1. Research Code of Practice Research Ethics Review Procedures
Approved by Senate on 20th September 2017

2. Research Code of Practice
The previous Guidelines for University of Malta Research Ethics Committee contain an amalgam of principles and procedures relating to research with human participants.
Principles of ethical behaviour in all types of research are now laid out in the
Research Code of Practice
Procedures relating to research ethic committees and the research ethics review process for all research now in
Research Ethics Review Procedures

3. Research Code of Practice

4. Research Code of Practice
Based on “Golden Rules to Ethical Research Conduct” of the European Union.
European Commission Ethics for Researchers (2013)
Applies to all those undertaking research on the University’s premises using its facilities, or on behalf of the University, including staff, students, visiting or affiliate staff, associates, contractors and consultants.
Covers ALL research, not only that involving human participants.

5. Research Code of Practice
Principles of Ethical Research Conduct
Guidelines on the application of the Principles
Obtaining Consent from Research Participants
Ensuring privacy and personal data protection
Research involving vulnerable populations

6. Research Ethics
Review Procedures

7. Research Ethics Review Procedures
All research at the UM shall comply with the University’s Research Code of Practice and be guided by the European Commission’s Ethics for Researchers: Facilitating Research Excellence in FP7 (2013).
Senate, on the advice of the University Research Ethics Committee (UREC), may also require that research in certain areas complies with research-related policies, guidelines and principles published by internationally recognised organisations.

8. Research Ethics Committees Faculty Research Ethics Committees (FRECs)
Each faculty shall have a FREC, composed of at least three members, to manage the research ethics review process and to ensure that the University’s Research Code of Practice is adhered to.
FRECs may appoint sectoral sub-committees to advise them (e.g., on animal research)
Institutes, Centres or Schools shall make arrangements with Faculties that carry out research in similar areas for research ethics and data protection reviews to be carried out by the appropriate FREC.

9. Research Ethics Committees University Research Ethics Committee (UREC)
UREC shall have a chairperson and a minimum of ten committee members.
UREC Dec Dec 2019
Prof. Patrick J. Schembri (Chair)
Dr Leonie Baldacchino
Dr Marie Briguglio
Prof. Noellie Brockdorff
Dr Michelle Camilleri
Dr Mireille Caruana
Dr Elisabeth Conrad
Prof. Mary Darmanin
Dr Owen Falzon
Prof. Ian Thornton
Prof. Mario Valentino

10. Research Ethics Committees University Research Ethics Committee (UREC)
UREC is to have two streams: an Ethics stream and a Data Protection stream. The UREC chairperson shall chair the committees for both streams. The chairperson may propose a delegate from amongst the members of UREC to act on their behalf if necessary.

11. Research Ethics Committees University Research Ethics Committee (UREC)
The UREC-Ethics Committee (UREC-E) shall be composed of the UREC chairperson and a minimum of six members from the UREC committee, who together, bring expertise in i. Arts and Humanities, ii. Social Sciences, iii. Natural sciences, iv. Applied sciences, v. Medical Science, vi. Animal Research.
UREC-E meetings shall be chaired by the UREC chairperson or their delegate, and consist of a minimum of two members from the UREC-E committee who are experts in the area of research of the proposals being reviewed

12. Research Ethics Committees University Research Ethics Committee (UREC)
The UREC-DP Committee (UREC-DP) shall be composed of the UREC chairperson, or delegate, and a minimum of four additional members from the UREC committee who are knowledgeable in data protection.
UREC-DP meetings shall be chaired by the UREC chairperson or their delegate, and consist of a minimum of two members from the UREC-DP committee who are familiar with the area of research of the proposals being reviewed

13. Research Ethics Review Procedures Overview
Process starts with the Principal Investigator (PI)* completing a self-assessment exercise on Research Ethics and Data Protection (REDP).
*Principal Investigator - The primary individual responsible for the preparation, conduct, and administration of a research project. In the case of student projects, the PI is the student, duly guided by an academic supervisor.

14. Research Ethics Review Procedures Overview
Depending on the outcome of this self-assessment, the PI may either
commence the research or
submit an application for review to the FREC.

15. Research Ethics Review Procedures Overview
FRECs are authorised to review and approve REDP reviews on behalf of the University, that are not automatically approved through the self-assessment process,
except in the case of sensitive personal data as defined in Chapter 440 of the Laws of Malta (Data Protection Act), and
where ethics or data protection issues cannot be resolved with the PI.
In these instances, the FREC shall refer the application to UREC.
Sensitive personal data is that which reveals race or ethnic origin, political opinions, religious or philosophical beliefs, membership of a
trade union, health, or sex life.

16. Research Ethics Review Procedures Overview
In all instances, it is the FRECs that communicate with PIs about the outcome of any REDP review.
The FREC will, if necessary, assist with the resolution of any matters that require to be addressed and with the preparation of a revised REDP review application.

18. Thank you for your attention
Further questions should be sent to: