Irish Clinical Research Ethics Committee Protocol Approval Application

Irish Clinical Research Ethics Committee Protocol Approval Application

Conducting clinical research in Ireland requires approval from a recognised Research Ethics Committee (REC) to ensure participant safety, ethical standards, and regulatory compliance. This Irish Clinical Research Ethics Committee Protocol Approval Application template streamlines the entire submission process, helping researchers, medical institutions, and pharmaceutical organisations prepare thorough applications that meet Irish and EU regulatory requirements.

Built for Irish Clinical Research Standards

This form template addresses the specific requirements of Irish RECs, including adherence to the Health Research Regulations 2018, GDPR data protection standards, and the EU Clinical Trials Regulation (EU) No 536/2014. Whether you're applying through a hospital-based ethics committee, a university REC, or submitting to the Health Research Consent Declaration Committee (HRCDC), this template covers essential protocol details, informed consent procedures, data protection measures, and participant safeguards.

The form captures comprehensive research details including study objectives, methodology, participant selection criteria, risk assessments, and data management plans. It also addresses informed consent procedures specific to Irish regulations, ensuring vulnerable populations are appropriately protected and participants' rights are respected throughout the research process.

Streamline Your Ethics Application Workflow

With Paperform, you can brand this application form to match your institution's identity, embed it on your research portal, or share it as a standalone link with investigators. Conditional logic ensures researchers only see relevant sections based on their study type—whether it's a clinical trial, observational study, qualitative research, or retrospective data analysis.

Once submissions come through, use Stepper (stepper.io) to automate your review workflow. Route applications to the appropriate committee members, trigger email notifications for document requests, update your research management database, and track approval status without manual data entry. This creates an efficient, auditable process that keeps everyone informed and ensures no application falls through the cracks.

For studies requiring additional documentation like consent forms or participant information sheets, use Papersign (papersign.com) to collect electronic signatures from investigators, co-investigators, and study sponsors, maintaining a complete digital audit trail for regulatory inspections.

GDPR-Compliant and Secure

Built with data protection at its core, this template helps Irish research institutions maintain GDPR compliance while collecting sensitive research information. Paperform is SOC 2 Type II compliant, offering secure data handling, custom data residency options, and role-based access controls perfect for multi-site research organisations.

Whether you're a university research office, hospital ethics administrator, pharmaceutical sponsor, or independent researcher, this Irish Clinical Research Ethics Committee Protocol Approval Application provides a professional, compliant foundation for your ethical review process—all without requiring IT support or custom development.