Regulatory, Ethics, Insurance

Clinical trials must be conducted in accordance with Good Clinical Practice (GCP). GCP is a set of internationally recognised ethical and scientific quality requirements that must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Following the implementation of the Clinical Trials Directive 2001/20/EC, compliance with the principles of GCP became a legal requirement and was transposed into law in each member state. In Ireland this was transposed into law via Statutory Instrument No. 190/2004.  A new clinical trials directive is due to be introduced Clinical Trials Regulation (CTR) EU No. 536/2014 which will be transposed into Irish law once it becomes effective.

To open a trial that meets the definition of a “Clinical Trials on Medicinal Products for Human Use” (SI No 190 of 2004) ^* in Ireland, you need to seek:

1. Regulatory Approval from the Health Products Regulatory Authority (HPRA)
2. Central Ethical Approval from one of the twelve Recognised Ethics Committees (REC) (regardless of the number of trial sites at which the trial is to be conducted). The REC is authorised by the ECSB (Ethics Committee Supervisory Body/Minister of Health) to issue a single opinion for the whole state.

The department of health’s form for the Application to the Research Ethics Committees (REC) opinion on a clinical trial for a medicinal products is available on the Department of Health website.

Note: In July 2019 the Department of Health published the General Scheme of the National Research Ethics Committee Bill. The bill will establish a national office for research ethics committees (to be hosted by the Health Research Board). The current REC system requires updating in order to meet the requirements of the new EU Clinical Trials of Medicinal Products Regulation 2014.

3. Hospital sign-off/Organisational Approval is required before commencing the study at each participating Hospital. This refers to the signing of the Clinical Trial Agreement, Clinical Trial Indemnity Form and EC Site Specific Assessment Form by the hospital legal representative.

The Department of Health’s Site-Specific Assessment Form (SSA is available on the Department of Health’s website.

All clinical trials conducted in Ireland much have the appropriate insurance/indemnity in place. The requirement for insurance/indemnity is specified in SI 190 of 2004. In addition, GCP requires a sponsor to indemnify the institution and investigator in respect of claims made on behalf of the clinical trial subjects.  The following needs to be considered in relation to insurance/indemnity for the clinical trial:

• In Ireland the Clinical Indemnity scheme provides cover for personal injury to patient participants in a clinical trial resulting from a negligent act during the professional of medical services. Investigators/Sponsors should contact the state claims agency to see if their research can be covered under the CIS scheme.
• Sponsor/Clinical Trial Insurance must be in place. The CIS works on a legal liability basis only and does not extend to include no fault compensation. The sponsor should arrange clinical trials insurance with a limit of indemnity of no less than €6.5million in the annual aggregate.
• Products Liability; it is recommended that product liability insurance is arranged with no less than €6.5m in the annual aggregate.
• Other organisational insurance such as employer’s liability and public liability.

Please see the State Claims Agencies website for the Clinical Trial Indemnity Form.