Funded research is usually underpinned by contracts or legal agreements between funders, sponsors,
universities and healthcare organisations. These range from service level agreements for the
commissioning of research activity from a third party, to complex legal agreements for clinical trials with
pharmaceutical companies.
The sign-off of these documents represents the primary form of governance within most public health
sector organisations, and it may require legal negotiations with a third party to ensure that the interests
of the healthcare organisation are protected. Governance issues arise in a number of scenarios, for
example:
a) Commissioning of research services from the third level sector:
The standard Service Level Agreement (SLA) templates issued by the HSE procurement division
are not tailored for research activity. This leads to protracted negotiations due to onerous terms and
conditions placed upon the academic institutions, which are also public institutions, and may not be
in a position to accede to them. As they are generic SLAs for the provision of services, they are not
specific enough for research activity. The Research Directorate Mid West legal adviser is Racheal Batten, National Lead for Legal Support and Data Protection.
A Draft Research Collaboration Agreement which might serve as a starting point for interacting wit collaborators is available here.
b) Clinical trials sponsored by third parties:
Regulated clinical trials require a clinical trial agreement which is generally signed-off by the hospital
CEO or another authorised person. These are not standard and are generally complex documents
that need to be reviewed by our legal adviser before they can be signed-off by the hospital. The
development of an agreed national template for clinical trials is being considered and would significantly reduce the legal costs for the HSE and associated organisations. It would also reduce the complexity of setting up multi-site studies, where agreements are negotiated individually with each centre.
c) Memorandum of Understanding (MOU) and data sharing frameworks for research engagement
with the third level sector and section 38 and 39 organisations:
Universities are an important partners in much of the research that takes place in the health service.
They are responsible for the staff in the Clinical Research Facilities and are often formal sponsors of
clinical trials and clinical research. These relationships are not always underpinned by a formal contractual
agreement between the university and the hospital group outlining the roles and responsibilities of
each partner in the collaboration.
Data sharing frameworks for research are also being worked on between the HSE and Section 38 and 39
organisations, as these are independent data controllers and separate from the HSE.
Intellectual Property Management
Research may lead to innovations that can generate intellectual property (IP). IP can be bought, sold
or commercialised by licensing, and this may result in income generation. The HSE has no IP policy,
no mechanism to support IP protection, and no process to enable technology transfer, which generally
results in the healthcare organisation handing over the rights to third parties, thereby missing out on a
potential revenue opportunities.