1.0 Definitions
Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Researcher: The primary individual (e.g., Principal Investigator, Research Support Officer, academic staff member) responsible for the preparation, conduct, and administration of a research project. In the case of student projects, the Researcher is the student, duly guided by an academic supervisor.
2.0 Scope
One of the principal and essential functions of a university is the carrying out of research. The University of Malta (UM) recognises its responsibility to researchers and the wider community to ensure that the highest standards of integrity and professionalism are observed in the conduct of research carried out under its auspices.
This document contains the UM's Procedures for the Review of Ethics in Research. It applies to all UM staff, students, and anyone else carrying out research under its auspices.
The committees established in this policy may consider requests for ethics and data protection review by Researchers external to the UM. This shall be done against payment to be determined by the Director of Finance, unless the research team includes UM staff or students, in which case no payment shall apply.
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).
3.0 Overview of Research Ethics Review Procedure
The procedure commences with the Researcher completing a self-assessment exercise on Research Ethics and Data Protection (REDP). Depending on the outcome of this self-assessment, the Researcher may either commence the research or submit an application for REDP Review to the FREC.
FRECs are authorised to review and approve REDP review applications on behalf of the University, that are not automatically approved through the self-assessment process, except:
- if the proposed research involves special categories of personal data (SCPD) as defined in EU Regulation 2016/679 (GDPR), and
- where ethics or data protection issues cannot be resolved with the Researcher.
In these instances, the FREC shall review the application for any ethics considerations and make a recommendation to UREC.
In all instances, it is the FRECs that communicate with Researchers 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.
4.0 Research Ethics Committees
4.1 Faculty Research Ethics Committees (FREC)
Faculties shall have a FREC to manage the research ethics review process within that entity and to ensure that the University's Research Code of Practice is adhered to. Institutes, Centres or Schools shall normally 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.
Composition
- Each FREC shall have at least three members
- Members are appointed by Senate for a period of three years, on the advice of the Faculty Board
- Members shall have knowledge about the various types of research conducted within the Faculty
- Where necessary, FRECs may appoint sectoral sub-committees to advise them
Review Process
- FRECs shall normally provide a response to the Researcher within 30 working days of receipt of the application
- Applications shall be assessed by a minimum of two FREC members and the FREC chairperson or their delegate
Conflict of Interest
A member of a FREC may not participate in a review of research in which the member has a conflicting interest (including being the supervisor of the research), except to provide information.
4.2 University Research Ethics Committee (UREC)
UREC shall have a chairperson and a minimum of ten committee members. UREC has two streams: an Ethics stream and a Data Protection stream.
The chairperson and members of UREC are appointed by Senate for a two-year term, renewable. A member of UREC may not participate in a review in which they have a conflicting interest.
4.2.1 UREC-Ethics Committee (UREC-E)
Composed of the UREC chairperson and a minimum of six members bringing expertise in: Arts and Humanities, Social Sciences, Natural Sciences, Applied Sciences, Medical Science, and Animal Research. At least one member shall have expertise in Research Ethics.
The role of UREC-E is to:
- Carry out annual audits of research ethics self-assessments and FREC reviews
- Prepare an annual report to Senate
- Arbitrate where Researchers do not agree with FREC decisions on ethics issues
- Prepare recommendations to Senate for improvement of Research Ethics policies
4.2.2 UREC-Data Protection Committee (UREC-DP)
Composed of the UREC chairperson and a minimum of four additional members knowledgeable in data protection.
The role of UREC-DP is to:
- Liaise with the Malta Information and Data Protection Commissioner (IDPC)
- Review research proposals involving special categories of personal data (SCPD) referred by FRECs
- Carry out annual audits of research data protection self-assessments
- Prepare an annual report to Senate
- Arbitrate where Researchers do not agree with FREC decisions on data protection matters
- Prepare recommendations for improvement of Research Data Protection policies
5.0 Research Ethics Review Procedure
5.1 Self-Assessment
All Researchers planning to undertake a research project must complete and submit a REDP form prior to undertaking any data collection. Within the REDP form, applicants first complete a self-assessment. Once correctly completed, it will guide Researchers to one of two outcomes:
- Outcome A: The research project has no further Ethical and Data Protection review requirements. The Researcher sends the completed form to the appropriate FREC for record and audit purposes and the research may commence.
- Outcome B: The research project has some further Ethical or Data Protection review requirements. The Researcher completes the full REDP proposal form and submits it to the appropriate FREC. The Researcher must await FREC's feedback before commencing any data collection.
In the case of students, the self-assessment shall be guided by the academic supervisor, who shall also be required to endorse the form submitted to FREC. Supervisors accept responsibility for ensuring the research proposal conforms with Senate policies and procedures.
5.2 FREC Review
FREC may decide that the issues flagged raise no serious ethical or data protection issues and inform the Researcher that they may commence research.
If the proposal raises issues, FREC may require clarification or improvement. The following outcomes are possible:
Concerns about Ethics
FREC provides feedback to the Researcher and attempts to resolve the issue by suggesting changes. If the changes address the concerns, the FREC informs the Researcher that they may commence research. If the issue cannot be resolved by dialogue, the proposal is forwarded to UREC-E.
Concerns on Data Protection (non-SCPD)
FREC provides feedback and attempts to resolve the issue with the Researcher. If unresolved, the proposal is forwarded to UREC-DP.
5.3 UREC-DP Review
Special Categories of Personal Data (SCPD)
After reviewing the proposal for ethics issues, the FREC forwards the proposal together with a recommendation to UREC-DP. UREC-DP reviews the proposal, submits its recommendation to the IDPC, and communicates the IDPC's decision to the FREC.
- If no changes are required - approval is granted
- If minor changes are required - approval is granted on condition that amendments are carried out and verified by the FREC
- If significant changes are required - the Researcher must submit a point-by-point response together with amended documents for further UREC-DP review
5.4 Accelerated Approval Procedure
In most instances, research may proceed upon completion of the self-assessment form. Where FREC review is required, the initial response shall normally take no more than 30 working days from submission. If UREC-DP review is also required, an additional 30 working days applies.
Where a funded programme involves a specific tight deadline, an accelerated approval process may be requested:
- The Researcher submits a request to the UREC Chairperson
- If justified, the UREC Chairperson requests the relevant FREC to review with urgency
- FRECs shall provide a response within 10 working days
- If UREC-DP review is also required, UREC-DP shall provide a response within 10 working days
Approved by Senate in September 2017 and amended by Senate on 21 March 2019.