RECoPP - Research Ethics Code of Practice & Procedures
The RECoPP sets out the University of Malta's framework for research ethics review. It was approved by Senate on 23 April 2026 and applies to all research conducted under UM auspices.
- Research Code of Practice University of Malta Senate - approved 2017, amended 2019 View →
- Research Ethics Review Procedures University of Malta Senate - approved 2017, amended 2019 View →
- RECoPP Quick Reference - §4.0 Triggers What requires FREC review at a glance View →
- Research Data Management Policy (POL-002-01) University of Malta Senate - approved 19 September 2025; sets out FAIR data principles, DMP guidance and the drUM repository Download PDF
Form Templates
Use the templates below when preparing your REDP submission. All forms must be submitted via URECA - do not email forms directly to CMMBrec.
- Participant Information Sheet (PIS) - Standard For adult participants with full consent capacity - editable Word template, adapt to your study before submission Download DOCX
- Consent Form - Clinical & Laboratory Studies For adult participants in clinical trials, clinical research or laboratory-based studies - adapted from the WHO ERC template Download DOCX
- Parent/Guardian Consent & Child Assent Form - Clinical & Laboratory Studies Combined template for minor participants - parent/guardian consent plus child-friendly assent in one document Download DOCX
- Data Management Plan (DMP) Template Required for all projects involving personal or sensitive data Download DOCX
- Recruitment Letter Template For recruiting participants via letter or email Download DOCX
* Templates will be uploaded when confirmed by CMMBrec. Contact research-ethics.cmmb@um.edu.mt in the meantime.
GDPR & Data Protection
Research involving personal data must comply with the General Data Protection Regulation (GDPR) and Malta's Data Protection Act (Cap. 586).
Key requirements
- A Data Management Plan (DMP) is required for all projects involving personal data
- Special Categories of Personal Data (SCPD) require referral to UREC-DP
- Data must be stored securely and not retained beyond the stated period
- Participants must be informed of their GDPR rights (access, erasure, portability)
What are Special Categories?
Under GDPR Article 9: genetic data · health data · biometric data · racial/ethnic origin · political opinions · religious/philosophical beliefs · trade union membership · sex life or sexual orientation.
Guidance Notes
- Guidance: When does my research require FREC review? Quick visual checklist - the five most common triggers at a glance View →
- Guidance for Applicants What CMMBrec looks for - scope of review, recruitment, consent, data protection, samples, genetics, AI tools and more View →
- Guidance: Writing a Data Management Plan (DMP) UREC guide (approved 9 March 2021) - what a DMP is, why it matters, and a Q&A walkthrough covering data nature, storage, sharing and retention Download PDF
- Guidance: Writing a Consent Form Choosing the right template, voluntariness, data protection, retention and more View →
- Guidance: Writing a Participant Information Sheet What to include and plain-language requirements Download PDF
- Guidance: Secondary Data Use and Ethics When secondary data requires FREC review Download PDF
- REDP Triage Tool AI-assisted triage of URECA submissions (Chair use) Open →
External Links
- URECA PortalSubmit and manage REDP applicationsVisit ↗
- UREC - University Research Ethics CommitteeUniversity-level oversight bodyVisit ↗
- UREC-DPData protection referralsVisit ↗
- Office of the Information and Data Protection Commissioner (IDPC)Malta's national data protection authority and guidanceVisit ↗
- Centre for Molecular Medicine and BiobankingCMMB home pageVisit ↗