Regulatory, Ethics, Insurance

Regulatory, Ethics, Insurance

Regulatory, Ethics and Insurance Considerations for conducting a Clinical Trial in Ireland

Before setting up a clinical trial of a medicinal product in Ireland there are a number of considerations to keep in mind.

The regulatory/legislative aspects, the necessary approvals and insurance requirements of conducting a clinical trial in Ireland are detailed below.

Please contact the HRB NCTO Quality and Regulatory Affairs Manager by email on: ruben.keane@ucc.ie if you require additional guidance.

Regulatory, Ethics and Insurance Considerations for conducting a Clinical Trial in Ireland

Before setting up a clinical trial of a medicinal product in Ireland there are a number of considerations to keep in mind.

The regulatory/legislative aspects, the necessary approvals and insurance requirements of conducting a clinical trial in Ireland are detailed below.

Please contact the HRB NCTO Quality and Regulatory Affairs Manager by email on: ruben.keane@ucc.ie if you require additional guidance.

FAQ’S

Regulatory And Ethics Approvals For Clinical Trials Of Investigational Medicinal Product (CTIMP):

The EU Clinical Trial Regulation 536/2014 came into force at end of January 2022. During the transition period, which ends on 31 Jan 2023, sponsors may apply for approval under the old Clinical Trials Directive 2001/20/EC (CTD) OR under the new Clinical Trials Regulation (CTR) 536/2014.

  • CTD: Submit CT applications to the Regulatory Authorities in each country where you wish to carry out the trial, in Ireland this is the Health Products Regulatory Authority (HPRA). You must also apply for Research Ethics approval in each country. NREC is the national research ethics committee in Ireland.
  • CTR: Submit the Clinical Trial application via the Clinical Trial Information System (CTIS). CTIS is the portal which allows sponsor to make a single application covering all EU countries. The application is considered by the regulatory authorities in each country where the trial is being carried out (known as the ’concerned member states’ CMS) and by the National Research Ethics Committee in each of the CMS. One member state is chosen to coordinate the response (known as the ’reporting member state’- RMS). Sponsors receive one approval which covers Regulatory and Ethics approvals for all sites in all the CMS.

Clinical trials must be conducted in accordance with ICH-Good Clinical Practice (ICH-GCP), an internationally recognised ethical and scientific quality standard encompassing the design, conduct, recording and reporting of clinical trials and allowing mutual acceptance of clinical trial data.

Regulatory and Ethics Approvals For Clinical Investigations Of Investigational Medical Devices:

Depending on the type of medical device being trialled it will fall under one of two EU medical device regulations:

  • Medical Device Regulation (EU) 2017/745.
  • In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746.

To apply for approval to conduct a clinical investigation in Ireland sponsors need both regulatory (HPRA) and ethical approvals (NREC-MD).

Post marketing clinical investigation of a CE marked device may only require notification to HPRA (rather than an application).

Clinical Investigations should also adhere to ISO – ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice.

Regulatory and Ethics Approvals For Other Interventional Studies (e.g Food supplement) and Observational Studies.

For these lower risk studies it is not necessary to apply for HPRA approval but it is necessary to apply for ethical approval from a local ethics committee.

All clinical trials conducted in Ireland much have the appropriate insurance/indemnity in place. The following needs to be considered in relation to insurance/indemnity for the clinical trial: 

  • In Ireland, the Clinical Indemnity scheme (CIS) run by the States Claims Agency (SCA) provides cover for personal injury to patient participants in a clinical trial resulting from a negligent act during the professional of medical services under certain specific circumstances. These include where the trial is carried out (HSE site or other) and who is carrying out the trial (HSE employee or other) Clinical Indemnity Scheme – State Claims Agency. The CIS works on a legal liability basis only and does not extend to include no fault compensation. 
  • Sponsor/Clinical Trial Insurance must be in place to cover the protocol and the product. The sponsor should arrange clinical trials insurance with a limit of indemnity of no less than €6.5million in the annual aggregate for Clinical Trials of IMP.  
  • No sum for sponsor insurance of Clinical Investigations of Medical Devices has been specified. The amount should be proportionate to the type of device and the risks.  
  • Other Sponsor organisational insurance such as employer’s liability and public liability may be required. 

The HSE National Central Repository (NCR) is a single source system for accessing, storage, and document control of HSE National Policies, Procedures, Protocols, Guidelines and Clinical Guidelines (PPPGs).