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Marais, D., Toohey, J., Edwards, D., & IJsselmuiden, C. (2013). Where there is no lawyer: Guidance for fairer contract negotiation in collaborative research partnerships. Geneva: Council on Health Research for Development.



This fair research contracting guidance document is the culmination of work COHRED has been engaged in with key partners over the past few years. The rationale for developing this guidance was to highlight the key issues for consideration when entering into formalised research partnerships, and to provide tools and resources for negotiating fairer research contracts. Although the issue of inequitable research partnerships is not new, previous work has not addressed the crucial role that equitable contracts and contract negotiations play in defining the nature of research collaborations, in building the foundations for successful long-term partnerships, and in enhancing the research systems of low- and middle-income countries (LMICs). Previous work often called on the high income country (HIC) partner to abide by principles of fair partnership. The essential difference in this guidance document is that it aims to shift the locus of control of research benefits to the LMIC partner. At the current time, there are no such efforts focused on “where there is no (intellectual property) lawyer”. There have been sporadic attempts at levelling the playing field through, for example, attempts by HIC institutions to transfer patents to LMICs. However, in general, LMIC institutions simply do not have the necessary contracting or legal expertise available to negotiate the technical terms of such arrangements. This guidance document aims to clarify the problems experienced in research relationships between high income and low income institutions (including south-south collaborations and public-private partnerships). In particular, we focus on issues that can be effectively addressed by developing and implementing guidance on research contracting in which the rights, responsibilities and requirements of all partners are recognised and addressed in an equitable and transparent manner.
Council on Health Research for Development
Where there is no lawyer:
Guidance for fairer contract
negotiation in collaborative
research partnerships
Where there is no lawyer:
Guidance for fairer contract negotiation
in collaborative research partnerships
What do we mean by fair research contracting? 1
Background to this guidance document 2
What are the key issues? 3
Using this guidance document 4
Where there is no lawyer:
Guidance for fairer contract negotiation
in collaborative research partnerships
Debbie Marais, Jacintha Toohey, Danny Edwards and Carel IJsselmuiden
COHRED is grateful to the Netherlands-African Partnership for Capacity Development and Clinical
Interventions against Poverty-Related Diseases (NACCAP) for nancial support towards the development
of this guidance document.
Special thanks to the Bellagio meeting participants and their respective institutions for their invaluable
contributions to this initiative before, during and after the Bellagio meeting. Thanks, too, to the Rockefeller
Foundation for providing nancial support towards the Bellagio meeting, at which important progress
was made towards this guidance document. (See
We would also like to acknowledge those who made valuable contributions at the start of this initiative
some years ago: Andrew Kennedy (former Senior Research Ocer: COHRED), David Sack (former Executive
Director: ICDDR,B), and Michael Behan (former legal counsel, ICDDR,B).
Key words: fair research contracting, negotiation, collaborative partnerships, intellectual property rights,
technology transfer, capacity building, data and sample ownership, indirect costs, legislative frameworks
Disclaimer: The content of this document is intended as guidance and should not be seen as a substitute for
relevant national or international legislation or policy directives. Readers are also advised that, wherever possible
and practical, they should seek expert legal advice when entering into legally binding contractual agreements.
For more information, go to See also
Copyright @ Council in Health Research for Development
Permission granted to reproduce for personal and educational use only. Commercial copying, hiring and lending
are prohibited.
Published June 2013
Geneva & Pietermaritzburg
ISBN: 978-92-9226-059-0
Fair Research Contracting
Recent snapshot surveys of research institutions in the African and Asian regions have revealed some
signicant gaps in the contracting and contract management capacity of low- and middle-income country
(LMIC) institutions in these regions. Many institutions had not previously considered research contracting
to be a legal issue and reported having no specialist legal expertise, with the result that contractual terms
and conditions were often poorly understood. Better contract negotiation expertise in LMIC institutions will
help improve the distribution of benets of collaborative research, such as overhead costs, data ownership,
institutional capacity in research management, technology transfer, and intellectual property rights. This
booklet is about optimising research institution building through better contracts and contracting between
institutions. Although this initiative started by focusing on collaborative research between LMIC institutions
and high income country (HIC) institutions, the guidance presented here is equally relevant in the growing eld
of south-south collaborative research.
In recent years, the importance of local research and innovation for the development of sustainable solutions to
address health problems in LMICs has increasingly been recognised. There has also been a sharp rise in research
partnerships between low- and middle-income institutions and high income institutions. These partnerships
provide a great deal of potential for building strong research infrastructure in lower income settings. However,
such sustainability is only achievable if research funding also allows for capacity building and sharing of other
benets from research partnerships which leave the low income partner in a stronger position.
The growing volume of research conducted in and with LMICs is welcome but also brings with it a number of new
challenges for research institutions and government departments in those countries. A greater volume of global
health research has likewise resulted in increased complexity of legal arrangements accompanying funding and
benet-sharing – but without a corresponding increase in legal and negotiating resources in LMIC institutions.
Calls for low income country researchers to share greater amounts of biomedical and public health data can only
be achieved through increased data management capacity, greater protection of local knowledge, and adapted
models of intellectual property rights. Perhaps not surprisingly, LMICs are also increasingly asserting their rights
to intellectual property and calling for fairer technology transfer arrangements.
To keep up with these developments, capacity building eorts should be fore-grounded in all collaborative
research partnerships. The Council on Health Research for Development (COHRED) is a key partner in increasing
the research competitiveness and innovation capabilities of LMICs in this highly competitive global research
environment. Strengthening LMIC institutions ability to negotiate fair research contracts with their higher
income partners is a critical part of this. Without fair research contracts, a major global opportunity is lost to
transfer the kind of research capacities and benets to LMIC institutions that would enable them to engage
in research and innovation on their own terms. For these reasons, improving research contracting capacity
in LMICs is not merely a matter of fairness. It is key to developing a thriving research and innovation sector in
LMICs, which will advance sustainable health, equity and development.
This fair research contracting guidance document is the culmination of work COHRED has been engaged in with
key partners over the past few years. The rationale for developing this guidance was to highlight the key issues for
consideration when entering into formalised research partnerships, and to provide tools and resources for negotiating
fairer research contracts. Although the issue of inequitable research partnerships is not new, previous work has not
addressed the crucial role that equitable contracts and contract negotiations play in dening the nature of research
collaborations, in building the foundations for successful long-term partnerships, and in enhancing the research
systems of LMICs. Previous work often called on the HIC partner to abide by principles of fair partnership. The essential
dierence in this guidance document is that it aims to shift the locus of control of research benets to the LMIC partner.
At the current time, there are no such eorts focused on “where there is no (intellectual property) lawyer. There have
been sporadic attempts at levelling the playing eld through, for example, attempts by HIC institutions to transfer
patents to LMICs. However, in general, LMIC institutions simply do not have the necessary contracting or legal expertise
available to negotiate the technical terms of such arrangements.
Existing eorts in this eld mostly direct their appeals towards high income research partners to engage in good
partnerships’. In contrast, our initiative is aimed at strengthening LMIC institutions to negotiate better partnerships
which support their research and innovation capabilities, reducing dependence on goodwill as the main mechanism
for achieving fair outcomes. By developing tools which place contracting knowledge and skills directly in the hands of
institutions and governments who currently have limited expertise in this area, the fair research contracting initiative
will be instrumental in helping to level the playing eld in global health research partnerships.
This guidance document aims to clarify the problems experienced in research relationships between high income
and low income institutions (including south-south collaborations and public-private partnerships). In particular, we
focus on issues that can be eectively addressed by developing and implementing guidance on research contracting
in which the rights, responsibilities and requirements of all partners are recognised and addressed in an equitable and
transparent manner.
Experience suggests that high income institutions that collaborate with or commission research from lower income
institutions often include implicit and explicit conditions which comparatively disadvantage those institutions. This is
not only related to institutional policies, but can be a consequence of the funding source for the collaborative research. It
applies similarly when a for-prot business engages in partnerships with research institutions, for example. Consequently,
international research partnerships are likely to have less impact on sustainable research institution building in LMICs than is
possible with good contracts. Post-research benet sharing, obtaining a fair share of any intellectual property rights, the need
for capacity building (not just of researchers, but also of institutional or governmental research managers) and technology
transfer are some of the key issues that LMIC governments and institutions need to be better equipped to negotiate.
Without adequate legal capacity, contract negotiations can lead to agreements which disadvantage the LMIC partner.
The disadvantages may allow for only a limited role for the LMIC partner in the academic aspects of the work – for
example, restricted rights in authorship of publications and ownership of intellectual property – and little technology
transfer or capacity building for the sustainable development of local research and innovation systems. In addition,
these partnerships can result in LMIC institutions being nancially disadvantaged by entering into contracts that
may not cover the true cost of the work, with the knock-on eects of drawing research activity away from national
priorities and the needs of decision makers in the country.
Results from a number of recent straw poll surveys, conducted by our partners in LMIC institutions, made it clear that
negotiating fair contracts which enable country ownership and stronger research and innovation systems remains a
central issue for these institutions. Many organisations in LMICs across a number of dierent regions lack access to
legal expertise, while their ability to negotiate mutually benecial research contracts is further hampered by a lack
of contract management ability, nancial know-how, managerial and administrative structures. The result is that the
research partnerships that these organisations engage in risk perpetuating a situation in which LMIC institutions
remain only junior or nominal partners in collaborative health research.
We have identied ve key issues that, when properly negotiated by both partners, can lead to substantially improved
outcomes for LMIC institutions. In the long run, an environment in which all partners are able to negotiate fair contracts will
enhance research and innovation for health and bring global health benets.
Intellectual property rights
Exclusive ownership of intellectual property rights (IPRs) are
frequently claimed by the high income funder or partner. An
appropriate balance of IPRs needs to be identied where these
rights are used to facilitate the development of local research
capacities, and research results are made available and accessible
in lower income settings.
Capacity building & technology transfer
Capacity building refers to strengthening the ability of
an institution to carry out its key functions, from research
management and nancial control to greater training and
development of scientic and professional sta, to ‘bricks and
mortar infrastructure, to being able to negotiate fairer research
contracts to ensure benet sharing that results in sustainable
research and innovation.
Compensation for indirect costs
Linked to capacity building, this refers to the overhead costs
that LMIC partners incur when the research project is housed
and conducted within that institution. Not providing adequate
funding for such costs within the research contract circumscribes
the potential for capacity building in the LMIC institution.
Ownership of data & samples
A common issue is the claiming of exclusive data or sample
ownership by research sponsors, even though the materials have
been collected by the LMIC institution from its own population.
Debates on the issue of data sharing and ownership are ongoing.
Research contracts in (legislative) context
The issue of lawyer or no lawyer assumes that there is a legal or institutional contracting framework to begin with. However, this is
not always the case. Similarly, contracts often describe ways of settling disputes, but it is not always easy to identify a neutral body
for dispute settlement. Most draft contracts have indemnication clauses but many are one-sided or, at best, potentially confusing
to an institution without adequate legal stang.
Using this guidance document
The issues identied above can promote or hinder equitable collaboration, depending on how
they are dealt with in the contractual agreement. They are the focus of this guidance document.
Each section begins with a brief description of the issue, highlighting why it is important. The
two objectives of each section are to equip readers with a deeper understanding of the issue
Understand) and to guide readers through some of the main points to consider when
contracting around each issue (
Consider). Where relevant, examples of clauses relating to
each issue are included. In each section, there are references on where to go to nd out more,
case studies, tips, and examples of best practice.
This guide has been designed to oer broad guidance in practical terms on some of the key
challenges faced in fair research contracting. It is not intended to assert rigid rules or procedures,
but rather to suggest considerations to think through as you engage in negotiations with research
partners. It is hoped that this guidance will add to existing good practice documents by translating
good partnership principles into pragmatic actions for fair research contracting.
This guidance document is just the beginning. As we move into the next phase of this
initiative, we plan to make this guidance more web-based and interactive. The guidance
presented here will continue to be improved and updated as we receive feedback from you,
the users. We invite you to submit comments on this fair research contracting guidance here, or by emailing Debbie Marais at
Strategies for Negotiation
A solid, equitable contract is the bedrock of a fair research partnership. Negotiating fair contracts is, however,
a process. Contracting guidance cannot replace building mutually respectful relationships based on good
communication and trust, which require a longer-term investment on the part of both partners. This goes
beyond having technical know-how to greater individual and institutional capacity for negotiation. A critical
part of negotiating fair research contracts is recognising that every partner has something to bring to the table
to negotiate with. Negotiation is often regarded as a mechanism that becomes necessary when a conict of
interest or dispute arises between parties which needs to be resolved. When we think about it in the context of
collaborative research, however, we prefer a wider view of negotiation as a dynamic, exible process that denes
the parameters of both the contract and a mutually benecial partnership.
Dierent types of partnership allow for dierent levels of negotiation. Where research occurs under a grant
award, for example, the conditions are usually prescriptive and leave less room for negotiation than a research
collaboration in which all parties are engaged in the work of the partnership and responsibilities are equally
shared. Understanding the parameters of the partnership – including knowing what your partner expects you to
contribute to and to get out of the partnership – is critical for knowing where the potential for negotiation lies.
This section highlights key points to consider when engaging in the negotiation process and provides a
broad overview of the main drivers of dierent types of research partnerships.
Although developing a research contract is largely a once-o
process, negotiation is a process that might begin with dening
the conditions of the contract, but continues throughout the life
of the research partnership. Respectful negotiation and ongoing
discussion are crucial to the building of trust and to ensuring that
the concerns, interests and needs of each party are addressed.
A number of principles of fair research partnerships have been
identied and are applied here to the fair negotiation of research
contracts (see KFPE (2012) and Costello & Zumla (2000)). This
guidance document is based on the understanding that it is
important to have a contract in place that outlines how key
components of the research partnership will be fairly handled;
negotiation is the tool for making this happen.
Negotiation is not about ensuring that every partner is the same;
it’s about engaging in frank and transparent discussion about how
each partner can expect to contribute to and benet from the
collaboration based on their capacities and resources. Striving for
equality does not mean that you are striving to be the same. Rather,
it means that you strive to share responsibilities and benets in a
way that supports all the institutions engaged in the partnership.
Equally, it is important to be clear about what is and what is not
negotiable. Some decisions are out of the hands of both partners.
Prior to entering the negotiation process, it is important to take
time to understand the motivations, expectations and the needs
of your partner. Negotiation also involves identifying the various
stakeholders who need to be involved in the contracting process
and clarifying the roles and responsibilities of each partner upfront.
KFPE’s principles of partnership
1. Set the agenda together
2. Interact with stakeholders
3. Clarify responsibilities
4. Account to beneciaries
5. Promote mutual learning
6. Enhance capacities
7. Share data and networks
8. Disseminate results
9. Pool prots and merits
10. Apply results
11. Secure outcomes
TIP: The importance of strong institutions
Given the abundant obstacles to equitable agenda
setting, the strength of the LMIC institution in a HIC-LMIC
partnership stands out as the primary factor aecting the
successful negotiation of research agendas that are both
mutually benecial and rooted in LMIC priorities. Currently,
many partnerships are premised on the assumption that all
those involved are well-intended, well-informed, culturally
sensitive people, and that these qualities are sucient
for equitable agenda setting. While good intentions and
respect facilitate smooth agenda-setting processes, they
cannot substitute for the advantages that strong LMIC
institutions enjoy in partnership negotiations. In the context
of research partnerships with high income partners, strong
institutions are characterised by a realistic awareness
of their own strengths and weaknesses; sound
administrative systems; and relatively stable nances.
Most importantly, they have a clear institutional
mandate and agenda.
, 2008, p. 682)
Guidelines for equitable partnership practice: The Partnership Assessment Tool
The Canadian Centre for Global Health Research (CCGHR) have developed a toolkit which is designed to provide additional support for
fair partnerships. The Partnership Assessment Tool (PAT) draws upon the previously developed principles and checklists for partnerships,
but contains a number of unique features…While contracts and other such agreements are essential formal arrangements between
partners, the PAT plays a dierent role; it provides guidelines for equitable practice within the partnership throughout its duration,
and provides a means through which to negotiate potential diculties or “road blocks”, thus protecting the partners and maximizing
the benets obtained from the collaboration…Barriers related to inequity and power are hard to break down. The CCGHR team argue
that it is essential that the persistence of inequitable LMIC-HIC research partnerships be acknowledged, and that LMIC partners in
particular have a tool to guide their negotiations within research collaborations. Open, frank discussion and honesty are encouraged.
Simply by engaging in these conversations, steps will be taken toward equity in partnerships.
(Adapted from Afsana, Habte, Hateld, Murphy & Neufeld, 2009).
(KFPE, 2012)
Identify your needs and motivations for engaging in the partnership and assess the contract
based on your expectations of the outcomes based on these motivations. What would need
to occur for you to consider the partnership a success?
Although it is often a reality that LMIC institutions – and indeed, many HIC institutions – are
under-resourced in some area of research capacity, such institutions will always have
something to oer that their (perhaps better resourced) partner stands to gain from the
partnership. Each partner will have unique knowledge and skills that can be brought to bear
on interactions within the partnership. Ownership of skills and capacities by all parties is critical.
Partners from high-income institutions will have skills and resources to contribute that should
not be overlooked in attempts to make everyone appear equal. But these research partners
also stand to gain an enormous amount from working with LMIC partners. These contributions
can be made explicit and used as leverage in the negotiation process. As holders of cultural
and locally relevant knowledge and as gatekeepers of participant communities, LMIC partners
can make invaluable contributions to research programmes in which they partner with HIC
institutions. The questions for you to answer are what is our strength?, and where do we want to
add to at this stage in our development?
Do not treat individual research projects as separate events, but keep the whole picture in
mind. Collectively, all collaborative research projects should add up to make your institution
better able to conduct, manage, evaluate, use and communicate research and engage in
contracts that enable you to do so.
Consider what contributions are within your institution’s capacity to commit to – in terms
of funding, time and resources. Where extra support (nance, training, infrastructure) will be
needed in order for you to make these contributions, discuss possibilities for building this
support into the contract. The implicit promise of research collaboration is that each partner
has the opportunity and agency to provide input to the partnership, in whatever form this
input might take. Given the inevitable constraints under which less resourced partners might
be operating, considerable eort should be spent early on to negotiate how the partnership
might address these gaps.
Select the right person / people from your team to negotiate. Negotiation is a set of
skills involving good human and relationship management skills, an ability to consider the
perspectives of all partners, and to present a particular position with the right balance of
authority and diplomacy. Consider building multidisciplinary teams with individuals who can
contribute diverse skills and experience to the contracting process.
Clarify the roles and responsibilities of each partner. It is also important to identify the
dierent role players and stakeholders who will need to be involved in the contracting
process. Who will manage what? Who do you need to liaise with at your own institution? What
established structures and procedures are in place to facilitate the contract negotiation process?
Dierent roles and responsibilities will come into play at dierent stages of the process.
Know your partner: Types
of research partnerships
Dierent types of partnerships
may raise dierent kinds of
contractual issues. The type
of institution and the sector
they are positioned in (for
example, private or public) will
inuence the extent to which
the issues covered in this
guidance document factor
into the contract negotiations.
A research partnership taking
place between a private and
a public organisation will
have dierent parameters
to one between two public
institutions. A private-public
partnership is increasingly
seen as an eective model
for achieving health gains,
but can raise particular
issues around research
ownership, benet sharing
and intellectual property. It is
important to be aware of the
context of the partnership
and the parameters or drivers
of each partners research
Consider cont…
Assess how compatible each partner institution is with the other. Although each partners’ interests might not be completely
congruent, they should at least be compatible in that they both share the goal of improving health (for example). Institutional
compatibility is particularly important where there might be high sta turnover. Ensuring that collaborative contracts and
agendas are negotiated by institution-wide teams, rather than only by senior management or individual researchers, can ensure
your institutions position in the partnership.
Consider the context/s in which the research is intended to occur. When negotiating the research agenda of the partnership,
for example, consider whether and how this addresses your national research priorities. Consider what terms may need to be
negotiated with respect to the participant communities that will be involved in the research, and your responsibilities towards
these communities.
Assess the risks and benets of each partners contribution and consider whether this is acceptable to all. Be aware that these do
not have to be the same for each partner: each will benet from the partnership in dierent ways.
Be aware of the power dierential between partners, where it exists, and the ways in which power might operate in the
partnership. Power can create a barrier to successful negotiation and compromise. Where time and energy is invested in obtaining
or maintaining power, less can be invested into the work of the partnership. A solidly negotiated research contract should reduce
the negative impact of power dierences between partners.
Dierent levels of collaboration are required to make a partnership work – not just between two people or two institutions,
but between people and departments within each institution. At dierent times in the research contracting process, for dierent
reasons, these levels of collaboration will become salient – and can impact on the negotiation process. While discussions may start
o between researchers at respective institutions, negotiations will likely move to a point where sta in the research oce, nance
department or technology transfer oce may need to become involved.
Discuss the dicult issues before entering into the partnership, and agree on at least a broad strategy for how they should be
handled. Clarifying expectations upfront can counter such diculties, as will an appreciation that partners will have both shared
and individual objectives and that this is okay. Consider a principle-based approach to negotiation: “Principled negotiation, which
focuses on dierences in interests, is an eective tool for much dispute resolution. It concentrates on creative problem solving and
fair accommodation of diverse interests (Bammer, 2008, p. 880). Focus on how dierent goals and diverse perspectives can be
integrated to achieve cooperative objectives and outcomes.
Know your partner
As the gure to the left illustrates, the
interaction point between two or more
partners in a partnership will be inuenced by
the dierent requirements of each organisation
in terms of the rationale or purpose of the
research, the intended contributions or input
by each partner, the expected outputs or
benets for each partner, and the policy and
legislative context in which each institution
operates. Note, too, that partnerships are often
between more than two organisations; there
are networks and multiple pathways through
which contributions are made.
Rationale / Purpose / Agenda
Contributions / Input
Policies & Legislation
‘You do not necessarily have to share the interests of another partner, but you do have to understand them, and you
do have to accept them (Director of a Southern university-based research institute)” (Migot-Adholla & Warner, 2005, p.
4). Stewardship, eciency and transparency are highly valued by funding agencies – all of which require a number of
capacities to be in place in their LMIC partners. Situated in the middle of these two positions are primary award recipients
– frequently institutions in high income countries – who are concerned with protecting their own interests (maximising
return on investment) and minimising their own risk. If not handled explicitly, this could result in a typically defensive or
restrictive position when negotiating contracts with LMIC partners. Get to know your partner and what you can expect from
them. As far as possible during the negotiation process, encourage all partners to reveal their strategic interests and assess
how far these are aligned with shared partnership objectives – or where modications might be necessary.
Afsana, K., Habte, D., Hateld, J., Murphy, J., & Neufeld, V. (2009). Partnership Assessment Toolkit. Canadian Coalition
for Global Health Research.
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Coalition for Global Health Research.
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321, 827-829
Fisher, R., & Ury, W. (1981). Getting to YES: Negotiating agreement without giving in. New York: Penguin Books.
KFPE (2012). A guide for transboundary research partnerships: 11 principles. Berne: KFPE.
Bagshaw, D., Lepp, M., & Zorn, C.R. (2007). International research collaboration: Building teams and managing conicts.
Conict Resolution Quarterly, 24, 433-446.
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Intellectual Property Rights
In order to understand the relevance of intellectual property (IP) in the context of fair research contracting, it is important to
be clear about what IP actually is. Firstly, IP is not a stand-alone issue nor is it only about patenting, licensing, trademarking,
copyright and commercial issues. IP is much broader and is applied in a variety of contexts, including science, technology,
trade/competition, research, innovation and development. More specically, IP is an idea which develops into what is
commonly referred to as an invention or innovation. Once an invention has been created, the inventor can choose to bring
into play various intellectual property rights (IPRs). IPRs allow the inventor to exercise certain controls over the invention, and
derive value from it. Four common elements arise from an IPR:
1) ownership of the IP;
2) access and use of the IP;
3) rights and responsibilities attached to the IP;
4) mechanisms available to manage and/or negotiate disputed issues around IPRs
Underlying these factors is the issue of which laws and/or policies are available to protect IPRs and whether these, if they
exist, provide adequate protection or enforceability of such IPRs.
Intellectual property can be a complex area to engage with. This can be particularly true in the context of negotiating fair
research contracts in research and innovation where LMIC institutions engage in partnerships with HIC institutions. However,
as detailed in the previous section, it is critical that the risks and benets for all parties in a research partnership are claried
upfront. It is thus important for all partners to have a satisfactory level of awareness about IP and IPRs in general, and about
the protections available to LMIC institutions in particular.
Exclusive ownership of IPRs has frequently been claimed by the high-income partners in research contracts. Similarly, IPRs,
when used inappropriately, may hinder the development of local research capacities through, for example, preventing
open access to research results. On this reading, one could assume that the exercise of IPRs is invariably bad for the LMIC
partner. However, as signicant research results begin to emerge from LMICs, the protection of IP created by LMICs becomes
more important.
Many LMIC institutions do not have the necessary IP protection mechanisms available to them, such as national legislation
and institutional policies to protect their IP rights in agreements they enter into with HIC institutions. Similarly, there may be
a lack of understanding about why certain IP rights should be sought, and what the longer term value of exercising control
over IP might be.
Some of the reasons that LMIC institutions may be at a disadvantage when negotiating IP ownership include:
1. Lack of awareness of what IP is;
2. High dependence on HICs for funding;
3. Lack of adequate support structures, such as technology transfer and research oces;
4. Lack of capacity regarding the risks/benets involved in negotiating IP in research partnerships;
5. Lack of awareness of international standards, national frameworks, and/or institutional IP policies.
As a result, LMIC institutions may be unable to safeguard their interests in IP when engaging in research partnerships. To this
end, research collaborations tend to weigh heavily in favour of HIC institutions, while LMIC institutions are disadvantaged
due to inequitable contract negotiations. It is for this reason that LMIC institutions need to be aware and able to ensure that
their IP interests are protected and they do not contract on any terms. In this section, we clarify the notion of intellectual
property and provide guidance on the various factors to consider when negotiating IP in research contracts, as well
as the legal protections available for research partners.
Protection and enforcement of IP can vary from country to country. In order to
encourage member countries to establish a consistent level of IP protection, the
World Trade Organization (WTO) established the Trade Related Aspects of Intellectual
Property Rights (TRIPS) agreement. The TRIPS agreement sets out a uniform set of
general principles applicable to IP protection and enforcement, which member
states commit to upon joining the WTO. The TRIPS agreement covers principles
such as the trading system, international property agreements, intellectual property
rights, enforceability of these rights, and settling of disputes relating to intellectual
property. Those member states who have agreed to the TRIPS agreement commit
to incorporating these principles into their national legislative frameworks and
to establishing policies that enforce this model of IP protection. It is useful to note
that the TRIPs agreement allows for a degree of exibility in the application of its
requirements, in order for countries to implement IPRs which suit their context.
Further, there are exemptions from the requirements of TRIPs for specic time periods
for certain countries, such as the Least Developed Countries (LDCs). An extension to
an existing exemption was recently agreed at the WTO TRIPS Council, which means
LDC members of the WTO do not need to apply TRIPS in their national IP legislation
for an additional 8 years from 2013. The text of the decision recognises the need for
“exibility to create a sound and viable technological base” for such countries.
Intellectual property takes a number of forms. It could be an invention, a literary work,
some music, a design, a shape, a trade name, trademark or a trade secret. Protection of
IP is achieved through the application for and exercise of intellectual property rights.
IPRs can be divided into the following main categories: copyrights, patent rights,
trademark rights, trade secrets, geographical indications, protection of undisclosed
information and anti-competitive practices in contractual licences. The consequence
of having an IP right is that ownership is conferred to an individual or institution to
own and use exclusively, save for certain exceptions.
Inventions in the form of products or information are protected by a patent right. A
patent right provides for exclusive ownership over an invention, which means that
no other person or organisation may make, sell, distribute, copy or use a patented
intellectual property without the owners permission for a period of 20 years.
However, an owner of a patent may assign, sell, share or transfer the right to another
via licensing agreements. Patent rights have certain limitations, however, as they
are only enforceable in the country where the patent right is registered. In other
words, if the patent is not registered in a particular country, the invention may be
commercially exploited without infringing on the owners exclusive right. Copyright
of intellectual property covers a broad spectrum including literary works, reference
works, newspapers, publications, computer programmes, databases, lms, musical
compositions and choreography, artistic works, architectural works, advertisements,
maps and technical drawings, research ndings, and so on. Copyright protection
gives the owner the exclusive rights of use and prohibits the reproduction, recording
and translation of the works without the owner’s permission.
Determining issues relating to IP such as ownership, use, rights, and responsibilities,
enforceability and management, depends on what has been negotiated at the
outset between partners entering into a research collaboration, and formalised, in
most instances, into a written contractual agreement. Data ownership is frequently
considered as an IP right, although in some instances, it is not. For further guidance
we refer readers to the section on ownership and sharing of data and samples in this
guidance document.
TIP: Harnessing IP
In trying to move the focus in
discussions away from patents alone,
participants at the FRC Bellagio meeting
highlighted that IP is about more than
just patents and is not always (only)
about commercial benet. For example,
the importance of clauses about data
ownership or sharing and publications
should be considered in all guidance. IP
can also be useful as a tool for protecting
the interests of research participants and
low- and middle-income institutions
and countries. (COHRED, 2012)
Recommendations for funders
In line with the development agenda
that aims to capacitate LMIC institutions
to engage in research and innovation,
HIC partners should aim to be exible in
IP negotiations where there is a need to
discuss further the risks and benets of
exclusive or jointly owned IP rights. While
the risk of losing exclusively owned IP is an
issue, it would be benecial for all partners
if there was a move away from exclusively
owned IP toward increasing transfer of
technology to least developed countries.
It is critical in balancing interests to
approach IP management as ultimately
a mechanism to protect the interests of
both HIC and LMIC institutions in research
innovation and public benet.
Best practice example:
The Danforth Centre
The Donald Danforth Plant Science
Center (Danforth Center) is a not-for-
prot research institute with a global
vision to improve the human condition
through plant science. Their best practice
model is based on respect for protection
and sharing of IP (intellectual property)
rights, interinstitutional and international
collaborations and scientic partnerships.
Their philosophy, entrenched in their
overall mission, is not to infringe or misuse
the IP rights or materials entrusted to
them. This is evidenced in the way they
draft agreements.
Establishing a basis of trust and mutual benet in research partnerships is fundamental to
negotiating fair research contracts. It is crucial for LMIC institutions to consider and discuss
from the outset the various expectations that would arise from the research collaboration,
which includes discussion on how IPRs should be handled. The following considerations
are key for LMIC institutions in discussions with high income partners – whether in high
income countries or in south-south collaborations or public-private partnerships – when
negotiating IP issues in fair research contracts:
Describing the nature and purpose of the research and identifying potential IP that may
result is an important part of establishing legitimate expectations. Research partners
could consider:
a) What you both bring to the table (background);
b) How the work of the research partnership will build on this;
c) What comes out of the partnership (foreground); and
d) Any new IP that is generated as a result of the partnership (sideground).
Discuss and build these considerations into the contract, including who will have rights
in respect to these IP. This may go as far as detailing the potential IP results of research
and breaking these down into individual components. This will ensure that, right from
the start, you have identied the specic IP issues that may arise from your collaboration
and you can properly apportion and manage any IP rights and benets arising from the
exploitation of those resources.
High income institutions are often in a far greater bargaining position, with greater legal
capacity, and thus it may seem as though their interests outweigh the interests of low
or middle income institutions. It is thus critical that institutions entering into research
partnerships clarify issues around IPRs and benet sharing upfront in a contract, to
minimise conict of interests later on. To resolve such conict, some partners set out in
their policy documents dispute resolution provisions. It is useful, then, to negotiate upfront
good practice measures around each partners rights and responsibilities and obligations,
and to outline, in the case of conicts of interest later on, what procedures have been
agreed on for dispute resolution.
Check what national legislation exists in your country with respect to IP. Where your
institution or county lacks a national legislative framework and /or institutional policy
relating to IP protection and enforcement, you may consider looking to existing
international norms and standards that relate to contractual terms and conditions.
Although this will not be legally binding where national legislation does not subscribe to
these conventions, it is nonetheless a useful starting point when thinking through clauses
in contracts with research partners, particularly those from another country. Refer, for
example, to WTO’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement,
other eective national legislative frameworks from developing countries (e.g. South
Africas Intellectual Property Rights from Publicly Financed R&D Act (2008)), and related
policies. Other international sources include the following treaties: the Paris Convention
for the Protection of Industrial Property, the Berne Convention for the Protection of Literary
and Artistic Works, the WIPO Copyright Treaty (WCT), the Patent Cooperation Treaty (PCT).
Rights of ownership of IP
A typical clause on ownership of
IP rights species that the IP is
owned by the research partner/s,
either exclusively or jointly.
A condentiality clause describes
in detail the information that
must be kept condential and by
Rights and obligations
A rights and obligations clause
describes the contractual duties
that must be adhered to and
respected by each party to the
Conicts of interest/
Dispute resolution
A dispute settlement clause
describes the process that will
be followed in the event that a
conict arises in the contract.
The World Intellectual Property
Organization (WIPO) oers a
fully established service for such
procedures for mediation and
Consider cont…
Clarify upfront with partners who will own the IP. Discussions around who will own the IP, exclusively and jointly owned, are at
the heart of this section. Establish how important ownership of IP is to the respective partners. Generally, a right of ownership
rests with the institution that is hosting the research. Researchers, students, and sta employed by the LMIC institution who
create IP in the course and scope of their work do so under the express or implied agreement that ownership of the IP belongs
to that institution. This is normally established by way of a Participation Agreement or found as a clause in a general Conditions
of Service contract. Obtaining, holding and exercising such rights should promote a mutually benecial outcome, and the
equitable sharing of benets. Joint ownership of IP rights is one other method of ensuring that a research partner can retain a
form of control over their IP, but this method has limitations and may not always be an appropriate benet-sharing mechanism.
For example, joint ownership does not necessarily create an entitlement to receive benets from the other owner’s exploitation
of the common IP rights. In some jurisdictions, joint ownership of patent rights does not require one owner to share economic
benets derived from ownership with the other owner.
In most instances, the term disclosure, in research contracts, refers to the disclosure of IP. Establish when and how
partners will disclose (i.e. declare and describe to another party) any IP arising from the partnership. Consider establishing
condentiality arrangements pertaining to the IP. Privacy and condentiality issues may also apply where research activities
involve the creation and publication of papers or information which has copyright implications.
Identify each partners rights with regard to the IP and their responsibilities regarding fullment of the IP. If one of the
partners to the research contract fails to full their responsibilities regarding agreed upon IPRs, then this is known as a
breach of duty or infringement. Consequences of this breach are usually included in the contract.
Management of IP arising from the research partnership might include all the components described in this section, or it
may pertain to a specic aspect of IP, such as licensing. For detailed guidance on IP management, readers are referred to the
Intellectual Property Handbook (Krattiger, Mahoney & Nelsen, 2009), an online resource providing comprehensive guidance
regarding all aspects of IP management.
Consider who will apply for and pay for the acquisition of IP rights. Often, IP (e.g. patenting) has signicant cost implications,
which may involve signicant risks for the primary research sponsor in particular. When including benet sharing and IPR
clauses, consider the cost implications if there is likely to be patenting and licensing potential of products and technologies
arising from the partnership.
Identify, where relevant, what your obligations are to make your research ndings available for public benet. It is widely
agreed that public funds should lead to public goods. However, this is depending on the jurisdiction you and your partners
are operating in.
A number of resources on IP are available at:
CREST Expert Group on IPR (2006). CREST cross-border collaboration decision guide.
Krattiger, A., Mahoney, R.T., & Nelsen, L., et al. (Eds.) (2009). Intellectual property management in health and agricultural
innovation: A handbook of best practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at
Lambert Toolkit for university-industry collaboration: (in high income settings)
WIPO (n.d) A brochure on intellectual property rights for universities and R&D institutions in African countries. Geneva:
WIPO (2004). Intellectual property handbook: Policy, law and use. Geneva: WIPO.
Blakeney, M., & Mengistie, G. (2011). Intellectual property and economic development in Sub-Saharan Africa. The Journal of
World Intellectual Property, 14, 238–264.
Correa, C. (2000). Intellectual property rights, the WTO and developing countries. London: Zed Books/Third World Network.
Fink, C. (2009). Enforcing intellectual property rights: An economic perspective. In ICTSD (2009). The global debate on the
enforcement of intellectual property rights and developing countries, Programme on IPRs and Sustainable Development,
Issue Paper No. 22, Geneva: International Centre for Trade and Sustainable Development.
ICTSD (2009). The global debate on the enforcement of intellectual property rights and developing countries, Programme
on IPRs and Sustainable Development, Issue Paper No. 22, Geneva: International Centre for Trade and Sustainable
Merso, F. (2013). IP trends in African LDCs and the LDC TTIPS transition extension. Policy Brief No 16.Geneva: International
Centre for Trade and Sustainable Development.
Mota, S.A. (2005). TRIPS: Ten years of disputes at the WTO. Computer Law Review & Technology Journal, 2004-2005, 455-478.
Ramsden, P. (2011). A guide to intellectual property law. Cape Town: Juta & Co.
Simons, J.J. (1999). Cooperation and coercion: The protection of intellectual property in developing countries. Bond Law
Review, 11, Article 5.
The Online IP Healthcheck is available at www.Ipo.Gov.Uk/Iphealthcheck.
University of Kwazulu-Natal (2010). Intellectual property policy.
WIPO (2013). Draft intellectual property guidelines for access to genetic resources and equitable sharing of the benets arising
from their utilization: Consultation draft. Geneva: WIPO.
WIPO (n.d.). Guidelines on developing intellectual property policy for universities and R&D organizations. Geneva: WIPO.
Benet sharing
The term benet sharing is often understood in the context of sharing genetic resources and intellectual property (under international
standards such as the Convention on Biological Diversity) with developing countries and regions. The concept is also frequently used
to refer to the ethical obligation to ensure that reasonable benets are received by LMIC participants and their communities as a
result of their participation in clinical trials and research studies (International Ethical Guidelines for Biomedical Research Involving
Human Subjects). However, we highlight here that benet sharing in the context of international collaborative research can also refer
to the sharing of research benets between research partners – particularly with LMIC institutions. Notwithstanding the standard IP
issues that can be negotiated as a research benet, research partners can discuss alternatives that extend beyond the traditionally
accepted approaches to benet sharing. Benet sharing is not limited to those research benets of monetary value but can also be
of non-monetary value (such as sharing of research results; publications; opportunities to visit partner sites; conference attendance;
collaboration for further grant opportunities; transfer of equipment or materials; or strengthening capacities for technology transfer).
Often research partners opt for benet sharing in the form of capacity building in various forms, which might be made explicit in the
research contract, or may occur in implicit ways throughout the duration of the research partnership.
Ownership & Sharing of
Data and Samples
Within collaborative research, there is increasingly the expectation that the data and samples (tissue
samples, biospecimens, genetic material and other biological samples) generated within the partnership
will be shared, both among partners and with other interested parties outside the partnership. A common
issue in collaborative research is the claiming of exclusive data or sample ownership by funders or high
income partners, even though the data have been collected by the low- or middle-income institution
and the biological materials have been collected from participants in LMIC populations. The notion of
open access to genetic and other biological samples has become commonplace in genomics research,
but there are also growing calls for open access to public health data. It is generally accepted that the
products (data and samples) from publicly-funded research should be made freely available to encourage
further research and maximise the benets of such research to society. The increasingly global, cross-
border nature of research will have a signicant impact on issues of ownership, management, sharing and
access to research data. In particular, it highlights issues of equity and fairness with respect to the capacity
of LMIC researchers to collect, analyse, manage and store such data in ways which also maximise the
benets to themselves, their institutions and their study populations.
In addition to ensuring that the interests of LMIC researchers are protected, the sharing of data and
samples adds another dimension for consideration: protecting the interests of research participants. The
notion of ownership – and sharing of benets derived from the research – extends beyond the rights
of those who have collected the data, to the perceived, symbolic ownership of data and samples of
participant communities. Negotiating conditions around data release and access, then, is ultimately a risk-
benet analysis. Good practices are emerging: there is a multitude of guidance from the eld of genomics
research and a growing body of literature regarding sharing of datasets. The guidance presented in this
section pertains particularly to data ownership and sharing, although many of the principles apply
equally to sharing of biospecimens and samples.
There are undoubtedly good reasons to share data, including facilitating the
discovery of new knowledge, more eective use of existing data, public health
benets, increased visibility and enhanced opportunities for partnership. But
there are a number of issues to consider when entering into research partnerships
where the expectation is that the data will ultimately be made available as open
access. Some of the concerns include misinterpretation and misuse, fear of
marginalisation from loss of recognition and control over the data, governance
challenges relating to sharing costs and benets, risk of identity disclosure and
potential stigmatisation of study participants, and legislative vacuums in many
LMICS with respect to policies and procedures for data sharing and protection
of privacy. Data or sample sharing is frequently included under the umbrella
term of intellectual property, and is usually associated with some form of benet
sharing. We refer readers to the relevant sections in this document for further
guidance on intellectual property rights.
When contracting around the sharing of research data, researchers need to
consider the legislative, ethical and practical implications of how they negotiate
ownership, control, access, storage, management (maintenance) and use.
Ownership refers to who owns the rights in relation to the relevant data; control
refers to any restrictions or conditions that apply to use of the data; storage,
management and maintenance of the data refers to the practical systems and
capacities required to archive and manage the data; access and use refers to the
terms and conditions under which access to and use of the data is permitted.
Determining who has rights of ownership (and can therefore confer on others
rights of access and use) can be complex. “Whether these parties can be said
to own or control the data will depend upon various factors including the
circumstances in which the data has been generated, obligations relating to
maintenance and management of the data and the operation of laws (such as
copyright and condentiality) which confer legally enforceable rights exercisable
in respect of the data (Fitzgerald & Pappalardo, 2007, p. 28). These issues need to
be claried upfront in the research contract.
Tip: Levels of Access
Ownership and access rights are often
confused. Giving access to one’s data does
not mean giving the data away. The owner
may retain ownership rights over the data
to varying degrees, depending on the
level of access granted. Levels of access
include open access, licensed access,
restricted licensed access and managed
closed access. The level of access granted
will also determine how much input is
required of the data owner in terms of
management and maintenance.
Best practice: INDEPTH Data Sharing
and Access
The INDEPTH Network is a network of health
and demographic surveillance systems in
Africa, Asia and Oceania. To facilitate access
to the longitudinal data generated by its 19
member centres, INDEPTH has established
iSHARE to achieve its goal of making its data
widely and freely available to all researchers
and decision-makers. The INDEPTH Data
Access and Sharing Policy (iDASP) can be
found here: http://www.indepth-network.
Guidance from Funders
A landscape survey of the twenty funding
organisations making up the Joint
Funders’ Initiative revealed that about half
have dedicated policies on data sharing
and management – while the other half
lack clear guidance on data sharing for
grantees. Data sharing requirements
– such as time frames for data release –
seem to vary substantially from funder to
funder. Funders’ guidance typically covers
ve broad areas: 1. Data management
plans; 2. Time frames; 3. Use of public
databases and central repositories; 4.
Ethics and condentiality requirements;
and 5. Compliance.
Case Study: MalariaGEN’s policy on building capacity for data sharing
The Malaria Genomic Epidemiology Network (MalariaGEN) is a partnership of
malaria researchers in over 20 countries supported by the Grand Challenges in
Global Health Initiative. In MalariaGEN, a number of attempts have been made
to address the more exacting challenges (of data sharing), in addition to material
transfer agreements and research contracts. First, the network developed a
capacity building scheme in which young researchers from all partner sites were
trained in the analysis of genomic data. Second, the network recognised the need
to enable all contributing researchers to analyse their own data before it was made
publicly available and incorporated this into the MalariaGEN Data Release Policy
( Third, the network sought
to develop software that allows the remote analysis of genomic data – meaning
that Malaria-GEN researchers anywhere in the world could analyse data without
the need to invest in expensive in-house infrastructure for data analysis and
storage. (De Vries et al., 2011).
rameworks: Policies & legislation
Consider developing an institutional data sharing and access policy, if you do not already
have one. The policy can help guide how you negotiate with partners on data sharing
issues. Institutional data sharing policies should cover:
• The kinds of data to which the policy applies (Note: not all data generated in research
projects will be suitable for reuse due to, for example, ethical or legal restrictions).
A research contract can specify which data, materials etc will be shared across the
partnership, and which will remain exclusively in the domain of individual researchers
or institutions (clauses about the ownership of research data and materials that will
be retained at the end of the research project, with terms about if and how this data
will be made available).
• Conditionsunderwhichdatawillbeshared.
• Rolesandresponsibilityofresearchersanddatamanagers.
• Responsibilities of users(e.g.protecting condentiality, citationof source ofdata,
reasonably involving producers of data in research outputs such as publications).
• Timeframeforsharing.Alimited,denedperiodofexclusiveusefortheoriginators
of the data is considered reasonable.
• Planforstorageandmanagementofdata(seedata management plan).
• Consider the culture of your institution and incorporate current practices and
academic conventions around data sharing and use. Data is often considered a
researcher’s intellectual capital, and appropriate career development and other
incentives should be considered to encourage data sharing. Include how credit /
acknowledgement will be distributed among partners and incentives for researchers
to share data.
• Whendraftingpolicyornegotiatingdatasharingclauses,consideralsothelegislative
frameworks that govern how data can be managed and shared in accordance with
national laws (e.g. privacy laws, intellectual property or patent laws, copyright law,
protection / freedom of information laws, public records legislation). Also be aware
whether there is any discordance between legal and ethical guidance.
In a data/information management plan, outline practical procedures and structures
required for implementing the policy and consider these requirements when negotiating
data sharing arrangements with research partners. The data management plan is usually
required along with project proposal submissions. A data management plan might include:
• Howdataistobecollected,analysedandstored.
• Databaseorrepositoryinfrastructure.
• Qualityassurancemeasures.
• Howdatawillbemanagedanddisseminated.
• Datasecuritymeasures.
• Howandwhenaccess/futureusewillbemadepossible.
• Projected costs involved in i) preparing data for storage (e.g. cleaning and
anonymising the data) and ii) maintenance and ongoing management (some
institutions charge access fees to cover the operational and administrative costs of
maintenance, for example, but be aware that this may not be possible in cases of
publicly-funded research).
Many funders have data sharing policies in place which will need to be adhered to once
you have signed a contract – review these before entering into partnership, inquire about
exibility around terms, and negotiate according to your institutions needs and capacities.
A hyperlinked index to various data sharing policies is included in a table at the end of this
In addition to the partnership
contract, there are a number
of contractual agreements
pertaining to ownership and
sharing of data and samples.
Each of these agreements can be
stand-alone, or relevant clauses
pertaining to conditions of use,
condentiality protections or
commercial arrangements can
be included in the overarching
research contract.
Material Transfer Agreements
A contract which governs the
transfer of tangible research
materials between parties
involved in a research project,
when the recipient intends
using these materials for their
own research purposes. It
usually species the rights and
obligations of the provider
and the recipient with respect
to the transferred materials,
including which materials
will be transferred, the work
to be done on the materials,
the conditions of storage and
management. There is usually an
agreement about collaborative
opportunities for the provider
in the analysis (e.g. authorship
on publications), and MTAs
are thus an important means
of protecting the interests of
researchers who collect and
supply the data / materials.
Condentiality Agreements
A contract which covers the
transfer of condential material
or information between parties
for certain purposes, but which
restricts the disclosure of such
information to third parties. It
will identify the information to
be treated as condential, the
rights of the provider of the
condential information, the
obligations of the parties with
whom the information is shared,
and the consequences of failure
to comply.
CLAUSES (Continued)
Access Agreements
A contract which outlines the
terms under which access will
be granted to data, when a
decision has been made to
share such data with one or
more party. It will specify who
has permission to access the
data and the purposes for which
the data may be used. There
will also usually be conditions
that prevent the transfer of
access rights to third parties.
Intellectual property clauses
are typically included in such
agreements – either to refer
to the holders of intellectual
property rights or to declare
that the data providers retain no
rights to intellectual property.
Licensing Agreements
A contract in which the provider
of data grants a license to
another party to use the data
for certain purposes, while the
provider retains ownership
of the data. The contract will
identify the data / materials that
are covered by the agreement,
the work that is permitted
on the materials, and any
restrictions on the person to
whom the license has been
granted. It will also usually
specify conditions for informing
or compensating the provider
for certain outcomes of use.
For diagrammatic examples
of these agreements, we refer
readers to Fitzgerald and
Pappalardo (2007).
Consider cont…
Governance and monitoring requirements
• Identifywhatdatamanagementprocessesandstructureswillbenecessarytostore
and share data.
• Considerwhat oversightmechanisms andregulatory structureswill needto bein
place – such as Data Access Committees (see INDEPTH Data Sharing and Access box).
Consider making provisions for the establishment of such structures in partnerships
that will make heavy demands on data management and sharing.
Capacity: Operational and technical considerations
The Swiss Commission for Research Partnership with Developing Countries contends that
the organizing principle here should be capacity-building. It is not that research ownership
is important as an end in itself, but rather as a means to garner increased funding or human
capital. For that reason, there should be discussion amongst collaborators as to what types of
research ownership are most important in developing local capacity—publication in journals,
inclusion on grant proposals, or technical training (Chokshi & Kwiatkowski, 2005, p. 12).
• Whattechnologicalsystemsandinfrastructureareneededforcollecting,storingand
disseminating data?
• Whatskillsandcapacitiesdoresearchersneedinordertocollect,clean,archiveand
analyse data?
• Where possible, make provisions in the contract for training, skills transfer and
capacity building so that data producers are also capacitated to be data users.
• Consider sustainability needs: ensure that data management is recognised in
contracts as an essential component of the research project. Consider what costs
will be involved in managing and maintaining the data after the research project is
Ethical issues / protections for participants
Sharing data or biological materials changes researchers’ responsibilities towards research
participants. Be aware of these ethical responsibilities and the additional demands they may
place on your researchers and Institutional Review Boards (IRBs).
• It will be important to maintain the trust of your research communities, so it is
reasonable to insist that secondary users assume the ethical responsibilities that
come with the privilege of accessing shared data.
• ConsidertheResearchEthicsCommittee(REC)orIndependent ReviewBoard(IRB)
capacity required to review the ethics relating to release and future use of data. In
the absence of Data Access Committees, IRBs are sometimes expected to take on
oversight or regulatory functions regarding secondary users. Regulation of data
access is often not within the capacity of many LMIC IRBs.
• Consentforfutureuseaddsacomponenttostandardconsentforms.
• Considerprivacy,anonymisationofdata,condentialityprotections,andidentiability
/ discrimination risks.
• Considerincludingrequirementsforfeedbackofresultsbythirdpartiestoparticipants,
as well as benet sharing in the results of research.
Commercial aspects
When negotiating to share samples in particular, consider the commercialisation potential
and include clauses about intellectual property rights and the sharing or distribution of
eventual benets – not just to the primary researchers and their institutions, but also to the
participant communities.
Fitzgerald, A., & Pappalardo, K. (2007). Building the infrastructure for data access and reuse in collaborative research:
An analysis of the legal context. Brisbane: Open Access to Knowledge (OAK) Law Project. [For a comprehensive
approach to data sharing, and diagrammatic examples of data sharing agreements, we refer readers to this source]
INDEPTH (2012). INDEPTH data access and sharing policy. Ghana: INDEPTH Network.
OECD (2007). OECD principles and guidelines for access to research data from public funding.
Tangcharoensathien, V., Boonperm, J., Jongudomsuk, P. (2011). Sharing health data: developing country perspectives.
Bulletin of the World Health Organization, 88, 467–468.
Cambon-Thomsen, A., Rial-Sebbag, E., & Knoppers, B.M. (2007). Trends in ethical and legal frameworks for the use of
human biobanks. European Respiratory Journal, 30, 373-382.
Chokshi, D.A., & Kwiatkowski, D.P. (2005). Ethical challenges of genomic epidemiology in developing countries. Genomics,
Society and Policy, 1, 1-15.
Chokshi, D.A., Parker, M., & Kwiatkowski, D.P. (2006). Data sharing and intellectual property in a genomic epidemiology
network: policies for large-scale research collaboration. Bulletin of the World Health Organization, 84, 382-387.
de Vries, J., Bull, S.J., Doumbo, O., Ibrahim, M., Mercereau-Puijalon, O., Kwiatkowski, D., & Parker, M. (2011). Ethical issues
in human genomics research in developing countries. BMC Medical Ethics, 12:5.
Jentsch, B., & Pilley, C. (2003). Research relationships between the South and the North: Cinderella and the ugly sisters?
Social Science & Medicine, 57, 1957-1967.
Kaye, J. (2011). From single biobanks to international networks: developing e-governance. Human Genetics, 130, 377–
Kuula, A., & Borg, S. (2008). Open access to and reuse of research data – The state of the art in Finland. Tampere: Finnish
Social Science Data Archive.
Lowrence, W.W. (2006). Access to collections of data and materials for health research: A report to the Medical Research
Council and the Wellcome Trust. and
Parker, M., Bull, S., de Vries, J., Agbenyega, T., Doumbo, O.K., & Kwiatkowski, D.P. (2009). Ethical data release in genome-
wide association studies in developing countries. PLoS Medicine, 6: e100143.
Rathgeber, E.M. (2009). Research partnerships in international health: Capitalizing on opportunity. Stakeholders meeting
on strengthening research partnerships for neglected diseases of poverty, GTZ, Berlin, 16-18 March 2009. WHO/
Federal Ministry for Economic Cooperation and Development.
Sankoh, O., IJsselmuiden, C.B., et al. (2011). Sharing research data to improve public health: A perspective from the
global south. The Lancet, 378, 401-402.
Vickers, A. (2006). Whose data set is it anyway? Sharing raw data from randomized trials. Trials, 7: 15.
Walport, M., & Brest, P. (2011). Sharing research data to improve public health. The Lancet, 377, 537-539.
World Economic Forum (2011). Global Health Data Charter. Geneva: World Economic Forum.
Capacity Building &
Technology Transfer
Capacity building in relation to research partnerships refers to a wide range of areas of potential focus, from
the capacity to dene national research agendas and set priorities, to greater training and development
of scientic and professional sta, to ‘bricks and mortar infrastructure, to being able to negotiate fairer
research contracts which build sustainable research and innovation capacity. While capacity building was
once understood simply as a technical process of transferring knowledge, skills and technology, it is now
understood more systemically, recognising also the importance of building the capacity of institutions
to produce and use knowledge. This shifts the focus to capacitating an enabling environment in which
research occurs, coupled with a growing appreciation for country or institutional ownership of capacity
development initiatives. As such, capacity building is not just a box to be ticked but a long-term process
that requires signicant commitment and resources from all partners.
Capacity is understood as the ability of people, organisations and society as a whole to manage their aairs
Capacity development is understood as the process whereby people, organisations and society as a whole
unleash, strengthen, create, adapt and maintain capacity over time.
Promotion of capacity development refers to what outside partners –domestic or foreign –can do to support,
facilitate or catalyse capacity development and related change processes. (OECD, 2006).
Any eort to build capacity should consider how such eorts best t the current circumstances and needs
of the partner institution. As such, in negotiating fair research contracts, it is important for institutions to be
able to communicate their capacity needs to their partners. For the purposes of this guidance document,
aimed at partner institutions, the focus will be on individual and institutional capacity considerations, while
recognising that building these capacities can contribute to national system capacity. In COHRED’s work,
we focus on system optimisation, rather than on capacity building per se, to acknowledge that, irrespective
of sector or level or organisation, there is always prior capacity in place. System optimisation avoids the
notion that capacity building is a one-sided transfer from capacity builder to capacity recipient. Instead,
the goal is to enable partners to identify where the gaps might be and to determine how best to ll them
in order to maximise what works.
Understand: Capacity Building
There are various ways in which capacity can be developed as part of a
research partnership. Capacity building can be seen as incorporating a wide
range of activities aimed at addressing gaps in the ability of institutions to
produce, manage, use, implement and scale up their research endeavours. It
occurs in research partnerships in formal and informal ways. Some research
partnerships are explicitly about capacity building, others exchange
knowledge and skills as part of meeting the objectives of the research
project. There is increasingly a move towards making capacity development
an explicit component of all research partnerships, in part as a means of
realising the ultimate goal of institutional ownership of their research and
development agendas, and building long-term, sustainable capacity to
meet their own research and development objectives.
Capacity development is not just a one way process. The term capacity
building can imply that the exchange of capacity is one-sided, rather than
a partnership of mutual benet. Both or all partners stand to benet in
dierent ways from the interaction. What is often overlooked in capacity
development eorts is that LMIC institutions have existing skills, resources
and knowledge systems that can provide valuable insight and contributions
to the research process. The rationale for this section is to respond to
the needs of the less capacitated partner, but this should not create the
impression that the capacities of the high income institution will not also be
enhanced in dierent but important ways by engagement in the research
partnership. This section focuses on ways in which low and middle income
partners can negotiate for greater commitment to building capacity for
long-term development. Ultimately, with greater capacity, all partners will
benet in the long term from stronger institutions.
Example of best practice: Capacity
exchange’ in an international
collaborative research partnership
A research partnership formed between
South African and American researchers
to design and implement a prison
intervention to reduce the rate of HIV is
an example of a successful collaboration
in which all partners beneted from
mutual capacity building eorts. Clear
and direct institutional support on both
sides of the partnership, involvement
of both teams in all stages of the
planning and decision making process,
and joint control of the budget were
key aspects of this collaboration that
resulted in strengthened capacity at
the South African site. Recognising that
both partners had particular expertise
to contribute to the project, a mutual
respect for the talent of all partners was
identied as a critical starting point in
skills and knowledge transfer. In this
partnership, special consideration was
given to proportional distribution of
power, resources and decision making,
towards the achievement of mutually
agreed upon goals.
, Taylor & Sifunda, 2002)
Type of
Level of
Individual Institution Research system Socio- economic
& political
& linkage
Master level
Grants manage-
Priority setting
Increase demand
for research
(e.g. alignment &
Doctoral level
promotion system
Research ethics
review capacity
Civil society
Fair research
* equity-focus
researchers, peer
Monitoring &
evaluation of
output & impact
Focus on health,
equity & socio-
Focus on research
The actions listed in this grid are selected examples of capacity strengthening at each level.
Many more actions can be undertaken in each cell.
(Adapted from Ghaar, IJsselmujden & Zicker, 2008).
Capacity Components: Research Capacity Strengthening (RCS) grid
Understand: Technology Transfer
Part of capacity development is building an institutions technological and
innovation capability to take research results from ‘bench to market’. Technology
transfer is a term used to describe the processes by which technological knowledge,
in its various forms, moves within or between organisations. Technology transfer is
traditionally understood as a commercial or trade-related process in the innovation
chain involving the acquisition and use of technology and the knowledge and
skills needed to operate it. In the context of research partnerships, it can also be
understood as the process of technological learning and benet from technical
exchanges in the partnership.
In this guidance document, technology transfer is understood as a way of governing
the transfer of certain kinds of capacity, and is addressed here in three broad ways:
the informal transfer of technical know-how and technological capabilities during
the course of the research partnership; the process of transferring technology from
one institution to another to enable the partner institution to use the technology
for their own application and production (horizontal technology transfer); and the
process of moving research results from ‘bench to market, usually with the support
of Technology Transfer Oces (TTOs) (vertical technology transfer). The latter two
typically involve a structured process of technology transfer in which licenses and
intellectual property rights are granted to allow partners to use various technologies
for production and commercialisation purposes. It is important for institutions
engaging in research partnerships which involve technology transfer to know and
exercise their rights with regards to benet-sharing and ownership of intellectual
property rights. This section takes a general approach to these issues, and we refer
readers to a substantive body of guidance on technology transfer to nd further
information on the nuances of such arrangements.
Much technology transfer occurs between willing partners in voluntary transactions
of informal collaboration, learning and exchange of knowledge and know-how
between individuals in dierent institutions (Maskus, 2004). For technology transfer
to result in successful innovation, an institution needs to have sucient absorptive
capacity that is, an enabling environment and a certain amount of pre-existing
infrastructure and skills to optimise their ability to replicate, use, adapt and benet
from the technology. It is important to be aware that your organisation is unlikely to
simply be a passive ‘user of technology. Every institution will have certain strengths,
opportunities and needs that it can build on to use, adapt, learn and build capacity
in technology. Any form of technological capacity building should take these into
account. Increasingly, many LMIC institutions are engaging in their own technology
transfer processes, as evidenced by the growing trend of universities partnering with
industry to move research results from the academy to the market. This calls for intra-
institutional coordination and is facilitated by the establishment of, for example, TTOs.
To achieve sustainable transfer of knowledge, the transfer process must be based
on a genuine partnership that is founded on the concept of reciprocal exchange. An
equitable, participatory, and knowledge based approach in which everyone plays a
role is essential. Along with the technology itself, a thorough understanding of the
principles underlying the technology needs to be transmitted for independence to
be achieved” (Harris & Tanner, 2000, p. 818). Ultimately, technology transfer should
enhance the technological capabilities of the LMIC partner.
Denitions of Technology Transfer
There is no universally recognised
denition of what ‘technology transfer’
means. Technology transfer may
mean dierent things to countries
and institutions at dierent stages of
development. Some useful approaches
to understanding technology transfer
are presented here.
Technology transfer is a broad set of
processes covering the ows of know-
how, experience and equipment…It
comprises the processes of learning
to understand, utilise and replicate a
technology, including the capacity to
adapt it to local conditions (WIPO, 2005)
Technology transfer encompasses the
transfer of technical information, tacit
know-how and performance skills,
technical materials or equipment, jointly
or as individual elements, with the
intent of enhancing the technological
capacity of the recipients. Such transfer
can take place within a variety of
domains, including public and private,
institutional and individual, formal and
informal, through partnerships and joint
ventures, and within and across national
borders (Sampath & Roe, 2012).
Horizontal technology transfer refers
to the movement of an established
technology from one operational
environment or organisation to another
Vertical technology transfer refers to
the transmission of technologies from
generation (R&D) phase to operational
application to commercialisation
Technological learning refers to the
process of accumulating the capability
to innovate (SciDev.Net)
Technological capability refers to the
ability to make use of knowledge to
acquire, assimilate, adapt and change
existing technologies and develop new
products and processes (SciDev.Net)
Case study: South – South
technology transfer
With the growth of the so-called
BRICS economies (Brazil, Russia,
India, China & South Africa), south-
south partnerships between
LMICs are becoming more
common. A classic example of
south-south technology transfer is
the launch in 2012 of Africas rst
fully public antiretroviral factory in
Mozambique, in partnership with
Brazil’s Oswaldo Cruz Foundation:
Case study: A funder’s
approach to capacity building
The Special Programme for
Research and Training in Tropical
Diseases (TDR) structures its
research capacity strengthening
activities according to the needs
of each country / institution.
TDR works on the principle
that, to achieve long-term
outcomes, what is needed
are comprehensive capacity
building programmes that
provide continuing professional
development, support, and an
enabling environment, rather
than scientic training alone…
Research capacity strengthening
(RCS) is both explicit and
embedded in its programmes:
“Everything we do is RCS, and we
try not to waste any opportunities
– even if a scientic research
project is being funded in the
north, then we will try to bring in
a fellowship for someone from the
south (Ghaar, IJsselmuiden &
Zicker, 2008, pp. 64-65).
This section highlights points to consider with regards to capacity building
components when negotiating research contracts. The goal is to formalise these
arrangements so that capacity strengthening becomes an explicit part of the research
Identify the capacity building needs of your institution. Capacity needs assessments
can be an important way to begin the dialogue with partners. Identify indicators for
capacity building at the start of the partnership (see, for example, ESSENCE (2011)
and Bates et al. (2006)).
Consider developing an explicit capacity building plan, based on a needs
assessment, where components of the plan can be built into the contract. (Refer to
Capacity Components box).
Prioritise your institutions capacity needs and consider what could be incorporated
into the existing project / partnership. Be clear about why capacity strengthening
is needed, what purpose the capacity is being built for, and who the capacity will
Does the contract assume an enabling environment and existing infrastructure? Are
there provisions for this if it does not exist or is insucient? Try to secure explicit
commitment from the partnership to strengthen capacity of partner institutions.
Be sure to clarify what kinds of capacity building are planned for during the
partnership and ensure that all partners are on the same page in understanding
what will be provided / developed / shared / transferred. Focus oncapacity
exchange’ – how can each partner complement the other?
Local ownership and control are critical to any capacity strengthening process.
Ensure that capacity building eorts within the partnership are aligned with existing
institutional strategies and resources for capacity strengthening. Reinforce what
already exists and works, and anchor capacity building in institutional priorities,
initiatives and structures.
When engaging in more than one research partnership, consider how to harmonise
capacity building eorts. Where possible, try to balance external funding sources
with domestic sources of funding.
Capacity building is often incorporated into the ‘indirect costs’ of a research project.
See the section on compensation for indirect costs for guidance on negotiating a
fair share of core funding that will enable realistic and sustainable capacity building
eorts. Try to nd other ways in which capacity can be built into the research
partnership, beyond what might be allowed for in indirect costing. It is in the
interests of all partners that each institution in the partnership is equipped to work
eectively and is able to contribute fully to the success of the project.
Identify and partner with institutions and research sponsors that make capacity
building an explicit component of their funding partnerships.
For capacity building to be sustainable, decision makers from local partner
institutions should be given equal say in how resources are allocated and managed.
This will often require coordination and communication between dierent sectors or
institutional departments.
Consider cont…
Consider pooling skills and resources across institutions in networks to attract
funding and benet from combined capacities.
Capacity development should take into consideration all the individual, institutional
and systemic capacity components. Even where capacity building focuses only on
particular components, this will inevitably have an impact on other components, so the
relationships between these components need to be understood.
Is there scope for including training (formal or informal) components into the
contract? Identify opportunities for workshops, conference attendance, short courses
and academic programmes.
Include strategies to promote the retention of a critical mass of skilled and experienced
researchers, managerial and support sta. Examples include career pathways, job security,
networking opportunities, and so on. This may require a change in the mindset of research
sponsors, to allow the use of core funds towards these purposes.
Is there scope for engaging with partner institutions for proposal writing and grant
management training / workshops? Capacity for resource mobilisation is critical to
the sustainability of research institutions.
What can be built into the contract in terms of institutional capacity building?
Move beyond focusing only on individual capacity building, to include institutional
components (See Capacity Components box).
Identify ways in which capacity building can be incorporated into the success of the
research project. Frequent communication is needed, for example, if the partnership is to be
successful; this may mean investing in the communication infrastructure of less capacitated
partners. This includes increasing individual and institutional access to information.
Recognise the potentially powerful position that your institution occupies. High income
partners and research partners require your involvement in the partnership to engage in
locally-based research, for example. Recognising your position in these terms can empower
your institution to insist on equal partnership with explicit capacity strengthening components.
Where technology transfer is an important component of the partnership, consider
establishing a dedicated technology transfer and support team. (See Technology
transfer resources box).
Negotiate for mutually benecial arrangements which balance the concerns and interests
of technology generators/suppliers and those institutions that rely on transfer of technology
and technical know-how for their technological development (Roe & Tesfachew, 2002).
The implementation process of technology transfer takes time and requires ongoing
follow up in which the ‘technology donor’ serves as a long-term resource for
scientic consultation, technical guidance and provision of relevant information and
materials (Harris & Tanner, 2000).
For comprehensive guidance on technology transfer considerations, readers are
referred to existing guidance listed in Technology transfer resources.
Technology transfer resources
Where no technology transfer
oce or support exists, there are
initiatives that seek to address
this by providing resources and
guidance on aspects of technology
transfer, management of
innovation and IP. See, for example:
Southern African Research &
Innovation Managers’ Association
SARIMA builds capacity and
promotes best practice in the
management, administration
and support of research and
innovation. Resources include
training on aspects of technology
transfer and IP management.
The Association of University
Technology Managers (AUTM)
Based in the United States, AUTMs
objective is to support and
advance academic technology
transfer globally.
The Intellectual Property
Handbook (iphandbook)
The IP handbook is an online
resource providing comprehensive
guidance regarding all aspects
of IP management. Technology
transfer is addressed in a number
of ways, including TTO functions
and examples of technology
transfer and licensing agreements.
The Lambert Toolkit
The Lambert Toolkit contains
model agreements for university
and industry partners looking to
engage in collaborative research.
World Intellectual Property
Organization (WIPO)
WIPO provides a number
of resources for navigating
the transfer and licensing of
technology. Its Exchanging Value
training manual is particularly
aimed at non-specialists.
Capacity building resources:
Bates, I., Akoto, A., Ansong, D., Karikari, P., Bedu-Addo, G., Critchley, J., & Agbenyega, T. (2006). Evaluating health
research capacity building: An evidence-based tool. PLoS Medicine, 3: e299
ESSENCE (2011). Planning, monitoring and evaluation framework for capacity strengthening in health research. Geneva:
Ghaar, A., IJsselmuiden, C., & Zicker, F. (2008). Changing mindsets: Research capacity strengthening in low- and middle-
income countries. Geneva: COHRED, Global Forum for Health Research and UNICEF/UNDP/World Bank/WHO
Special Programme for Research and Training in Tropical Diseases (TDR),
OECD (2006). The challenge of capacity development: Working towards good practice. Paris: OECD.
Technology transfer resources:
Krattiger, A., Mahoney, R.T., Nelsen, L., et al (Eds.) (2007). Intellectual property management in health and agricultural
innovation: A handbook of best practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at
Lambert Toolkit for university-industry collaboration: (in high income settings)
Resources available on the website of the Southern African Research & Innovation Managers’ Association (SARIMA):
WIPO (2005). Exchanging value: Negotiating technology licensing agreements. A training manual. Geneva: WIPO.
Acharya, T. (2007). Science and technology for wealth and health in developing countries. Global Public Health, 2, 53-63.
Bates, I., Taegtmeyer, M., Squire, S.B., Ansong, D., Nhlema-Simwaka, B., Baba, A., & Thoeobald, S. (2011). Indicators of sustainable
capacity building for health research: analysis of four African case studies. Health Research Policy and Systems, 9: 14.
CIOMS (2002). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS.
GlaxoSmithKline (2011). Technology transfer, capacity building and the developing world. GSK.
Harris, E., & Tanner, M. (2000). Health technology transfer. British Medical Journal, 321, 817 – 820.
IJsselmuiden, C., Marais, D.L., Becerra-Posada, F., & Ghannem, H. (2012). Africas neglected area of human resources for health
research – the way forward. South African Medical Journal, 102, 236-241.
Malairaja, C., & Zawdie, G. (2004). The ‘black box’ syndrome in technology transfer and the challenge of innovation in developing
countries. International Journal of Technology Transfer Management and Sustainable Development, 3, 233-251.
Maskus, K.E. (2004). Encouraging international technology transfer. UNCTAD-ICTSD Project on IPRs and Sustainable
Development. Geneva: ICTSD & UNCTAD
Nuyens, Y. (2005). No development without research: A challenge for capacity strengthening. Geneva: Global Forum for Health
Potter, C., & Brough, R. (2004). Systemic capacity building: a hierarchy of needs. Health Policy and Planning, 19, 336-345.
Reddy, P., Taylor, S.E., & Sifunda, S. (2002). Research capacity building and collaboration between South African and American
partners: The adaptation of an intervention model for HIV/AIDS prevention in corrections research. AIDS Education and
Prevention, 14, Suppl B, 92-102.
Roe, P., & Tesfachew, T. (2002). Revisiting the technology transfer debate: Lessons for the new WTO working group.
Sampath, P.G., & Roe, P. (2012). Unpacking the international technology transfer debate: Fifty years and beyond. ICTSD Programme
on Innovation, Technology and Intellectual Property. Geneva: International Centre for Trade and Sustainable Development.
White, M.T. (2007). A right to benet from international research: A new approach to capacity building in less-developed
countries. Accountability in Research, 14, 73-92.
Compensation for
Indirect Costs
There is broad disagreement as to what is meant by indirect costs in research contracts. Most research funding
scenarios require a full costing budget, which is made up of both direct and indirect costs of all research and
related expenses. However, there are many instances where the indirect costs are not fully accounted for, if at all.
While direct costs refer to those expenses that relate directly to project activities (e.g. salaries, travel, equipment
and material supplies), indirect costs are those expenses which enable research institutions to carry out the
underlying operations (the get-up’) of research, and include costs such as rent, utilities, management costs,
administration and nancial service costs, maintenance, and legal and IP support. Indirect costs are also known as
overhead costs, institutional levies or taxes, facilities and administration (F&A) costs, core funding, or non-specic/
discretionary costs. The percentage of indirect costs in relation to direct costs is known as an indirect cost rate.
Diculties can arise where some research sponsors allow indirect costs in the full costing project budget and
others do not. There is a great deal of variation among funders regarding allowable indirect cost rates. Further,
the indirect cost rates applied to LMIC institutions are generally much lower than those set by institutions in high
income countries. While some research sponsors and high income partners do allow for indirect costs, they may
also place a limit (also known as compliance costs’) on the maximum allowable costs for these expenses carried
by the research activity, leaving a great burden on less capacitated institutions to make provisions for carrying out
the research in already low-resourced settings.
Because LMIC institutions very often lack supportive institutional structures and budgeting capacities, they are
at risk of underestimating the full cost of research, running research projects at a loss and not being able to
sustain their research environments. LMIC institutions are under tremendous pressure to grow and sustain their
research environments. Often they are not in a position to fund research and as a result depend largely on high
income partners for funding and support. The inadequacy of accurate costing around the full extent of indirect
costs in research budgets has a direct impact on the sustainability of the research activity itself and the research
environment as a whole. There may also be pressure on low income partners to provide a high income partner
or research sponsor with a reduced cost budget in an attempt to bring costs in line with keeping with grant
application requirements or conditions. This is not conducive to fair research contracting and very often benets
only the research sponsor or the partner directly in charge of budget allocations.
Against this backdrop, it is important to create an awareness of what indirect costs are and to strengthen the
capacity of LMIC institutions to accurately determine and negotiate for indirect costs in a full costing with high
income partners or research sponsors. This section gives a general overview of the importance of taking
indirect costs into account when calculating a full cost budget, and the dierent ways of calculating indirect
costs. We also provide some key pointers to consider when including indirect costs in a budget.
Indirect costs are those overarching costs that are utilised to sustain the research
activity before, during and after research output has been delivered. Research sta
engaged in the research environment should be able to accurately dene and allocate
such costs to a research costing (budget). Ultimately, a costing culture needs to be
fostered whereby full costs (i.e. the real cost of carrying out research activity) are
recognised and accounted for when budgeting. In some instances, LMIC institutions
lack policies on the minimum conditions for calculating indirect costs. Thus the aim of
this section is to provide a basic overview for establishing an eective costing culture.
There is no single approach to establishing indirect costs. It is important that all partners
work toward transparency and accountability. In determining accurate budgeting and
nancial planning, being open, realistic and accountable about indirect costs goes a
long way towards fostering a trusting and mutually benecial relationship between
research partners. Similarly, where LMIC institutions lack policies and practices on how to
determine indirect costs, high income partners that have access to such material should
consider creating an enabling environment that makes way for negotiations on how to
best resolve the issue of allocation of appropriate rates for indirect costs, to the mutual
benet of all concerned. In this section we broadly address indirect costs as they relate to
research contracts. For excellent guidance on calculating indirect costs, we refer readers
to the ESSENCE (2012a) Five keys to improving research costing in low- and middle-income
countries good practice document.
Example of Best Practice: South
Africas Full Costing Model
South Africa is so far the only
country in Africa that has used
legislation to encourage research
institutions to move towards full
costing. The Intellectual Property
Rights from Publicly Financed
Research and Development Act,
(No. 51 of 2008) came into eect
in August 2010. Its primary goal is
to ensure that intellectual property
generated through the use of
public funds is used to benet
the people of South Africa. The
Act applies only to projects and
research contracts that are fully
or partially state funded (in other
words, the Act does not apply
when funders cover the full cost of
the research). In terms of the Act,
the National Intellectual Property
Management Oce (NIPMO) was
established, and has called on all
publicly funded higher education
institutions to develop their own
full-costing policies as a step
towards developing a nationally
accepted full-costing model.
(From ESSENCE (2012a): Five keys to
improving research costing in low-
and middle-income countries)
TIP: Methods for calculating indirect costs
You may be able to recover indirect costs by either allocating the costs into direct costs,
or making use of discretionary funds for administrative costs, training/ development of
researchers and project oversight allocations. Below are a few ways that indirect costs
can be distributed in a budget to incorporate a cost recovery by distributing them in
direct costs.
Approaches to calculating indirect costs include:
Using total dir
ect costs
- Divide the indirect costs by total direct costs to determine the indirect costs rate;
- Apply the indirect cost rate to total direct costs in a research project.
Using modied t
otal direct costs as the basis of direct costs
- Determine the indirect costs;
- Determine the total direct costs;
- Determine the specic costs that should be taken into account (often this means the
total direct costs excluding capital expenditure for equipment, charges for patient
care, rental costs for o-site facilities, scholarships and fellowships, plus a portion of
subcontracts over a certain value);
- Set the indirect-cost rate by dividing the indirect-cost pool by the agreed set of direct
sing remuner
ation only as the basis of direct costs
- Determine total salaries and wages of all sta whether working directly or indirectly
on the project (also consider whether to include or exclude fringe benets);
- Determine the indirect costs;
- Determine the remuneration-distribution base (by subtracting the remuneration
included in the indirect costs from total remuneration costs);
- Set the indirect-cost rate by dividing the indirect costs by the remuneration distribution
base, and apply this to salaries and wages in a research project.
From: ESSENCE (2012a). Five keys to improving research costing in low- and middle-
income countries.
Recommendations for funders
In general, current indirect cost
percentages are not sucient
to build capacity. Funders could
• Site visits to get to know the
realities of the en
vironments in
which their grantees are working.
• Indirect
cost ra
should be
updated periodically to ensure
that the institutions costing
remain accurate and in line
with research environment
sustaining costs.
• Policies
and prac
facilitate dialogue and
collaboration for negotiating
consensus on what are fair
indirect costs.
• Allow for easier and more
essible grant application
processes and oer support
to those institutions that lack
adequate nancial systems and
Determine your institutions internal or indirect costs for conducting and supporting
research. Having a clear institutional policy around research costs is an important
tool for ensuring consistency across grants negotiated at your institution, and
provides leverage for negotiations with research sponsors. That said, an institutional
policy on indirect costs should be exible enough to accommodate the requirements
of dierent research partnerships.
Cost your institutions research activities at a reasonable and current market value,
and review these periodically. Being transparent and upfront about these costs will
assist in contract negotiations around budgets and nances. Where research funds
are in a dierent currency, be aware that exchange rate uctuations will aect the
total amount received over time.
Think about allocating your indirect costs in a number of dierent ways – for
example, as a percentage of the total direct costs, as a proportion of a specic set of
direct costs, or calculating indirect cost rates based on remuneration costs only. The
methodology for calculating indirect costs will be based on your institutions policy
around indirect costing.
Ideally, separate direct costs from indirect costs. Although there will be times
when they need to overlap in order comply with funders’ conditions on indirect costs,
it is preferable to treat the direct running expenses of a particular project as dierent
from those operational expenses that enable your institution to house and run such
Be clear on where the funding recovered from indirect costs will go and how it
will be used in your institution. Researchers are often unaware of how this funding is
allocated within their own institutions.
Develop good nancial mechanisms to strengthen nancial and administrative
reporting procedures. Build sta capacity in budgeting and nancial planning for your
research activities. Adopt good accounting principles and practice for determining,
allocating, implementing and accounting for such costs. Research sponsors are more
likely to agree to indirect cost rates if there is evidence of strong managerial and
nancial systems.
Establish whether partner institutions are exible on indirect costs. It is always
worth nding out how exible a funding organisations indirect cost rates are and
whether there is room for negotiation. Establish whether there is a xed, pre-
determined methodology or rate that partners provide on indirect costs. More
specically, where the rate is too low, there needs to be some negotiation with
the research sponsor or high income partner on adjusting the rate of indirect cost
allocation. This is where having a clear outline of institutional costs will be useful.
Establish whether funders’ rates for indirect costs can be adjusted in line with current
market rates toward promoting sustainable research environments.
Focus on how investments in infrastructure will benet your organisations
beneciaries. Even within the connes of a cost conversation, you can emphasise
how infrastructure investments may actually reduce the costs of serving beneciaries
over time (Gregory & Howard, 2009).
Tip: Calculating indirect costs
Universities in the United Kingdom
have been encouraged to have an
understanding of the full economic
costs (fEC) of their research activity,
and to be transparent in the way
that they account for these costs,
in order to ensure the sustainability
of the sector. Since September
2005, UK universities have been
calculating the fEC of individual
research projects. Under the fEC
model, traditional denitions of
direct and indirect costs no longer
apply. Instead, costs are to be
classied as:
Directly Incurred Costs: actual
costs that are explicitly identiable
as arising from the conduct
of a project (e.g. sta salaries,
equipment, materials, travel).
Directly Allocated Costs: costs of
resources used by a project that
are shared by other activities and
based on estimates (e.g. principal
and co-investigator costs)
Indirect Costs: non-specic costs
charged across all projects that are
based on estimates (e.g. human
resources and nance services,
library costs).
Taken from Wellcome Trust Grant
Policy: Full economic costs
Also see EUA (2008).
ESSENCE (2012a). Five keys to improving research costing in low- and middle-income countries. Geneva: ESSENCE.
ESSENCE (2012b). Research costing practices: Bridging the gap in the funding of health research in low- and middle-income
countries. Geneva : ESSENCE.
Estermann, T., & Bennetot Pruvot, E. (2011). Financially sustainable universities II: European universities diversifying
income streams. Brussels: European University Association.
European Commission Directorate-General for Research (2009). Diversied funding streams for university-based
research: Impact of external project-based research funding on nancial management in universities. Luxembourg:
Oce for Ocial Publications of the European Communities.
EUA (2008). Financially sustainable universities: Towards full costing in European universities. Brussels: EUA.
Bedsworth, W., Gregory, A.G., & Howard, D. (2008). Nonprot overhead costs: Breaking the vicious cycle of misleading
reporting, unrealistic expectations, and pressure to conform. The Bridgespan Group.
Gregory, A.G., & Howard, D. (2009). The nonprot starvation cycle. Stanford Innovation Review, Fall 2009.
Nonprot Overhead Cost Project (2004). Getting what we pay for: Low overhead limits nonprot eectiveness. Center on
Nonprots and Philanthropy, Urban Institute Center on Philanthropy, Indiana University, brief no. 3.
Wellcome Trust Grant Policy: Full economic costs: Position on full economic costs in UK universities.
Research Contracts in
(Legislative) Context
The issue of lawyer or no lawyer assumes that there is a legal or institutional contracting framework to
begin with. However, this is not always the case. Furthermore, research contracting is often not considered
a legal issue. Research institutions negotiating research contracts are less advantaged when they do not
have an adequate legislative framework they can utilise as leverage to negotiate complex arrangements in
global research partnerships. Moreover, a lack of legal expertise, contract management capacity and budget
preparation expertise can adversely aect the outcomes of a research contract. When research partners lack
legal capacity, both in-house and in the broader national context, to negotiate and evaluate their contracts,
they are limited in applying enforcement and protection mechanisms when disagreements arise from
contracts that are not carefully crafted. In addition, research contracts often include clauses such as dispute
settlement and indemnication but many of these are either one-sided (often in favour of the sponsor or
high income partner) or, at best, potentially confusing to an institution without adequate legal stang.
Having national legislative frameworks pertaining to dierent aspects of the research contract can have a
signicant bearing on the terms and conditions drafted in a contract. For example, the IP laws of a partner
country will to some extent determine the way that IP clauses are drafted in their contracts. In this section, we
present guidance on contracts as legal documents. There is no uniform legal system governing contracts;
the laws governing contracts can vary from country to country and may, in some cases, not exist at all. As a
result, research partners engaged in international research contracts may have a dicult time negotiating
these kinds of contracts where they concern two or more countries.
This section aims to provide some guidance on contracting in contexts where there is no clear
legislative framework. We provide an overview of the dierent types of contractual agreements that exist,
and outline some of the standard clauses and provisions that can be included when negotiating contracts,
such as dispute resolution and condentiality.
There is no universal legislative framework that applies to research
contracts for all countries. In some countries, contracts may be governed
by specic legal code; in others, there may be various sources of law
that the country derives its legal framework for contracts from. These
legislative frameworks may have roots in a number of sources. For
example, a countrys legal framework governing intellectual property
could be determined by their membership to international law, treaties
and conventions. But in instances where there is no such clear-cut legal
framework, a countrys laws may be rooted in common-law, judicial
precedent, custom, and customary law, with no specic protective
mechanisms such as intellectual property law. In other countries, there is a
relative legislative vacuum. In addition, there may be a lack of institutional
policies around contracting.
While there is no general applicable international law governing contracts,
there are international norms that can aid in formulating specic provisions
in a contract, such as intellectual property (IP) law. IP law has been developed
to such an extent that there is now a universal set of principles, the TRIPS
agreement, which many countries have committed to implementing in
their national legislative framework and policies. But this is not the case for
all countries, and this inconsistency can cause a signicant challenge for
those partners who enter into research contracts with inadequate legislative
framework to guide the contract negotiation process, specically around
terms and conditions concerning intellectual property. In the context of
this lack of legal uniformity, this section aims to outline standard terms and
conditions that can be found in contract agreements.
Where a country has legislation pertaining to relevant issues covered in
a contract, this will have signicant bearing on the enforceability of the
terms of that contract. However, in some contexts, a partner country
may have no clear legislative framework. In such cases, partners will look
to the contract terms and conditions that have been agreed upon. The
provisions in a contract are legally binding, so it is important to be clear
from the outset what you are agreeing to.
Below is a comprehensive outline of standard agreements and the
kinds of clauses that can be thought through in contract negotiations.
However, the template provided here is a only a guide; it should ideally
not be implemented as is but rather serve as a starting point for partners
to negotiate and renegotiate, if necessary, to the benet of all parties.
While having a strong legislative framework can inuence what can and
cannot be included in a contract, a partner country that does not have
an adequate legislative framework can still enter into a contract without
being obliged to sign on any terms’. There are many ways that a contract
can be negotiated to ensure that all parties benet from the agreements
they enter into.
International jurisdiction
in IP disputes
Many of the disputes that are put forward for
mediation or litigation concern intellectual
property. When partnerships involve more
than one country, the resolution of such
disputes is complex. The territorial nature of
IPRs usually means that most international
disputes over IP have to be adjudicated
before the courts of every country for
which protection is sought. A number of
legislative proposals have been developed to
streamline the adjudication of multi-country
disputes. These proposals contain detailed
provisions concerning matters of international
jurisdiction, choice of law, and recognition
and enforcement in IP cases. Jurčys (2012)
has conducted a comparative study of these
legislative proposals:
- Take into consideration each partner
countrys laws such as their patent
law, copyright law, and other specic
legislation relating to IP, as well as
any regulation of contracts, national
legal provisions covering discharge
of contract and potential dispute
settlement methods (e.g. mediation,
ors are normally advised
to think rst about the practical
arrangement or partnership that they
want to enter into, and then to think
about how that arrangement should
be expressed in legal terms.
WIPO website “Lex” is a one-
stop search facility for national laws
and treaties on intellectual property
of WIPO, WTO and UN member
There are many kinds of agreements used to protect the interests of partners
entering into research contracts. A contract is essentially an agreement on a set
of legally binding rights, obligations and responsibilities between two or more
parties. Contracts often describe these rights and obligations in provisions known
as clauses - for example, a clause describing the procedure for settling disputes.
Disputes will inevitably arise in managing contracts and intellectual property, so
there is a great need for provisions such as dispute resolution to be carefully drafted
in the negotiation of contracts so as to avoid or minimise conict that could hinder
successful collaboration. Dispute resolution clauses are often selected years before
an actual dispute arises, by people who are not involved in the issues later on in the
life of the contract or who have limited awareness of their specic implications in
a dispute-resolution development (Min, 2007). More detail on dispute resolution
clauses in particular is thus provided in the box to the right (Dispute resolution).
Types of contracts
Note: for the purpose of research contracting, the terms contract and agreement are used interchangeably.
In the context of negotiating fair research contracts, the contract, while an important
legal consideration, should ideally maintain the themes of mutual benet, trust,
respect and good communication. A contract is a promise or undertaking containing
mutual obligations of the provider and recipient that can be enforced by law. The
concept ‘mutually agreed terms’ indicates some kind of agreement (Tvedt, 2006,
p. 4). The contract system rests upon the basic assumption that those entering into
the partnership have partly overlapping interests and so are likely to negotiate a
relatively balanced agreement.
Below is a list of some of the dierent types of agreements which may either be
stand alone or clauses within larger contracts:
1. Participation agreement: a contract whereby researchers accept a policy
which assigns all rights in any intellectual property to the institution they are
employed or contracted by.
2. Service agreement: a contract whereby an institution agrees to perform
certain tasks such as conduct clinical trials and sets out to meet very specic
outcomes, as determined in the contract by mutual arrangement.
3. Condentiality agreement/non-disclosure agreement: a contract or part
of a larger contract that covers the information pertaining to the research
that must be kept secret. This type of agreement is put in place either before
sharing exclusive information with another party or seeking such information
from another party. It can be a separate agreement between disclosing and
recipient parties, or may be included in a research agreement as a term.
4. Materials transfer agreement (MTA): a contract that sets out the conditions
relating to use of materials that are only handed over to another party after
the MTA is agreed to by the owner of the IP. It includes the use and methods
to make the materials, where relevant, and often refers to transfer between
partners of biological specimens and samples.
5. Co-development agreement/collaboration agreement: a contract that
involves the specic contributions of multiple parties who contribute to a
mutual outcome. Two key aspects of a collaborative agreement are that i)
it is a legally binding document and ii) it includes a budget (documented
evidence of funding that the parties contribute).
6. Licensing agreement: sets out certain permitted uses of materials or rights
that the provider is entitled to grant, such as agreements to license the use of
associated traditional knowledge or other IP rights.
Dispute resolution
Certain fundamental practices
can be adopted in a contract in
anticipation of dispute settlement.
A dispute resolution clause might
cover aspects ranging from general
disputes to specic contentious
issues. This does not mean that
disputes will not arise between
parties but if they do, the dispute
resolution provision should
provide guidance on how conict
will be handled. Two established
mechanisms for dispute resolution
are mediation and arbitration.
These processes are far more cost
eective than a lengthy litigation
The various mechanisms for
resolving disputes should be
considered and agreed upon, with
a view to what is appropriate and
eective, particularly in partnership
with partners with limited capacity
in terms of eective formal legal
WIPO oers assistance on dispute
resolution issues, through the
WIPO Arbitration and Mediation
Centre. Other options include
the “Rules for Arbitration of
the International Chamber of
Commerce (ICC) which were
developed specically for business
disputes in an international context
and are published in thirteen
languages. The International Court
of Arbitration (ICA) organises and
supervises arbitration procedures
and helps in overcoming obstacles.
The Court will endeavour to ensure
that the award is enforceable in
national courts if required. Another
advantage of the ICA is that the
parties have the opportunity to
choose the law under which their
dispute is considered and also
the location and language of the
Consider cont…
7. Research agreement or Research and Development (R&D) agreement: denes various inputs to research or
to research and development, including nancial, material and intellectual contributions. Also species various
responsibilities in relation to the conduct of research and development of new products or processes, and sets
out how the monetary and non-monetary benets from this research and development should be managed and
shared. Some agreements are part of wider Co-operative Research and Development Agreements (CRADAs) as
a common tool in biotechnology research. In essence, the parties agree to contribute various resources, such as
existing IP, personnel, research facilities, in the collective pursuit of a shared research and development objective.
8. Patent licence, technology licensing and licence agreement: a contract that allows a party to use, make, sell
or further develop a patented (and/or trade-secret-protected) innovation of another party. Patent licenses may
be specic to one or several patents. Technology licences usually include the transfer of know-how (which may or
may not be a trade secret) and sometimes materials.
9. Research agreement and distribution agreement: a contract that can contain any of the agreements listed
10. Memorandum of Understanding (MOU): a document whereby parties entering into a partnership agree to an
intended common purpose or set of goals. This is sometimes seen as more of a moral agreement rather than a
legally binding agreement, and thus it may lack the enforceability of a legal document.
11. A Memorandum of Agreement (MOA) or cooperative agreement: a document whereby parties willingly work
together on an agreed upon project or meet an agreed upon objective. The purpose of an MOA is to have a written
understanding of the agreement between parties.
Standard to all these contracts or agreements listed above are the following elements:
1. Broad purpose of the agreement.
2. Preamble, and ‘whereas clause‘.
3. Parties to the agreement.
4. List of terms and denitions: clearly describe the meaning of commonly used terms in the contract.
5. Clauses, which can include:
- disclosure/non-disclosure;
- condentiality;
- exclusivity,
- liability;
- payment;
- dispute resolution;
- indemnication: indemnication is usually a legally binding undertaking to protect a party from
nancial loss. This clause can be described as a form of direct compensation for any loss incurred.
- intellectual property provisions: partners should describe all kinds of IP (existing and potential) included
in the research collaboration, to the extent of ownership, protection and access;
- publication.
6. Term and Termination.
7. Jurisdiction (where disputes will be resolved): The choice of law governing the agreement has signicant
implications in international agreements. There is often a lack of information about the procedures in many
countries. It is therefore necessary for a research partner to carefully consider the jurisdiction under which the
contract will be governed as this will have bearing on legal processes and costs.
8. Warranties and notices: carefully consider your institutions ability to provide warranties in stating ownership of IP.
9. Illegal/unenforceable provisions: If a court of competent jurisdiction considers an agreement and nds any
provision invalid, illegal, or unenforceable, that provision is considered severed from the contract. The remaining
legal provisions will still be enforceable on the parties. In other the words, but for the illegal and unenforceable
provisions, the contract remains intact.
10. Subject law: the subject-law clause describes where parties to a contract wish to have an agreement interpreted
and adjudicated.
11. Name, address and capacity of individuals to whom ocial communication is to be sent.
12. Signatories of authorised representative (i.e. agents who are able to bind the organisation).
A Collaboration between the National Cancer Institute and the CEO Roundtable on Cancer (2008). Proposed
standardized/harmonized clauses for clinical trial agreements.
Min, E.J. (2007). Alternative dispute-resolution procedures: International view. In A. Krattiger, R.T. Mahoney, L. Nelson
et al. (Eds.) Intellectual property management in health and agricultural innovation: A handbook of best practices (pp.
1415-1427). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A.
Mahoney, R.T., & Krattiger, A. (2007). Agreements: A review of essential tools of IP management. In A.Krattiger, R.T.
Mahoney, L. Nelson et al. (Eds.) Intellectual property management in health and agricultural innovation: A handbook
of best practices (pp. 675-687). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A.
Potter, R., & Rygnestad, H. (2007). Organizing and managing agreements and contracts. In A. Krattiger, R.T. Mahoney,
L. Nelson et al. (Eds.) Intellectual property management in health and agricultural innovation: A handbook of best
practices (pp. 651-658). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A.
Recommended WIPO contract clauses and submission agreements.
Steinbock, M.B. (2007). How to draft a collaborative research agreement. In A. Krattiger, R.T. Mahoney, L. Nelson et al.
(Eds.) Intellectual property management in health and agricultural innovation: A handbook of best practices (pp. 714-
724). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A.
See also
COHRED (2012). Fair research contracting Bellagio meeting report, 22 – 26 October 2012. Geneva: COHRED.
Jurčys, P. (2012). International jurisdiction in intellectual property disputes. JIPITEC, 3, 174-226.
KFPE (2012). A guide for transboundary research partnerships: 11 principles. Berne: KFPE.
Knowledge Transfer Working Group of the European Research Area Committee (2012). European Research Area Guideline:
Intellectual property (IP) management in international research collaboration agreements between European and Non-
European partners.
OECD Global Science Forum (2009). Investigating research misconduct allegations in international collaborative research
projects: a practical guide. OECD.
Tvedt, M.W. (2006). Elements for legislation in user countries to meet the fair and equitable benet-sharing commitment.
The Journal of World Intellectual Property, 9, 189-212.
UNCTAD-ICTSD (2005). Resource book on TRIPS and development: An authoritative and practical guide to the TRIPS
agreement. Geneva: UNCTAD-ICTSD Capacity Building Project on IPRs.
Useful TRIPS resources available on the WTO webpage:
Williams, B.A. (2000). Consensual approaches to resolving public policy disputes. Journal of Dispute Resolution, 8, 135-152.
WIPO (2013). Results of the WIPO Arbitration and Mediation Center international survey on dispute resolution in technology
transactions. Geneva: WIPO.
Repository of Policies
& Templates
research &
property &
ownership of
Data sharing
transfer &
Budgeting for
indirect costs
Africa Centre
building policy
Astra Zeneca Data privacy
Bandim Health
Data sharing
Institutes of
CIHR grants and
awards guide
Guide to
Best practices
for protecting
Agency (CIDA)
Center for
Control &
Policy on IP
Standards to
facilitate data
sharing and use
Policy on
releasing and
sharing data
principles for
data sharing
consortia terms
of reference
Open and
access policy
European &
Clinical Trials
General terms
for grant
Policy on IPRs Budgeting
Data access &
sharing policy
data sharing
Data sharing
Centre for
Data access
Data licensing
research &
property &
ownership of
Data sharing
transfer &
Budgeting for
indirect costs
Centre (IDRC),
Grant terms &
grant terms &
Patent policy Guidelines for
Institutes of
Health (NIH)
Grants policy Grants policy Grants policy
Data sharing
policy &
Data sharing
Grants policy
South Africa
Exploitation of
IP policy
The Global
Guidelines for
Grant standard
terms &
Guidelines for
The Wellcome
Policy on
Exploitation of
trust-funded IP
Policy on data
and sharing
United States
Agency for
Guidance on
property rights
of KwaZulu-
Natal, South
Grants and
contracts policy
IP policy
statement on
overhead and
indirect costs
IP disclosure
World Health
Terms and
conditions for
Guidelines on
developing IP
Brochure on
IP for African
Council on Health Research for Development
Supporting research and innovation systems for health, equity and development
Council on Health Research for Development COHRED Africa
1 – 5 Route des Morillons
PO Box 2100
1211 Geneva 2
Tel: +41 22 591 89 00
Fax: +41 22 591 89 10
COHRED representatives also available in:
Arab World
Prof. Hassen Ghannem
University Hospital Farhat Hached
Department of Epidemiology
Tel: +21 655 404 357
Latin America
Dr Francisco Becerra-Posada
PO Box 22-151
Mexico DF
Mexico 14091
Find us on:
South Africa
Debbie Marais
University of KwaZulu-Natal
School of Applied Human Sciences
P/Bag X01, Scottsville
Pietermaritzburg, 3209
South Africa
Tel: +27 33 260 6135
P/Bag 00265
Plot 50654, Machel Drive
Maranyane House (BOTEC)
Tel: +267 391 6427
Fax: +267 391 3289
Contact: Boitumelo Mokgatla-Moipolai
... To assist low-and middle-income country institutions to enter more equitable partnerships, the Council on Health Research for Development (COHRED) has developed Guidance for Fairer Contract Negotiation in Collaborative Research Partnerships. This guidance document identifies five key topics to address in negotiations in order to generate more equitable partnerships: intellectual property, capacity-building and technology transfer, ownership of data and samples, compensation for indirect costs, and contracts [26]. Similarly, the Sangha experience identified capacity-building and data ownership as key requests (amongst others) to make and the matter of CO compensation was a key topic raised with researchers. ...
... Contracts were addressed via the development of a MOU between VGKK and the district Sangha. However, the COHRED guidance document describes many other forms of contract [26]. It may be useful for other COs to consider this broader spectrum of contracts and determine which best apply to meet their needs. ...
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Background: Community organisations and community members are increasingly being involved in health research projects worldwide as part of the engagement movement. Achieving deeper forms of community engagement like partnership demands that decision-making power be shared with community partners. However, how can community partners assess if meaningful engagement and shared decision-making will be possible when approached by prospective research partners? In this paper, we explore how community organisations decide to join health research projects when approached by health researchers. Methods: Case study research was undertaken on a health systems research project in Karnataka, India called Participation for Local Action, which was carried out by local researchers in partnership with the Zilla Budakattu Girijana Abhivrudhhi Sangha, a community development organisation. In-depth interviews were conducted with the researchers, Sangha leaders and field investigators from their community. Results: Thematic analysis identified two main themes - 'context' and 'deciding to engage'. The Sangha's experience offers lessons to other community organisations that can help them when deciding to engage with researchers in terms of what features to look for in research partners and in proposed research projects, what requests to make of prospective research partners, and what sorts of outcomes or partnership agreements to accept. These lessons may be especially applicable in contexts where relationships of trust already exist between partners and where they have the skills to lead data collection and analysis. Conclusions: We hope that this guidance will help empower community organisations to select good research partners and promote more equitable partnerships between community partners and academic researchers.
... 17 Importantly, it is now expected that all partnerships should have capacity development at their forefront. 12 However, despite discussion for well over a decade, a good proportion of the international community still feels that partnerships are not yet equal, 12 23 24 and they cannot be until the power divide is addressed 15 because LMICs are unable to negotiate for a fairer deal. 15 25 26 In an effort to adjust the power balance, there have been conscious efforts towards recognising local research capacity in LMICs. ...
... 28 The paucity of monitoring and evaluation data is a recognised problem, 5 58 60 with authors attributing it to long time-lags to achieve objectives, 11 outcomes such as organisational culture being difficult to measure, 11 lack of commonly agreed and conceptually robust indicators, 59 60 102 and most evaluation data not being published. 129 To remedy this situation, guidance on Fragmented research systems Undertake a situational analysis and build on existing assets 28 29 57 92 Collaboratively develop research agendas with LMIC stakeholders 55 70 75 Create a research coordinating body or scientific councils 29 64 93 Recently gaining popularity (12) Insufficient research funding Establish a research finance system using innovative revenue generation 52 94 95 Provide long-term funding and flexible grants 8 63 96 Advocate for funding through shared causes and engaging with the media 68 97 Growing popularity (21) Limited use of research evidence Build capacities of policymakers to demand and scrutinise research 25 84 98 Develop evidence repositories and use Research-to-Action-Groups as knowledge brokers to package findings appropriately 39 99 Create knowledge translation platforms to support evidence dissemination and dialogue between research producers and users 30 39 64 100 Consistent popularity (11) Limited governance and regulatory capacity ...
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Objectives Locally led health research in low and middle income countries (LMICs) is critical for overcoming global health challenges. Yet, despite over 25 years of international efforts, health research capacity in LMICs remains insufficient and development attempts continue to be fragmented. The aim of this systematic review is to identify and critically examine the main approaches and trends in health research capacity development and consolidate key thinking to identify a more coherent approach. Methods This review includes academic and grey literature published between January 2000 and July 2013. Using a predetermined search strategy, we systematically searched PubMed, hand-searched Google Scholar and checked reference lists. This process yielded 1668 papers. 240 papers were selected based on a priori criteria. A modified version of meta-narrative synthesis was used to analyse the papers. Results 3 key narratives were identified: the effect of power relations on capacity development; demand for stronger links between research, policy and practice and the importance of a systems approach. Capacity development was delivered through 4 main modalities: vertical research projects, centres of excellence, North–South partnerships and networks; all were controversial, and each had their strengths and weaknesses. A plurality of development strategies was employed to address specific barriers to health research. However, lack of empirical research and monitoring and evaluation meant that their effectiveness was unclear and learning was weak. Conclusions There has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required. Despite an evolution in development thinking, international actors continue to use outdated development models that are recognised as ineffective. To realise newer development thinking, research capacity outcomes need to be equally valued as research outputs. While some development actors are now adopting this dedicated capacity development approach, they are in the minority.
... The principle expressed in these examples from the literature can be applied easily to other scenarios of research and data transfer in an emergency. We agree with recommendations that low-and low-middle income countries must improve their capacity for legislation and rapid ethics reviews to support MTAs and data sharing [21,29] and that these discussions must be further encouraged on international and national levels to focus on specific legislations that address authority, movement and biosafety and biosecurity of samples [23]. ...
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Scientific communication, collaboration and progress are enhanced through the exchange of data, materials and ideas. Recent advances in technology, commercial proprietary discovery and current local and global events (e.g., emerging human, animal and plant disease outbreaks) have increased the demand, and shortened optimal timelines for material and data exchange, both domestically and internationally. Specific circumstances in each case, such as the type of material being transferred (i.e., select agent, disease-causing agent and assessed biosafety risk level) and current events, dictate the level of agreements and requirements. Recent lessons learned from emerging disease issues and emergencies have demonstrated that human engagement and increased science diplomacy are needed to reinforce and sustain biosafety and biosecurity practices and processes, for better scientific transparency. A reasonable and accepted framework of guidance for open sharing of data and materials is needed that can be applied on multiple cooperative levels, including global and national. Although numerous agreement variations already exist for the exchange of materials and data, regulations to guide the development of both the language and implementation of such agreements are limited. Without such regulations, scientific exchange is often restricted, limiting opportunities for international capacity building, collaboration and cooperation. In this article, we present and discuss several international case histories that illustrate the complex nature of scientific exchange. Recommendations are made for a dual bottom-up and top-down approach that includes all stakeholders from beginning negotiation stages to emphasize trust and cooperation. The broader aim of this approach is to increase international scientific transparency and trust in a safe and open manner, supporting increased global one health security.
... No que concerne a modelos de boas práticas financeiras em contextos de investigação, a Universidade de Stanford desenvolveu uma série de recomendações para a gestão financeira que salienta a responsabilidade fiscale não meramente científica -dos líderes dos projetos de investigação [56]. Para além das deficiências ao nível da organização fiscal de algumas instituições do Sul, a falta de capacidade de negociação acaba por se manifestar em parcerias desiguais, pelo que, como vimos na secção 4, o COHRED desenvolveu uma série de recomendações para as negociações contratuais em contextos de investigação colaborativa [23]. Mais recentemente, estas recomendações foram expandidas para um documento que visa desenvolver estratégias para sistemas de inovação e investigação mais robustos. ...
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Apesar dos esforços recentes das Nações Unidas em desenvolver parcerias globais para o desenvolvimento, até ao momento não existem instrumentos concretos para avaliar as dinâmicas das parcerias internacionais de investigação ao nível da saúde. A Iniciativa para a Equidade na Investigação assume-se como um mecanismo para colmatar esta lacuna, tendo para esse efeito recolhido um conjunto de documentos e práticas que constituem uma base de evidências sobre as melhores práticas ao nível das parcerias de investigação, em particular na área da saúde. Neste artigo iremos levar a cabo uma revisão de literatura sobre a base de evidências recentemente criada no âmbito do RFI em relação ao domínio da Equidade de Oportunidade (1). A literatura compilada para esse efeito inclui artigos científicos, relatórios, documentos de estratégia e várias diretrizes, entre outros. Os vários tópicos subjacentes a este domínio incluem temas como o relevo para as comunidades, o envolvimento inicial dos parceiros e práticas equitativas de contratação e de cofinanciamento. Através da seleção dos documentos mais significativos, iremos elencar as questões, definições e soluções mais relevantes subjacentes ao domínio da equidade de oportunidade, analisando de que forma o RFI promove uma mudança de paradigma ao nível das parcerias de investigação na saúde e na investigação e desenvolvimento de uma forma mais geral. Despite the recent efforts of the United Nations in the enactment of global partnerships for development, at the moment there are no concrete tools to assess the dynamics of international research partnerships in the health domain. The Research Fairness Initiative (RFI) aims at filling this gap, and in order to do so it collected a wide range of documents and practices which constitute an evidence base on the best practices regarding research partnerships, particularly in the field of health. In this article we will carry out a literature review on the evidence base regarding the domain of Fairness of Opportunity (1). The literature we will analyse includes journal articles, reports, policy papers and various guidelines, among others. The various topics underlying this domain include themes such as the relevance to communities, early engagement of partners and fair research contracting and co- -financing. Through the selection of the most relevant documents, we will reflect on the most relevant questions, definitions and solutions in the domain of fairness of opportunity, analysing the ways in which the RFI promotes a paradigm shift in research partnerships in health and research and development in a broader sense.
... According to the Council in Health Research for Development (COHRED), 'recent snapshot surveys of research institutions in the African and Asian regions have revealed some significant gaps in the contracting and contract management capacity in these regions'. 45 The major challenges identified by COHRED include the negotiation on the overheads, the supply of investigational medicinal products (IMPs), the transfer and sharing of trials' data and samples, and the policy insurance contract. ...
Background The Good Clinical Practices (GCP) codes of the World Health Organization and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without considering the challenges faced by clinical researchers in low- and middle-income countries (LMIC). Methods We analysed the challenges met when conducting clinical trials in LMIC, including in several locations in sub-Saharan Africa and in EDCTP-funded trials. We compared these challenges to GCP guidance, in order to (a) verify if there are gaps between the international GCP codes and the field reality in LMIC, and (b) formulate recommendations for GCP improvement if needed. Results We identified shortcomings in the GCP guidance concerning three broad domains: ethical, legal and operational. We identified also eleven specific issues: the double ethical review of ‘externally sponsored’ trials; the informed consent in children; the informed consent in illiterate people; the informed consent comprehension; the definition of vulnerability; the post-trial access to communities; the role of communities as key stakeholders in research; the definition of sponsor; the guidance for contractual agreements; the clinical monitoring; the laboratory quality management systems; and the quality assurance of investigational products. For each specific issue, we formulated a recommendation for the improvement of GCP. Conclusions Clinical trials are increasingly conducted in LMICs, thus a comprehensive revision of GCP guidelines is needed, to ensure adequate guidance for researchers operating in these contexts, and to maximise protection of research participants. The revised GCP code should be strongly rooted in ethics, sensitive to different socio-cultural perspectives, and allow consideration of trial- and context-specific challenges. This can be only achieved if researchers, sponsors, regulators and ethical reviewers from LMIC are transparently involved in the revision process, as well as non-commercial researchers and sponsors, and major agencies that fund international collaborative clinical research.
... According to the Council in Health Research for Development (COHRED), 'recent snapshot surveys of research institutions in the African and Asian regions have revealed some significant gaps in the contracting and contract management capacity in these regions'. 45 The major challenges identified by COHRED include the negotiation on the overheads, the supply of investigational medicinal products (IMPs), the transfer and sharing of trials' data and samples, and the policy insurance contract. ...
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The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of ‘externally sponsored’ trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients’ representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time ‘global’, ‘context centred’ and ‘patient centred’.
By foregrounding a widened view of the rule of law in transnational legal processes, the works under discussion in this symposium can support innovative critical perspectives on global health law –a field that has gained wide attention due to the spread of COVID-19 around the world (Lander, 2020; Bhatt, 2020). Legal and socio-legal scholars in the decade and a half before the pandemic worked on locating global health law and articulating its underlying principles. Lawrence Gostin's 2014 monograph offers a synoptic view centred on international institutions (e.g. the World Health Organization, World Trade Organization, UN Human Rights Council) and problems (e.g. infectious-disease response, tobacco control), along with an elaboration of its normative basis in universal moral principle and international human rights law (Gostin, 2014). Struggles over access to essential medicines and intellectual property in the early 2000s are, for example, represented in terms of the right to health constraining international trade law. Andreas Fischer-Lescano and Guenther Teubner's 2004 reading is oriented more by social theory than by doctrinal or ethical frames (Fischer-Lescano and Teubner, 2004, pp. 1006, 1008). A functional health regime has ‘differentiated out’, they observe, and operates as a discrete communication system across borders, albeit one that is threatened by the preponderant economic system. On this model, the battle for access to medicines amounts to ensuring, via human rights guarantees, that the rationality of the health system is not replaced by that of its economic rival in legal and policy communications (Fischer-Lescano and Teubner, 2004, pp. 1030, 1046).
Several health research organisations whose work focuses on international collaboration outline guidelines that support ethical practice in health research partnerships including building consensus around good collaborative research practice. This paper explores researcher’s perspectives, experiences, and reflections on the elements of successful health research partnerships between Northern and Southern countries/institutions. The study adopted a qualitative research approach using in-depth interviews to explore what an authentic partnership is as experienced and aspired by stakeholders in health research partnerships in Zambia. Interviews were conducted with stakeholders implementing various health research activities in the country. Our findings revealed that Southern partners aspired for equal status and participation, transparency, and accountability, interdependency, and reciprocity, commitment to shared goals, open dialogue and sustainability in partnerships. While to some extent these aspirations overlap with the categories covered throughout the different partnership guidelines, some key aspects go beyond what is included in existing recommendations such as status and recognition which are salient in the broader guidelines. An important aspect in dismantling power structures that causes inequality in partnerships is through generating knowledge and innovation using local resources in the South to address local needs which can be subsequently re-used to address challenges at the global level.
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Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other research counterparts. Non-commercial sponsors of clinical trials should surely invest in the development of adequate legal, administrative and management skills. By acknowledging their role and specificities, and by providing them with adapted guidance, the international Good Clinical Practices codes would provide valuable guidance and support to non-commercial clinical research, whose relevance for global health is increasingly evident.
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At Doha, Ministers agreed to establish a working group to examine 'the relationship between trade and transfer of technology, and of any possible recommendations on steps that might be taken within the mandate of the WTO to increase flows of technology to developing countries.' The Doha Ministerial Declaration also states that the 'General Council shall report to the Fifth Session of the Ministerial Conference on progress in the examination.' The debate on transfer of technology to developing countries is not new. It acquired special importance in the international economic agenda with the launching of negotiations on a draft International Code of Conduct on the Transfer of Technology in the 1970s. Although negotiations on the code of conduct ended in 1985, 1 their failure did not necessarily mean that the interest and concerns about transfer of technology to developing countries had diminished. To the contrary, technology transfer to developing countries has been a recurrent theme in the multilateral discussions that have taken place in recent years. In the context of multilateral environmental agreements (MEAs), for example, the issue of technology transfer, more specifically environmentally sound technologies (ESTs), to developing countries has been a regular feature of any such agreements negotiated ever since the Rio de Janeiro Earth Summit. Indeed, in these agreements, the transfer of ESTs to developing countries is often presented as an essential condition for successful realisation of the agreements. Hence many MEAs include provisions on the transfer of technology on favourable terms, including financial support. The Framework Convention on Climate Change states, for instance, that: 'The developed country Parties... shall take all practicable steps to promote, facilitate and finance, as appropriate, the transfer of, or access to, environmentally sound technologies and know-how to the parties, to enable them to implement the provisions of the Convention. In this process, the developed country Parties should support the development and enhancement of endogenous capacities and technologies of developing country Parties...' (Article 4.5).
Skip Main Navigation Click here! The Lancet . RSS Feeds Subscribe | Register | Login Close. Username: Password: Forgotten Username or Password? Remember me on this computer until I logout. ... outline goes here. The Lancet , Volume 377, Issue 9765, Pages 537 - 539, 12 ...
This article illustrates some of the issues that arise when the commonly espoused principles of research partnerships are considered in the practice of North-South collaborations. It points to dynamics that may occur when research agendas are not shared by collaborators. Moreover, it questions the roles partners adopt during fieldwork in relation to the distribution of control over a research project. Related to this, the article explores issues of funding. What is the potential for collaborations with a project lead by Southern partners, which would reflect more strongly Southern realities in research projects? It is concluded that hierarchical research arrangements may be desirable in some circumstances, for example, where they favour the South; that Northern and Southern capacities and weaknesses should be made explicit; and that capacity building should be pursued beyond the point where it serves the North.
Co-operation between researchers in the global North and South is critical to the production of new knowledge to inform development policies. However, the agenda-setting process is a formidable obstacle in many development research partnerships. The first section of this article examines how bilateral donor strategies affect collaborative agenda-setting processes. The second section explores researchers' motivations for entering into North-South partnerships; the obstacles that Southern researchers encounter in agenda-setting processes; and the strategies that they employ to ensure that research partnerships respond to their concerns. This analysis suggests that while strong Southern research organisations are best placed to maximise the benefits of collaboration, donors and researchers alike are well advised to recognise the limitations of this approach and use it prudently, because North-South partnerships are not necessarily the best way to advance research agendas rooted in Southern priorities.
The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights in article 7 states that the protection and enforcement of intellectual property rights (IPRs) “should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare”. This article examines the developmental claims for IPRs in developing countries and least developed countries with a particular focus on sub-Saharan Africa.
With increasing recognition of the health and psychosocial challenges in developing countries, more research in these countries is essential. Research collaborations between wealthier and less wealthy countries are, however, complex. A partnership model has been proposed which emphasizes the importance of mutually respectful and beneficial relationships in international research. Using an example of a mother-infant intervention project in South Africa we describe the elements of an equitable partnership model of research. An issue which has been overlooked, however, is the reality of power differentials within the poorer countries themselves. We show that there are many intersecting levels of relationships within intercountry research, and suggest that power dynamics within countries deserves equal attention as international issues. Based on our experiences, we present some tentative guidelines for international research which builds long-term capacity and recognizes the importance of multiple levels of analysis and interaction.