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The HRB National Clinical Trials Office (NCTO) has a dedicated medtech expert, the Clinical Industry Liaison Officer (CILO). The CILO role is funded by Enterprise Ireland and works with medical device companies and medtech entrepreneurs to help them navigate the clinical research landscape and supports available in Ireland.

The CILO can help you with any medical device focused queries regarding clinical investigations and can give guidance relating to the Competent Authority in Ireland, Health Products Regulatory Authority (HPRA) and/or the National Research Ethics Committee for Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices (NREC-MD).

Questions regarding clinical investigations involving medical devices in Ireland can be directed to: ncto@ucc.ie.

CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party’s responsibilities and obligations for the clinical trial.

It is imperative that researchers and sites understand the importance of CTA development, negotiation, and execution, as effectiveness in these areas will increase efficiency, protect researchers/sites and subjects, and help advance research.

Provision of a single standard clinical trial agreement (CTA) for Ireland will reduce delays, costs, increase efficiencies and enable more trials to set up on time in Ireland. To that end a standard (model) CTA, devised by the IPHA in collaboration with the HSE, was introduced and became mandatory in November ’22. The model CTA is standardised and therefore changes to the standard text in the document are not permissible. However, in cases where negotiations have commenced, the existing CTA undergoing negotiation may continue to be used in the clinical trial.

To access the CTA please use the following link: https://hseresearch.ie/clinical-trials-2/#HSE-approved-Clinical-Trial-Agreement-Templates

Note: Work to develop an agreed Model CTA for tripartite engagements (Commercial Sponsor, Hospital, Academic Partner) and CTA with academic sponsors is underway.

The National Office for Research Ethics Committees is an important component of the research environment in Ireland.  It is an independent office that hosts National Research Ethics Committees (NRECs) The NRECs work in a mixed-model system to support research ethics across the spectrum of health research in Ireland – its has the mandate to return ethics decisions that are respected nationally (‘single national ethics opinion’).

The National Office has launched RECs in a variety of health research areas to include clinical trials of medicinal products for human use, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices. This is to ensure Ireland is meeting the obligations as an EU Member State in line with EU Regulations on clinical trials (Regulation EU 536/2014),medical devices (Regulation EU 2017/745) and in vitro diagnostic medical devices (Regulation EU 2017/746).

Queries relating to clinical trials of an investigational medicinal products, please contact: clinicaltrials@nrec.ie 

Queries relating to clinical investigations of medical devices/ performance studies of in vitro diagnostic devices, please contact: devices@nrec.ie

For all other queries, please contact: nationaloffice@nrec.ie

The National Competent Authority, Health Products Regulatory Authority (HPRA) are tasked with the regulation of medicines and devices for the benefit of people and animals.

HPRA remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

On their industry homepage you will find product information as well as regulatory updates for the sectors, services and facilities regulated by the HPRA.

The Competent Authority in Ireland, Health Products Regulatory Authority’s (HPRA) Innovation Office provides regulatory support and advice to individuals, academics, small and medium enterprises, pharmaceutical and medical device companies, and other groups who are developing innovative health products or technologies.

What kind of support and advice is available?
The Innovation Office can advise individuals or companies directly on regulatory requirements and provide general guidance on technical or scientific issues that they need to consider during the development of their product or technology. Queries can relate to any area regulated by the HPRA including medicines, medical devices, drug-device combination products and cosmetics. Where more detailed scientific advice would be appropriate, the Innovation Office will provide information on how such advice can be obtained. The Innovation Office also publishes general updates and information about regulatory and scientific issues related to innovation.

Queries should be submitted using the online enquiry form available via the Innovation Office webpage which can be accessed through the website; or alternatively via e-mail: innovationoffice@hpra.ie.

The Health Research Regulations are set down in Irish legislation and provide for the safeguarding of personal data for health and social care research in Ireland. A key element of the Regulations is the mandatory safeguard of obtaining explicit consent from participants – consent that is informed and recorded.

Under the Regulations, in exceptional cases where consent cannot be obtained the Health Research Consent Declaration Committee (HRCDC) may make a consent declaration where the public interest in conducting the
research significantly outweighs public interest in the requirement for consent. This consent declaration allows researchers to lawfully process personal data for health research in the absence of explicit consent.

Click here for further information and guidance on the consent declaration process and its requirements.

The Data Protection Commission (DPC) is the national independent authority in Ireland responsible for upholding the fundamental right of individuals in the European Union (EU) to have their personal data protected. Accordingly, the DPC is the Irish supervisory authority responsible for monitoring the application of the General Data Protection Regulation (GDPR).

Under the GDPR, Data Protection Impact Assessments (DPIAs) are mandatory for any new high risk processing projects.

DPIAs can be used to identify and mitigate against any data protection related risks arising from a new project, which may affect an organisation or the individuals it engages with.

Click here for general guidance on data protection, DPIAs and further information on GDPR requirements.