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Policy Forum

Grand Challenges in Global Health:


Ethical, Social, and Cultural Issues
Based on Key Informant Perspectives
Kathryn Berndtson*, Tina Daid, C. Shawn Tracy, Anant Bhan, Emma R. M. Cohen, Ross E. G. Upshur, Jerome A. Singh,
Abdallah S. Daar, James V. Lavery, Peter A. Singer

However, the GCGH ESC program


is the first large-scale science project Citation: Berndtson K, Daid T, Tracy CS, Bhan A,
focused exclusively on ESC issues Cohen ERM, et al. (2007) Grand Challenges in Global
Health: Ethical, social, and cultural issues based on
related to the developing world [1]. key informant perspectives. PLoS Med 4(9): e268.
The ESC issues identified here should doi:10.1371/journal.pmed.0040268
be of interest to the science and Copyright: © 2007 Berndtson et al. This is an
development community, especially open-access article distributed under the terms
to those focused on global health. of the Creative Commons Attribution License,
which permits unrestricted use, distribution,

I
n 2005, we launched the Ethical, Moreover, we hope our approach, and reproduction in any medium, provided the
Social and Cultural (ESC) Program and specifically the way we went about original author and source are credited.
for the Grand Challenges in identifying ESC issues, will be useful Abbreviations: CSO, civil society organization;
Global Health (GCGH) initiative, as to future large-scale science projects ESC, ethical, social, and cultural; GCGH, Grand
focused on the developing world. Challenges in Global Health; NGO, nongovernmental
described in the first article in this organization
series [1]. To identify key ESC issues,
we conducted group discussions with Our Findings The Ethical, Social and Cultural Program of the Grand
Challenges in Global Health initiative is based at
investigators and program officers from The developing world experts the Program on Life Sciences, Ethics, and Policy at
the GCGH projects, as well as interviews identified thirteen issues, discussed the McLaughlin-Rotman Centre for Global Health,
University Health Network/McLaughlin Centre for
with developing world experts. Our below and illustrated with direct Molecular Medicine, University of Toronto, Toronto,
approach is shown in Box 1. quotations. Ontario, Canada. Kathryn Berndtson is at the Program
This compilation of views from Community engagement. As on Life Sciences, Ethics, and Policy, McLaughlin-
Rotman Centre for Global Health, Toronto, Ontario,
investigators and developing world described in greater detail in the Canada. Tina Daid is at the Centre for Global Health
experts is the first description of ESC third article in this series, community Research, St. Michael’s Hospital, University of Toronto,
engagement is the process of working Toronto, Ontario, Canada. C. Shawn Tracy is at the
issues for the GCGH initiative. To our University of Toronto Joint Centre for Bioethics and
knowledge, it is also the first analysis collaboratively with relevant partners the Primary Care Research Unit at Sunnybrook Health
of ESC issues related to a large-scale who share a common goal and interests Sciences Centre, Toronto, Ontario, Canada. Anant
Bhan is an independent researcher in Pune, India and
science program in the developing [4] . Many GCGH projects require bioethicist in the Ethical, Social and Cultural Program
world. In this article we outline the ESC extensive interactions with host for the Grand Challenges in Global Health Initiative.
issues identified by these key informants. communities, and both investigators Emma R. M. Cohen is at the McLaughlin-Rotman
Centre for Global Health, Toronto, Ontario, Canada.
and developing world informants Ross E. G. Upshur is at the Joint Centre for Bioethics,
What Is Already Known stressed the need for appropriate and the Departments of Family and Community
community engagement. Medicine and Public Health Sciences at the University
As discussed in the first paper of this of Toronto, Toronto, Ontario, Canada. Jerome A.
series [1], the Human Genome Project For example, investigators Singh is at the Department of Public Health Sciences,
set a standard for addressing ESC introducing an intravaginal vaccine, and the Joint Centre for Bioethics at the University of
Toronto, Toronto, Ontario, Canada; the Centre for the
issues in large-scale science projects. conducting an observational study of AIDS Programme of Research in South Africa, Durban,
Subsequent large-scale projects—such severe cerebral malaria, or developing KwaZulu-Natal, South Africa; and the Howard College
as the International HapMap Project genetic strategies to control vectors School of Law, University of KwaZulu-Natal, Durban,
KwaZulu-Natal, South Africa. Abdallah S. Daar is at
[2] and National Nanotechnology will require adequate opportunities to the McLaughlin-Rotman Centre for Global Health
Initiative [3]—contain ESC programs. listen to and understand the concerns and the Department of Public Health Sciences and
and interests of the communities in Massey College at the University of Toronto, Toronto,
Certain ESC issues surface across Ontario, Canada. James V. Lavery is at the Centre for
all three projects: community which they work. Developing world Research on Inner City Health and Centre for Global
engagement, public engagement, experts stressed the need for early Health Research, the Keenan Research Centre in
the Li Ka Shing Knowledge Institute of St. Michael’s
benefit sharing, economic impacts community engagement that involves Hospital, the Department of Public Health Sciences
of technologies, cultural issues, and the negotiations and deliberations and Joint Centre for Bioethics at the University of
accessibility. necessary to make relationships Toronto, Toronto, Ontario, Canada. Peter A. Singer is
at the McLaughlin-Rotman Centre for Global Health
between the investigators and and the Department of Medicine at the University of
The Policy Forum allows health policy makers around community successful, respectful, Toronto, Toronto, Ontario, Canada.
the world to discuss challenges and opportunities for
and fair. “I think the most important * To whom correspondence should be addressed.
improving health care in their societies.
lesson,” said Gita Ramjee, “is to E-mail: kathryn.berndtson@utoronto.ca

PLoS Medicine | www.plosmedicine.org 1445 September 2007 | Volume 4 | Issue 9 | e268


investigators and developing world
experts expect that some of the
proposed studies will require well-
developed strategies for engaging
the public, gauging their views and
concerns, and incorporating their
insights into the implementation of
the intervention [7]. “You have to
somehow get the information through
the radio, newspapers and the TV,” said
Florence Wambugu. “But sometimes,
to get to the grassroots you have to
get to the community through schools
and churches. We have to get to the
people.” Respondents recognized that
public engagement is a two-way process.
Cultural acceptability. Some
of the Grand Challenges involve
the introduction of novel vaccine
delivery systems, such as intravaginal
or aerosolized vaccines, or the
introduction of nutritionally enhanced
foods that may differ (e.g., in color)
from the varieties from which they are
derived. In several cases, investigators
identified possible cultural barriers
to adopting these technologies.
Developing world experts noted that
researcher awareness of cultural issues
stemming from gender, religion,
historical context, sexual practices and
contraception use, and the existence
of a “culture of science” influence
whether people who need a technology
will use it. Calestous Juma argued
that “Every technology is viewed first
off in the context of how it might
destroy the culture.” An anonymous
participant linked this suspicion to
colonialism: “Technology in Africa
doi:10.1371/journal.pmed.0040268.g001 was introduced with colonization,
Figure 1. ESC Issues Identified during Group Discussions (Seattle, Washington, November 2005) and what the people of this continent
GC, Grand Challenge; IP, intellectual property were seeing is that colonial power will
bring in only those technologies which
engage the community right from program, it has to be owned by the were targeting natural resources…to
the beginning, making sure that their community.” sustain their own economies.” Gita
issues are addressed, making sure Public engagement. Public Ramjee recommended: “Rather than
that they have representatives at the engagement is a process that provides shooting down the cultural beliefs, try
highest level and at the lowest level, people with trustworthy information to integrate the new technology in an
and just effective communication on key policy issues, elicits their input, appropriate way that doesn’t impinge
and ongoing transparency between and integrates it into decision making on their cultural beliefs.”
the researchers and the community.” and social action. Several of the GCGH Gender. Developing world experts
Community engagement seeks to projects could require investigators identified gender as a critical ESC issue.
prevent exploitation [5,6] and involves to assess public perceptions of and They stressed the challenges of working
attention to community authorization, demand for new technologies. with vulnerable populations such as
permission, ownership, and legitimacy. Developing world experts stressed that commercial sex workers, girls, and
It also requires representativeness public engagement will be important adolescents, encouraging researchers
of community leadership, assent in the introduction of nutritionally to make efforts to empower their
among community members, and enhanced foods and genetic strategies subjects against abuse and exploitation
the community’s acceptance of new to control mosquito populations. Based through education, skills training,
research strategies. As Dara Amar on experience with the introduction and counseling. “We’re researchers,”
stated, “For sustainability of any of genetically modified foods, GCGH said Koleka Mlisana, who works with

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Box 1. Our Approach
We identified ESC issues in the GCGH initiative through a Health Organization regions: Africa, the Americas, the Eastern
sequential process of document analysis, group discussions with Mediterranean, South-East Asia, and the Western Pacific. They
investigators and program staff, and interviews with experts came from government, academia, industry, and civil society. We
from the developing world. We did not define ESC issues for asked participants to identify key ESC issues related to the GCGH
our respondents. Rather, we included in our analysis any issue technologies and then to comment on the ESC list generated by
that a respondent characterized as ethical, social, or cultural. GCGH investigators and program officers.
This method produced a broad and inclusive set of ESC issues Interviews maintained flexibility to pursue emergent issues,
appropriate for a large-scale project with diverse needs. allowing informants to share information on the basis of
In April and May 2005, we reviewed the proposals for the personal insights and/or issues raised by other informants. Each
GCGH projects to identify ESC issues. Some of the proposals key informant was provided in advance an overview of the GCGH
explicitly identified ESC issues and provided specific strategies program and a description of a number of relevant projects in
to address them. In our preliminary review, we identified implicit order to promote informed discussion. The interviews took place
ESC issues in the proposals. Each proposal was reviewed in in English, with Chinese interpreters in some instances. During
depth by a member of our team, and we developed a common the interview, participants were presented with the ESC issues
framework for ESC issues across the proposals. identified by the GCGH principal investigators and program
In November 2005, at the GCGH kick off meeting in Seattle, staff, as shown in Figure 1. They were asked if the list captured
Washington, we held group discussions to identify ESC issues the ESC issues in the GCGH initiative, if there were any issues
from the standpoint of the investigators and program staff. missing, any listed that should not be, or any that needed to be
We held 11 group discussions with a total of 168 investigators modified. Participants were also asked another set of questions
and program officers (see Table S1). We asked them about about the factors (e.g., scientific, political, financial) that facilitate
gaps in knowledge with regard to the key ESC issues affecting or impede development or adoption of health biotechnology
the ultimate adoption of the technologies arising from their in the developing world, and this analysis is reported elsewhere
projects. We used our knowledge of the proposals to ask [10]. We audiotaped, transcribed, and verified the interviews,
follow-up questions about specific issues in the groups. One and then performed a content analysis of the data. All named
member of our team took detailed notes of these sessions, and informants gave permission to be quoted. Anonymous
these data were analyzed using content analysis to identify participants chose not to be linked to their quotations but
key ESC issues by their relevance to particular Grand Challenge agreed to be listed among the study participants.
goals (Figure 1). We presented the listing of ESC issues to Developing world experts confirmed the ESC issues identified
the GCGH investigators and program officers at a member by GCGH investigators and program officers. However, they also
check, in a February 2006 activity report, in the June 2006 provided important modifications to the list shown in Figure 1:
ESC newsletter, and in a volume of ESC working papers at the
1. Almost all ESC issues were seen to cut across almost all GCGH
October 2006 annual meeting. The list was well received in all
goals, so the issues are no longer categorized by goal.
contexts.
Between May and September 2006, as part of a larger study 2. The issue “unintended promotion of unsafe sexual practices”
on the key forces influencing the development and adoption of was expanded to apply to other GCGH goals as “unintended
health biotechnologies in the developing world, we conducted consequences.”
semi-structured, face-to-face interviews with experts from the 3. Three other ESC issues were added: “gender,” “corruption,”
developing world in academia, government, civil society, and and “accessibility.”
the private sector. A few of these interviews were conducted 4. “Communication strategy” (i.e., the media strategy for the
in small groups of two or three or over the telephone. Of the GCGH projects) was removed as a separate ESC issue since this
99 interviewees we originally contacted based on input from was seen to be part of community and public engagement.
GCGH project teams and staff, the ESC team, literature searches,
and snowball sampling, 70 participated (see Table S2). While 5. “North–South collaboration” became “collaboration” to reflect
we received no response from a very small number of these the importance of South–South collaboration.
invitees, most of those who were not enrolled were agreeable 6. The ESC issue in Figure 1 entitled “Socio-economic and cost–
to being interviewed, but we had reached saturation in the benefit analysis of technologies” became the broader theme
data so did not proceed to interview them. Of the participants, of “affordability,” which also incorporates ethical notions of
21% were female. Participants represented the following World equity.

commercial sex workers in Durban, a lack of discourse around the taboo Quarraisha Abdool Karim. “HIV...
“but if you pick up an issue unrelated topic of sex, prevents women from acutely highlights gender differences—
to your research topic like domestic educating themselves about available greater burden of infection [in
violence what then is your obligation? reproductive health interventions. This women], and also the North–South
Can we just turn our backs?” discrimination, said informants, limits divide in that 90% of infections in
The key informants noted that opportunities for women to fill gaps women are really in developing
culturally engrained discrimination in the public health infrastructure, countries and primarily in Sub-Saharan
can leave women dependent on men, advocate for their needs, and make Africa.”
affecting their access to health care contributions in science and health. “I Post-trial obligations/benefit
and contraceptives. Limited access don’t think we’ve had strong enough sharing. Some GCGH investigators,
to schooling for girls, in addition to advocates for women’s issues,” said particularly those proposing clinical

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trials or observational research with in developing countries, in the requires adequate equipment and
a clinical focus, identified issues conduct of research and the uptake of facilities staffed by competent health
related to benefit sharing with the host technologies resulting from research care workers. Many cited poor
communities and individual research findings. The fourth paper in this series infrastructure, especially in rural areas,
participants. Developing world experts explores further the role of CSOs in as leading to power cuts that break
stated that exploitative histories of trials research [8]. cold chains, inadequate roads and
in developing countries complicate In particular, investigators transport that prevent patients from
investigator–subject relationships. recognized that some of the GCGH reaching clinics, or a lack of potable
“Very little of the good results of all projects might attract the attention water to administer pills. “In terms of
the research that has been done in of CSOs, and they were eager to adopting technology,” said Rosemary
sub-Saharan Africa ever gets back identify constructive partnerships. Wolson, “particularly in countries with
to the people who took part in the “My experience with sleeping sickness, large rural populations, the question of
studies,” said Godfrey Tangwa. Most malaria and others has been that access to healthcare altogether is one
participants in the GCGH group they [NGOs and CSOs] have been that’s very tricky.” Wolson described
discussions and key informant crucially important,” said Niresh challenges such as “transport for
interviews felt that investigators had Bhagwandin. Developing world experts people to get to hospital…refrigeration
a responsibility to ensure continued noted that CSOs can play a critical and cold chains…power cuts and
treatment for their subjects after a trial role in improving delivery of health roads.”
ends. “If you provide somebody with interventions with already established Regulatory issues. Both investigators
contraceptives, then you can not just networks and rural outreach efforts. and developing world experts stated
take that away when the trial is over,” However, according to one anonymous that weak or absent intellectual
said Gita Ramjee. “One needs to look participant, partnerships with NGOs property frameworks discourage
at sustainability of an intervention are only successful when the missions researchers from taking the risks that
that is provided, and you cannot start of the collaborating organizations lead to innovation. “If we want to join
something and take it away later.” are aligned: “For example, some of the kind of the development ladder
Collaboration. Most of the GCGH the religious groups, if you talk to we have to agree that the intellectual
projects involve collaborative them about HIV, they put such a property is something that we have to
research. Developing world experts negative view…that they do more respect,” said Yongyuth Yuthavong.
emphasized the importance of capacity harm than good.” Other limitations Regulatory structures must be balanced
strengthening and collaboration arise when the NGO is not an accurate between ensuring consumer safety and
between public and private sectors in representative of community needs. encouraging product development
the developing world, both to create Mpoko Bokanga commented on: “The and distribution. The absence of
sustainable science infrastructure NGO community…interposing itself functioning regulatory regimes in
and also to facilitate adoption of the between the research and the farmers, the developing world diminishes
resulting technologies. “International pretending that they know the needs of both consumer trust and regional
partnership is critical,” said M. K. Bhan, the farmers better than the researcher.” collaboration. As R. A. Mashelkar
“not only to help find solutions but Affordability. Although GCGH stated, “We [India] don’t have a
stimulate a culture in these emerging investigators identified “socio-economic world class FDA [Food and Drug
economies where, in future they could cost–benefit ratios” as an ESC issue, Administration]. We must build one
increasingly make a contribution to developing world experts expanded progressively.” However, key informants
that [biotechnology innovation].” this theme into the broader notion said that for the world’s most dire
The key informants emphasized of affordability. These experts saw health emergencies, the human right
the importance of balanced affordability as an ethical issue rooted to access essential medicines must
power dynamics in North–South in the notion of equity. In populations supersede concerns about intellectual
collaboration. Finally, they emphasized living on less then a dollar a day, said property. Yuthavong continued: “In
the importance of South–South participants, new technologies will not certain cases, for example cases of
collaboration in developing regionally reach those in need unless they are drugs for AIDS, we have to stand firm
relevant technologies and sustainable donated or made affordable through that we cannot really allow the price
economic benefits. N. K. Ganguly subsidies. to be the international price, we have
commented that developing countries “The cost really has to be affordable,” to somehow make it cheaper, because
should be both the producers and said Nares Damrongchai. “What if we there’s a lot of people who are affected,
the consumers of relevant health were successful and really could deliver and it’s a question of humanity.”
technologies: “These products need to the solution in terms of technology Collection, management, and
move from the developing countries solution, but the cost is too high storage of tissue samples. Many of the
if they are meant for developing and the people who really need the GCGH research projects require the
countries.” technology could not afford it…what collection, storage, and use of human
Role of civil society organizations. kind of mechanism should we put in tissue samples, and both investigators
Both investigators and developing place to make the technology or the and developing world experts
world informants highlighted the role drug or the vaccine cheap enough to identified obstacles inherent in those
of civil society and nongovernmental be affordable to people?” processes. During the group discussion
organizations (CSOs and NGOs) in Accessibility. Ensuring accessibility, sessions, investigators recognized that
working with communities, especially said developing world experts, guidance on the use of human tissues

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in research is still poorly developed, transmitted diseases due to perceived program, we are now exploring many
particularly for international immunity as a result of GCGH vaccines of the issues identified in greater depth
collaborative research projects. or other technologies) as an ESC through global case studies. 
Developing world experts noted that issue. Developing world experts saw
the lack of guidelines can hamper broader application for this theme. Supporting Information
research, while overly strict regulations Beyond the promotion of unsafe sex, Table S1. Composition of Group Discussions
can have the same effect. You Lin participants identified unintended (See Box 1 of the first paper in this series for
Qiao said: “[The] only difficulty is the consequences stemming from gaps details on the goals and grand challenges
[1])
regulatory, the government…They in knowledge regarding clinical trial
have very, very strict rules, so any... site selection, phase III clinical trial Found at doi:10.1371/journal.
pmed.0040268.st001 (75 KB DOC).
biological material…you have to get outcomes, the effects of genetically
it approved. Some experiments have modified organisms on biodiversity, Table S2. Developing World Key Informants
to cancel or delay. It is not good for local economy disruption, and drug Found at doi:10.1371/journal.
pmed.0040268.st002 (111 KB DOC).
our research and scientific exchange.” resistance. Kiran Mazumdar-Shaw
Developing world experts also spoke stated that unfamiliarity with the Acknowledgments
to the need to develop guidelines that variables of a region when conducting
The authors would like to acknowledge the
promote both scientific research and clinical trials can “make a mess of
individual study participants, without whom
safety, and stressed that investigators the whole program.” An anonymous this research would not have been possible.
must collaborate to enhance local participant, discussing genetically A special thanks also to all members of
research capacity to collect, manage, modified foods, stated: “Of course, I the ESC research team for their invaluable
and store tissue samples [9]. An want to be sure that people are safe in assistance with this project. Specifically,
anonymous participant said: “If it eating these crops and that they’re not Jocelyn Mackie and Andrew Taylor assisted
[management, storage, and collection exposed to future disease problems. with data collection during the group
of tissue samples] can be done in South In curing one issue, we don’t want to discussions in Seattle, and Dilzayn Panjwani
Africa and we have capacity to do it, create a public health disaster…and assisted with data collection and cleaning
for the developing world key informant
we would do it…it’s much better than we must take whatever safeguards we
interviews. The helpful comments by GCGH
having foreigners coming in.” can to prevent cross-pollination and
program staff are also kindly acknowledged.
Corruption and poor governance. pollution of a gene pool.” As R. A. Nalin Mehta and G. D. Ravindran assisted
Developing world experts cited Mashelkar stated, “In science, there with participant recruitment in India.
corruption as an obstacle to accessing are unintended consequences,” and Thank you also to Michael Keating for
new technologies. In the media, their ethical implications cannot be editorial assistance and to the professional
Musthaque Chowdury identified a underestimated. transcriptionists who worked on the project,
tendency to “play into the hands namely Kathy Kimmerly (Just Dicta), Diane
of some vested interests,” with Next Steps Granato (DigitScribe), and New Age Word
media coverage “not necessarily We recognize that this study reflects Processing.
Author contributions. CST, ASD, and PAS
based on facts.” The concentration only a small sample of highly educated
designed the study. KB, TD, CST, ERMC,
of government power and lack developing world informants. However,
and PAS analyzed the data. KB, TD, CST,
of transparency in the approval as leaders and experts in their fields, AB, ERMC, REGU, JAS, ASD, JVL, and PAS
and regulatory processes of new their understanding of these issues contributed to writing the paper. TD, CST,
technologies persuaded some brings experience and perspective AB, and PAS collected data. CST enrolled
developing world experts that public that adds tremendous value to our key informants.
health came second to political research. Additionally, we recognize Funding. The primary source of funding
expedience. Informants with the limitations of group discussions as a for this project is a grant from the Bill
experience in civil society said that methodology which may not permit all & Melinda Gates Foundation through
collaboration with the public sector participants to cover all relevant issues the Grand Challenges in Global Health
Initiative. Ross Upshur receives support
breaks down when government comprehensively.
from the University of Toronto through a
partners demand bribes. They also Notwithstanding the inherent
Canada Research Chair in Primary Care
stated that poor governance starves limitations of the methodology and Research, and from the Sunnybrook
public health initiatives of funds and composition of group discussions and Health Sciences Centre, Toronto, Canada.
staff. Commenting on the 2006 Kenyan interviews, this study fills a gap in the Jerome Singh receives support from the
administration, Judi Wakhungu said: literature as the first description of Centre for the AIDS Program of Research
“That’s the only time when we have a ESC issues in the GCGH initiative. in South Africa, which forms part of the
quorum in parliament, is when it is for This paper offers insights on thirteen Comprehensive International Program of
their own benefit. So their salaries are ethical, social, and cultural issues, Research on AIDS funded by the National
absolutely exorbitant now, and then raising the unique perspectives of Institute of Allergy and Infectious Disease
at the National Institutes of Health and
they’ve been in power since January developing world experts. The findings
the US Department of Health and Human
2003, and they have increased their may help guide other researchers
Services (grant #1 U19 AI51794). Abdallah
remuneration three times.” in global health focused on the Daar and Peter Singer are supported by the
Unintended consequences. GCGH developing world, allowing them to McLaughlin Centre for Molecular Medicine,
investigators identified unintended identify and address key potential University of Toronto. Peter Singer is also a
promotion of unsafe sexual practices ethical concerns with greater clarity Distinguished Investigator of the Canadian
(e.g., increased exposure to sexually and efficiency. In the GSGH ESC Institutes of Health Research. James Lavery

PLoS Medicine | www.plosmedicine.org 1449 September 2007 | Volume 4 | Issue 9 | e268


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