INT J TUBERC LUNG DIS 24(s1):48–56
Q 2020 The Union
http://dx.doi.org/10.5588/ijtld.17.0897
Upholding ethical values and human rights at the frontier of TB
research
J. Stillo,1 M. Frick,2 Y. Cong3
1
College of Liberal Arts and Sciences, Wayne State University, Detroit, MI, 2Treatment Action Group, New York,
NY, USA; 3Program of Medical Ethics, Peking University Health Science Center, Beijing, China
Until recently, human rights have played a minor role in
the fight against tuberculosis (TB), even less so in TB
research. This is changing, however. The WHO’s End
TB Strategy and Ethics Guidance stress respect for
human rights and ethical principles in every area of TB
care, including research. The desired reductions in TB
incidence and mortality are impossible without new
tools and strategies to fight the disease. Yet, little
suggests that the current state of TB research—including
funding levels, evidence being produced, and community
involvement—will alleviate concerns related to the
availability, accessibility, and acceptability of TB diag-
nostics, drugs, and prevention in the near future. In this
FOLLOWING AN ANEMIA DIAGNOSIS in 1960,
Eleanor Roosevelt experienced declining health.
There followed a battery of medical tests and
interventions—blood transfusions, bone marrow
aspirations, prednisone treatment, chest X-rays, two
periods of hospitalization, and, towards the end of
her life, 6 weeks of treatment with isoniazid and
streptomycin for presumed miliary TB.1 On 27
October 1962, Roosevelt received confirmation from
her physician, David Gurewitsch, that she had
tuberculosis (TB).2 Upon hearing her TB diagnosis,
Roosevelt reportedly told Gurewitsch: ‘‘I want to
die’’. She had repeatedly expressed discontent with
the growing invasiveness of her care, at one point
describing hospital tests as ‘‘articles of torture,’’ a
sentiment echoed by her daughter and other family
members who felt the extraordinary efforts to extend
Roosevelt’s life should stop.1 Against these wishes,
Gurewitsch and other physicians on her medical team
felt compelled to do everything to save her, doubling
Roosevelt’s dose of isoniazid in her final days and
attempting to resuscitate her through cardiopulmo-
nary resuscitation and an adrenaline shot to her heart
when her breathing stopped. On 7 November 1962, 8
days after Gurewitsch confirmed her TB diagnosis,
she died at home after suffering a major stroke.
Correspondence to: Jonathan Stillo, Department of Anthropology, Wayne State University, 656 W Kirby St F/AB 3054,
Detroit, MI 48202, USA. e-mail: jstillo@gmail.com
Article submitted 24 December 2017. Final version accepted 20 October 2018.
TB & ETHICS SUPPLEMENT
SUMMARY
article, we consider these ethics concerns in relation to
the right to enjoy the benefits of scientific progress and
the right to health. We also reflect on community
involvement in research and offer recommendations in
the spirit of the rights to health and science, such as
involving affected communities in all aspects of research
planning, execution, and dissemination. Finally, we
argue that states have a responsibility under interna-
tional law for the continued realization of the right to
health. This realization rests, in part, on the realization
of the right to science.
K E Y W O R D S : ethics guidance; End TB Strategy; right
to science; right to health
Gurewitsch’s efforts would not have mattered: testing
later indicated that the TB strain was resistant to both
isoniazid and streptomycin. At that time, only one
other anti-TB medicine was widely available (para-
aminosalicylic acid), which would not have been
enough to cure her. Her autopsy showed TB had
disseminated to Roosevelt’s bone marrow, lungs,
liver, spleen, and kidneys.
Roosevelt’s death is less remembered for its
association with drug-resistant TB (DR-TB) than for
the way decisions about her end-of-life care presaged
a revolution in medical ethics. Starting in the 1960s, it
began to shrug off the paternalism and techno-
enthusiasm of Western medicine in the post-War era
in favor of a new normative consensus, one that
recognized the patient as an autonomous agent with
the right to information and decision-making pow-
er.3,4 This shift grew out of collective efforts to
grapple with revelations of gross ethical violations in
settings of medical experimentation (e.g., the Nazi
medical experiments revealed during the Nuremberg
trials, or the Tuskegee syphilis study), and also with
dilemmas arising from the advent of new technolo-
gies, some of which (e.g., ventilators) extended life to
points once impossible.3 Ultimately, this shift gave
rise to many of the bioethical precepts and guidelines

still in force today, from the Belmont Report to the
Declaration of Helsinki.5,6
This newfound respect for persons also took root in
one of Roosevelt’s most lasting achievements: the
Universal Declaration of Human Rights (UDHR).7
Among the rights set forth in the UDHR is the right to
health (Article 25) and the right to science (Article
27), both of which found fuller expression in the
legally-binding International Covenant on Economic,
Social and Cultural Rights (ICESCR).7,8 Where the
new bioethics redefined the relationship between
patient and physician, the international human rights
system sought to clarify the relationship between
individuals and their governments. Stated most
simply, individuals were conceived of as rights
holders and governments as duty bearers.
That one of the chief architects of the UDHR died
with DR-TB is more than historical coincidence.
Today, as calls for patient-centered TB care gain
volume, Roosevelt’s story resonates deeply with a
nascent but growing movement to mainstream ethics
and rights into every aspect of the TB response, from
palliative care to the realm of TB research and
development (R&D). The ethics and human rights
dimensions of TB research are the concern of the
section titled ‘‘New frontiers in TB care and control’’
of the World Health Organization Ethics Guidance
for the Implementation of the End TB Strategy
(hereafter Ethics Guidance).9
Here we review how the Ethics Guidance frames
TB research in relation to ethics and human rights
and expand on several of its key arguments. While
most discussions of ethics in TB research inhabit the
disciplinary terrain of bioethics and focus on the
setting of the clinical trial, the Ethics Guidance adopts
a more expansive view by situating TB research in
relation to the social, political, and cultural contexts
in which science takes place. Within this bigger
picture, we pay particular attention to the human
rights to health and science. We argue that states have
a responsibility under international law to promote
research and ensure that new tools and intervention
strategies are studied and put into practice in ways
that benefit all people with and at risk of TB.
CURRENT GAPS IN TUBERCULOSIS RESEARCH
Many of Roosevelt’s experiences with TB would
sound familiar to people with DR-TB today—late
diagnosis, limited therapeutic options, challenging
side-effect management, and a total lack of palliative
care. In 2017, the WHO estimated that only 25% of
the 558 000 people who fell sick with rifampicin-
resistant or multidrug-resistant TB started treat-
ment.10 This is due to a lack of research as well as
to a failure to connect people to the advances in TB
care that research has yielded since Roosevelt was
alive. The section ‘‘New frontiers in TB care and
Ethics at the frontier of TB research 49
control’’ of the Ethics Guidance opens with the
observation that ‘‘there is an urgent need to develop
an enhanced evidence base for TB prevention and
treatment, and to improve the standard of care.’’9
This urgency assumes that the reductions in TB
incidence and mortality called for by the WHO’s End
TB Strategy require both the optimal use of current
tools, including those in the pipeline, and the
introduction of new tools, including a vaccine, new
drugs, and point-of-care tests for all forms of TB by
2025.11 This is an ambitious goal considering the
current state of TB diagnosis, treatment, and preven-
tion. One of the greatest barriers to eliminating TB is
diagnosis. Only 50% of people with DS-TB and 22%
with DR-TB are put on treatment.12 Despite WHO
guidance promoting the use of rapid molecular
technologies, many people with TB are still diagnosed
using smear microscopy and X-rays, and only 56% of
cases are bacteriologically confirmed.10,13 Children
are often missed entirely.14 For those put on
treatment, it is long and difficult for DS- and DR-
TB. Globally, DR-TB treatment success rates are only
about 50%. The reasons for this are myriad, but all
should agree that these outcomes are unacceptable
for a curable disease. Prevention is perhaps the most
neglected aspect of TB management. There is no
effective vaccine for pulmonary TB, and the treat-
ment of latent TB has generally been limited to
wealthy, lower-burden countries. Finally, despite
recommendations for social, economic, and psycho-
logical support for people with TB, many do not
benefit from these services. TB remains a profoundly
disruptive and financially ruinous event in people’s
lives. There are challenges that must be overcome in
every aspect of TB management, which we will
consider in further detail below in the context of
opportunities for future research.
TUBERCULOSIS RESEARCH AND THE RIGHT TO
HEALTH
Human rights are rights which all people have by
virtue of being human and generally concern an
individual’s relation to the state. The Ethics Guidance
is built upon these rights, describing them as
‘‘concrete legal expressions of ethical values, includ-
ing human dignity, equity, non-discrimination, par-
ticipation, solidarity, and accountability.’’9 At its
center is the right to health. This right is Article 12
of the ICESCR, which has been signed and ratified by
166 countries.8 The right to health is also contained
in more than 130 national constitutions.15 Under the
right to health, governments must ensure that quality
health goods and services are available without
discrimination. In addition, these must be physically
and economically accessible. It also means that
information about TB and its prevention, diagnosis,
and treatment should be accessible to those who need
50 The International Journal of Tuberculosis and Lung Disease
it.16 These four dimensions of accessibility mean, for
example, one’s membership in a minority group, or
inability to afford the direct or indirect costs of care,
should not prevent one from accessing quality TB
prevention, diagnosis, treatment, and support. How-
ever, there are large gaps in the availability and
accessibility of the goods and services required to
manage TB, as well as many local inequities which
limit access among the groups most vulnerable to TB,
including migrants, miners, ethnic minorities such as
the Roma, and people in rural places.
The global TB community is not succeeding in
ensuring the equitable distribution of TB-related
goods and services. However, distribution of existing
goods and services is only part of the problem. The
WHO’s constitution defines health as a state of
‘‘complete physical, mental, and social well-being,’’
and the right to health provides for the ‘‘highest
attainable standard of physical and mental
health.’’7,17 The limits of attainable health depend
not only on the distribution of goods and services, but
also upon scientific progress, which is itself a human
right set forth in ICESCR Article 15.1(b).8 In this
sense, the continued realization of the right to health
rests, in part, on the realization of the right to science.
As science advances, our understanding of what
constitutes the highest attainable standard of health
must also advance.18 For diseases such as TB, where
current tools are clearly inadequate, meeting right to
health obligations to ensure the availability of health
goods and services may require states to invest in
research to develop them.19 This investment is not
limited to technology development, but includes:
investigations into the social and structural determi-
nants of TB and how to mitigate their effects; studies
to increase our understanding of infection control;
efforts to improve the effectiveness of adherence
strategies; and work by social scientists on how
communities understand TB and its challenges.9 In
order to produce the highest quality data, much of
this research should be multi-disciplinary, with efforts
put into engaging local and international experts
working in relevant fields such as anthropology,
sociology, and geography—a point emphasized by the
Ethics Guidance.9
ALIGNING BIOETHICS AND HUMAN RIGHTS IN
THE CONTEXT OF TUBERCULOSIS SCIENCE
The Ethics Guidance sketches out the human rights
dimensions of science and health in asking the
question: ‘‘Why is developing TB research ethically
important?’’.9 Acknowledging from the outset that
research conduct must respect ethical principles, the
section ‘‘New frontiers in TB care and control’’ of this
Ethics Guidance outlines three reasons why research
on TB is itself ethically relevant:
First, the way research is financed, conducted,
owned, and disseminated can either advance or
undermine the realization of ethical values. New
technologies, including drugs, diagnostics, and ap-
proaches to care, should be available without
discrimination, and clinical guidelines should be
written with equity in mind and not foster double
standards between countries.20
Second, inadequate progress in TB research over
the past several decades has created or reinforced the
ethical dilemmas that TB programs face. Many of the
ethical challenges in patient care discussed through-
out the Ethics Guidance can be traced back, in part,
to the reliance of TB programs on drugs of limited
efficacy and considerable toxicity to which patients
struggle to adhere.21
Third, advances in TB research can shift cultural
perceptions of TB. At the community level, improved
understandings of TB or new technological capabil-
ities may aid efforts to combat stigma and discrim-
ination. Just as the advent of highly active
antiretroviral therapy transformed HIV from a death
sentence into a treatable condition, the introduction
of short, novel regimens composed of safe, effective
drugs might lessen the intense fear that surrounds
DR-TB.22 On a political level, scientific progress may
signal new possibilities for eliminating TB, making
the case for sustained investment more saleable.
To this list, we would add a fourth consideration:
that TB research can strengthen legal petitions for
redress of TB-related harms. For example, knowledge
of TB transmission dynamics, such as that TB is
rapidly rendered noninfectious after initiation of
effective therapy, could help to ensure that the
deprivation of liberties people with TB face in
situations of isolation or detention are strictly
necessary to protect public health, are evidence-
based, time-limited, and proportional to the risks at
hand.23 Indeed, the Ethics Guidance makes clear that
involuntary isolation should only be used as a
measure of last resort and cannot be taken as a
reason to deprive people of other rights.9
TUBERCULOSIS RESEARCH AND THE RIGHT TO
SCIENCE
The Ethics Guidance hints at, but does not explicitly
mention, recent work by a number of scholars and
activists to focus attention on a neglected corner of
human rights law: the right to enjoy the benefits of
scientific progress and its applications (i.e., the ‘‘right
to science’’). Illuminating the influence of right to
science concepts on the Ethics Guidance is important.
Efforts to define and apply this right count among the
most promising developments for promoting needs-
driven R&D. Market-based approaches to innova-
tion neither adequately address established epidemics
such as TB that primarily affect the poor nor
anticipate emerging global health threats.24 Locating

government support for health research as an
obligation within international human rights law
could strengthen advocacy, action, and accountability
in this area.25
The right to science is introduced in Article 27 of
the UDHR and is most clearly articulated in ICESCR
Article 15.7,8 It also appears in regional human rights
charters, and many national constitutions recognize
specific aspects of the right.26 As stated in ICESCR
Article 15.1(b), States parties must ‘‘recognize the
right of everyone. . .to enjoy the benefits of scientific
progress and its applications.’’ To achieve the full
realization of this right, ICESCR Article 15.2 tasks
States parties with taking steps ‘‘necessary for the
conservation, the development, and the diffusion of
science and culture.’’8 Normative consensus on the
meaning of this right and the obligations it places on
governments is developing quickly. A 2012 report by
Farida Shaheed, former United Nations Special
Rapporteur in the field of cultural rights, outlines
the right’s normative content in terms of four areas:
. . .(a) access by everyone without discrimination to
the benefits of science and its applications; (b)
opportunities for all to contribute to the scientific
enterprise and freedom indispensable for scientific
research; (c) participation of individuals and com-
munities in decision-making and the related right to
information; and (d) an enabling environment foster-
ing the conservation, development, and diffusion of
science and technology.26
The Ethics Guidance addresses all four of these
areas. The principle of participation, for example,
underlies the document’s recommendation that
. . .all stakeholders. . .and the community must par-
ticipate in the generation of research questions and
the design and implementation of studies.9
This acknowledges that individuals have a right to
participate in research beyond their role as potential
trial participants.27 Researchers seeking to promote
participation can find practical advice in several
guidelines, including the Good Participatory Practice
Guidelines for TB Drug and Vaccine Trials (GPP-TB
and GPP-TB VACC). As envisioned by these guide-
lines, participation should enable the meaningful
engagement of affected communities and civil society
across all stages of the research lifecycle, including:
setting research priorities, reviewing study protocols,
contributing to ethical and efficient trial conduct,
disseminating results, and advocating for the uptake
of research findings in policy and practice.28,29 Many
research projects fall short of this standard. One way
to operationalize these guidelines is through the
engagement of community advisory boards (CABs),
or independent groups of research-literate activists
and community members who provide guidance to
researchers. CAB feedback may relate to the ethical
obligations of researchers, the needs of TB-affected
Ethics at the frontier of TB research 51
communities, and technical concerns aimed at in-
creasing the quality of data that is ultimately
obtained.30 Although GPP-TB and GPP-TB VACC
were written specifically for clinical trials, the
principles within can be applied to all types of TB
research.28
In concordance with the right to science, the Ethics
Guidance also discusses the obligation of states to
diffuse science. For example, it notes:
Participants should be kept informed of research
findings and the application of these findings.9
Crucially, the Ethics Guidance reaffirms that the
obligation to diffuse science under ICESCR Article 15
goes beyond general knowledge to include the
tangible applications of discoveries such as new
health technologies.26,31 The Ethics Guidance says
‘‘research results should lead to technology transfers,
wherever applicable, for the benefit of the affected
population,’’ and states that ‘‘research should be
designed so that the populations in which it is carried
out stand to benefit from the results.’’9 The language
here not only references right to science concepts, but
also draws on the work of bioethicists to tie ethical
research to the generation of social value for the
communities in which research is conducted. One
prominent exploration of this idea by Emmanuel et
al. links social value to participation, or what the
authors call ‘‘collaborative partnerships’’ with com-
munities.32
The lack of availability of delamanid, until very
recently, in countries where it was tested, such as
South Africa and Peru, was caused by Otsuka’s initial
strategy of only seeking registration in comparatively
wealthy, low TB burden places such as South Korea
and the European Union. This is probably the most
blatant violation in recent years of the obligation to
diffuse the benefits of science. While corporations do
not have the same human rights obligations as states,
most people agree that they must, at a minimum,
respect rights (i.e., not do anything that violates
rights).33,34 Ultimately, states are responsible for
creating the legal and regulatory frameworks that
govern the diverse range of stakeholders involved in
research. As one expert in access to medicines
commented in a global survey of scientists’ percep-
tions of the right to science:
Governments have created the current innovation
system. Governments create norms and incentive to
promote innovation, governments pay for research
and for the outcomes of this research. And at the end
of the day all stakeholders, be they public or private
innovators. . .behaves or reacts to a policy environ-
ment that the government has created.35
The Figure maps specific obligations of state and
non-state actors under the right to science along the
clinical development pathway, from basic and trans-
52 The International Journal of Tuberculosis and Lung Disease
Figure Obligations of state and non-state actors under the right to science along the clinical development pathway. IP ¼ intellectual
property.
lational science to clinical development to post-
marketing activities.
Helpfully, the Ethics Guidance devotes a section to
discussing pre-approval access to investigational
compounds.9 This has become an ethical flashpoint
in recent years, and an aspect of diffusion in need of
much greater normative clarity on the scope of state
and non-state actor responsibilities. Mechanisms for
pre-approval access include compassionate use and
expanded access provisions such as open-label phase
IV trials. The urgency of the ethical debate around
pre-approval access stems from the persistent struggle
of many to access newer TB tools and services.
However, approval by a stringent regulatory author-
ity (SRA) does little to ensure access to new drugs. For
instance, as of August 2018, only 24 659 people had
received bedaquiline and 2020 had received delam-
anid under routine, programmatic conditions—a
small portion of those who could possibly benefit
from these drugs.36 The reasons for the slow rollout
of tools both new and old are myriad and include
regulatory challenges, cost issues, and the conserva-
tive approach of some national TB programs.37
Because of these challenges, we suggest that access
provisions be planned for throughout the research
process, including after SRA approval. We also urge
states that host TB research, including clinical trials,
to require local registration and other provisions
which will ensure that the communities which
participate in research also benefit from its fruits.
While many actors have a role in the realization of the
rights to science and health, the ultimate responsibil-
ity to respect, protect, and fulfill these rights, lies with
the states that have signed and ratified the ICESCR.
If TB research is to benefit all people, then it must
address the needs of vulnerable groups. This requires
promoting the inclusion of groups that have histor-
ically been underrepresented in, and often excluded
from, clinical trials (e.g., children, pregnant women,
people with HIV with low CD4 counts). Without
such inclusion, the equity proposition of TB research
is severely restricted in that the benefits of science will
not readily accrue to those most in need. Two groups
merit dedicated discussion: pregnant women and
children. The Ethics Guidance specifies that research
on children should be seen as a ‘‘natural and necessary
part of the health care system.’’9 Pregnant women are
often excluded from clinical trials, and a consequence

of this is the stark absence of robust data on the
safety, tolerability, and pharmacokinetics of TB drugs
during pregnancy.38 The lack of research on pregnant
women and children does not change the fact that
many get TB and that they have the same rights to
benefit from science as other groups. In 2011, there
were an estimated 216 500 active cases of TB in
pregnant women globally, and an estimated one
million children under age 15 get active TB each
year.39,40 The fact that women and children are
getting sick with TB in such numbers is cause for
concern and suggests that excluding them from
research, while ostensibly done to protect them from
the risks inherent to research, may ultimately cause
them greater harm by preempting the very research
which could yield safer, more effective ways to treat
them.41 Because of the disproportionate harm TB
inflicts on these populations, investigators should
plan for their inclusion in studies unless the risks are
so great as to outweigh the benefits of additional
data. Part of the challenge will be switching the
ethical starting point from one of exclusion to one of
presumed inclusion whereby the case for excluding
children or pregnant women from a trial is clearly
articulated and not merely assumed at the outset.
IMPROVING THE QUALITY OF TUBERCULOSIS
CARE THROUGH INTERDISCIPLINARY
RESEARCH
Under the right to science, governments not only have
an obligation to diffuse science and its benefits, they
must also develop science. In a 2012 report, Shaheed
notes that development entails state support for
research through, for example, the provision of
public funding; the creation of partnerships with the
private sector; and the promotion of freedom of
scientific research.26 Importantly, this support should
take the form of ‘‘purposive development,’’ or the
allocation of resources to address the innovation
needs of vulnerable groups.31 In directing scientific
advancement toward those most in need, purposive
development is an avenue for realizing ethical values
such as equity. As a disease that primarily affects the
poor and which has weathered decades of underin-
vestment, TB is the paradigmatic example of a
problem requiring the ‘‘purposive development’’ of
science.21 It is meaningful, then, that the section
‘‘New frontiers in TB care and control’’ of the Ethics
Guidance opens with the statement:
Underfunding in TB research, and the consequently
slow progress in the development of improved ways to
prevent, diagnose, and treat TB, raise a number of
ethical and human rights concerns on which. . .govern-
ments should act.9
However, additional funding for TB research,
while badly needed, does nothing on its own to
Ethics at the frontier of TB research 53
guarantee that the current violations of the rights to
health and science that plague TB in what concerns
the availability and accessibility of essential medi-
cines and diagnostics will not be perpetuated. While
the current situation reveals that violations of these
rights are the norm, especially regarding DR-TB,
neither existing human rights frameworks, nor the
Ethics Guidance offer a solution to the lack of
accountability that accompanies the lack of access
described above.
Much of this article is devoted to research gaps and
inadequacies in global TB management, but in this
section, we offer three examples of recent and
ongoing research projects with the potential to
improve current models of care. This is particularly
important from an ethical point of view because
access to the best available diagnostics and drugs is
not equitable. Thus, the ‘‘purposive development’’ of
TB research requires understanding how these
inequities are experienced at the local level and what
is needed to address them, both in terms of better use
of current tools and the form that new ones should
take. A good example comes from Romania, an
upper-middle income country where access to diag-
nosis and treatment is limited by where one lives, with
variations in DST rates of 10–100% between
counties, and unavailability of the full complement
of DR-TB drugs in most treatment sites in the
country.42-45 China also provides an example where,
despite recent progress, access to diagnosis and
treatment is limited. Only 45% of people are notified
that they have rifampicin-resistant and MDR-TB and
are enrolled on treatment.10 More troublingly, of the
total number of estimated people in China with
MDR-TB, only 5 in 100 are reported to receive
proper treatment.46 Data like these are often not
visible in publicly available statistics, but are impor-
tant to address in order to achieve more equitable TB
care. Three examples of research projects with the
potential to improve current models of care are:
1 The Quality of Tuberculosis Care in Urban India
project is a multidisciplinary research project that
assesses care quality by using standardized cases
played by actors.47,48 This allows the research team
to assess the care that a person with a defined set of
symptoms will receive from multiple caregivers.
Determining the quality of TB care is complex, but
the broad set of methodologies the project employs,
which include ethnography, surveys, and inter-
views, has the potential to better understand and
improve patient pathways and care quality in India
and globally.
2 A second multi-disciplinary project that could
improve the experiences of people during ambula-
tory treatment is the video-observed therapy
(VOT). This research has taken place in several
sites including the UK, Moldova, and Belarus. It
54 The International Journal of Tuberculosis and Lung Disease
investigates a mobile phone application developed
by the University of California, San Diego, USA
which is capable of video recording and asynchro-
nous uploading, which allows it to be used even if a
person has intermittent Internet access. The UK
research was a randomized control trial and has
shown encouraging results.49 A trial using the same
tool in the USA is examining VOT for latent TB
treatment using the 3HP regimen.50 Whether or not
treatment observation should be required is beyond
the scope of this article, however, the burden that
treatment observation places on health systems,
patients, and their families is well-document-
ed.51–54 As long as treatment observation is
required for TB, there is an ethical obligation to
ensure that the economic and time costs it places on
people with TB are minimized.
3 Another example of promising, multidisciplinary
research on TB that addresses a major research gap
is the Community Randomised Evaluation of a
Socioeconomic Intervention to Prevent TB (CRE-
SIPT) project in Peru. CRESIPT randomizes commu-
nities to test various patient support interventions.
This is noteworthy because socioeconomic interven-
tions for TB are rarely subjected to this level of
methodological rigor. As with the two previous
examples, CRESIPT is multidisciplinary and provides
valuable data on the effectiveness of various types of
social and economic interventions.55
There are gaps across the full spectrum of TB
research that governments, working in partnership
with communities and other sectors, must fill. Even
though current funding levels are inadequate to
address each priority, this does not necessitate placing
basic science, product development, operational
research, and social science in competition. This is a
false choice. These activities are complementary and
do not necessarily draw from the same funding
sources or involve the same researchers. There is a
great, largely untapped opportunity for socio-behav-
ioural research to be conducted in partnership with
local and foreign university social science and public
health departments. If these sorts of partnerships
were supported at higher levels—with efforts to
facilitate research permissions and funding, research-
ers, including graduate students, could make valuable
contributions to our understandings of social, behav-
ioural, and economic aspects of TB, including the
important work of identifying and ranking barriers to
care.56
CONCLUSION
Despite tremendous advances in medical science since
Roosevelt’s time, many people around the world
continue to live with little reasonable expectation of
benefitting from research that redraws the frontiers of
knowledge and medicine. On the margins of markets
and society, too many people with and at risk of TB
struggle to access dated diagnostic, therapeutic, and
preventive technologies. Writing in 1999, and taking
TB as an example, Paul Farmer challenged public
health and human rights practitioners to forge a
‘‘pragmatic solidarity’’ linking scientific progress to
the provision of services:
If everyone has a right ‘to share in scientific
advancement and its benefits,’ where are our prag-
matic efforts to improve the spread of these advances?
Such efforts exist, but. . .even as our biomedical
interventions become more effective, our capacity to
distribute them equitably is further eroded.57
Farmer’s words are truer than ever. A solution to
both the inadequacy of research and the inequitable
distribution of its fruits must be found and some
mechanism for accountability must be developed. It is
beyond the scope of this paper to suggest such a
mechanism. However, the Ethics Guidance is a step
toward forging this kind of pragmatic solidarity by
uniting fields and actors more often treated as
separate entities: research and programs; bioethics
and human rights; scientists working to overcome TB
and the communities that confront it every day.
Acknowledgements
Conflicts of interest statement: none declared.
The authors express their gratitude to I Diaconu-Stillo for editing
assistance.
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Jusqu’à tout récemment, les droits de l’homme ont joué un
rôle mineur dans la lutte contre la tuberculose (TB), et ce
d’autant moins dans la recherche sur la TB. Cependant, la
situation est en train de changer. La stratégie End TB de
l’Organisation mondiale de la Santé et les directives
éthiques insistent sur le respect des droits de l’homme et
des principes éthiques dans tous les domaines des soins
antituberculeux, y compris la recherche. Les réductions
souhaitées de l’incidence et de la mortalité liées à la TB
sont impossibles sans de nouveaux outils et stratégies pour
lutter contre la maladie. Néanmoins, peu de choses
suggèrent que l’état actuel de la recherche sur la TB—y
compris les niveaux de financement, les preuves produites
et la participation communautaire—permettra d’atténuer
les préoccupations liées à la disponibilité, l’accessibilité
Hasta hace muy poco, los derechos humanos cumplı́an
una función menor en la lucha contra la tuberculosis y
eran aún menos importantes en la investigación sobre la
enfermedad; sin embargo esta situación está cambiando.
La Estrategia Fin a la TB de la Organización Mundial de
la Salud y directrices en materia de ética destacan los
principios de respeto de los derechos humanos y de ética
en cada aspecto de la atención de la TB, incluida la
investigación. La disminución prevista de la incidencia y
la mortalidad por TB es imposible de alcanzar sin
herramientas y estrategias nuevas para combatir la
enfermedad. No obstante, existen pocos indicios de
que la situación actual de la investigación en TB,
incluidos los niveles de financiamiento, las evidencias
obtenidas y la participación de la comunidad, aliviarán
en un futuro cercano las preocupaciones con respecto a
Ethics at the frontier of TB research i
R É S U M É
et l’acceptabilité des diagnostics, des médicaments et de
la prévention de la TB dans un avenir proche. Dans cet
article, nous examinons ces préoccupations éthiques en
relation avec le droit de bénéficier des bienfaits du
progrès scientifique et le droit à la santé. Nous
r éfl échissons également à la participation de la
communauté dans la recherche et proposons des
recommandations dans l’esprit des droits à la santé et
à la science, telles que l’implication des communautés
concernées dans tous les aspects de la planification, de
l’exécution et de la diffusion de la recherche. Enfin,
nous soutenons que les États ont une responsabilité en
vertu du droit international pour la réalisation continue
du droit à la santé. Cette réalisation repose, en partie,
sur la réalisation du droit à la science.
RESUMEN
la disponibilidad, la accesibilidad y la aceptabilidad de
los medios diagnósticos, los fármacos y la prevención de
la TB. En el presente artı́culo se examinan estas
inquietudes éticas con respecto al derecho de gozar de
los beneficios del progreso cientı́fico y el derecho a la
salud. Asimismo, se analiza la participación de la
comunidad en la investigaci ón y se formulan
recomendaciones a tenor de los derechos a la salud y el
derecho a la ciencia como la inclusi ón de las
comunidades afectadas en todos los aspectos de
planificaci ón, ejecuci ón y difusi ón de las
investigaciones cientı́ficas. Por último, se sostiene que
en virtud del derecho internacional, los estados son
responsables de la satisfacción constante del derecho a la
salud. Esta tarea depende en parte de la plena efectividad
del derecho a la ciencia.