problems in global health (Lurie and Wolfe 1997 ; Varmus and Satcher
1997 ). Until then, most bioethical refl ection had concentrated on domestic topics,
aside from revisions to the Declaration of Helsinki and other documents. ACTG076, however , energized discussion about, among other things, the nature of ethical
obligations and commitments to groups, countries, and regions—whether of
researchers to research participants , of science to society, or sponsors to host countries (Shapiro and Meslin 2001 ). Accusations of parachute research and double
standards abounded, leading many to rethink the applicability of accepted ethical
principles and practices and to consider new contexts. They also questioned whether
E.M. Meslin and I. Garba
247
researchers, sponsors, or governments owed any continuing obligation of care to
research participants at the end of a study . The bioethics principles developed over
three decades by Beauchamp and Childress ( 2009 ) provided a formidable foundation upon which debates about research and health care could be played out—even
in the face of critiques about their adequacy and suffi ciency as moral theory (Clauser
and Gert 1990 ). Other principles have been recommended by scholars (Lavery et al.
2007 ) and organizations (United Nations Educational, Scientifi c and Cultural
Organization [UNESCO] 2005 ), but even proponents of principle-based approaches
recognized that more was needed to meet challenges in emerging areas of science
(e.g., public health genomics and transborder studies) (Lavery et al. 2007 ; Emanuel
et al. 2008 ; Macklin 2008 ).
Indeed, early in the tenure of the National Bioethics Advisory Commission
(NBAC) that later reported on the ethics of clinical trials (NBAC 2001 ), Ezekiel
Emanuel proposed that the Commission review the Belmont Report principles. He
urged the Commission to adopt a new principle to its canon of bioethics , namely a
principle of c ommunity to accommodate ethical issues arising from the recruitment
of groups. Although the Commission did not adopt this principle, Emanuel’s proposal has since emerged as one of several benchmarks for assessing ethical acceptability of clinical research in developing countries (Emanuel et al. 2004 ). More
relevantly, the concept of community engagement and participation has taken on a
greater role in discussions about the importance of partnerships.
The cases by Timms and by Lee, Kleinfeld, and Glassford illustrate the utility of
using ethical principles to frame the unique challenges of global collaboration in
biomedical research . Timms raises a critical issue about whether a multinational
pharmaceutical company conducting clinical trials in an LMIC is responsible for
harms sustained by research participants during its investigations. The ACTG-076
debate has broadened the question of accountability , recognizing that impoverished
and poorly educated populations living with underdeveloped regulatory, health, and
social service infrastructures must prompt reassessment of a multinational trial
sponsor’s ethical obligations . Such reassessment has focused, naturally, on measures that prevent exploitation of vulnerable and desperate individuals in LMICs
(e.g., appropriate informed consent , vigilant recruitment practices). But it has also
raised the question of whether foreign sponsors and researchers have an ethical
obligation to the host community or country supplying the large and diverse recruitment pool at comparatively lower cost .
In the case described by Lee, Kleinfeld, and Glassford, a researcher must determine, apart from questions of scientifi c validity and potential health utility, whether
proper informed consent was obtained in the acquisition of data and tissue samples
being used for research on which she has been invited to collaborate . These data and
specimens were gathered using various consent methods from six African countries,
none of which had ethics review boards or national research guidelines . Her collaborator assures her that the consent modalities applied, though varying widely, were
appropriate to the settings in which they were used. In deciding whether to coauthor
an article based on acquired data, the researcher must consider how (or whether) the
requirements of informed consent , a foundational principle of ethical research, can
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be met in different global settings, particularly those characterized by cultural or
linguistic differences, low health literacy, and absence of regulatory infrastructure.
8.3.2 Human Rights
Human rights constitute a compelling ethical framework for global collaboration.
Based on an ethical vision discernable in early Greco-Roman writings, these principles matured in the work of such social contract theorists as Thomas Hobbes ,
Jean-Jacques Rousseau , and John Locke . The modern view of human rights presupposes that all persons, simply for being human, have inherent dignity. This dignity
constitutes the normative foundation for people having certain inalienable rights.
The terms inherent and inalienable mean such dignity and rights belong to people
naturally and are, certainly, not bestowed by a political authority . According to
human rights theory, a political authority has no ethical basis for arbitrarily depriving individuals of these rights (not having granted such rights in the fi rst place). But
because some needs are common and not all goals can be met individually, people
choose to surrender certain rights to a public authority established to ensure these
ends are realized. Hence, a government
… exists to ensure the well-being of the individuals who give up certain rights in exchange
for certain protections and benefi ts […]. The same applies to the community they jointly
establish. From this analysis, the traditional roles of government include such things as collective security, the administration of justice , the protection of property and […] the promotion of the public’s health…. (Meslin and Garba 2011 )
This theoretical sketch provides a backdrop to the 1948 U.N. Universal
Declaration of Human Rights (UDHR) , the ethical cornerstone of the human rights
system since the end of World War II. Using human dignity as its starting point, the
UDHR codifi es a unifi ed ethical vision for preserving a peaceful and just international order while also emphasizing “social progress and better standards of life”
(U.N. 1948 ). Correspondingly, the UDHR contains rights that are broadly political
(e.g., fair trial, free speech, freedom of religion) and others that focus on economic
and social conditions (e.g., housing, education, health).
As discussed previously, however, the Cold War introduced ideological rivalries
into the U.N., rifts that split the unifi ed ethical vision of the UDHR into two treaties:
the International Covenant on Civil and Political Rights (ICCPR) (U.N. 1966a ) and
the International Covenant on Economic, Social and Cultural Rights (ICESCR)
(U.N. 1966b ). 8
The two treaties refl ected the priorities of the opposing sides—the
ICCPR advocated by the U.S.-led capitalist alliance and the ICESCR championed
by the U.S.S.R.-led communist bloc. Having two treaties hindered the deployment
of human rights as an effective ethical framework for health collaboration during
the latter half of the twentieth century.
8
Article 12 of the ICESCR codifi es the right to health.
E.M. Meslin and I. Garba
249
As the Cold War abated, the global community adopted a more holistic approach
to human rights , including the right to health . This was captured in the 1993
U.N. Vienna Declaration and Programme of Action , a document that reaffi rmed
human rights as “universal, indivisible, and interdependent and interrelated” (U.N.
1993 ). The Vienna Declaration laid the foundation for the creation of the Offi ce the
United Nations High Commissioner for Human Rights (OHCHR) , an agency that
oversees the promotion and protection of human rights throughout the U.N. system .
Moreover, the U.N. Human Rights Council (HRC) , 9
through its special procedures,
appoints independent experts (or “special rapporteurs”) 10 to report on areas of concern, including such health-related themes as food, physical and mental health ,
adequate housing and extreme poverty, and healthy and sustainable environments. 11
As noted previously, this holistic approach was also refl ected in the adoption of the
Millennium Development Goals (most of which are related to health) and exemplifi ed in the coordinated approach to tackling HIV/AIDS . The health and human
rights movement , which gained traction during the global discussion on sexual and
reproductive health, fi rmly took root once health professionals responded to the
peculiar challenges of treating HIV-positive people facing discrimination (Gruskin
et al. 2007 ; Mann 1997 ).
Quite apart from the scarcity of fi scal resources that often plague LMIC governments , other challenges preclude adopting an integrated approach to the right to
health . For example, a long-standing argument is that the right to health as codifi ed
in the International Covenant on Economic, Social and Cultural Rights attaches to
individuals and is, hence, unsuited for effectively achieving public health objectives, goals that by defi nition focus on population health (Meier 2006 ). In addition,
the proliferation of non-state actors in global health mentioned earlier (e.g., relief
agencies, academic health partnerships, corporations, philanthropies) make coordination and accountability about the right to health more demanding. By and large,
governments are the sole entities authorized to sign health-related human rights
treaties such as the ICESCR . International treaties typically have mechanisms for
ensuring that signatories fulfi ll legal commitments. But as discussed earlier, the
diminishing role of governments in national policy and the increasing privatization
of public services under globalization (WHO 2002 ) mean that treaty law will likely
play a correspondingly smaller role in global health collaboration . Although the
infl ux of new non-state actors allows stakeholders to partner in innovative ways to
address challenges in global health, the stability and accountability of international
human rights law remains a valuable asset in a constantly evolving fi eld.
Most cases in this chapter feature ethical issues that are illuminated but sometimes complicated by the human rights framework. In Jensen and Gaie’s case,
human rights potentially impede a public health strategy for controlling the spread
of HIV/AIDS . The case calls for a public health offi cial to balance the human rights
9
Until 2006, the U.N. Commission on Human Rights.
10 The Human Rights Council also uses working groups.
11 For special procedures of the Human Rights Council, see http://www.ohchr.org/EN/HRBodies/
SP/Pages/Welcomepage.aspx
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of individuals (possibly suffering discrimination and stigma-related violence under
routine or mandatory testing policies ) against the health of the community, which,
arguably, is better served by precisely such testing regimes.
A distinguishing mark of globalization is the increased infl uence of transnational
businesses on the policies of LMIC governments . Timms’ case illustrates the impact
of this development . Given the economic and political clout of transnational businesses, there are continuing discussions on the extent of their human rights obligations (Weissbrodt and Kruger 2003 ; Ratner 2001 ). In this case, even if the
pharmaceutical company conducting research in India is not directly bound by a
human rights treaty, is it obliged to comply with human rights norms on some other
basis (e.g., national laws , industry standards , corporate codes of conduct)?
In 2011, the U.N. Human Rights Council endorsed the Guiding Principles on
Business and Human Rights , a document outlining what has come to be known as
the U.N. “Protect, Respect and Remedy” framework. Guiding Principles recognizes
governments’ duty to protect human rights, acknowledges corporate responsibility
to respect human rights , and requires governments to ensure that people harmed
within their jurisdiction have access to effective judicial and nonjudicial remedies .
List and Boyd’s case questions how one’s freedom of expression (Article 19,
ICCPR ) affects public health. Should one be allowed to use the free press to advocate on behalf of fellow citizens? Does the free press furnish a forum for an informed
and representative discussion on public health policy ? Are expatriate workers less
likely than nationals to face offi cial retaliation when they use media outlets to criticize government ?
Confl ict in the Balkans and killings in Rwanda in the early 1990s revived lively
debate on the international community’s obligation to intervene in internal affairs of
member countries to defend human rights (KardaÅŸ 2010 ; Chopra and Weiss 1992 ).
Organizing international action to address human rights violations remains a perennial challenge—exemplifi ed by the intractable situation in Syria following major
pro-democracy protests in 2011. But ideological alliances and rivalries during the
Cold War made consensus building around such interventions arduous (Eisner
1993 ). The Balkan and Rwandan confl icts and a growing atmosphere of cooperation
in the face of global challenges (e.g., environmental degradation, climate change )
contributed to an increase in peacekeeping and humanitarian operations organized
by the international community. These operations, though designed to further
human rights , sometimes undermined the target population’s right to health .
Millum’s case and that of Al-Faisal, Hussain, and Sen raise issues that result,
paradoxically, from increasing adoption of the human rights framework as an international norm . Millum’s case questions responsibility during a major cholera outbreak originating in a camp occupied by Nepali soldiers on a U.N. peacekeeping
mission in the Caribbean. The Al-Faisal, Hussain, and Sen case considers how the
health of vulnerable groups in Iraq and Syria is affected by economic sanctions
imposed on the two countries’ governments and shows how interventions intended
to protect human rights can still have adverse health consequences.
Increasingly, human rights are being used to frame responses to global public health
challenges (Adorno 2009 ; Mann 1997 ). Human rights are a pervasive transcultural and
E.M. Meslin and I. Garba
251
normative discourse. Issues once relegated to bioethics are now cast as human rights
concerns (Adorno 2009 ; Faunce 2005 ). For example, UNESCO adopted three declarations that use human rights to frame health challenges: the Universal Declaration on
the Human Genome and Human Rights ( 1997 ), the International Declaration on
Human Genetic Data ( 2003 ), and the Universal Declaration on Bioethics and Human
Rights ( 2005 ). Each declaration codifi es the principle of informed consent —a principle at stake in the case cited by Lee, Kleinfeld, and Glassford and, to a lesser degree,
the case by Timms. The cross- fertilization of concepts and concerns between bioethics
and human rights is a salutary consequence of public health partnerships forged in an
increasingly interconnected and complex world.
8.3.3 Social Determinants of Health
The social determinants of health (SDH) framework is based on social justice (Lee
2004 ). The guiding principle of SDH is equity. As with public health, SDH emphasizes population health and prevention . However, SDH goes beyond traditional public health approaches because, in addition to deploying interventions aimed at
reducing population mortality and morbidity, SDH targets “the social context and
conditions in which people live” (Blas et al. 2011 ). These contextual factors and
conditions that affect health outcomes in a given population are called social determinants of health .
12 These include such factors as housing, education, transportation, employment, insurance coverage, and access to health care (Brennan Ramirez
et al. 2008 ).
The SDH framework stands on 40 years of research demonstrating that clinical
care alone cannot improve health outcomes unless social factors are addressed
(WHO 2007 ). Statistical associations between social disadvantage and poor health
became increasingly clear, impelling the inference that closing the gap in health
status between populations required corresponding improvements in the social contexts of disadvantaged populations.
The ethical norm underlying efforts to eliminate these preventable health differences is the principle of equity . Health in equities are differences “socially produced;
systematic in their distribution across the population ; and unfair” (WHO 2007 ). On
the other hand, health equity is “the absence of unfair and avoidable or remediable
differences in health among population groups defi ned socially, economically,
demographically, or geographically” (WHO 2007 ). These defi nitions highlight two
aspects of SDH. First, the differences in health are not merely descriptive but prescriptive as well, implying an ethical obligation in favor of their elimination. Second,
the focus on social context and conditions means that policy and action must be
intersectoral , involving actors and spheres outside the health fi eld (WHO 2007 ).
12 The social determinants of health have also been characterized as “the conditions in which people live and work that affect their opportunities to lead healthy lives” (Labonté and Schrecker
2007 ).
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Health disparities among populations in different parts of the world motivate
public health interventions and assist the development of useful analytical tools for
global health. A case in point would be the gaps in infant mortality rates and life
expectancy between countries with strong economies and LMICs . These gaps provide moral stimulus for elimination and benchmarks for setting goals and assessing
progress (e.g., the health-related Millennium Development Goals ).
The SDH framework faces several challenges and limitations. Most people do
not realize the impact of social and contextual factors on health outcomes . Political
orientations and worldviews further impede the acceptance of SDH as a viable policy alternative (Gollust et al. 2009 ). Some argue that variations of SDH oversimplify
the link between wealth and health, thereby failing to consider other causes of health
disparities (Poland et al. 1998 ). Even though statistical links have been made
between social context and ill health, scientifi c questions remain on the mechanisms
that account for these associations. This is especially critical in the fi eld of mental
health , where attempts have been made to clarify associations between SDH and
psychological well-being (Marmot et al. 1997 ; Bovier et al. 2004 ; Fisher and Baum
2010 ; Paananen et al. 2013 ).
Aside from the availability of HIV/AIDS health services and medication , the
Jensen and Gaie case and Zinner case demonstrate how social factors affect health.
In Jensen and Gaie, advocates of client-initiated voluntary testing (vigilant, rightsbased) offer compelling reasons to minimize the potential for discrimination and
stigma-related violence against people living with HIV . As the case points out, the
risk of violence or discrimination is particularly high in LMIC societies where
social, cultural, and legal protections are nonexistent or being developed.
Although HIV-positive status can have adverse social consequences, Zinner illustrates how social factors increase the risk of infection in the fi rst place. In this case, an
international anti-AIDS program administering pre-exposure prophylactic medication is deciding whether to budget small sums of money to educate young girls in the
community. Investing in education should reduce their likelihood of getting infected
in unequal liaisons with older men (sugar-daddy relationships) while creating openings in the program for other at-risk groups to participate. In effect, the program is
considering medical intervention (i.e., a pre-exposure prophylactic drug) and social
determinants of health (i.e., girl–child education) in making its allocation decisions.
Both Timms’ and Lee, Kleinfeld, and Glassford’s cases show how social determinants (e.g., gender, caste, economic status, literacy) infl uence the effectiveness of
informed consent for vulnerable LMIC populations participating in drug research .
Less direct but equally critical, these cases also show how geographic disparities in
social conditions establish context for global health research. The challenge of
ensuring that drug research is conducted ethically in LMICs derives from such contextual factors as greater disease burdens in these regions due to underdeveloped
health systems, lax regulation of biomedical research due to ineffective governance
structures, and economic and social vulnerability of most potential research participants (Barlett and Steele 2011 ).
In the context of SDH, empowerment “is inseparably linked to marginalized and
dominated communities gaining effective control over the political and economic
processes that affect their well-being” (WHO 2007 ). List and Boyd’s case demonE.M. Meslin and I. Garba
253
strates how citizens of LMICs can use mass media to infl uence their governments
on public health topics. A physician-national in an East African country fears retaliation if she talks to the media about a TB medication stock-out potentially due to
government corruption and misuse of public funds. Her fears underscore the risks
and responsibilities associated with the role of health workers as advocates for the
socially and politically marginalized in their communities (Pérez and Martinez
2008 ; Farmer 2004 ; Geiger and Cook-Deegan 1993 ). Also pertinent from a global
SDH perspective is the likelihood that an expatriate whistleblower, especially a citizen from a higher-income country, would not face as serious a risk.
8.4 Summary
The approaches and methods for collaborating in global public health are diverse—
just like the cases in this chapter. These cases refl ect the rich and multifaceted context for global public health while also emphasizing the role that different ethical
standards (and the foundations for those standards) play. In so doing, the cases offer
a fresh and innovative perspective on the ethics of public health.
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8.5 Case 1: The Ethics of HIV Testing Policies
Kipton E. Jensen
Department of Philosophy and Religion
Morehouse College
Atlanta , GA , USA
e-mail: [email protected]
Joseph B. R. Gaie
Department of Theology and Religious Studies
University of Botswana
Gaborone , Botswana
This case is presented for instructional purposes only. The ideas and opinions
expressed are the authors’ own. The case is not meant to refl ect the offi cial position,
views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions.
8.5.1 Background
The global public health community has signifi cantly advanced our understanding
of the biology of the human immunodefi ciency virus ( HIV ) and developed reliable
diagnostic tests and effective antiretroviral treatments . Despite these advancements,
the rate of prevalence and transmission, especially in low- and middle-income countries , remains alarmingly high. HIV prevention , often considered better than a cure,
E.M. Meslin and I. Garba
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remains the mainstay of our collective response to the epidemic. By all accounts,
HIV testing plays a pivotal role in treatment and prevention , yet in low- or middleincome countries, only 10 % of those who have been exposed to HIV infection may
have access to counseling and testing (UNAIDS/WHO 2004 ; Centers for Disease
Control and Prevention 2012 ) . In general, HIV testing policies range from voluntary
or client-initiated counseling and testing to provider-initiated approaches (e.g., routine testing, mandatory HIV screening ). Most policy makers and health workers
have promoted voluntary HIV testing, although routine HIV counseling and testing
increasingly is being adopted. Notably, however, the global health community has
adamantly discouraged mandatory HIV testing (UNAIDS/WHO 2004 ).
Resource-poor countries may be unable or unwilling to ensure social and medical
infrastructures adequate for safeguarding the human rights of people seeking services. As a result, global health offi cials have encouraged countries to adopt voluntary or client-initiated counseling and testing policies opposed to routine or
provider-initiated policies. Even in settings in which voluntary counseling and testing
is readily available, few people take advantage of these services. Stigmatization persists as an obstacle to HIV counseling and testing, which, by all accounts, is vital to
effectively treat people living with HIV and AIDS and to reduce further infection.
Many public health ethicists recommend that policy makers and health workers
carefully consider the ethical consequences of routine testing policies, especially
for people in locales that lack protections against discrimination and stigma-related
violence (Rennie and Behets 2006 ). To protect individuals against HIV-related discrimination and threat of violence, advocates of the human-rights approach vigilantly oppose the application of standard methods of disease control, which include
mandatory testing and partner notifi cation. But this vigilant rights-based approach
to HIV prevention , an approach that Bayer ( 1991 ) labelled AIDS exceptionalism ,
can undermine society’s ability and indeed responsibility to control the epidemic.
And although public health offi cials are a minority, some argue for mandatory HIV
testing (Schuklenk and Kleinsmidt 2007 ), seeing it as the only way to control the
HIV epidemic. Failure to apply standard methods of disease control, some argue,
devalues public health and social justice (Frieden et al. 2005 ; De Cock et al. 2002 ).
By treating HIV/AIDS differently than other infectious diseases , AIDS exceptionalism may inadvertently increase stigmatization rather than reduce it (De Cock et al.
2002 ). Proponents of testing point to its potential to reduce stigma by raising awareness, preventing transmission, expanding treatment , and empowering individuals
(Crepaz et al. 2004 ).
HIV testing policy recommendations from the global international public health
community can also challenge if not undermine the authority of the indigenous
knowledge system or indigenous ethical codes (Chilisa 2005 ; Dube 2006 ; Jensen
and Gaie 2010 ). These recommendations typically stipulate ethical preconditions
within voluntary HIV testing policies , such as strict confi dentiality, informed consent , and competent pre- and post-test counseling. Some argue that preconditions
constitute a Western approach that blocks local efforts to control the epidemic.
Although many believe that the context of provider-initiated HIV testing preserves
“suffi cient voluntariness,” others have criticized this approach. Critics maintain
that opting-out from provider-initiated HIV testing differs signifi cantly from
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client- initiated or voluntary HIV counseling and testing (Kenyon 2005 ). In either
case, all agree, medical practitioners and policy makers cannot guarantee ideal or
even adequate social and institutional support services (Weiser et al. 2006 ).
These disputes are by no means merely theoretical. In Botswana, for example,
policy has shifted within the past 5 years from a client-initiated to a providerinitiated or routine HIV diagnostic counseling and testing strategy (Botswana
Ministry of Health 2012 ). More recently, in response to a parliamentary-approved
public health bill presently being contested as unconstitutional (Botswana Network
on Ethics, Law and HIV/AIDS 2012 ), the debate has shifted to whether certain
conditions render mandatory testing ethically permissible.
8.5.2 Case Description
The Minister of Health of a sub-Saharan nation has asked you, a public health offi cial
and physician from a Western country, to recommend an effective HIV testing policy .
The sub-Saharan nation is among the hardest hit by the HIV epidemic (e.g., the HIV
prevalence rate among pregnant women aged 15–49 is >25 %). In this resource-poor
nation, people with HIV and AIDS are commonly stigmatized despite national campaigns to reduce stigma. Even if the nation were to adopt a policy of voluntary HIV
counseling and testing , more than 50 % of people living with HIV and AIDS are unaware
of their serostatus. Although HIV treatment is currently unavailable, international donors
have promised to provide free or inexpensive antiretroviral therapies (ART) .
You have sought the input of your colleagues in global public health only to discover they are contentiously divided. Some vigorously oppose enhanced HIV testing policies that would move from voluntary to routine HIV testing to protect the
community against discrimination or stigma-related violence. They also oppose in
principle Western-based interventions, which, they say, undermine traditional loci
of authority and indigenous systems of medical knowledge. Other colleagues insist
that human rights-based approaches undermine public health’s ability, as well as
responsibility, to control the HIV epidemic. They are for moving beyond clientinitiated approaches and vigorously support mandatory HIV testing . These
colleagues feel that the only way to control the HIV epidemic is to apply the standard methods of disease control.
Given these divergent views, you hope to be able to recommend a HIV policy
that strikes a balance between the Hippocratic ideal of doing no harm and the
equally compelling mandate to protect if not improve public health.
8.5.3 Discussion Questions
1. How might an emphasis on protecting human rights in HIV prevention reduce
the importance of public health and social justice?
2. Is opting in, or not opting out, as part of the routine testing strategy, ethically
equivalent to acquiring consent within a voluntary testing site? What are the
E.M. Meslin and I. Garba
259
necessary and suffi cient conditions, ethical or otherwise, for “adequate information ” or “suffi cient voluntariness” in cases of HIV testing ?
3. Is there an ethical confl ict between one’s duty, whether as a physician or a public
health offi cial, whether as the minister of health or simply as a person, to adopt
what are considered to be effective methods of controlling disease, e.g., HIV , and
the obligation to respect indigenous knowledge systems and approaches to public health? If there is a confl ict, which duty should take precedent ?
4. What policy would you recommend under these circumstances? And what ethical principles guided your recommendation?
5. How would your recommendation provide, if at all, protections against discrimination and stigma-related violence?
References
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England Journal of Medicine 324(21): 1500–1504.
Botswana Ministry of Health. 2012. Routine HIV Testing (RHT). Gaborone, Botswana: Department
of HIV and AIDS Prevention & Care.
Botswana Network on Ethics, Law and HIV/AIDS. 2012. Public health bill shocking and regressive . Press Release, December 6. http://www.bonela.org/index.php?option=com_k2&view=ite
m&Itemid=223&id=104:06-december-2012. Accessed 17 July 2013.
Centers for Disease Control and Prevention. 2012. Strategic plan, division of HIV/AIDS prevention
(2011 – 2015). http://www.cdc.gov/hiv/pdf/policies_DHAP-strategic-plan.pdf. Accessed 23 Jan
2014.
Chilisa, B.C. 2005. Educational research within postcolonial Africa: A critique of HIV/AIDS
research in Botswana. International Journal of Qualitative Studies in Education 18(6):
659–684.
Crepaz, N., T.A. Hart, and G. Marks. 2004. Highly active antiretroviral therapy and sexual risk
behavior: A meta-analytic review. Journal of the American Medical Association 292(2):
224–236.
De Cock, K.M., D. Mbori-Ngacha, and E. Marum. 2002. Shadow on the continent: Public health
and HIV/AIDS in Africa in the 21st century. Lancet 360(9326): 67–72.
Dube, M.W. 2006. Adinkra! Four hearts joined together: On becoming healing-teachers of African
indigenous religion/s in HIV & AIDS prevention. In African women, religion, and health:
Essays in honor of Mercy Amba Ewudziwa Oduyoye , ed. I.A. Phiri and S. Nadar, 131–156.
Maryknoll: Orbis Books.
Frieden, T.R., M. Das-Douglas, S.E. Kellerman, and Henning K. J. 2005. Applying public health
principles to the HIV epidemic. New England Journal of Medicine 353(22): 2397–2402.
Jensen, K., and J.B. Gaie. 2010. African communalism and public health policies: The relevance
of indigenous concepts of personal identity to HIV/AIDS policies in Botswana. African Journal
of AIDS Research 9(3): 297–305. doi:10.2989/16085906.2010.530187.
Kenyon, K. 2005. Routine HIV testing: A view from Botswana. Health and Human Rights 8(2):
21–23.
Rennie, S., and F. Behets. 2006. Desperately seeking targets: The ethics of routine HIV testing in
low-income countries. Bulletin of the World Health Organization 84(1): 52–57.
Schuklenk, U., and A. Kleinsmidt. 2007. Rethinking mandatory HIV testing during pregnancy in
areas with high HIV prevalence rates: Ethical and policy issues. American Journal of Public
Health 97(7): 1179–1183.
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UNAIDS/WHO. 2004. UNAIDS/WHO policy statement on HIV testing. Geneva: World Health
Organization. http://www.who.int/ethics/topics/en/hivtestingpolicy_who_unaids_en_2004.pdf.
Accessed 17 July 2013.
Weiser, S.D., M. Heisler, K. Leiter, et al. 2006. Correction: Routine HIV testing in Botswana: A
population-based study on attitudes, practices, and human rights concerns. PLoS Medicine
3(10), e395. doi:10.1371/journal.pmed.0030395.
8.6 Case 2: Just Allocation of Pre-exposure Prophylaxis
Drugs in Sub-Saharan Africa
Susan Zinner
School of Public and Environmental Affairs
Indiana University Northwest
Gary , IN , USA
e-mail: [email protected]
This case is presented for instructional purposes only. The ideas and opinions
expressed are the author’s own. The case is not meant to refl ect the offi cial position,
views, or policies of the editors, the editors’ host institutions, or the author’s host
institutions .
8.6.1 Background
During the summer of 2012, the U.S. Food and Drug Administration (FDA)
announced the approval of Truvada (emtricitabine/tenofovir disoproxil fumerate)
for use in pre-exposure prophylaxis programs (PrEP) for people at high risk of HIV
infection (FDA 2012 ). After successful use of antiretroviral therapy (ART) drugs to
treat HIV/AIDS-infected populations , researchers found that daily prophylactic use
of these drugs in uninfected individuals who engaged in high-risk activities was also
effective in reducing their risk of HIV/AIDS . The U.S. Centers for Disease Control
and Prevention (CDC) noted that PrEP could reduce HIV rates for men having sex
with men if those at high risk of HIV infection were targeted and if PrEP was used
as part of a comprehensive set of preventive services, including regular monitoring
of HIV status, adherence, and risk behaviors (CDC 2011 ). Candidates for Truvada
should fi rst be tested for HIV to ensure that they are in fact HIV negative before
beginning the PrEP program.
This innovative prophylactic approach to reducing the likelihood of contracting
HIV holds great promise. One study found that Truvada reduced the risk of HIV
infection 42 % compared with men taking placebos and having sex with other men
(Grant et al. 2010 ), whereas a second study found that risk fell by up to 75 % compared with serodiscordant couples taking placebos (Baeten et al. 2012 ). However,
Truvada is associated with some side effects, including nausea and vomiting (CDC
2011 ) and possible decreases in bone mineral density (Grigsby et al. 2010 ).
E.M. Meslin and I. Garba
261
Furthermore, Truvada is contraindicated for anyone with decreased kidney function.
Regular testing of kidney function is recommended for those people taking this
medication (CDC 2011 ).
Truvada has been tested only in serodiscordant couples —not in women. Its effi –
cacy in the general population of women, in sex workers, and in young girls in
sugar-daddy relationships (i.e., young girls in unequal relationships with older
males) is unknown.
Sub-Saharan Africa has been hit especially hard by HIV/ AIDS . An estimated
two-thirds of people affected by HIV worldwide are concentrated in this area,
although signifi cant variations exist in different parts of the continent (Kalipeni
et al. 2004 ). Unfortunately, the distribution and availability of ART drugs have
exposed the inadequacies of some African national health systems, such as the negative effects of a long-neglected health sector, economic challenges, declining public expenditures, and decentralized funding (Schneider et al. 2006 ).
Many international aid groups help fund public health programs, including programs to reduce the spread of HIV/AIDS . Programs such as PEPFAR (The United
States President’s Emergency Plan for AIDS Relief) , the Global Fund , the World
Bank , the United Nations , and the Gates Foundation have all contributed large sums
of money for this purpose.
African groups at high risk of contracting new infections (and thus good potential candidates for PrEP ) include sex workers, men having sex with men, serodiscordant couples , and girls in sexual sugar-daddy relationships. The latter group poses
specifi c ethical issues. These girls, typically teenagers, may be coerced into sexual
relationships with men old enough to be their fathers or even grandfathers through
the offering of gifts or money. These sugar daddies generally engage in multiple
sexual relationships, possibly with a spouse and several young women, while putting the girls at risk of HIV . Every averted case of HIV increases economic productivity, lowers the risk of social unrest, strengthens the labor force, and improves the
investment climate (Over 2011 ).
8.6.2 Case Description
You are the head of an international anti-AIDS effort currently stationed in a community of 40,000 in sub-Saharan Africa, where the HIV prevalence rate is 21 %. You
have received funding from different world organizations, including some based in the
United States . Your organization is piloting the use of Truvada in populations that are
at high risk of HIV . The organizations funding this project will allow you and the two
health workers assigned to assist you to make all allocation decisions.
The cost of Truvada for one patient is about $500 per year. Those living in this
community are poor, and none could afford this drug without the existence of your
program. Many populations in the community are at high risk of HIV infection ,
including homosexual and bisexual men who routinely engage in sex with other
men, girls in sugar-daddy relationships, sex workers, and serodiscordant couples .
You have been given enough Truvada to treat and monitor 100 patients for a year.
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The funding organizations have indicated that they are likely to provide more
Truvada if you fi nd its use results in no or few new infections during the year among
the 100 selected patients. The community of 40,000 people include the following:
• 80 men who have sex with other men ;
• 80 girls in sugar-daddy relationships;
• 40 sex workers; and
• 30 serodiscordant couples (60 people; noninfected partner receives Truvada
while the infected partner is not medically eligible for ART ).
One challenge you face is that many feminist organizations and child health advocates are pressuring you to include all girls in the group because ample research shows
that girls in sugar-daddy relationships are relatively powerless and cannot ask their
partners to wear a condom, virtually ensuring that these girls will become infected.
There is some evidence, however, that simply paying girls a small amount of money
to attend school (and thus dramatically reducing the possibility of these relationships)
is cost effective. If you adopt this approach, you could use the Truvada for the other
groups. You may need to consider whether to request more money from the funding
organizations if you adopt this approach. One of your organization’s goals is to respect
cultural norms and beliefs if the health of those at risk of HIV/AIDS is not jeopardized. You have been asked to allocate the PrEP drugs in your community.
8.6.3 Discussion Questions
1. What role should the community play as you make your allocation decisions?
How do you remain culturally sensitive when implementing this program?
2. Create a rubric to help you consider each group for inclusion in the PrEP program. What factors will you weigh in making allocation decisions? If you do not
pick an entire group, what criteria do you use to select individuals in that group?
How would your criteria differ if you were distributing ART drugs to infected
individuals (and not to those who are at risk but not infected)?
3. What role should the likelihood of patient adherence play in your allocation
decision? Keep in mind that patients are expected to take their medication daily
on a strict time schedule.
4. How will you determine if your program is successful? How will you determine
whether your allocation decisions are just and fair?
References
Baeten, J.M., D. Donnell, P. Ndase, et al. 2012. Antiretroviral prophylaxis for HIV prevention in
heterosexual men and women. The New England Journal of Medicine 367(5): 399–410.
doi:10.1056/NEJMoa1108524.
Centers for Disease Control and Prevention (CDC). 2011. Interim guidance: Preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. Morbidity and
E.M. Meslin and I. Garba
263
Mortality Weekly Report 60(3): 65–68. http://www.cdc.gov/mmwr/preview/mmwrhtml/
mm6003a1.htm. Accessed 5 May 2013.
Food and Drug Administration (FDA). 2012. FDA approves fi rst drug for reducing the risk of sexually acquired HIV infection. FDA News Release July 16. http://www.fda.gov/NewsEvents/
Newsroom/PressAnnouncements/ucm312210.htm. Accessed 15 May 2013.
Grant, R.M., J.R. Lama, P.L. Anderson, et al. 2010. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. The New England Journal of Medicine 363(27): 2587–
2599. doi:10.1056/NEJMoa1011205.
Grigsby, I.F., L. Pham, L.M. Mansky, R. Gopalakrishnan, and K.C. Mansky. 2010. Tenofovirassociated bone density loss. Therapeutics and Clinical Risk Management 6: 41–47.
Kalipeni, E., S. Craddock, and J. Ghosh. 2004. Mapping the AIDS pandemic in Eastern and
Southern Africa: A critical overview. In HIV & AIDS in Africa: Beyond epidemiology , ed. E.
Kalipeni, S. Craddock, J.R. Oppong, and J. Ghosh, 58–69. Malden: Blackwell Publishing.
Over, M. 2011. Achieving an AIDS transition: Preventing infections to sustain treatment.
Washington, DC: Center for Global Development.
Schneider, H., D. Blaauw, L. Gilson, N. Chabikuli, and J. Goudge. 2006. Health systems and
access to antiretroviral drugs for HIV in Southern Africa: Service delivery and human resources
challenges. Reproductive Health Matters 14(27): 12–23.
8.7 Case 3: Drug Trials in Developing Countries
Olinda Timms
Department of Health and Humanities
St. Johns Research Institute
Bangalore , Karnataka , India
e-mail: [email protected]
This case is presented for instructional purposes only. The ideas and opinions
expressed are the author’s own. The case is not meant to refl ect the offi cial position,
views, or policies of the editors, the editors’ host institutions, or the author’s host
institutions .
8.7.1 Background
Clinical trials outsourced to India offer, in addition to business opportunities for
clinical research management, the prospect of health infrastructure development
and collaborative research . Since 2005, drug trials in India have increased as foreign
drug companies eagerly take advantage of the favorable research environment
(British Broadcasting Corporation [BBC] News 2006 ; Russia Today 2010 ; Overdorf
2011 ; John 2012 ). These advantages include highly qualifi ed English-speaking
doctors, a large and diverse population , and lower costs and relative freedom from
burdensome regulations for privately funded research trials (World Health
Organization 2008 ). As a result, clinical research organizations working on behalf
of pharmaceutical companies frequently approach doctors in private or government
practice to recruit patients for drug trials, often offering attractive payouts per recruit
and promising coauthorship and publication credits as incentives.
8 International Collaboration for Global Public Health
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For vast sections of its demographic, India grapples with inadequate access to
health services and high rates of infant mortality and communicable diseases
(Government of India Planning Commission 2011 ). Only a small slice of the population can afford the high-end private and corporate hospital care in urban pockets
of the nation. Though extremely deferent to physicians, the Indian population is
insuffi ciently informed about the risks and benefi ts of clinical trials . Illiterate,
impoverished, and unaware of the implications of participation , many drug trial
recruits are vulnerable to exploitation (Srinivasan and Nikarge 2009 ). With limited
health care options, some gladly enroll in a drug trial, considering themselves fortunate to receive medical attention, food, and compensation for local travel. Such
circumstances compromise the intent behind freely giving informed consent .
The media has drawn attention to several high-profi le cases. These involved poor
people from lower castes who enrolled in drug trials without adequate consent ,
resulting in severe adverse effects, including death (Lloyd-Roberts 2012 ). Citing
data for 2005–2012, the BBC reported that 2,000 clinical trials took place in India .
The death count among people enrolled in these clinical trials was 288 in 2008,
637 in 2009, 668 in 2010, and 438 in 2011 (Lloyd-Roberts 2012 ). The media also
raised concerns about inadequate regulation of private trials, inconsistent application of informed consent requirements, and irregularities in ethics reviews (The
Hindu 2011 ; The Indian Express 2012 ).
Although offi cials have been responsive to these concerns, their efforts still leave
the vulnerable unprotected. In 2000, the Ministry of Health and Family Welfare
established legal guidelines regulating the conduct of research in India that align
with international guidelines on research ethics including the International
Conference on Harmonisation of Good Clinical Practice (ICH-GCP) ( 1996 ), the
Declaration of Helsinki (World Medical Association 2008 ) and Council for
International Organizations of Medical Sciences (CIOMS) guidelines ( 2002 ). The
Indian Council of Medical Research also developed guidelines specifi cally for clinical trials ( 2006 ). Further, the Drugs and Cosmetics Rules were amended to require
review and registration of trials and to compensate trial participants or their families
in the event of an adverse event (Government of India 2005 ) . Unfortunately, adverse
events go grossly underreported. Few recruits receive compensation, and hardly any
investigations result in convictions for unethical research practices .
8.7.2 Case Description
Sharada, a 45-year-old woman of a low social caste in an impoverished town in India ,
lives on less than 2 U.S. dollars a day. She has access only to the government hospital system that provides free health care to underserved citizens. Complaining of
chest pains, she is taken to the nearest government hospital and diagnosed with heart
and renal failure. Pharmakon, a multinational pharmaceutical company , happens to
be conducting a trial for a drug that has renal-protective effects in cardiac failure.
From a colleague serving as a site investigator for this trial, Sharada’s cardiologist
hears that pilot testing of the drug has shown promising results. But he also learns that
E.M. Meslin and I. Garba
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his colleague’s compensation is tied to the number of subjects he enrolls in the study.
Worse, Pharmakon has a history of enrolling patients without ensuring they fully
understand they will be participating in a research project . Despite misgivings about
this history and his colleague’s fi nancial incentive to enroll patients, Sharada’s cardiologist recommends that she enroll in the drug trial. He emphasizes that enrollment
offers the only way to obtain an expensive drug necessary to save her life that would
otherwise be unaffordable. Given the family’s lack of education, he is uncertain how
much they understood, yet they seem grateful for the prospect of immediate care and
treatment . While on this medication , Sharada develops cardiac arrhythmias, is taken
off the drug, and is discharged from the hospital in a few days. Almost a month later,
she succumbs to cardiac arrest at home. Soon thereafter, the high number of serious
drug-related complications forces discontinuation of the drug trial.
8.7.3 Discussion Questions
1. Who are the stakeholders in this case, what is at stake for each of them, and what
values does each bring to the situation?
2. What are the risks and benefi ts of enrolling impoverished, uneducated patients
living in developing countries in clinical drug trials? What are the barriers to
obtaining true informed consent from these patients, and what can be done to
overcome these barriers?
3. What are the ethical implications of tying a researcher’s compensation to the
number of subjects enrolled? Should this practice be permitted?
4. Are multinational pharmaceutical companies that benefi t from cost-effective
drug trials in developing countries obligated to improve the lives of people living
in those countries?
5. Who should be held responsible for adverse events due to a drug trial conducted
by a multinational company in a country where there is limited health insurance,
no social security, and poor enforcement of regulations ? What international or
grassroots efforts might help ensure accountability for adverse events?
References
British Broadcasting Corporation News. 2006. Drug trials outsourced to Asia. April 22. http://
news.bbc.co.uk/2/hi/south_asia/4932188.stm. Accessed 27 June 2013.
Council for International Organizations of Medical Sciences (CIOMS). 2002. For biomedical
research involving human subjects. http://www.cioms.ch/publications/layout_guide2002.pdf.
Accessed 27 June 2013.
Government of India. 2005. Drugs and cosmetics rules: Schedule Y. http://dbtbiosafety.nic.in/act/
Schedule_Y.pdf. Accessed 23 Jan 2014.
Government of India Planning Commission. 2011. Report of the working group on National Rural
Health Mission (NRHM) for the Twelfth Five Year Plan (2012–2017). New Delhi: Government of
8 International Collaboration for Global Public Health
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India. http://planningcommission.nic.in/aboutus/committee/wrkgrp12/health/WG_1NRHM.pdf.
Accessed 27 June 2013.
Indian Council of Medical Research. 2006. Ethical guidelines for biomedical research on human
participants. New Delhi: Indian Council for Medical Research. http://icmr.nic.in/ethical_
guidelines.pdf. Accessed 27 June 2013.
International Conference on Harmonisation of Good Clinical Practice (ICH-GCP). 1996.
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. Good clinical practice. http://ichgcp.net/. Accessed 27 June
2013.
John, S. 2012. Trial and error: India can attract 5–10% of the global market for drug trials. Times
of India , October 22. http://timesofi ndia.indiatimes.com/business/india-business/Trial-andError-India-can-attract-5-10-of-the-global-market-for-drug-trials/articleshow/16910327.cms.
Accessed 27 June 2013.
Lloyd-Roberts, S. 2012. Have India’s poor become human guinea pigs? BBC News Magazine ,
November 1. http://www.bbc.co.uk/news/magazine-20136654. Accessed 27 June 2013.
Overdorf, J. 2011. India: Deadly drug trials. GlobalPost , June 19. http://www.globalpost.com/
dispatch/news/regions/asia-pacifi c/india/110618/india-health-drug-trials. Accessed 27 June
2013.
Russia Today. 2010. India becomes global drug trial ground for pharmaceuticals. October 23.
http://rt.com/news/india-drug-trial-pharma/. Accessed 27 June 2013.
Srinivasan, S., and S. Nikarge. 2009. Ethical concerns in clinical trials in India: An investigation.
Mumbai: Centre for Studies in Ethics and Rights. http://www.fairdrugs.org/uploads/fi les/
Ethical_concerns_in_clinical_trials_in_India_An_investigation.pdf. Accessed 27 June 2013.
The Hindu. 2011. Opinion/editorial: A shockingly unethical trial. May 15. http://www.thehindu.
com/opinion/editorial/a-shockingly-unethical-trial/article2021657.ece. Accessed 27 June
2013.
The Indian Express. 2012. 10 die per week in drug trials in India. July 8. http://indianexpress.com/
article/india/regional/10-die-per-week-in-drug-trials-in-india/. Accessed 27 June 2013.
World Health Organization (WHO). 2008. Clinical trials in India: Ethical concerns. Bulletin of the
World Health Organization 86(8): 581–582. doi:10.2471/BLT.08.010808.
World Medical Association. 2008. Declaration of Helsinki—Ethical principles for medical
research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/
index.html. Accessed 27 June 2013.
8.8 Case 4: Ethical Issues in Responding to International
Medication Stock-Outs
Justin List
Robert Wood Johnson/VA Clinical Scholars Program
University of Michigan
Ann Arbor , MI , USA
e-mail: [email protected]
Andrew Boyd
Department of Medicine, Section of Hospital Medicine
Columbia University
New York , NY , USA
E.M. Meslin and I. Garba
267
This case is presented for instructional purposes only. The ideas and opinions
expressed are the authors’ own. The case is not meant to refl ect the offi cial position,
views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions .
8.8.1 Background
The World Health Organization (WHO) maintains a list, updated every 2 years, of
medications it considers essential—medications that a given country should have on
hand to distribute to its citizens (WHO 2015 ). In functioning health systems, the
intent is to have essential medicines of assured quality available at all times in adequate amounts, in appropriate dosage forms, and at an affordable price (WHO
2015 ). Among those medications are treatments for tuberculosis (TB), a ubiquitous,
slow-growing bacteria that kills 1.4 million people annually (WHO 2012 ).
Control of TB requires the availability of medication for months of treatment .
Procurement of TB medication requires an intact and predictable supply chain.
Ideally, ministries of health in low-income countries forecast accurately the number
and types of medications needed to treat the local burdens of disease. Then governments typically purchase medications to store in a central facility for regional distribution. Ineffi ciencies in drug supply forecasting; stocking practices; storage
capabilities; transportation capacity; and timely funding, procurement, and delivery
can lead to a breakdown in a supply chain.
One barrier to TB control in low-resource countries, as well as in the United
States , is intermittent unavailability of TB medication , an occurrence known as a
stock- out (Centers for Disease Control and Prevention 2013 ). Medication stockouts often result in delayed treatment , an increased risk of drug resistance in incompletely treated people, and the potential for untreated or incompletely treated people
to infect others. Stock-outs occur for different reasons, including budget constraints,
poor drug procurement policies and distribution networks, and political corruption
slowing drug availability (Stop Stock-outs Campaign 2010 ).
Although 80 % of national ministrie s of health reporting to WHO have an uninterrupted supply of fi rst-line TB medications, 45 % of the 20 highest-burden countries report stock-outs (WHO 2009 ). More recently, 14 countries experienced
anti-TB drug stock-outs in 2011 (Stop TB Partnership 2011 ). To contend with
recurrent stock-outs, the Stop TB Partnership provides technical support and drug
procurement avenues to resource-poor nations through its Global Drug Facility
(GDF) and Green Light Committee (GLC) (Stop TB Partnership 2011 ). Although
GDF and GLC are essential players in ensuring at-risk nations have adequate drug
supplies , both are limited in how quickly they can respond to stock-outs.
Advocacy groups and nongovernmental organizations can generate widespread
public attention in hope of quicker resolution of stock-outs. A paucity of literature
covers the ethical roles of expatriate health workers in stock-outs. The model of
“ethics of engaged presence” in health practice for expatriate health workers in lowincome countries may offer a framework of solidarity with local people (Hunt et al.
8 International Collaboration for Global Public Health
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2012 ). This nondirective framework broadly centers on the moral dimensions of
expatriate involvement in humanitarian health work undertaken with local individuals. Still, limited ethical guidelines exist for expatriates who seek to enter foreign
political and social forays to affect change—leaving the problem of essential TB
medication stocks-outs unresolved.
8.8.2 Case Description
You are a visiting researcher in an East African country investigating TB case- fi nding
detection strategies in an urban area. This country has one of the highest TB burdens
in the world. Its government funds the national medical stores to stock anti- TB drugs
per WHO’s essential medication list. On occasion, you work in the TB clinic at the
local hospital treating TB patients, some of whom have multidrug- resistant TB . You
know that your research participants are guaranteed TB drugs through your study’s
funding. Potential participants who do not qualify for the study but have active TB
infection are referred to a local clinic.
After months living and working i n this country, you learn that many of the urban
and rural clinics carry an inadequate supply of anti-TB medications. You speak with
local doctors about the anti-TB drug shortage. They are frustrated and speculate as
to why there have been stock-outs. Some suspect corruption and misuse of funds by
the ministries of fi nance and health are to blame. Others blame drug manufacturers
for unreliable supplies.
You search for drug stock-outs in this country using Internet search engines and
come across stock-outs for other drugs but fi nd no mention of anti-TB drug stockouts. You return to a weekly clinic meeting and note that the news has not covered
the stock-outs your colleagues are experiencing at their clinics. You ask if any of
them will push the ministry of health to fi x the shortage. One physician says he
heard that the ministry will “provide the TB drugs again shortly.” You suggest that
one of the physicians contact someone from a media outlet to raise attention. After
a period of silence, a physician says she fears that the government will somehow
retaliate if this issue is raised.
After further conversations with colleagues, you decide to attract media attention
to this issue. Your local colleagues support you, even saying they will provide you
with data about the stock-out. Contacts in your U.S.-based sponsoring organization
feel ambivalent about your working with the media to raise attention but will not
prohibit it so long as you do not mention your affi liation.
You decide to contact an international health and human rights organization about
the stock-out, and its staff puts you in touch with a local partner organization. The
local partner wants you to speak, along with local human rights advocates, at a stockout conference and interview with newspaper reporters. Despite your wanting to help
those dependent on the national drug supply for their TB treatment , you are confl icted
about your participation and its possible repercussions. Before committing, you tell
the local partner that you need to think the matter through thoroughly.
E.M. Meslin and I. Garba
269
8.8.3 Discussion Questions
1. What are some risks and benefi ts of your involvement with the stock-out conference and contact with the media? What ethical concepts should inform your
decision? Would your decision change if your colleagues or sponsoring organization urged you to say nothing?
2. How does your limited understanding of local institutional hierarchy and governance inform your ethical analysis of whether or not to engage in advocacy
around stock-outs? If you conclude you should engage, are there ways to do so
besides public testimony?
3. Does it matter ethically if the stock-out pertained to antimalarial medications; that
is, a medication outside your research area ( TB medication )? Why or why not?
4. In terms of perceptions and consequences from the media and government ministries, how might your public reporting of the stock-out differ from a local offi –
cial reporting it? What different types of impact might result from each? How
might your ability to work with local health professionals in the future be affected
if you report the alleged stock-out?
5. Knowing that you have ready access to anti-TB medication for research participants, should you broaden the inclusion criteria to allow more patients to receive
guaranteed treatment ? Why or why not?
6. Should you attempt to bring the stock-out to the attention of the global health
international community by inviting members of the international media to the
stock-out conference? If not, why not? If so, what approaches might international and local nongovernmental organizations , World Health Organization
departments, and patient advocacy groups employ to effectively publicize and
resolve stock-outs? If not, why not?
7. Do you have an ethical duty to report the stock-out if local health offi cers will not
do so?
Acknowledgements Dr. List thanks staff members of the National Institutes of Health/Fogarty
International Clinical Research Scholars program, Physicians for Human Rights, and Action Group
for Health, Human Rights and HIV/AIDS (AGHA-Uganda) for advice on this case study’s content.
Both authors thank the leadership of the Yale/Stanford Johnson & Johnson Global Health Scholars
Program for training medical residents in ethics before their clinical work assignments in Rwanda.
References
Centers for Disease Control and Prevention. 2013. Interruptions in supplies of second-line antituberculosis drugs—United States, 2005–2012. Morbidity and Mortality Weekly Report. http://
www.cdc.gov/mmwr/preview/mmwrhtml/mm6202a2.htm. Accessed 24 Mar 2013.
Hunt, M.R., L. Schwartz, C. Sinding, and L. Elit. 2012. The ethics of engaged presence: A framework for health professionals in humanitarian assistance and development work. Developing
World Bioethics. doi:10.1111/dewb.12013.
8 International Collaboration for Global Public Health
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Stop Stock-outs Campaign. 2010. What are stock-outs? http://stopstockouts.org/stop-stock-outscampaign/what-are-stock-outs/. Accessed 28 Dec 2012.
Stop TB Partnership. 2011. Global drug facility annual report 2011. http://www.stoptb.org/assets/
documents/gdf/whatis/GDF_Annual_Report_2011_web_lowres.pdf. Accessed 28 Dec 2012.
World Health Organization (WHO). 2009. Global tuberculosis control 2009: Epidemiology, strategy, fi nancing , 37. Geneva: World Health Organization.
World Health Organization (WHO). 2012. Global tuberculosis report 2012: Executive summary. http://
apps.who.int/iris/bitstream/10665/75938/1/9789241564502_eng.pdf. Accessed 3 June 2015.
World Health Organization (WHO). 2015. Essential medicines. http://www.who.int/topics/essential_medicines/en/. Accessed 24 June 2015.
8.9 Case 5: Transmitting Cholera to Haiti
Joseph Millum
Clinical Center Department of Bioethics and Fogarty International Center
National Institutes of Health
Bethesda , MD , USA
e-mail: [email protected]
This case is presented for instructional purposes only. The ideas and opinions
expressed are the author’s own. The case is not meant to refl ect the offi cial position,
views, or policies of the editors, the editors’ host institutions, or the author’s host
institutions .
8.9.1 Background
Cholera is caused by infection with Vibrio cholerae bacteria, which colonize the
small intestine and produce cholera toxin. The disease is characterized by sudden
onset of severe, watery diarrhea and vomiting. Left untreated, cholera rapidly leads
to dehydration and shock. Severe cholera can be fatal in more than 50 % of cases.
Prompt treatment reduce s the case fatality rate to less than 1 % (Boore et al. 2008 ).
Treatment primarily addresses the loss of fl uids: patients should be aggressively
treated with oral rehydration solution or, if severely dehydrated, through intravenous fl uids. Treatment with antibiotics shortens the course of the disease.
Cholera is transmitted through contaminated food or water. In developing countries, where most infections and deaths occur, inadequate sanitation is frequently the
cause of the spread of V. cholerae , as untreated fecal matter from cholera sufferers
leaks into the water supply. Each year, 3–5 million cases of cholera occur, leading
to about 120,000 deaths (Harris et al. 2012 ).
Cholera is endemic in more than 50 countries. In many places, cholera outbreaks
are seasonal—fl aring up during the rainy season and dying down again during dry
periods. Outbreaks can be prevented or contained by properly treating sewage, promoting rigorous hygiene practices, and sterilizing drinking water. Two oral cholera
vaccines are commercially available but not included in most cholera control
E.M. Meslin and I. Garba
271
programs, although the World Health Organization (WHO) recommends them for
use in outbreaks and for high-risk populations (WHO 2010 ). Before 2010, Haiti had
not experienced cholera for at least a century.
Haiti , a country of ten million people, occupies the western portion of the island
of Hispaniola in the Caribbean. Although its per capita gross domestic product
(GDP) is about $1,200 (Central Intelligence Agency 2012 ), 13 a tiny elite controls
most of the country’s wealth. With 80 % of the population living below the poverty
line, Haiti is the lowest-ranked country in the Americas on the United Nations
(U.N.) Human Development Index (UNDP 2011 ) . The economy depends heavily
on remittances from Haitians working abroad and on foreign aid.
Life expectancy in Haiti is 62 years, while infant mortality is 52 per 1,000 live
births (UNDP 2011 ). Sixty-four percent of Haitians have access to an improved
water source (i.e., one that is protected from outside contamination), but just 26 %
have access to improved sanitation (i.e., a facility that separates human excreta from
human contact) (WHO/UNICEF 2013 ). Communicable diseases, including HIV/
AIDS , tuberculosis, diarrheal diseases , and malaria remain substantial causes of
disability and death. There are severe shortages of physicians, nurses, hospital beds,
and essential medicines. About 6 % of GDP is spent on health, of which threequarters is private expenditure. Out-of-pocket spending on health care is extremely
high (UNDP 2011 ).
Haiti has a long history of political instability, characterized by multiple coups, foreign interference and occupation, and extended periods of dictatorship, notably under
François Duvalier (Papa Doc) and his son Jean-Claude Duvalier (Baby Doc) between
1957 and 1986. Following a coup in 2004, the U.N. stationed peacekeepers in Haiti. The
U.N. Stabilization Mission in Haiti (MINUSTAH) has been in Haiti ever since.
In January 2010, a magnitude 7.0 earthquake struck Haiti . Hundreds of thousands
of people died and up to a million were left homeless. International aid agencies,
donor governments , and nongovernmental organizations (NGOs) mobilized rapidly
in response, and substantial amounts of money and aid were promised to assist in
rebuilding.
8.9.2 Case Description
In mid-October 2010, upstream of the Artibonite River, a sudden rush of people
began presenting at the local hospital with acute diarrhea, signaling the fi rst cholera
cases. People living nearby use the river extensively for washing, bathing, and
drinking water; farmers downstream use it for irrigation. Within days, the spread of
cholera to the Artibonite River Delta and settlements on the coast had overwhelmed
local clinics and hospitals. The facilities lacked cholera cots that allow patients to
defecate hygienically from their beds, while insuffi cient space for all patients prevented isolation of cholera victims. For the thousands of sufferers, the supply of
13 Purchasing power parity in 2011 U.S. dollars.
8 International Collaboration for Global Public Health
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doctors, nurses, and rehydration packs proved inadequate. The epidemic exploded
across Haiti . Since cholera was not endemic, the population lacked immunity.
Within months, thousands of people had died and hundreds of thousands had been
sickened.
NGOs and some international donor agencies , including from the U.N., who
were already in Haiti dealing with the aftermath of the earthquake, diverted resources
to combat cholera. They distributed medical supplies, organized educational campaigns on cholera prevention , trucked clean drinking water and water purifi cation
tablets across the country, and worked with local hospitals to institute rigorous
infection control measures.
The Haitian and international response to the cholera outbreak rapidly brought
the case fatality rate from around 9 % to less than 1 %. Although the outbreak died
down, the aid efforts failed to rectify the dire state of Haiti’s water and sanitation
infrastructure. During the rainy season, cases would spike again, exposing the diffi culty of improving the Haitian health care system so that it could respond to new
outbreaks without external assistance.
Haiti had been cholera-free for more than a century—so how had cholera got
there? Almost as soon as the outbreak started, rumors circulated blaming U.N.
peacekeepers. A contingent of soldiers from Nepal, where cholera is endemic, had
arrived in October 2010. They were stationed at a camp on a tributary of the
Artibonite River near where the outbreak began. Waste management at the base was
rumored to be inadequate and had allowed sewage to fl ow into the river.
Initially, U.N. offi cials denied responsibility for bringing cholera to Haiti . But
rumors and public protest persisted, fueled by independent investigations suggesting the camp as the source (Piarroux et al. 2011 ). Finally, the U.N. Secretary General
convened an independent panel of experts charged with determining the source of
the cholera outbreak. The panel completed its report in May 2011. It argued that the
evidence from the Artibonite River’s tributary system, the epidemiological timeline,
and genetic analyses of Haitian V. cholerae bacteria indicated that the outbreak
resulted from contamination of the river with feces carrying a strain of the current
South Asian bacterium. Moreover, the report noted that the “haphazard” plumbing
construction in the main toilet and showering area offered signifi cant potential for
cross-contamination, and that heavy rains could cause the open septic pit into which
black water was deposited to overfl ow into the tributary (Cravioto et al. 2011 ).
The report offered a series of recommendations to prevent similar occurrences
and concluded
The introduction of this choler a strain as a result of environmental contamination with feces
could not have been the source of such an outbreak without simultaneous water and sanitation and health care system defi ciencies. These defi ciencies, coupled with conducive environmental and epidemiological conditions, allowed the spread of the Vibrio cholerae
organism in the environment, from which a large number of people became infected.
The independent panel concludes that the Haiti cholera outbreak was caused by the
confl uence of circumstances as described above and was not the fault of, or deliberate
action of, a group or individual (Cravioto et al. 2011 ).
Since the initial outbreak, more than 7,500 Haitians have died from cholera and
more than 600,000 have been sickened. Subsequent independent genetic analysis
E.M. Meslin and I. Garba
273
confi rmed that the Haitian strain was almost identical with the strain currently circulating in South Asia (Hendriksen et al. 2011 ).
Many commentators believe that the systemic defi ciencies that enabled the outbreak are partly the fault of the Haitian government. It failed to take appropriate
measures to protect its population from disease, such as improving drinking water
and sanitation , investing in health care infrastructure, and so forth. The Independent
Panel concluded that the introduction of cholera by the U.N. mission was therefore
not the fault of the U.N. An alternative view is that multiple actors were at fault for
this tragedy, including the Haitian government, the U.N., and foreign governments
whose policies affect Haiti .
A distinct issue is whether and how the victims of the outbreak should be compensated. One option is to make compensation the responsibility of those at fault, although
the diffi culties in assigning fault may make this option challenging. An alternative is
to establish a no-fault scheme that would compensate anyone affected, but determining who must pay is also problematic. Donors working on earthquake relief in Haiti ,
for example, arguably should not have to divert funds to remedy a problem they did
not create. In November 2011, a legal suit was brought against the U.N. seeking compensation for the victims of the cholera outbreak (Sontag 2012 ). In February 2013, the
U.N. invoked legal immunity against such suits and refused to provide
compensation.
8.9.3 Discussion Questions
1. Which parties’ interests are affected by the cholera outbreak? Which parties
might have some responsibility to respond to the outbreak?
2. The U.N.’s Independent Panel of Experts concluded that “the Haiti cholera outbreak was caused by the confl uence of circumstances … and was not the fault of,
or deliberate action of, a group or individual.” Assume that they are correct about
the facts. Does it follow that no one is morally at fault? Explain why or why not.
3. Imagine that you are providing recommendations for compensating the victims
of infectious disease outbreaks, like Haiti’s. Should individual actors be held
accountable, or should a no-fault compensation scheme be put in place? If the
latter, who should provide compensation ? Explain the reasons for your responses.
(Douglas 2009 discusses “no-fault” compensation in another context.)
4. If the Haitian government has neglected its responsibilities to its citizens, does
this make any difference to the help that international aid agencies should provide to Haiti? Explain why or why not.
5. One possible concern with seeking compensation for the people who contracted
cholera is that it may have a “chilling effect” on international assistance. For
example, if aid agencies believe they are at risk of being sued for unintentionally
transmitting disease, they may be deterred from working in a country in the fi rst
place . Should the Haitian government or the lawyers representing the victims
take this concern into account? Why or why not?
8 International Collaboration for Global Public Health
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References
Boore, A., M. Iwamoto, E. Mintz, and P. Yu. 2008. Cholera and other vibrioses. In Control of communicable diseases manual , 19th ed, ed. D.L. Heymann, 113–127. Washington, DC: American
Public Health Association.
Central Intelligence Agency. 2012. The world factbook. https://www.cia.gov/library/publications/
the-world-factbook/. Accessed 29 May 2013.
Cravioto, A., C.F. Lanata, D.S. Lantagne, and G.B. Nair. 2011. Final report of the independent
panel of experts on the cholera outbreak in Haiti. http://www.un.org/News/dh/infocus/haiti/
UN-cholera-report-fi nal.pdf. Accessed 29 May 2013.
Douglas, T. 2009. Medical injury compensation: Beyond ‘no fault’. Medical Law Review 17(1):
30–51. doi:10.1093/medlaw/fwn022.
Harris, J.B., R.C. LaRocque, F. Qadri, E.T. Ryan, and S.B. Calderwood. 2012. Cholera. Lancet
379(9835): 2466–2476. doi:10.1016/S0140-6736(12)60436-X.
Hendriksen, R.S., L.B. Price, J.M. Schupp, et al. 2011. Population genetics of Vibrio cholerae
from Nepal in 2010: Evidence on the origin of the Haitian outbreak. mBio 2(4): e00157–
e001511. doi:10.1128/mBio.00157-11. http://mbio.asm.org/content/2/4/e00157-11.full.
pdf+html. Accessed 29 May 2013.
Piarroux, R., R. Barrais, B. Faucher, et al. 2011. Understanding the cholera epidemic, Haiti.
Emerging Infectious Diseases 17(7): 1161–1168.
Sontag, D. 2012. In Haiti, global failures on a cholera epidemic. New York Times , March 31.
United Nations Development Programme (UNDP). 2011. Human development report 2011:
Sustainability and equity: A better future for all. http://hdr.undp.org/en/content/humandevelopment-report-2011. Accessed 29 May 2013.
WHO/UNICEF Joint Monitoring Programme (JMP) for Water Supply and Sanitation. 2013. Data
and estimates. http://www.wssinfo.org/data-estimates/table/. Accessed 29 May 2013.
World Health Organization (WHO). 2010. Cholera vaccines: WHO position paper. Weekly
Epidemiological Record 85(13): 117–128. http://www.who.int/wer/2010/wer8513.pdf?ua=1.
Accessed 11 June 2015.
8.10 Case 6: Perilous Path to Middle East Peace :
The Sanctions Dilemma
Waleed Al-Faisal
Department of Family and Community Medicine, Faculty of Medicine
Damascus University
Damascus , Syrian Arab Republic
Primary Health Care
Dubai Health Authority
Dubai , United Arab Emirates
Hamid Hussain
Faculty of Medicine
University of Baghdad
Baghdad , Iraq
E.M. Meslin and I. Garba
275
Dubai Residency Training Program and Public Health Consultant
Dubai Health Authority
Dubai , United Arab Emirates
e-mail: [email protected]
Kasturi Sen
Global Public Health, Wolfson College (Common Room)
University of Oxford
Oxford , UK
This case is presented for instructional purposes only. The ideas and opinions
expressed are the authors’ own. The case is not meant to refl ect the offi cial position,
views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions .
8.10.1 Background
During the last century, public health practices have greatly improved the health of
individuals and societies in the Middle East and North Africa (MENA) region
through successful interventional programs like expanded immunization for children and universal salt iodization programs. The major challenge for public health
in the twenty-fi rst century is to simultaneously maintain and upgrade the infrastructure created to improve peoples’ lives.
Currently, the MENA region faces multiple challenges to its public health achievements, one of which is the impact of sanctions being used against MENA countries to
infl uence political behavior. Sanctions—defi ned as mostly economic but also political
and military penalties introduced to alter political/military threats and behavior—are
employed by the United States and other countries to discourage the proliferation of
weapons of mass destruction and ballistic missiles, bolster human rights , end terrorism , thwart drug traffi cking, discourage armed aggression, promote market access,
protect the environment, and replace governments (Haass 1998 ). Sanctions often
involve economic measures , such as restricting or eliminating foreign assistance ,
freezing countries’ assets, imposing export and import limitations, and revoking mostfavored-nation trade status (World Health Organization 2003 ).
Empirical evidence indicates that sanctions have profound long- and short-term
public health impact on the health of citizens in the affected countries, with the greatest harm affecting the elderly, women, and children (Garfi eld 1999 ; Ali and Shah
2000 ). This impact goes far beyond problems with medical supplies or other healthspecifi c resources. Public health services depend on a safe water supply, a functioning
sanitation system, and a reliable power infrastructure; on availability of equipment
such as ambulances , X-ray machines, and refrigerators for storing vaccines ; on the
public having resources to access health care (e.g., transportation, fi nancial resources);
and on human resources, the trained staff who use the equipment.
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Two examples of the use of sanctions were those imposed by the United Nations
(U.N.) against Iraq in the 1990s and against Syria beginning in 2011.
8.10.2 The Case of Iraq
To assess the health impact of the Iraq sanctions, the U.N. Children’s Fund
(UNICEF), in collaboration with the World Health Organization and local health
authorities surveyed child health in Iraq during February through May 1999
(UNICEF 1999a , b ). Between 1984 and 1989, infant mortality in Iraq was 47 per
1,000 live births (Ali and Shah 2000 ). In southern and central Iraq, the infant mortality rate almost tripled, rising to 108 per 1,000 live births during 1994 through
1999. The under-5 child mortality rate also drastically increased (more than doubled) from 56 to 131 per 1,000 live births for the same period (Ali and Shah 2000 ).
Yet in the autonomous northern region of Iraq, infant mortality declined from 64 to
59 per 1,000 live births and under-5 mortality fell from 80 to 72 per 1,000 live births
for the same period. These differences were attributed to better food and resource
allocation due to Western support for an autonomous region and the nonapplication
of universal sanctions (UNICEF 2002 ).
Other studies of the health impact of sanctions on Iraq have similar negative fi ndings (Armijo-Hussein et al. 1991 ; Hurwitz and David 1992 ; Central Statistical
Organization, Iraq 1996 , 1997 ). Table 8.1 summarizes data from these studies and
shows the change in health indicators once sanctions were imposed in 1990.
8.10.3 The Case of Syria
Since May 2011, economic sanctions against Syria signifi cantly affected the
exchange rate, devaluing its Syrian Lira (SL). The exchange rate of 45 SL for every
U.S. dollar increased to more than 200 SL and had serious economic ramifi cations.
The cos t of living essentials such as gas, eggs, milk, bread, and cooking oil more
than tripled over the past 2 years. At the same time, the purchasing power of
Table 8.1 Health status indicators before and after the 1990 sanctions against Iraq
Indicator 1985 1991 1996
Infant mortality rate 52 42 97
Under-5 mortality rate 64 42 126
Chronic malnutrition (%) 18 18 32
Stunting (%) 12 29 26
Maternal mortality per 100,000
births
– 121 294
Diarrhea episodes per child per year – 3.8 14.4
Births below 2.5 Kg (%) 5–9 4.5 12
Note. A dash indicates that reliable data are not available
E.M. Meslin and I. Garba
277
salaries was halved. Families, nearing starvation, were forced out of work, and
more than 20 % of the working population was unable to purchase living essentials
(Zarzar 2013 ; Food and Agriculture Organization of the United Nations 2013 ). The
collapse of the exchange rate increased the cost of health services and of medicines.
Despite the emphasis of sanctions on economic measures , they prevented entry of
essential medical supplies into the country, including those for chronic diseases
such as cancer, diabetes , and heart disease, which are not produced locally. Local
drug production, an area in which Syria had been 90 % self-suffi cient before the
sanctions and confl ict , largely collapsed. This opened channels for counterfeit
drugs and corruption among those who smuggled supplies through the country’s
porous borders. The high cost of heating and electricity during 2 years of confl ict
compounded the adverse effects of Syria’s extreme winter and summer temperatures. Most notably, the cold chain of vaccines were destroyed, contributing to the
virtual collapse of the once successful vaccination programme (Al Faisal et al.
2012a , b ). The combination of price increases, job losses, and lower salaries devastated families, especially those with children or members who were pregnant or
elderly (United Nations Offi ce for the Coordination of Humanitarian Affairs 2013 ).
Millions of small businesses collapsed in Syria. Many were small-scale and homebased, run by women providing invaluable income to cope with price infl ation and
to purchase food, school books and uniforms for children, and essential medicines
and emergency medical care.
8.10.4 Ethical Considerations
Before World War I, economic sanctions were considered acts of warfare that, like
military sieges, infl icted suffering on entire populations . Viewed this way, economic
sanctions appear ethically suspect from a number of perspectives. Sanctions violate
the just war ban on targeting noncombatants, the Kant’s philosophy not to use people as means to an end, and the negative right of populations not to be deprived of
their means of subsistence (Gordon 1999 ; United Nations 2005 ). However, after
World War I when the League of Nations was created, economic sanctions came to
be viewed as a peaceful, diplomatic alternative to war t hat could prevent military
intervention (Gordon 1999 ). This viewpoint holds that to justify sanctions, the benefi ts of avoiding the presumably far greater harms caused by war, civil war, or longterm political oppression must outweigh the harms sanctions impose on a populace.
But this grim utilitarian calculus must also consider the probability of the success of
sanctions, which generally is low. Pape ( 1997 ), for example, estimates that sanctions lead to political compliance less than 5 % of the time. More optimistically,
Hufbauer et al. ( 2009 ) judge sanctions effective in 34 % of situations used. However,
they stress that the success of sanctions depends on many factors including the purpose; the relative economic instability of the country receiving sanctions; whether
the country receiving sanctions is part of a broad array of diplomatic, economic,
military, and covert measures; and whether the sanctions are being imposed in the
context of a broader international coalition (Hufbauer et al. 2009 ).
8 International Collaboration for Global Public Health
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8.10.5 Case Description
You are a public health offi cial from a country in the Middle East researching the
impact of economic sanctions on the health of populations . You have seen fi rst-hand
the impact sanctions have had on vulnerable populations . You also have expertise in
public health ethics and have written extensively about ethics in the use of economic
sanctions. You have been invited by a United Nations commission to testify on the
health impact of sanctions. The commission values your opinion on whether sanctions are ever ethical and justifi ed.
8.10.6 Discussion Questions
1. What are the range of ethical considerations for and against the use of economic
sanctions? Are there ways of imposing economic sanctions that can avoid forms
of collective punishment and minimize subsequent adverse health impact on
individuals and populations?
2. In extreme situations where many human lives are at stake, such as emergency
disaster relief, doctors and public health offi cials often revert to simple utilitarian
calculations of lives lost or saved (e.g., triage decisions). To what extent is the
ethical logic surrounding economic sanctions similar or dissimilar to the ethical
logic of emergency disaster relief?
3. Can economic sanctions be ethically justifi ed
(a) as an alternative to long-standing political oppression and human rights
violations?
(b) to prevent civil war?
(c) to avert war?
(d) to effect regime change?
References
Al Faisal, W., Y. Al Saleh, and K. Sen. 2012a. Syria: Public health achievements and sanctions.
The Lancet 379(9833): 2241. doi:10.1016/S0140-6736(12)60871-X. http://www.thelancet.
com/journals/lancet/article/PIIS0140-6736(12)60871-X/fulltext. Accessed 5 July 2013.
Al Faisal, W., K. Sen, and Y. Al Saleh. 2012b. Syria: Public health achievements and the effect of
sanctions. Indian Journal of Medical Ethics 9(3): 151–153.
Ali, M.M., and I.H. Shah. 2000. Sanctions and childhood mortality in Iraq. Lancet 355(9218): 1851–
1858. http://www.thelancet.com/journals/lancet/article/PIIS0140673600022893/. Accessed 4
July 2013.
Armijo-Hussein, N.A., E. Benjamin, R. Moodie, et al. 1991. The effect of the Gulf Crisis on the
children of Iraq. New England Journal of Medicine 325(13): 977–980. doi:10.1056/
NEJM199109263251330.
Central Statistical Organization, Iraq. 1996. The 1996 Multiple Indicator Cluster Survey: A survey
to assess the situation of children and women in Iraq. Final Report with Results from South/
Centre Governorates. Iraq, UNICEF Ref IRQ/97/288, August.
E.M. Meslin and I. Garba
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Central Statistical Organization, Iraq. 1997. The 1996 Multiple Indicator Cluster Survey: A survey
to assess the situation of families in Iraq. Final Report with Results from Northern Governorates.
Iraq, UNICEF, Rep/97/166, May.
Food and Agriculture Organization of the United Nations. 2013. Four million Syrians are unable
to produce or buy enough food. http://www.fao.org/news/story/en/item/179446/icode/.
Accessed 6 July 2013.
Garfi eld, R. 1999. The impact of economic sanctions on health and well being , Relief and
Rehabilitation Network, Paper 31, 1–4. London: Overseas Development Institute.
Gordon, J.A. 1999. A peaceful, silent, deadly remedy: The ethics of economic sanctions. Ethics &
International Affairs 13(1): 123–142. doi:10.1111/j.1747-7093.1999.tb00330.x.
Haass, R.N. 1998. Economic sanctions: Too much of a bad thing. Brookings Policy Brief Series.
http://www.brookings.edu/research/papers/1998/06/sanctions-haass. Accessed 21 Apr 2013.
Hufbauer, G.C., J.J. Schott, K.A. Elliott, and B. Oegg. 2009. Economic sanctions reconsidered ,
3rd ed. Washington, DC: Peterson Institute for International Economics.
Hurwitz, M., and P. David. 1992. The state of children’s health in pre-war Iraq. London: Centre
for Population Studies, London School of Hygiene and Tropical Medicine.
Pape, R.A. 1997. Why economic sanctions do not work. International Security 22(2): 90–136.
United Nations. 2005. Economic, social and cultural rights: Handbook for national human rights
institutions , Professional Training Series No. 12. New York: United Nations. http://www.ohchr.
org/Documents/Publications/training12en.pdf. Accessed 8 July 2013.
United Nations Offi ce for the Coordination of Humanitarian Affairs. 2013. Syria Humanitarian
Assistance Response Plan (SHARP, 1 January–30 June 2013). http://www.unocha.org/cap/appeals/
humanitarian-assistance-response-plan-syria-1-january-30-june-2013. Accessed 21 Apr 2013.
UNICEF. 1999a. Iraq surveys show ‘humanitarian emergency.’ UNICEF Newsline. August 12.
UNICEF. 1999b. Questions and answers for the Iraq child mortality surveys. August 16. http://
www.casi.org.uk/info/unicef/990816qa.html. Accessed 9 Feb 2014.
UNICEF. 2002. Nutritional Survey 2002: Overview of nutritional status of under-fi ves in South/
Central Iraq. http://www.casi.org.uk/info/unicef/0211nutrition.pdf. Accessed 9 Feb 2014.
World Health Organization (WHO). 2003. Health situation in Iraq prior to March 2003. WHO/
EMRO: 5/2003: 47. Diaz, J., and R. Garfi eld. 2003. Iraq Watching Briefs: Health and Nutrition.
http://www.google.ae/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CCcQ
FjAA&url=http%3A%2F%2Fwww.corpwatch.org%2Fdownloads%2FIraqiHealthWatching_
Brief.doc&ei=Sxj3Ut7mCqip0AXUyoDwCg&usg=AFQjCNGKtg9iCFecdctGW6U-7Gt94E
8Hnw&sig2=EB5Zjewajg3mr6F0pse29g. Accessed 9 Feb 2014.
Zarzar, A. 2013. The ballooning cost of living in Damascus. Al-Akhbar. http://english.al-akhbar.
com/node/14624. Accessed 9 Feb 2014.
8.11 Case 7: Advancing Informed Consent and Ethical
Standards in Multinational Health Research
Drew E. Lee
Department of Family Medicine
Advocate Lutheran General Hospital
Park Ridge , IL , USA
e-mail: [email protected]
Sarah A. Kleinfeld
Department of Psychiatry
Medstar Georgetown University Hospital
Washington , DC , USA
8 International Collaboration for Global Public Health
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Rachel M. Glassford
School of Public Health and Health Services
George Washington University
Falls Church , VA , USA
This case is presented for instructional purposes only. The ideas and opinions
expressed are the authors’ own. The case is not meant to refl ect the offi cial position,
views, or policies of the editors, the editors’ host institutions, or the authors’ host
institutions .
8.11.1 Background
In the United States , regulations for informed consent largely came about during the
1950s through 1970s not only in response to unethical human experiments carried
out in Nazi Germany, but also to those within U.S. borders (Beecher 1966 ).
Experiments like the U.S. Public Health Service Tuskegee Syphilis Study (Jones
1981 ) prompted Congress to enact human research regulations , initially through the
1974 National Research Act. Subsequently, other research guidelines have been
developed and revised (World Health Organization 2000 ; Council for International
Organizations of Medical Sciences 2002 ; The International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use 1996 ; World Medical Association 2008 ), fostering expansion of ethics
commissions and review boards and making informed consent an integral component of health research (Meslin and Johnson 2008 ). Yet, half a century later, many
countries still lack adequate human research regulations or regulatory authorities.
These regulatory gaps leave research participants, their families, and communities at
risk for great harm through sociocultural discrimination , research-related illness, disability, and death and post-experimental medical abandonment. In Nigeria, Pfi zer
tested an unapproved drug on infants and children (Abdullahi v. Pfi zer Inc. 2002 ); in
India , Johns Hopkins tested cancer drugs on patients without proper consent (Sharma
2001 ); and other such incidents have been reported (LaFraniere et al. 2000 ). Even the
U.S. National Institutes of Health failed to produce consent forms for experiments on
HIV-positive women in developing countries (Public Citizen 1998 ).
On a practical and ethical level, debate continues over human research and
informed consent (Tri-Council 2010 ; Marshall 2008 ; Nuffi eld Council on Bioethics
2002 ) . While some argue for a single ethical standard for human research (Lurie
and Wolfe 1997 ; Angell 1997 ), others believe that imposing a global ethical standard irrespective of cultural differences would amount to ethical imperialism
(Resnik 1998 ). The New England Journal of Medicine “has taken the position that
it will not publish reports of unethical research regardless of their scientifi c merit”
(Angell 1997 ). But like other scientifi c journals, it has found diffi culty in determining what is unethical versus what is culturally appropriate research in different
settings.
E.M. Meslin and I. Garba
281
There are many challenges to obtaining informed consent . Some involve illiteracy; noncomprehension of information ; language and communication barriers; or
unfamiliarity with certain scientifi c, medical, or ethical concepts. Other challenges
are attributable to complex sociocultural, psychological, or structural elements,
such as shared decision making by community members, rather than by an individual (Marshall 2000 , 2008 ). Some studies, however, take the stance that such
challenges do not preclude an individual’s ability to understand or voluntarily participate in research studies (Pace et al. 2003 ). Consequently, in order to ensure that
research participation is voluntary , it is important to safeguard a participant’s right
to refuse or withdraw from a study at any time.
One practical solution to obtaining appropriate consent is by implementing culturally acceptable methods such as oral consent, video d ocumentation, or community meetings (Tri-Council 2010 ; Nuffi eld Council on Bioethics 2002 ; Dawson and
Kass 2005 ). Another is to require foreign researchers to receive dual approval
through a local review board and their own institutional review board (IRB) (World
Health Organization 2000 ; Council for International Organizations of Medical
Sciences 2002 ; Tri-Council 2010 ). Nevertheless, multinational collaborations in
research , especially those originating in regions that lack adequate research regulations , can be problematic because research “approval” may not provide adequate
protections.
De-identifi ed data and information 14 pose an additional complication for obtaining proper informed consent . These can include “x-rays, endoscopic images, images
of organs or tissues taken during an autopsy, still or video recordings of surgical
procedures, and microscopic images” (Tranberg et al. 2003 ). As long as these remain
de-identifi ed, researchers need not obtain informed consent (European Union 1995 ;
U.S. Department of Health and Human Services 2009 ; National Institutes of Health
2007 ). However, in countries lacking adequate research ethics infrastructures, waiving informed consent is problematic at several levels. First, verifying if appropriate
consent was obtained becomes virtually impossible. Second, the lack of consent can
be medically dangerous for research participants and have legal repercussions for
researchers (Flory et al. 2008 ). Finally, it can complicate the research process by
compromising the utility of research samples and data (Wendler 2008 ).
Continued globalization , international development and increased accessibility
to data through electronic medical records and online databases will increase multinational human research. As multinational research becomes more common, the
need to fi nd appropriate ethical standards and informed consent policies will become
more urgent. Ultimately, the goal of such standards and policies should be to ensure
that research participants and their information are safeguarded at the origin and
throughout every step of the research process.
14 De-identifi cation involves stripping data and information of personal identifi ers (e.g. names,
addresses, birth dates, photos, or any unique identifi ers), such that an individual’s identity remains
anonymous and cannot be retraced.
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8.11.2 Case Description
You are an infectious disease specialist working at a university in a high-income
country and are interested in researching cervical cancer in immunocompromised
patients. Because you collaborate regularly with colleagues worldwide, other
researchers commonly seek your input. An African colleague e-mails you for advice
on a multinational cervical cancer study she is conducting with several other researchers in seven different African countries. This study began 3 years ago to address the
local population’s health needs and has been funded by local hospitals and organizations. This colleague, a public health professional , has compiled the research data in
an online database. The information she sends you includes an electronic copy of the
preliminary report, de-identifi ed data set , and pathology slides of cervical specimens.
After reviewing her preliminary fi ndings, you agree that her research could positively impact the health outcomes of individuals in her community.
Excited by this initial review, your colleague invites you to coauthor an upcoming manuscript on the study. You carefully review the methods section of the preliminary report, focusing on how consent was obtained. In one research country,
consent was provided via video documentation; in two others, it was obtained
through a standardized consent form; and in a fourth, through verbal consent of
male community leaders before seeking consent from individual participants, a
practice in line with local cultural norms . For the remaining three countries, no
consent documentation exists.
You follow-up with your colleague about the various consent methods. She indicates that none of the countries involved in the project have IRBs or national
research guidelines , but that consent methods were typical for research projects in
these countries. Regarding the three countries lacking consent documentation, she
believes that some form of consent was obtained from the research participants,
although she lacks supporting evidence.
Although the information you received was de-identifi ed, you wonder about the
lack of uniformity in the consent process but attribute it to respect for differing cultural norms . Based on all information provided, you believe the research has scientifi c merit and the data collected is scientifi cally valid. You also believe the study
should be published, as it could signifi cantly improve the health of the region and
advance future research.
8.11.3 Discussion Questions
1. Who would you turn to in your institution for guidance regarding your involvement in the research , coauthorship of the manuscript, and other contributions to
this research study?
2. What are some appropriate ways to obtain informed consent when conducting
research in areas with culture or language different from yours? Name some pros
and cons to each approach.
E.M. Meslin and I. Garba
283
3. Does the use of multiple methods to obtain consent raise questions about the
reliability of the data or validity of the research project? Without confi rmation of
informed consent , would you consider the publication of this research study to
be scientifi c misconduct?
4. What are some appropriate ways to obtain informed consent for research conducted in countries with different consent standards and requirements? Are there
instances when one set of requirements should take priority over another?
5. Given th e multiple methods used to obtain consent , are you willing to coauthor
your colleague’s paper? Why or why not?
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reproduce the material.
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Medicine 337(12): 847–849.
Beecher, H.K. 1966. Ethics and clinical research. New England Journal of Medicine 274(24):
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Flory, J.H., D. Wendler, and E.J. Emanuel. 2008. Empirical issues in informed consent for research.
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Lie, F.G. Miller, and D. Wendler, 645–660. Oxford: Oxford University Press.
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use. 1996. The ICH Harmonised tripartite guideline: Guideline
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LaFraniere, S., M.P. Flaherty, and J. Stephens. 2000. The dilemma: Submit or suffer ‘Uninformed
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Lurie, P., and S.M. Wolfe. 1997. Unethical trials of intervention to reduce perinatal transmission of
the human immunodefi ciency virus in developing countries. New England Journal of Medicine
337(12): 853–856.
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E.M. Meslin and I. Garba

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