Improving international research contracting

Abstract

There has been a corresponding increase in complexity of the legal arrangements accompanying such funding without a corresponding increase in the legal resources and capacities of research institutions in LMICs. This can lead to an unequal power relationship between the institution and the funder (in this context often a donor agency, research council, multilateral agency, founda-tion, public–private partnership, private company or a research institution from a high-income country) – a relation-ship that should be mutually beneficial. While for the scientist and the funder, the major focus of the contract is the research protocol, the legal aspects are equally important for a successful partnership.The International Centre for Diar-rhoeal Disease Research, Bangladesh (ICDDR,B), experienced the increas-ing complexity in these agreements and decided to review past draft contracts and the negotiations that were needed to reach equitable agreements. It was noted that contracts were often sent to the Centre with the expectation that they would be signed with no revision. Fortunately, the ICDDR,B has legal staff to negotiate equitable clauses but such a resource is not available to many research institutions in LMICs.During the review, the following issues of greatest concern were identi-fied. Exclusive data ownership was often claimed by the funder even though data were collected by the institution. This was especially a problem with multisite studies where only the funder had access to the complete data set. Though they may have unique scientific merit, mul-tisite studies could be disempowering to local institutes since the local investiga-tors had little independence and were simply collecting data as prescribed by the funder. The funder sometimes claimed specimen ownership even though it had no way to actually store or use the specimens, and it sometimes restricted the use of the samples in other approved research activities. Exclusive ownership of intellectual property rights was often claimed by the funder and, in one case, was even claimed for intellectual property developed during a training programme conducted by the institution. Some draft contracts restricted the right to publish data and even contained language that would allow the funder to change the report before publication. Contracts often describe ways of settling disputes, however, it may be difficult to identify a neutral body for dispute settlement. Most draft contracts have indemnifica-tion clauses but many of those reviewed were one-sided or, at best, potentially confusing to an institution without ad-equate legal staffing and some included requirements for types of insurance not available in the country. The wide variety of contract formats developed by each funder further complicated the process for institutions in LMICs.These findings were presented to the WHO Advisory Committee on Health Research, where leading researchers from other institutes in LMICs confirmed that they faced simi-lar problems in contract negotiations.The issue of inequitable inter-national research partnerships is not new