This quick reference summarises RECoPP §4.0 triggers. For the full text see the
Research Ethics Code of Practice and Procedures (RECoPP, approved by Senate 23 April 2026) -
note that the review procedures previously issued as a separate "Research Ethics Review Procedures" document are now
incorporated directly into the RECoPP (§6.0–6.5).
Not sure? Use the AI Ethics Check or contact
research-ethics.cmmb@um.edu.mt.
At a Glance
🔴 CMMB REC Review required if your research involves…
- Direct data collection from human participants
- Unpublished or access-controlled secondary human data
- Live animals (vertebrates or cephalopods)
- Special Categories of Personal Data → also requires UREC-DP
✓ Records Only - no CMMB REC review needed if…
- Work uses commercial cell lines only (e.g. ATCC, gifted established lines)
- Purely computational or bioinformatics work
- Use of truly public, anonymised datasets
- In vitro lab work with no human participants or live animals
These examples are CMMBrec's practical interpretation of the RECoPP §4.0 self-assessment outcome (submission "for records" vs. "for review") - they are not an itemised list in the RECoPP itself.
Full RECoPP §4.0 Trigger List
The trigger categories (i)–(v) and their items are drawn directly from RECoPP §4.0 "Principles of Ethical Research Conduct". The "Outcome" tags - including the Borderline label - reflect CMMBrec's own practical classification of how each trigger is typically routed, not wording quoted from the RECoPP.
| Trigger | Examples | Outcome |
|---|---|---|
| Category (i) - Human Participants | ||
| Primary data collection from human participants | Surveys, questionnaires, interviews, focus groups, blood/tissue collection, physiological measurements | CMMB REC Review |
| Risk of harm to participants | Physical, psychological, legal, economic or social harm from participation | CMMB REC Review |
| Physical intervention on participants | Injections, blood draw, biopsy, invasive imaging, electrode placement | CMMB REC Review |
| Vulnerable participants | Children, prisoners, persons with disability, substance abusers, economically or educationally disadvantaged persons (illustrative list per UM's established guidance on vulnerable populations; the current RECoPP §4.0 names "vulnerable participants" as a trigger without itemising categories) | CMMB REC Review |
| Identifiable participants without explicit consent | Participants identifiable through direct attribution or indirect description | CMMB REC Review |
| Special Categories of Personal Data (SCPD) | Genetic data, health/medical data, biometric data, racial/ethnic origin, political opinions, religious beliefs, sex life (GDPR Art. 9) | CMMB REC + UREC-DP |
| Human tissue, cells or biological sample provenance | Human tissue, cells, blood, saliva, urine, body fluids or derived material obtained commercially, collected within the project, received from another project/laboratory/institution, obtained from a biobank, imported/exported, stored for future use, or linked to donor consent, clinical information, genetic testing or other personal data | CMMB REC + DP Review ...where samples are collected from participants, associated with health/genetic data, stored for future use, or may generate incidental findings - regardless of whether they are formally linked to donor identity, since genetic material can itself remain identifiable. Governance check needed for provenance, consent, authorisation, import/export and biobank permissions. |
| Withheld information when obtaining consent | Concealment of research purpose until after data collection; requires debriefing plan | CMMB REC Review |
| Opt-out recruitment | Consent implied by non-response rather than active opt-in | CMMB REC Review |
| Deception in data generation | Misleading participants about the nature or purpose of the research | CMMB REC Review |
| Potential incidental findings | Research that may unexpectedly reveal health or personal information about participants | CMMB REC Review |
| Category (ii) - Secondary Data | ||
| Unpublished secondary human data | Patient cohorts, clinical datasets, de-identified/pseudonymised data from another study | CMMB REC Review |
| Unpublished secondary animal data | Unpublished datasets involving animal subjects from another study | CMMB REC Review |
| No written permission from data controller | Using existing datasets without documented permission from the data controller | Borderline |
| Category (iii) - Animals | ||
| Primary data collection from live animals | Live vertebrates (mice, rats, zebrafish, rabbits) or cephalopods; applies 3Rs (Replace, Reduce, Refine) | CMMB REC Review |
| Harm to live animals | Pain, suffering, distress or lasting harm to vertebrates or cephalopods | CMMB REC Review |
| Dead animals acquired illegally | Use of specimens obtained without proper permits or in violation of wildlife law | CMMB REC Review |
| Category (iv) - Institutional & Other Concerns | ||
| Cooperating institution requiring prior CMMB REC approval | Some institutions require CMMB REC approval before researcher may approach them (e.g. schools, hospitals) | CMMB REC Review |
| Risk to researcher(s) | Physical safety, psychological trauma, legal risk to members of the research team | CMMB REC Review |
| Risk to environment | Destructive techniques, species/habitat harm, GMO release, toxic or pollutant discharge | CMMB REC Review |
| Commercial sensitivity | Confidential intellectual property, financial data, development plans | CMMB REC Review |
| Category (v) - Other Risks | ||
| Dual use / misuse potential | Research that could be misused by terrorists or military organisations | CMMB REC Review |
| Conflict of interest | Financial, personal or professional interests that could bias the research | CMMB REC Review |
| Dual role / power imbalance | Researcher is also lecturer, clinician or employer of participants | CMMB REC Review |
| Permission / licence required for research tools | Validated questionnaires, specialised equipment or databases requiring creator permission | CMMB REC Review |
| Collaboration in low / lower-middle income country | Research conducted in or using data/materials from LMIC - capacity building plan required | CMMB REC Review |
| Import / export of data, materials or specimens | Cross-border transfer of biological samples, personal data or research materials | CMMB REC Review |
| Harvest of data from social media | Collecting or recruiting via Facebook, Twitter/X, Instagram, LinkedIn, TikTok, Reddit etc. | CMMB REC Review |
| Criminal issues / incarcerated persons | Research involving criminal allegations, proceedings, convictions or incarcerated persons | CMMB REC Review |
| Category (vi) - Emerging & Specialist Risk Areas | ||
| Artificial intelligence, algorithmic systems or automated decision-making | Use of AI, machine learning, automated classification, predictive modelling, profiling, human-machine interaction, surveillance tools, decision-support systems, or systems that may affect individuals, groups, services, diagnosis, treatment, access, risk assessment or institutional decisions | CMMB REC + DP Review ...where human participants, personal data, profiling, surveillance, health/genetic data or decision-making affecting individuals are involved. Governance/specialist review may also be required. |
| Clinical trials, medical devices, IVDs or regulated medical interventions | Clinical trials, low-intervention clinical trials, use of medicinal products, biologicals, radiopharmaceuticals, advanced therapy medicinal products, medical devices, in vitro diagnostic devices, investigational assays, or interventions requiring authorisation, registration, insurance or liability arrangements | CMMB REC Review + regulatory approval ...and relevant regulatory approval. DP review additionally required where personal data, health data or special category personal data are processed. |
| Detailed personal data processing risks | Processing of personal data involving special category data, criminal offence data, large-scale datasets, profiling, systematic monitoring, surveillance, geolocation tracking, further processing of previously collected data, dataset linkage, data import/export, DPIA requirements, DPO involvement, data minimisation, pseudonymisation/anonymisation and data security | CMMB REC + DP Review CMMB REC Review applies wherever the data processing also creates ethical risk to participants, groups, researchers or communities - alongside the DP review of the processing itself. |
When CMMB REC Review is NOT Required
The following types of research are suitable for records only - submit the REDP self-assessment via URECA and research may commence upon acknowledgement by CMMBrec.
| Research Type | Examples | Outcome |
|---|---|---|
| Commercial cell lines only | ATCC-purchased lines; gifted established lines (HeLa, HEK293, MCF7, HCC lines, DLD1, etc.); no human recruitment | Records Only |
| Purely computational / bioinformatics | In silico modelling, sequence analysis, machine learning on public datasets | Records Only |
| Truly public, anonymised datasets | Open-access databases (Zenodo, public gene repositories) where data are genuinely non-identifiable | Records Only |
| In vitro work with no human participants | Proteomics, Western blotting, cell viability assays on established lines; no recruitment, no live animals | Records Only |
Possible Outcomes from CMMBrec
| Outcome | Meaning | Can research proceed? |
|---|---|---|
| Acknowledged (Records Only) | No ethical concerns identified; submission recorded for audit purposes | ✓ Yes, immediately |
| Approved | Full CMMB REC review completed; all ethical concerns addressed | ✓ Yes, upon approval |
| Returned | Revisions or further information required before a decision can be made | ✗ Not yet - resubmit |
| Referred to UREC-DP | Special Categories of Personal Data involved - referred to UREC-DP for data protection review | ✗ Await UREC-DP decision |
CMMBrec aims to respond within 30 working days of receipt. Accelerated approval (10 working days) may be requested for funded projects with tight deadlines. See Research Ethics Code of Practice and Procedures §6.5 - Accelerated Approval Procedure (the review procedures are now incorporated directly into the RECoPP, §6.0–6.5, rather than a separate document).
Submission Flow
Step 1 - Complete the REDP self-assessment on URECA
Answer all questions honestly. Use the AI Ethics Check if unsure.
Step 2 - Supervisor endorsement (students only)
Your principal supervisor must endorse the form before it reaches CMMBrec.
Step 3 - CMMBrec review
Records Only → acknowledged. CMMB REC Review required → committee reviews within 30 working days.
Step 4 - UREC-DP referral (if SCPD involved)
CMMBrec forwards to UREC-DP. Additional 30 working days for data protection review.
Step 5 - Commence research
Research may only begin once the appropriate approval has been received.