Key principles for funding international collaboration
The NIHR has a long established history of funding studies with an element of international collaboration. There are many examples of completed and current projects with an international arm, delivered as either UK-led or internationally-led projects. There are established collaborations for joint calls with NHMRC (Australia) and the NIHR HTA programme. In addition, NIHR is exploring international collaboration opportunities with other funders including ZonMW (Netherlands) and KCE (Belgium) aimed at supporting joint international projects and protocols.
The below principles, benefits, challenges, risks and scenarios articulate current practice and NIHR's joint approach to funding international projects.
NIHR funding for recruitment is only applicable to research in UK institutions. International recruitment is funded from other sources.
- Modest allowances for the extra central UK administration associated with international recruitment and collaboration will be considered.
- Applicants must demonstrate that they are seeking funding for recruitment at international centres from other sources when applying.
- Applicants should identify how the project will mitigate or allow for delays to international centre funding with clear stop/go criteria for the funding of international centre(s) and contingency plans if international funding is not approved.
- Apart from the NIHR Global Health Programme it would be very unusual for programmes to fund recruitment internationally.
An international study will be considered where the study is relevant to and a priority for the uk population
- Applicants must provide the rationale for international collaboration, including justification for why the trial cannot be completed in the UK e.g. number of patients, recruitment, expertise etc. Applicants should demonstrate that UK opportunities for recruitment have been fully explored and that innovative study designs to deal with small study populations have been considered.
- The project or proposed intervention must be deliverable and applicable to the UK population or clinical / health and social care settings.
- International centres should usually be in countries with similar health contexts and settings generalisable to the UK.
It is expected that the full international study will be able to determine whether there are statistically meaningful differences in outcomes
- The UK arm of the study is not expected to provide standalone statistical differences (or power).
- The UK arms of international studies should have sufficient UK participants to have credibility in the UK clinical community and to answer UK specific questions.
- NIHR programmes require at least 20% of all study participants should be in the UK arm and provide enough data for a health economic analysis to be done from a UK perspective.
- Avoids early closure or significant delays for a project with recruitment issues.
- Enables important projects in smaller UK patient group or with potential recruitment challenges to proceed.
- Develops NIHR's international reputation and reach.
- Pools international resources and provides opportunity for data analysis and learning.
- Enables understanding of shared international priorities and opportunities.
- Establishing responsibility in terms of publication, copyright, and research governance issues etc.
- Intellectual property issues and funders terms will need to be detailed through an agreement across contracting institutions.
- Recognise where key element(s) of the study are not relevant to a UK setting.
- Complex funding arrangements, international protocols or recruitment issues may reduce the success of potentially important international studies at NIHR funding boards.
- Challenging recruitment issues may increase risk of project failure and impact in NIHR reputation.
- Responsibility for key issues including publication, copyright, intellectual property and research governance issues etc. should be defined up front and managed between contractors.
- Ensuring NIHR specific requirements are are met eg cost effectiveness through a Memorandum of Understanding between funders and agreements between contractors.
- Limited influence over study protocol for international led and funded studies.