Research Offices or equivalent complement the role of the Research Ethics Committee (REC) in the process of overall research governance. While the REC provides ethical oversight, the Research Office is tasked with ensuring research compliance with all other aspects of legal, regulatory and organisational requirements.
Research offices are in the process of being established in the healthcare system and not all organisations have such a resource. Information on existing offices is included below. The Director of Research within a HSE Region or an institution is the overall person responsible for the operations of the Research Office.
The functions of a Research Office may include:
- Ensuring that studies are within the scope of the HSE Research Governance Framework.
- Performing a risk assessment to permit proportionate oversight arrangements
- Ensuring that the proposal has been submitted to the correct Research Ethics Committee.
- Allocation of responsibilities to the relevant legal entity/entities by way of relevant legal agreements.
- Ensuring that insurance and indemnity arrangements are appropriate
- Evaluation of compliance of the proposal with data protection legislation.
- Host site/management approval
On this page
1. Projects that can be supported by a HSE/Hospital Research Office (or equivalent)
2. Finding the correct Research Office for a research project
3. What documentation is required for Research Office submission?
4. Resources and support for Applicants (Under Development)
5. Resources and support for HSE/Hospital Research Offices
Projects that can be supported by a HSE/Hospital Research Office (or equivalent)
A research project can be supported by a HSE Research Office (or equivalent) when it is under the scope of the HSE National Framework for the Governance, Management and Support of Health Research
This includes health research projects
- which recruit participants via the HSE health service users, and/or their personal data and/or their biological samples
- which involve the participation of health or social care staff or require HSE healthcare services, premises, or infrastructure.
Further information about activities under the scope of the HSE RGMS Framework can be found in the RGMS Framework Scope guide [To be published]
Finding the correct Research Office for a research project
- Studies hosted by community based healthcare services
- Studies hosted by hospital based healthcare services
- Studies hosted by HSE Centre (formerly known as HSE Corporate and National Services)
What documentation is required for Research Office submission?
Researchers should contact their Research office to understand the research office requirements. In general the Research Office may require the following additional documentation:
- A completed registration form or copy of final REC application form.
- A completed risk scoring tool – to determine the level of risk of the project
- The completed Data risk scoring tool – to determine if the project needs a DPIA or not
- If required, the completed Research DPIA.*
- Any legal agreements received from third parties
- Copy of the protocol
- Copy of any consent documents, Participant Information leaflets (PIL), Informed Consent Form (ICF) etc.
*Where the HSE is the data controller, researchers need to complete the national Research DPIA template and submit to the research office.
Resources and support for HSE/Hospital Research Offices
Research Registration Process
Research offices can use a simple registration form that can be downloaded. Research office may require additional documentation – see What documentation is required for Research Office submission?
It is advisable for a Research Office to allocate a unique reference number to each project. This can then be used to track the study and enable the submission of further information.
Any regulated clinical trials should be registered with the relevant research office before submission to the National Research Ethics Committee. This will support the signature of the Site Suitability Template. (See www.NREC.ie for more information)
How to do a risk assessment
Health service delivery organisations have a responsibility to manage risks and ensure that research involving service users, their samples or their data is safe and conducted to best practice standards and in compliance with legislation. The RGMS framework includes the following key principles:
- Institutional governance for individual research studies should be proportionate to the level of risk.
- Research activity needs to be registered and risk assessed before it commences.
While data protection and ethical review processes contribute to the risk management of projects the level and frequency of oversight for each research study during the life time of a project should be determined by and proportionate to the assessment of the overall risk of the study.
To enable an assessment of organisational risk a Risk Assessment questionnaire and rating system has been developed and build as part of the RGMS standard application form. This assessment assigns a risk level of Low, Medium, High or Substantive to a study.
Ensuring that the proposal has been submitted to the correct Research Ethics Committee
Research Offices should check the proposal has been submitted to the correct Research Ethics Committee. Depending on the type of study, research under the remit of the RGMS function may require review by a
- National REC (regulated study or national Covid biobank study) *
- National review by a recognised REC (study involves medical exposure to Ionising Radiation )
- HSE Reference REC, a S38 or Hospital REC or RECs
For further information about which Research Ethics Committee is responsible for organisations within a geographical area or for a hospital please visit the HSE Research and Development website.
Ensuring that insurance and indemnity arrangements are appropriate
When conducting health research, it’s imperative to have appropriate insurance and indemnity provisions in place. These arrangements should cover compensation for participants in the event of study-related injuries and also protect the study and its staff.
The State Claims Agency operates two State indemnity schemes, namely the Clinical Indemnity Scheme (CIS) and the General Indemnity Scheme (GIS). For comprehensive guidance, please refer to the Indemnity and Insurance section. This should be read alongside the State Claims Agency’s guidance on indemnity for clinical research, which includes checklists and additional resources. Visit State Claims Agency for more information.
Please note, Aon Ireland act as an agent for the SCA on clinical research only, if you have any queries in relation to research that falls outside the scope of the CIS, please contact the SCA directly.
Research that falls outside the scope of the Clinical Indemnity Scheme (CIS).
Research that falls outside the provision of professional medical services, can be covered under the GIS. The GIS extends to cover all HSE business activities including research, once the following criteria are met:
- The research has received formal approval from the site/DSA management;
- The research has been appropriately risk assessed;
- The researchers are DSA employees;
- The research is taking place in a DSA;
- The third parties involved have provided appropriate insurance;
- A formal agreement is in place including DPIA where relevant;
- The research has Research Ethics Committee (REC) approval;
State indemnity does not extend to cover the negligence of third parties and the HSE should therefore ensure that the third parties involved in conducting the research have adequate insurance in place to cover liabilities associated with their negligence. In addition, the roles and responsibilities of all parties involved and the insurance and indemnity arrangements for the research should be outlined and documented in a formal agreement.
Evaluation of compliance of the proposal with data protection legislation
Detail guidance is available in our Research and Data Protection page.
Legal Agreements
‘All parties collaborating on the research study must, prior to starting the study, enter into an agreement that defines the roles and responsibilities of each of the collaborating organisations in the research study based on a factual analysis of their participation and the participation of their employees.’
HSE National Framework for Governance, Management and Support of Health Research
This agreement may be a collaboration agreement, data sharing agreement, clinical trial agreement, service level agreement, etc. and they set up the roles and responsibilities of all parties involved in the research, financial responsibilities, etc. Legal Agreements must be in place before the study commences.
The Health Service Executive (HSE) approved Clinical Trial Templates must be used for all HSE organisations. Visit HSE Clinical Trials page for further information.
Host Site/Department/service authorisation
The mechanism for host site authorisation varies from site to site.
The host site or relevant service provider ultimately retains the authority to decide not to commence the research study, even with a positive recommendation from the REC and the Research Office.
The HSE R&D template [HSE Site Authorisation Form] can be used to formalise the process of host site approval.
Note that the Site Suitability Template required by the National Research Ethics Committee does not indicate host site approval.
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