Global Health Partnerships & Ethics: Seminar Presentation Outline

Date: April 1, 2015

Presenters: Ryan Lukic and Avery Milne
Total time: 60 minutes
Our seminar will be in the style of a partnership engagement process for a trial for a new
vaccine against malaria in Burkina Faso, framed around the Partnership Assessment Toolkit.
We have formatted our outline so that questions we will pose to the class will be in red,
whereas our potential answers that we will provide (if need be) will be in blue.

Prior to class: Hand out page of resources to students including learning objectives, a summary
of the PAT and main ethical considerations. Also will hand out resource for each different group
for the activity, which summarizes key concerns and considerations regarding their point of view
for the research partnership (This is attached in the appendices). They will be expected to
integrate this point of view into their discussion of the PAT with their group members during the
role-play activity. We will also send an email to our classmates before class, specifying their
roles and providing extra links should they wish to prepare for the discussion ahead of time.

Introductions and Learning Objectives (2 minutes)

We will introduce ourselves and the theme for this week: Global Health Partnerships and Ethics.
We will then introduce our learning objectives:
1. Students will be able to identify the general purpose of research partnerships and their strengths
and concerns when applied to the case example.
We address this during the initial discussion period, and we expect this to emerge during the PAT
activity as well.

2. Students will be able to discuss the ethical concerns that need to be addressed to create equitable
partnerships
This will emerge during the discussion at the beginning, the discussion following the Ted Talk as
well as during the PAT exercise for example, the use of placebos and unsustainability of the
project are both ethical concerns.
3. Students will be able to apply elements of the Partnership Assessment Toolkit to a case study,
and assess a hypothetical partnership using the case study presented.
This will be achieved during the activity.
And we will briefly mention that our seminar also addresses Course Learning Objective # 4:
Understand the factors that contribute to equitable and sustainable health research partnerships

Our seminar mainly addresses the importance of equity in partnerships.

General Discussion about Partnerships in Global Health (7 minutes)

Ask the participants: what comes to mind when we are talking about partnerships in global
health and what are some of their benefits and risks? Probe that these ideas should emerge from
the readings this week.
Partnerships are strategies that aim at building and sharing expertise across collaborators
with the intention of ensuring that findings of research to directly impact health and
development. Usually there are participants from high and low-middle income countries. The
most important factor in deciding to partner is the exchange of knowledge. Partnerships can
improve capacities of both high resource participants and those in resource scarce areas though
application of each partners specific expertise (Afsana et al., 2009).

Benefits include: shared knowledge; capacity building for all partners, perhaps more for
Northern researchers it has been suggested, though there are more equitable South-South
relationships emerging; access to resources; impact to policy.

Risks: disparity in resource access between partners may lead to the partner with more
resources to have an inequitable influence on management; foreign donors might dictate research
priorities; possible exploitation as Southern researchers can be used for data collection but
other abilities are unused (Afsana et al., 2009; Bhutta et al, 2002).

Twitter Questions - Common themes discussed/ interesting or insightful comments

While discussing the above with the class, we will bring up different twitter comments
that we saw throughout the week that add to the discussion on partnerships and their benefits and
risks. We can use these twitter questions as prompts as well, to get students to elaborate their
points or comment on each others.
5 minutes Ted Talk by Boghuma Kabisen Titanji: Ethical riddles in HIV research (we will
watch the first 3 minutes)
Link: http://www.ted.com/talks/boghuma_kabisen_titanji_ethical_riddles_in_hiv_research?
language=en#t-212956

When watching the following video, keep this question in your mind: What is your opinion of
the mentioned study? Do you feel that there issues around equity and sustainability?
We thought while watching the video, there are a variety of ethical issues with the study.
First, the issue of informed consent as the research participant did not actually understand the
implications of the study or details such as the drugs she was taking. There are a variety of issues
surrounding the sustainability of the study as well: participants transportation during the study
was paid for, but after the study it became too expensive for many to transport to the healthcare
facility and access their ARVs. It appears the researchers up and left after gathering their data
without much communication to the community regarding the findings or consideration of the
participants well-being after the completion of the study. This mirrors the briefcase model
mentioned by Afsana et al., 2009.

Probing question: does anyone remember any of the main ethical principles that we discussed in
HSOC 308 ethics section with Dr. Guichon?
In 308, we mostly focused on ethics through a Canadian lens and discussed the U of Cs
rules, the Faculty of Medicines rules, and the Tri-Council Policy Statement 2: Ethical Conduct
for Research Involving Humans. The main guiding principles of this document were respect for
persons, concern for welfare, and justice (CIHR, 2010). It also looks at issues of consent and
conflict of interest in research, as well, it has a section focusing specifically on research with
Indigenous populations (CIHR, 2010). (Another example of ethical partnership guidelines
regarding Indigenous populations is the OCAP guidelines that the Cultural Competency seminar
touched on) (Schnarch, 2004). However, the TCPS2 is limited more to research done by one

group, and does not lay out any guidelines surrounding collaboration or partnerships. In terms of
global health ethics more broadly construed, one interesting example from the literature was by
Benetar et al., who identify several values they feel are most important to create a basis for
global health ethics: respect for all human life and universal ethical principles; human rights,
responsibilities and needs, equity, freedom, democracy, environmental ethics, and solidarity
(2003).

What are some important ethical dimensions to consider when planning a global health
partnership? Potential issues? (e.g. could be examples raised by Bhutta, 2002 or Afsana, 2009 in
the preamble, or past knowledge of ethics from 308, etc).
Bhutta raises a variety of ethical considerations and specific issues (2002). The first is
looking at community participation: that the communities themselves should be involved in the
research and the research should be linked to their own development, and there is a focus on
topics that are priority to the local country/community context. The next issue is prior
agreements and benefits of research: questions surrounding who will have access to the end
product of the research. For example, the CIOMS guidelines say, any product developed
through such research will be made reasonably available to the inhabitants of the host
community. Some argue that the CIOMS is too soft and that agreements need to be more
explicit, and that these should be agreed upon before embarking on any research to avoid
exploitation and unnecessary curiosity-driven research (Bhutta, 2002). Bhutta also explains it can
be difficult to make these assurances when testing something that will face a time lag before all
information can be gathered. Additionally, just because a product is available, it does not mean

that the necessary health infrastructure will be in place to effectively distribute and deliver it to
those in need (Bhutta, 2002).
Another major issue is surrounding the use of placebos in drug or vaccine trials,
especially when an alternative is present and is the standard of care in the region. Some argue
that the use of placebos is the most efficient and cost-effective way to get results, whereas others
raise the moral dimension of withholding treatment that may be effective from people who need
it (Bhutta, 2002). The main ethical consensus is that placebos should not be used as a comparison
to a new intervention if there is an existing current standard of care in place. However, there are
inconsistencies in how this is mandated in different national ethics guidelines: some completely
prohibit the use of placebos where an alternate established effective intervention exists, and some
say that scientific necessity may justify their use (WHO, 2013). One of the major historical
examples of this was HIV/AIDS drug trials in LMIC such as South Africa, Burkina Faso,
Malawi, etc (Lurie & Wolfe, 1997). Lurie & Wolfe looked at 16 different studies surrounding
HIV/AIDS treatment - and interestingly enough, the studies that took place in the United States
offered free ARVs to all participants, whereas those in the LMIC did not. One of the studies was
undertaken by a researcher at Harvard who planned to do an equivalency study comparing
zidovudine to ACTG 076, but when he applied for funding from the National Institutes of
Health, he received pressure from them to use placebos instead (Lurie & Wolfe, 1997). They also
highlight how there should not be a double standard: the sponsoring country should not accept
a standard of care that does not align with their standard of care at home (Lurie & Wolfe, 1997).
Case study: Vaccine study partnership (38 minutes)
We will split the class into four different stakeholder groups (1) Members of government
from LMIC, 2) Funders (Gates Foundation), 3) Scientists and drug company (Glaxo-Smith

Kline), 4) Community members of LMIC.) Students will also be encouraged to step outside their
assigned role for a moment to bring in perspectives from their specific concentrations if they feel
it can add a valuable added dimension to the conversation.
Different roles:
1. Members of government from LMIC - Morgan, Doug, Jagdeep, Emma
2. Funders (Gates Foundation) - Rachel, Kyla, Kevin, Danielle
3. Scientists and drug company (GlaxoSmithKline) - Aaron, Lindsey, Cheyanne
4. Community members of LMIC - Dana, Vanessa, Nicola

We will introduce the activity and get everyone to split into their different groups and read over
the handout we will provide that will give background information on unique considerations
their group may face when entering into this drug study partnership (see appendix). Then we will
all come together.

Our case study will be a hypothetical trial for a new vaccine against malaria. We will outline a
structure for the trial similar to one that happened in Kenya (Agnandji, 2011). There are many
different ethical considerations in the generation of the vaccine trial, or any global health
research, including use of placebo arms, the standard of care, availability of results, and
community participation in priority setting (Bhutta, 2002). However, we want the groups to
design the parameters of the partnership and project on their own through their discussions.

5 minutes - Class will separate into their different stakeholder groups and identify their groups
role, main objectives, ideal outcomes, and concerns for entering into the vaccine trial
partnership.
15 minutes - Class will come together to work through the first part of the PAT together, Phase I:
Inception. We will take turns answering the different questions and discuss the different
perspectives and interests of the stakeholder groups, as well as the expectations of the groups
both with regards to personal expectations and expectations of the other partners.

The discussion will focus on the following questions under the inception phase of the PAT:
Phase 1: Inception
1. What does each partner identify as their intentions and motivations for being involved in this
partnership?
2. Reflecting on the stated intentions and motivations for the partnership, what does each partner
see as the:
a. Best case scenario?
b. Worst case scenario?
3. What are the goals for the project upon which this partnership is based?
4. What resources will each partner provide?
5. How will results be disseminated? Who has intellectual ownership of the data sources, data,
and results?

After this discussion, we would encourage the participants to reflect on what all members had
said in terms of what the group had foreseen as an ideal partnership in this scenario. For the sake

of time, we will present a hypothetical set of outcomes from the study, given the four partners
involved.

3 minutes - Disseminate to the groups the hypothetical, completed research project including the
design and results, and their accessibility.
Scenario Synopsis - (We will use images in a powerpoint slide to make this more engaging)
The Bill and Melinda Gates Foundation, in partnership with GSK, funded the
trial of the malaria vaccine in a rural setting in Burkina Faso. Community members were
consulted about the research and agreed to allow the research to occur in their area.
Community members brought up concerns regarding the inclusion of only infants in the
original study design, and the limitation on the number of children that could be
enrolled. Due to the limitation of the grant, only 3000 children could be enrolled in the
study, and the original parameters were kept. Community members also expressed a
desire to be involved in the data collection process, and were therefore included in this
aspect of the study. Community members were also concerned with the accessibility of
the results to the community due to a lack of Internet access in rural areas. It was agreed
that representatives from the community would be provided with packages outlining the
results of the study to disseminate to the community - in addition to the open access
publishing of results. Government representatives were concerned that there would be no
sustainability plan in place if the vaccine was successful and that the cost of
administering such an intervention in the country would not be affordable.
The study sample was capped at 3000 children aged 6 to 18 months in a rural
setting in Burkina Faso. The study design was a double blind, randomized control trial.
The experimental arm was given the vaccine in three doses, spread equally over three
months, similar to trials elsewhere (Agnandji, 2011). The control arm was administered
three placebo injections at the same time. Both groups of participants were provided free
antimalarial drugs if a diagnosis was confirmed at a check up.
The experimental group showed a 30% decrease in the incidence of malaria at a
2-year follow-up, compared to the control arm, which had a relatively similar incidence
to the general population of the area. Deaths due to malaria were also decreased in the
experimental arm.
The scientists from GSK published the findings in an open access journal, in
accordance with the Bill and Melinda Gates Foundations policy on access. The
scientists recommended to the community group and government that parents are
encouraged to vaccinate their children using this new vaccine and that the vaccine be
made freely available at clinics in the country. An initial endowment from the Global
Fund and Bill and Melinda Gates Foundation was granted to implement a vaccination
campaign; funding was pledged by the government in a sustainable structure to maintain
the program for the next five years. However, the availability of health professionals to

administer the vaccine remained a concern for the government of Burkina Faso after the
research concluded.
10 minutes - Open discussion on the findings and how the study proceeded and whether or not
the partners felt that the way the project proceeded was equitable and what concerns they could
identify. Probing questions will be framed around the fourth phase of the PAT: Good Endings
and New Beginnings.
Probing Questions: Was the allocation of resources and responsibilities between partners
equitable? Does each party feel they would have been treated fairly, if this scenario were carried
out? What could be done to improve equity in this scenario (consider the ethical implications of
the research here as well)?
Community members may still have an issue utilizing the results if they are written with
a lot of scientific jargon. The government of Burkina Faso will likely be concerned with the
sustainability of the intervention - if there are not adequate resources to supply continued
vaccines, their participation in the study will have no long-term benefit. This mirrors the
briefcase model where researchers come in, collect data to fill their briefcase, and leave
(Afsana et al., 2009). One of the largest ethical issues at play in this study is the use of the
placebo arm. This is often controversial: it is cost-efficient and provides more definitive data for
the scientific researchers and drug company, GlaxoSmithKline, but also means that those
receiving the placebo were deprived from having access to the vaccine. Given that the most used
method of prevention for Malaria in Burkina Faso is the use of bednets (Bocoum et al., 2014),
the use of another vaccine for malaria to test against appears to not be feasible. However, the
Funders (Bill and Melinda Gates Foundation) and Scientists & Drug companies (GSK) would

likely be satisfied with the partnership, as they were able to display vaccine efficacy and do so at
a low cost.
Debrief on the case and use of the PAT as a way to assess partnerships (8 minutes)
Probing Question: Do you feel that the PAT was a good way to assess whether or not the
partnership described in the exercise was equitable or not? Why? Why not?
Ask the class what their overall views on the Partnership Assessment Toolkit and what
the strengths and weaknesses they see are.
We thought a strength of the PAT was the consultation with various LMICs, something
that is often missed in ethical partnership consultations (Afsana et al., 2009). Another strength
was that the PAT stresses that it should be considered a living document, and thereby
encourages ongoing discussion rather than just one initial negotiation. Another strength is that it
was created to be transferable outside of the Global Health realm as well, and can be applied to
other types of partnerships (Afsana et al., 2009). It also seemed comprehensive in that it
addressed multiple points of the partnership, from the inception to conclusion stages.

One potential drawback is the PAT assumes that all parties are invested in equity, though
there may be other motivations behind parties entering into partnerships. Drawbacks that arent
specific to the PAT include that it is time and resource intensive, and may be seen as merely extra
paperwork if it isnt implemented correctly.

Take home messages / Any last questions? (2 minutes)

We hope that you felt you addressed the learning objectives through the seminar, and can
now identify the general purpose of research partnerships and their strengths and concerns when

applied to the case example, the ethical concerns that need to be addressed to create equitable
partnerships, and feel you now have a working understanding of the PAT after applying it to the
case study.
There are a variety of ethical considerations to keep in mind when entering into a
research partnership, to avoid inequitable outcomes such as the briefcase model. The PAT is one
example of a tool that can be used to provide a guideline when entering a partnership, in an
attempt to ensure it is equitable and that partners can work together to ensure both their needs are
met through this collaboration.

Bibliography
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toolkit. Ottawa: Canadian Coalition for Global Health Research.
Agnandji, S. T., Lell, B., Soulanoudjingar, S. S., Fernandes, J. F., Abossolo, B. P.,
Conzelmann, C., ... & Odero, C. (2011). First results of phase 3 trial of RTS,
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rationale for mutual caring. International Affairs, 79(1), 107-138.
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Bocoum, F. Y., Belemsaga, D., Adjagba, A., Walker, D., Kouanda, S., & Tinto, H. (2014).
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world. Bulletin of the World Health Organization, 80(2), 114-120.
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World Health Organization. (2001). Legal status of traditional medicine and

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Appendix I - Handout for members of LMIC Government of Burkina Faso

You are a member of government in Burkina Faso,
a country with a high prevalence of malaria. This
costs your government a significant amount of
money per year. More than half of your countrys
financing comes from NGOs such as the Global
Fund and USAID: about $2 per capita for malaria
control (WHO, 2014). Members of your country
have expressed concern of potential harm
stemming from the vaccine, as well as questions of
sustainability of the vaccine after the trial period is
finished. You are also concerned on how the data
will be made available. Additionally, your
scientific advisors have cautioned that the use of
placebo in the study could be considered controversial. While you are hopeful that the vaccine
trials can benefit your population and lessen the burden of malaria, you are also hesitant of the
possibility of unintended harms. Currently, the main method of prevention for Malaria in
Burkina Faso is the use of bednets, which are mostly acquired for free through various programs
(Bocoum et al., 2014)

Appendix II - Handout for Funders (Gates Foundation)

You are part of the Bill and Melinda Gates
Foundation, who have identified malaria as a top
funding priority (Bill & Melinda Gates Foundation,
2015). To date, your foundation has pledged over $2
billion to fight malaria through several partners
including the Global Fund to fight AIDS, TB and
Malaria, Malaria No More, and Nothing But Nets.
Your organization mobilizes resources around three
main targets: an accelerated path to elimination; invest
in new interventions; and mobilize support resources.
In particular, funding for research on new vaccines to
block transmission of malaria has emerged under your organizations funding.
Your stated goal is a world free of malaria, and the founders of your organization have
committed to continued funding for this goal.
The main method of prevention for Malaria in Burkina Faso is the use of bednets, which are
mostly acquired for free through various programs (Bocoum et al., 2014). You have been advised
by some that going ahead with a placebo arm in the trial, as opposed to a non-malaria comparator
vaccine, which is a vaccine for another illness in lieu of the experimental vaccine, may not be
perceived well by the public. However GSK wants to ensure the efficacy of the vaccine in this
trial. You are the majority funder of the research, but want to ensure that the community gets the
experimental vaccine as you have already invested in its development. Your organization also is
invested in reaching out to communities to understand their needs and barriers and are
internationally recognized for this.

Appendix III - Handout for GlaxoSmithKline Scientists

Your organization has been at the forefront
of development on potential vaccines for
malaria. You receive funding from the
Gates Foundation, and have been able to
develop vaccines that have reached phase 3
clinical trials (Agnandji, 2011). You have
also announced that if your vaccines against
malaria are successful, you will see them at
cost, plus 5%. The profits will reportedly be
reinvested into research on other communicable diseases.
The vaccine you are testing in this situation has been shown to be effective in previous studies at
reducing the risk of contracting malaria, when three doses have been administered, over a three
month span. However, previous research has been against non-malaria comparator vaccines.
However, to ensure that the vaccine is the factor that is protective against malaria, not a
compound that is shared by both the vaccine and the comparator, you are invested in this study
being a randomized control trial with a placebo arm with a non-Malaria comparator vaccine. The
main method of prevention for Malaria in Burkina Faso is the use of bednets, which are mostly
acquired for free through various programs (Bocoum et al., 2014). Your scientists are also
working on a limited budget and only have the resources for a small number of children to
receive any type of vaccine (assume placebos are cheaper). You are also hoping to rely on the
expertise of local community members to aid in the recruitment of the study, however do not
have the resources to necessarily train local staff to administer and track the impact of the
vaccine.

Appendix IV - Handout for Community Members

You are a member of a rural community in
Burkina Faso, an area with a high prevalence of
malaria, especially in child populations (WHO,
2014). You have likely seen the effects of this
disease in your day-to-day life. You have heard
about the possibility of a malaria vaccine, and
while hopeful, you are also skeptical of the
large drug company, GlaxoSmithKline, which
is funding the study. You express that you feel
the findings of this study should be made
available to members of the community, and
the data collection should involve members of
the community as well, so it is a collaborative
effort. You also worry about the sustainability
http://stompoutmalaria.org/wp-content/up 1
of this project. If the vaccine turns out to be
efficacious and it was tested on members of
your community, you feel that there should be a long-term benefit and access to this vaccine as
taking part in the study feels like a significant risk. As more than 80% of the population in
Burkina Faso uses traditional medicine, which is a part of the local culture, this may influence
your perception of the study and the scientists carrying it out (WHO, 2001).
The main method of prevention for Malaria in Burkina Faso is the use of bednets, which are
mostly acquired for free through various programs, such as in the photo shown above (Bocoum
et al., 2014). However, most of your community feels as though that measure has not done
enough to reduce Malaria incidence, and other prevention methods would be welcome.