Unlike in the UK, where there is a standard model non-commercial agreement (mNCA) that can be used between non-commercial sponsors and participating NHS sites, a research agreement will need to be developed to put in place between the sponsor and participating international sites. Differing healthcare systems, national & local legislation and organisational arrangements can lead to long periods of contract negotiation which can adversely affect trial timelines. Different time zones and potentially language barriers can mean that even simple queries can take a while to resolve.
Sponsors may choose to contract directly with all research sites, or may choose to sub-contract this responsibility to a spoke/lead site.
The host institution/sponsor contracts with all international research sites.
Working with a translated document will significantly increase the amount of time required for contract negotiation. If a translated contract is insisted upon, one option is to complete contract negotiations with an English version of the document and once finalised, arrange for a translated copy to be signed in conjunction with the English version. This will act to avoid any misunderstanding with the contract, however it should be noted in both agreements that the English version would prevail in case of dispute.
- Funder requirements: are there any terms from the main funding agreement that are required to be filtered down to any sub-contracts in order for the host institution to remain compliant with the main funding agreement with the funder?
- Insurance provisions: level of insurance, and what this would cover, from the host institution for the trial should be clearly detailed within the agreement in addition to listing any local insurance requirements for sites. Types and levels of insurance required will depend on the overall risk of the trial (link to insurance section)
- Clear division of responsibilities between both parties: It is recommended if possible that research sites are responsible for obtaining all necessary ethical, regulatory or other approvals required for conduct of the trial at their site, in addition to being responsible for any local reporting that may be required by applicable laws, regulations and/or guidelines
- Local/national legislation differences: Differences in legislation should be considered when developing the research agreement for international sites. This includes, but is not limited to, data protection, clinical research and good clinical practice (GCP).
Key Areas for Disputes
- Jurisdiction of agreement/governing law: For a UK host institution, the starting position would usually be to state the agreement will be governed by the local national laws and any dispute will be subject to the jurisdiction of the local national courts e.g. the English Courts. Sites may wish to change this to reflect their local governing laws, however it would be preferable to agree to remain silent on jurisdiction if this is the case.
- Warranties, indemnity and insurance clauses: this may be disputed if sites are unable to comply with local insurance requirements detailed in the trial agreement e.g. they may hold the required insurance but not to the level stipulated in the agreement. In this case, it will need to be assessed whether the site can take part in the trial with the level of insurance held.
- Intellectual property rights
- Publication rights: Will sites be able to publish data relating to their own patients prior to the trial be analysed? It is recommended that a publication policy for the trial is agreed by the Trial Management Group
- Financial payment schedule: Will payments be made on a regular basis throughout the trial, or as a bulk payment at the end of the trial?
Another option is to make the payment upfront upon signature of the agreement, however whilst this may reduce the risk of experiencing an adverse currency fluctuation, this does pose another risk in that it may be difficult to recoup any money paid if the sites do not then go onto fulfil their role in the trial.