Category Archives: Fair research contracting

COHRED Fairness Index: Where there is need for best practices in health research collaborations

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SPEED READ

– The field of international health research partnerships is vast and mostly unstructured with gaps that often leave the expectations of actors in international collaborative partnerships unattended. Every year significant amount of global expenditure is drawn towards improving global health through partnerships and yet there are prominent North-South discrepencies in health related benefit sharing around the globe. Evidence has increasingly shown that North-South research partnerships have been plagued by inequity and unfair practices, including the use of Southern research resources to serve Northern priorities. As a result, decades of global support for health research in low and middle-income countries (LIMCs) have not substantially improved the systems that countries need to prioritize, conduct, commission, partner or finance research and to translate results into effective policy, practice and products.

– Availability of global health funds and resources is not adequate to resolve the issue. This is becoming an increasingly accepted vision of many researchers in LMICs who now have a focus on ‘ownership’ and demand for a ‘change in approach’. Indeed, increased involvement of LMICs in their national research and innovation agenda is a pre-requisite for making country-led strategies in health happen and for addressing local priority problems especially those that are not funded by global health funds. Such increased involvement has been an enabling factor for many emerging markets such as India, China as well as Thailand and now the Philippines and South Africa to poise for on-going growth, leveraging this capacity to become globally competitive and to support their own economies through research and innovation.

– It is often challenging for a single institution especially in a LMIC to rise and expand without support from global research and partnerships. To learn from China where according to the World Bank, all Millennium Development Goals are within reach, the country has made promising progress in this direction by holding majority of partnership stakes at all times for amelioration of its national business, research, drug and vaccine production.

– In spite of these efforts, several LMICs lag behind in their ability to sufficiently reap the benefits from research and innovation partnerships for system building and enhancing their economic activity. A crucial bottleneck is that bulk of these benefits finds its way into high-income countries and institutions. In 2005, the economic impact of global health activity in Washington State was such that it bolstered its taxes, jobs and social development. This clearly illustrates how global health research is not merely about global health but also about reinforcement of economic activity, employment and growth – sadly a benefit package streaming into high-income countries.

– The COHRED Fairness Index seeks to change this by proposing a certification mechanism that will encourage a fairer distribution of all benefits of research and innovation – not just products, but also measurable impacts on the economy and system building in LMICs. And ultimately, it intends to increase research and innovation capacity for global health by building up research and innovation systems everywhere – especially in LMICs.

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North-South research partnerships: building on equitable foundations

Years of global support for health in LMICs, has made it clear that international aid from governments, research institutions, for-profit enterprises, non-profit organisations, research sponsors and donors in high-income countries have helped LMICs achieve access to improved health care services and even products. And yet these countries are still seeking to achieve autonomy in priority setting and in aligning their research results and outcomes with their regional policies.

One of the major setbacks of continued donor dependency of LMICs is that they have not been able to address building the relevant capacity required to deal with their own health needs. Indeed, if the guiding principle that health is a public good and that all partners should share the burden and benefits of doing research for health equally, then the choice of identified priorities as areas of work and the investment in local research capacity must become equally important.

Building an environment where equitable research partnerships can flourish is possible. Human Heredity and Health in Africa (H3Africa) research, for example, is a framework aimed at fostering the study of the complex interplay between environmental and genetic factors by investigating   disease susceptibility and drug responses in African populations. Founded by the Wellcome Trust and the National Institutes of Health, H3Africa research initiative spurred from concerns over inequality and exploitation, and strives to place “a firm focus on African leadership and capacity building as guiding principles for African genomics research,” with grants awarded to, and managed by, African scientists and institutions.

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Shaping a useful tool…

In line with this, the Council on Health Research for Development (COHRED) has embarked on the development of a standard: the COHRED Fairness Index (CFI) that would serve as a certification mechanism by providing guidelines for best practices in international collaborative partnerships in research for health. The CFI will not be about ‘naming and shaming’ but rather a mechanism that would encourage improvement of practices in international collaborative research partnerships for health. The CFI will thus include indicators, a measurement process, and a reporting system that is independent, transparent and that can address the key problems, potentials and challenges of collaborative research partnerships. Increased capacity of LMICs to perform research, enhanced ownership of data and results, reduction of harm of research to people, and reduction of reputational risk to all partners in the research process are a few examples of the ultimate impact of the implementation and use of the CFI.

Using a rigorous methodology, the development of the CFI started in early 2014 and its design is the result of a multi-sector consultation approach involving a Technical Working Group (TWG) with 30 representative key stakeholders from NGOs, international organizations, philanthropies, donors, the public and private sector as well as academic institutions. The input received from these key stakeholders in global research and innovation has been consolidated into a report, The COHRED Fairness Index Global Consultation Document. It formulates the outcomes of the consultation and is structured to give an overview of the scope of the CFI, its operational model as well its potential application and uptake by end users. The report is open for comments and contributions from the public until 27 March 2015. The purpose of this global consultation phase is to give every stakeholder outside of the CFI Technical Working Group an opportunity to steer certain aspects of the CFI according to their relevant expertise and needs.

Fair Not Unfair Sticky Note

 

…and making research and innovation work for everyone!

All such input will be invaluable for helping us revise the report, improving the alignment of the principles and scope of the CFI with the real needs of all stakeholders, and making it certain that the new version of the CFI receives broad approval. In April 2015, the Fourth COHRED Colloquium will bring together 80-100 key representatives of different stakeholder groups during a 2-day meeting at the Wellcome Trust in London. The results of the first global consultation will be presented at this meeting. Over the next 6 months, COHRED’s core writing group and Technical Working Group will then prepare an update of this document. Because COHRED seeks to institutionalise fair and equitable practices in international partnerships in research for health, we have decided to prioritize a part of our efforts on developing opportunities for meaningful endorsements or sponsorships to collaboratively sustain and strengthen an inclusive framework where all stakeholders of the CFI feel engaged and own the CFI experience (more information on endorsement or sponsorship for the CFI can be obtained by contacting musolino@cohred.org).

Finally, it is expected that the CFI will be inaugurated before the end of 2015. The pre-launch of the CFI is scheduled this year in August at the Global Forum on Research and Innovation for Health 2015 in Manila, Philippines. With its implementation in January 2016, we hope the CFI will serve its stakeholders to add value to specific areas of operation in research for health allowing to improve the alignment of interests of all partners in global health research in the first instance, and in the long run to increase the capacity of LMICs, to optimize the use of research to improve health, reduce inequity and finally stimulate socio-economic development.

Najia Musolino and Janis K. Lazdins-Helds

Fair research partnerships: being clear over data access, control and ownership

COHRED’s Fair Research Contracting (FRC) Initiative, aimed at identifying best practices for negotiating equitable collaborative research partnerships that could help build sustainable research and innovation systems in low- and middle-income countries, continues to stir interest and to generate positive feedback. Recently, we have received a query via Twitter from Maternova Research, a non-profit affiliate of Maternova, which provides us the opportunity of remarking some important issues.

Maternova tweet

In a collaborative research partnership researchers should always consider the legal, ethical and practical implications for the data access, control and ownership. Research data, can often be referred to under the concept of Intellectual Property Rights. Thus, while some contracts may have specific terms and conditions pertaining to data rights, others may refer to data access under the general clause of Intellectual property rights. Negotiating data access and publication rights is an important and complex issue with some funding institutions placing restrictions such as exclusive ownership and access to research project data. Indeed, the landscape of intellectual property is broad and most often partners in health research lack the tools or strategies to make appropriate decisions that fit a rational engagement.

COHRED’s FRC Initiative aims to encourage research partners to carefully consider how they intend to approach the issue of data rights (often termed data ownership, data sharing or data access) from the outset when negotiating with a collaborative research partnership. While there exists a wealth of literature and some institutions have gone as far as developing template clauses for data rights, we encourage researchers to take the step insofar as it means to address complex issues early on in the research contracting process and not necessarily sign template contracts provided by funding institutions. COHRED’s FRC encourages that such clauses fit the disparate needs of the partner in research. The FRC initiative supports fairer research principles and practice and the maintenance of data integrity. Therefore, issues such as who will own and have access to research data/outputs in research collaborations context are very important.

Depending on the kind of research conducted, data can be varied and thus research partners would need to carefully consider how they wish to make it available for future use, for further research, to others or public benefit. Thus a carefully tailored data access/sharing clause is key.  The difficulty arises when some institutions have specified data sharing policies and the recipient funding institutions find themselves limited in negotiating around such clauses in a contract and as a result feel obliged to sign contracts at the cost of losing the funding where the research data or outputs are owned exclusively by the funding institution. Thus the implication is that data ownership is restricted and may not be freely available for further use in other research undertakings. In such cases, an in depth evidence based analysis can be made to demonstrate that the needs for access to data is the core for the accomplishment of fair research outputs. Under such circumstances, gaps in the clauses need to be filled to ensure that the partner in question has access to essential data.

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Image from “Kofi’s Cheese Project”, a cartoon produced to disseminate the FRC project outputs (http://www.cohred.org/frc/)

We can’t say with certainty that there is one particular template that sets out the best boilerplate language for data access and publication rights. However, there are a number of resources that we have developed to help research partners think through similar issues before signing off on a research contract as well as the types of factors that need to be considered in the negotiation process. This is particularly the case when a funding institution provides a template agreement, which could well be negotiated for more equitable terms. This would go a long way in strengthening global collaborations in health research partnerships.

The FRC Initiative addresses some key challenges relating to Intellectual Property, research costing, technology transfer, the legislative context and data sharing in the health research context. In addition to this we have developed 5 key guidance notes and a guidance booklet to assist in the ‘soft’ skills of negotiation (how to engage with your negotiation partner to get the best results for your organization). These materials aim to assist research-based organisations (who may not have specialist research contracting departments or have a lack of access to legal expertise) to get greater benefit from collaborative research activities about the issues in research contracting, particularly inequitable research collaborative contracting arrangements.

We would like to refer you to our website, where we offer useful guidance on research for health contracting. In particular, we would suggest you to go through the guidance note ‘3’ entitled ‘Ownership & Sharing of Data & Samples’. Also, please check page 17-21 of the FRC document entitled ‘Where there is no lawyer: Guidance for fairer contract negotiation in collaborative research partnerships’. In addition to this, WIPO, the Wellcome Trust, the National Institutes of Health and INDEPTH are typical examples of organisations that have developed extensive policy guidelines on access to research data, outputs and resources.

Jacintha Toohey (COHRED)

 

Note: for other useful links and for reading through sample clauses in research contracts, please go here

Kofi’s Cheese Project: Tools for negotiating fairer research partnerships

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SPEED READ

– The Council on Health Research for Development (COHRED) today launched Phase 2 of its Fair Research Contracting (FRC) Initiative, aimed at identifying best practices for negotiating equitable collaborative research partnerships that could help build sustainable research and innovation systems in low- and middle-income countries (LMICs).

– Phase 2 outputs include guidance notes presented in a checklist format to allow researchers to work through key issues within important areas of research contracting; a guidance booklet aimed at addressing the ‘softer’ skills of negotiation, in order to prepare those inexperienced in research contracting for the reality of the negotiating process; and a cartoon entitled Kofi’s cheese project.

– “This new guidance provides straightforward advice about steps to take to make sure that the opportunities which collaborative health research presents to institutions are maximised, especially where contracting capacity is limited or absent”, said Danny Edwards, Programme Manager, Fair Research Contracting Initiative.

– Plans are underway for COHRED Colloquium 4, at the Wellcome Trust, London, United Kingdom, in the near future, which will look at designing a Fairness index for International Collaborative Health Research. The Colloquium is co-hosted by the Wellcome Trust.

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Getting to fairer research contracts 2.0

Collaborative health research has grown significantly in recent years, not only in terms of quantity, but also as for complexity of study design and geographical distribution. This has increasingly involved multi-centre collaboration, with research institutions based in high-income countries (HICs) seeking to establish partnerships with institutions in LMICs. But while HIC partners are usually fully aware of intellectual property rights and know how to maximize the benefit of research for their institutions, such knowledge is less present in LMICs generally, and in Africa particularly. This asymmetry can severely limit LMICs’ power to negotiate favourable contracts and achieve equitable allocation of benefits of research to participating institutions and individuals. Consequently, international research partnerships risk missing opportunities to build research and innovation capacity and national development.

Last year, about this time, COHRED launched a new guidance document on fair contract negotiation in collaborative research partnerships, thanks to funding from the NWO Science for Global Development Programme (WOTRO). This was part of a broader initiative aimed at identifying best practices for the research contracting (negotiation) process that could help build sustainable research and innovation in LMICs. The guidance was developed particularly for contexts where there may be no lawyer or legal expertise, or where these might be present but associated with limited capacity.

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Although “[t]he issue of inequitable research partnerships is not new …… previous work has not addressed the crucial role that equitable contracts play in defining the nature of research collaborations, in building the foundations for successful long-term partnerships, and in enhancing the research systems of LMICs. The essential difference in our guidance document is that it attempts to shift control over negotiating research benefits to the LMIC partner, instead of reliance on the good intentions of the high income country partner,” wrote COHRED’s Debbie Marais and Carel IJsselmuiden in the Lancet Global Health blog.

Following the great success of the guidance, COHRED FRC Initiative is now entering ‘Phase 2’.

New FRC tools launched in June

With the support of the Doris Duke Charitable Foundation, five more accessible guidance notes have been established in a checklist format, to allow researchers in organisations with limited contracting capacity to systematically work through the key issues involved in the key problematic areas of research contracting:

  • Fair research contracting
  • Intellectual property
  • Data ownership
  • Technology transfer and system optimisation
  • Indirect costs

Each of these guidance notes includes key questions to consider, a case study, a list of relevant tips/lessons, and an indication of where to look for additional information.

“This new guidance provides straightforward advice about steps to take to make sure that the opportunities which collaborative health research presents to institutions are maximised, especially where contracting capacity is limited or absent”, said Danny Edwards, Programme Manager, Fair Research Contracting Initiative.

Another practical output of the second FRC phase has been the development of a guidance booklet aimed at addressing the ‘softer’ skills of negotiation, presented through a series of vignettes/case studies to prepare those inexperienced in research contracting for the reality of the negotiating process. This new enabling document is organized to cover the three stages of the negotiation process, based upon the lifecycle of a research contract: pre-contract negotiations, contract, and post-contract.

“We also wanted to provide guidance to assist in the ‘softer’ skills of negotiation – how to engage with your negotiation partner to get the best results for your organisation. To us, and to researchers we spoke to, this was viewed as just as important as understanding the technicalities of a research contract,” said Jacintha Toohey, Project Assistant on the Fair Research Contracting Initiative.

The guidance booklet frames the issue like this within the introduction:  “Key to understanding negotiation is appreciating that: Simply because something arrives in a pro-forma contract, it does not mean it is non-negotiable. With the right approach, many things can be negotiated; A mutually beneficial relationship means that partners enter negotiations with mutual respect and balanced power. This is particularly important when partners might appear to be different levels of bargaining power.”

Last but by no means least; a super nice cartoon – the story of Kofi the mouse and its cheese project – has been produced to disseminate the project outputs even further. The rationale for this choice is grounded on the increasing use of cartoons as a winning communication strategy to effectively convey ‘serious’ messages to a more diverse audience.

What next?

This new set of guidance is just the next step in the Fair Research Contracting Initiative’s plans. In the next phase, we will be transforming our contracting support into a web-based decision support system. In the meantime, we welcome feedback on how we can further improve these tools.

In addition, plans are well underway for COHRED Colloquium 4, at the Wellcome Trust, London, to be held in London, United Kingdom, in the near future, which will look at designing a Fairness index for International Collaborative Health Research. The Colloquium is co-hosted by the Wellcome Trust.

Colloquium 4 will bring together decision-makers from all the sectors engaged in global research and innovation for health to design an innovative research-based index to boost multi-stakeholder research collaborations by taking into account the expectations of fairness of all the partners.

Regrettably, now that this ‘finish line’ has been reached, Danny Edwards is now moving on from this project to take on a fresh challenge at another organisation. Golbahar Pahlavan has joined COHRED in the meantime, and will be looking after Colloquium 4 amongst other responsibilities. Jacintha Toohey will continue to work and support the team in helping to make research contracts fairer.

Danny Edwards, Golbahar Pahlavan, Jacintha Toohey and Carel IJsselmuiden