Clinical Trial Consent Form (Ireland)

A Clinical Trial Consent Form in Ireland puts facts or consent on the record under a formal declaration so they can be relied on by a regulator, court, or third party.

The legal framework for clinical trials in Ireland is now governed primarily by EU Regulation No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (the Clinical Trial Regulation, or CTR), which entered into application in Ireland on 31 January 2022. The CTR directly repealed and replaced the EU Clinical Trial Directive 2001/20/EC and the Irish implementing regulations made under that Directive — principally the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 190 of 2004). As an EU Regulation, the CTR is directly applicable in all EU Member States, including Ireland, without the need for domestic implementing legislation.

The Health Products Regulatory Authority (HPRA) is the Irish national competent authority for clinical trials under the CTR, responsible for the scientific and safety review of clinical trial applications (Part I of the CTR application process). The HPRA's role is defined by the CTR and further elaborated in its guidance document 'Guide to Clinical Trials Conducted Under the CTR in Ireland' (AUT-G0170, currently Version 4). The HPRA is also responsible for pharmacovigilance (monitoring adverse events) and inspection of clinical trial sites for compliance with Good Clinical Practice (GCP).

The National Office of Research Ethics Committees (NREC), operated under the Health Research Board (HRB), is responsible for the ethics review of clinical trial applications in Ireland (Part II of the CTR application). NREC replaced the previous network of individual institutional research ethics committees (RECs) for CTR trials, providing a centralised, consistent ethics review process. The NREC has published guidance on the format and content requirements for consent forms and participant information leaflets for trials reviewed under the CTR.

Good Clinical Practice (GCP) — the international quality standard for designing, conducting, recording, and reporting clinical trials, reflected in the ICH E6(R3) guideline adopted by the EMA — imposes additional requirements for informed consent that must be met by all clinical trial investigators and sponsors in Ireland. The Declaration of Helsinki (World Medical Association, as amended) provides the ethical foundation for clinical research and informs the approach of Irish ethics committees to consent review.

A Clinical Trial Consent Form is needed before any person in Ireland can be enrolled in a clinical trial of a medicinal product regulated under EU Regulation No 536/2014. It is a mandatory pre-requisite for trial participation, and no investigational medicinal product (IMP) or trial procedure may be administered to a participant before a properly executed consent form is on file at the trial site.

You need a clinical trial consent form when your research site has received a positive opinion from both the HPRA (Part I) and the NREC (Part II) and is ready to commence participant recruitment. Before approaching potential participants, the investigator must have the approved consent form and participant information leaflet available and must have been trained in the GCP-compliant consent process.

You need a clinical trial consent form when a participant's circumstances change during the trial in a way that requires re-consent — for example, if the trial protocol is amended in a way that affects the participant's risks, benefits, or trial procedures; if a significant new safety finding emerges that must be communicated; or if a participant initially enrolled under a legally designated representative's consent recovers capacity and needs to be consented directly.

You need a clinical trial consent form when a participant (or their representative) wishes to withdraw from the trial. While withdrawal does not require a new consent form, the withdrawal should be documented and the participant reminded of which data already collected may be retained for scientific and regulatory purposes, consistent with the consent previously given and GCP requirements.

You need a clinical trial consent form when enrolling a participant who belongs to a special population under the CTR — a minor (under 18 in Ireland), an adult lacking capacity (Article 31 CTR), an incapacitated adult in an emergency situation (Article 35 CTR), or a pregnant or breastfeeding woman (Article 34 CTR). Each of these categories requires additional consent documentation and procedural safeguards beyond those required for standard adult participants with capacity.

You need a clinical trial consent form when translating consent materials for a participant whose first language is not English, to confirm that the translated materials have been verified for accuracy and appropriateness before use, consistent with NREC requirements and GCP.

A thorough Irish Clinical Trial Consent Form compliant with EU Regulation 536/2014, HPRA guidance (AUT-G0170), and NREC requirements must address the following key elements.

The trial identification section clearly identifies the trial by its EudraCT/CTIS number, protocol number, title (in plain language), phase, and the names of the sponsor and principal investigator at the Irish site.

The participant information confirmation section records that the participant has received and read the Participant Information Leaflet (PIL) for the trial (identified by version number and date), has had an opportunity to ask questions and have them answered to their satisfaction, and understands that participation is entirely voluntary.

The right to withdraw declaration confirms the participant's understanding that they can withdraw from the trial at any time without giving a reason and without any effect on their medical care — as required by Article 29(2)(b) CTR. The consequences of withdrawal for already collected data (which may be retained for scientific and regulatory purposes under Article 29(2)(e) CTR) should be explained.

The risks and benefits section confirms that the participant has been informed of the reasonably foreseeable risks, discomforts, and potential benefits of the trial, as required by Article 29(2)(a) CTR.

The data protection declaration confirms the participant's understanding of how their personal data will be processed: who will have access, for what purposes, retention periods, international transfers, and their GDPR data subject rights — consistent with Article 29(2)(k) CTR and GDPR Articles 13–14.

The biological samples section (where applicable) confirms the participant's separate consent to the collection, storage, and use of biological samples (blood, tissue, genetic material) and specifies whether samples will be retained after the trial for future research.

The signature section records the date, the participant's (or representative's) signature, and the investigator's (or their designate's) signature confirming the consent process was conducted in accordance with the CTR, GCP, and the approved protocol.

For paediatric trials, separate age-appropriate assent sections for children aged 6–11 and 12–15 are required, as well as parental/guardian consent sections under Article 32 CTR. The forms-legal.com Clinical Trial Consent Form (Ireland) template covers the mandatory elements under Sale of Goods and Supply of Services Act 1980.

Additional compliance elements for a Clinical Trial Consent Form (Ireland) used in Ireland include: Data Protection — the Data Protection Act 2018 and GDPR Article 6 require a lawful basis for processing personal data; Governing Law — specify Irish law and the jurisdiction of Irish courts; Dispute Resolution — parties may refer disputes to the Workplace Relations Commission (WRC) for employment matters or initiate proceedings in the Circuit Court or High Court of Ireland for civil claims. Under Irish law, the Data Protection Act 2018 and GDPR Article 6 govern personal data in this document. The Consumer Rights Act 2022 protects individuals in consumer transactions. Section 67 of the Land and Conveyancing Law Reform Act 2009 applies to personal property matters. The Circuit Court and District Court have jurisdiction over personal disputes under the Courts (Supplemental Provisions) Act 1961. The Commissioners of Irish Lights and Revenue Commissioners may have compliance roles depending on the transaction type. Revenue Commissioners require appropriate tax treatment of payments made under the agreement, including VAT under the Value-Added Tax Consolidation Act 2010 where applicable.