Read all about the University of Malta Research Ethics Review Procedures found on the University Research Ethics Committee’s (UREC) website.

If you are a researcher (also referred to as applicant) follow the guidelines outlined in the University of Malta Research Code of Practice.

If you are a researcher carrying out research with disabled people follow the Ethical Guidelines for Carrying Out Research with Disabled People.

If you are a researcher carrying out research with incarcerated persons, follow the Ethical Guidelines for Conducting Research with Incarcerated Persons.

Make sure to refer to the guidelines regarding the use of inclusive language.

You are also advised to refer to the Frequently Asked Questions (FAQs), sample documents  and the procedure for obtaining consent from online/remote participants, all available on the UREC website as well.

You can download the full replica of the University Research Ethics Committee Application’s (URECA) Research Ethics and Data Protection form (URECA-REDP) to familiarise oneself with its contents and requirements.

Fill in and submit the URECA-REDP form. On the UREC website this form is referred to as URECA or REDP interchangeably.

The URECA-REDP form consists of three sections:

• Part 1: Applicant and project details
• Part 2: Self-assessment and relevant details
• Part 3: Submission

For further guidance, have a look at the instructional videos. 

Read these important notes carefully:

• Fill in Parts 1, 2 and 3.  If any of the questions in Part 2 are marked as ‘Yes / Unsure’ the application will be REVIEWED by FREC before starting any data collection. In cases where none of the questions in Part 2 are marked as ‘Yes / Unsure’ the application will be received by FREC for filing and kept for RECORDS and audit purposes. In this case data collection may start immediately.
• Researchers who have Identifiable Participants (Part 2, question 4) and/or who are collecting Special Categories of Personal Data (SCPD) (Part 2, question 5) require a Data Management Plan. 
• Applicants who will be recruiting participants through social media are to attach a social media blurb to the URECA-REDP form together with the relevant trail of correspondence with administrators, when applicable.
• Applicants should mark Part 2, question 17 as ‘Yes / Unsure’ if:
  • cooperation from gatekeepers of institutions is required to recruit non-professionals, i.e. participants recruited not in their professional capacity, such as current or previous service users, clients and/or patients, hence making these cooperating institutions known also as sensitive intermediaries [PDF]; or
  • the Office of the Registrar and/or Communications Office will be asked to disseminate their call for participants.

Such applicants need to first submit their application, including the draft letter/s to the cooperating institution/s, information sheet/s, consent form/s and interview guide, and obtain FREC approval before approaching the cooperating institution/s. Applicants can contact the cooperating institution/s following FREC approval, which is issued on condition that a copy of the exchange of communication (full email threads in PDF format) with such institutions is attached to the URECA-REDP form.

• If your participants are non-professional, you must always regard the gatekeepers as sensitive intermediaries.
• Applicants should mark Part 2, question 17 as ‘No / N.A.’ if:
  • cooperation from gatekeepers is required to recruit older persons through care homes and/or informal carers through a cooperating institution. Such applicants need to first contact the cooperating institution/s and attach a copy of the exchange of communication (full email threads in PDF format) with such institutions to the URECA-REDP form; or
  • cooperation from gatekeepers is required to recruit professionals in their professional capacity through a cooperating institution. Such applicants need to first contact the cooperating institution/s and attach a copy of the exchange of communication (full email threads in PDF format) with such institutions to the URECA-REDP form; or
  • they require to recruit professionals, who will be participating in their professional capacity, directly through their professional public contact. Such applicants must only attach the draft letter/s to the professional/s to the URECA-REDP form. Contact with the professionals can be made prior to or after FREC approval.
• If professional participants are identifiable or if you are using elite interviews you need to address this specifically in the draft letter to the professionals, in the information letter and in the consent form (see UREC samples).
• The full email threads with the gatekeepers (in PDF format) should have the researcher’s original request and the gatekeeper’s reply that they are willing to distribute the information letter/consent form to potential participants. The information letter/consent form should only be sent by the gatekeeper to potential participants once the application is approved by FREC. This should be clearly indicated in the original email correspondence.
• Email threads are always the preferred evidence for communication with cooperating institutions. However, this is sometimes impossible when the gatekeepers are Facebook administrators. Permission from Facebook administrators is usually sought via Messenger not email. When applicants send private messages to the Facebook administrators and then these administrators give them permission to post information about the researcher’s study on the respective Facebook page, such trail of correspondence may be presented as chat screenshots. In this case, since email threads are not possible, chat screenshots of consents (in PDF format) are acceptable.
• Part 2, question 22 should only be ticked as ‘Yes / Unsure’ if questions 1 to 21 are marked as ‘No / N.A.’ and you need FREC’s review and approval due to publication and/or funding purposes. It should also be marked as ‘Yes / Unsure’ when the application needs to be submitted for Review, and following FREC’s requested amendments that Part 2 questions 1 to 21 should be marked as ‘No / N.A.’. Since the first submission would have been submitted for Review, FREC would need to check that the requested amendments were carried out to issue the approval.
• Only personal data that identifies the participant can be kept confidential while the research data should be pseudonymised or anonymised.
• Consent forms should reflect the requirements indicated in Section 3.1.3 of the University of Malta Research Code of Practice.  
• All attachments (also referred to as supporting documents) should be sent in PDF format. Same documents in different language versions should be saved as one PDF document indicating what the document is about and the languages used in the file name (e.g., Information Letter-English-Maltese).
• Students should not use the University of Malta (UM) logo in their supporting documents. However, Mater Dei Hospital requires that the UM logo is used. Only in this case can students use the UM logo for the purpose of the research. The documents with the UM logo should be used for Mater Dei Hospital ONLY.
• The Principal Supervisor is to ENDORSE the URECA-REDP form and all attachments.  As indicated in the Research Ethics Review Procedures, supervisors are responsible for the documents they endorse. 
• Supervisors should ensure the URECA-REDP form and related materials are up to standard before forwarding their approval. This includes proper use of English and Maltese without grammatical errors and typos. 
• Once the URECA-REDP form and attachments are submitted, the supervisor receives it automatically.  FREC will only receive the application once the supervisor endorses it.

• When the URECA-REDP application is filed for Records researchers cannot state that FREC has reviewed/approved their study. UREC encourages the use of the following statement where no FREC review is necessary: 'This research is in conformity with the University of Malta’s Research Code of Practice and Research Ethics Review Procedures.' 
• When the URECA-REDP application is for Review, applicants shall wait for ethical approval before starting any data collection.
• Amendments to all supporting documents should be made using the Microsoft Word track changes function, showing ‘All Markup’, and saved as PDF documents. The URECA-REDP form does not have this function. Therefore, amendments to the URECA-REDP form ONLY should be made using square brackets [ ] to indicate anything you want to delete, and CAPS to indicate anything you want to add. Applications submitted without track changes or the required squared brackets and CAPS will NOT be reviewed.
• The same URECA-REDP form with the same REDP Application ID (e.g., SWB-2023-00001) should be used for the same research until it is finally approved.
• In case changes need to be made after the application had been approved, the URECA-REDP form needs to be withdrawn, amended in track changes and resubmitted. The cover note to FREC (Part 3), should include an explanation of what changes are being made. If supporting documents will be amended or added, the cover note to FREC should also indicate which documents these are by quoting their file name. The application will be received by FREC after the supervisor’s endorsement.
• Infringements of regulations and/or policies concerning ethics and data protection are matter for disciplinary action.
• For any questions regarding any issue/s related to FREC please contact us via email or by calling us on 2340 2237.

Submit the application, for the consideration of FREC, by these deadlines:

4 September 2023

9 October 2023

6 November 2023

4 December 2023

8 January 2024

5 February 2024

4 March 2024

8 April 2024

6 May 2024

3 June 2024

8 July 2024

9 September 2024

Applications will be accepted until 23:59 of the dates indicated. The supervisor’s endorsement is to reach the SWB FREC by the given deadlines, otherwise, the application will be considered as a late submission. Late submissions will be reviewed in the subsequent FREC meeting.

NOTE: The above dates are subject to change only in adaptation to UREC-DP meetings and to extraordinary circumstances which are beyond FREC's control.

UM's Research Ethics Review Procedures, apply 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. However, the University Research Ethics Committee (UREC) also provides ethics and data protection reviews to non-University of Malta applicants, including commercial entities.

Such external applicants need to contact UREC via email. They will be assigned credentials which they can use to fill in the form on URECA and submit this, together with any ancillary documentation, to the appropriate Faculty Research Ethics Committee (FREC/REC) depending on the area of research, clearly indicating that this is an external application. Refer to the list of FRECs.  

A non-refundable fee is charged for this service as follows:

• external non-commercial researchers: EUR 95
• commercial rates: please contact UREC for a quotation. 

Non-commercial applicants may pay using the online form. A copy of the receipt is to be appended with the application when this is submitted to the FREC.

Approved, no UREC
The submission is completely approved and research may commence.

Approved, pending UREC
The submissions containing Special Categories of Personal Data (SCPD) need first to be approved by FREC and then forwarded to UREC-DP for approval of the data protection component. As the submission is NOT completely approved, research may NOT commence. UREC-DP’s feedback is sent to FREC which will be forwarded to the researcher. Amendments to the supporting documents should be carried out in Microsoft Word using track changes and saved as ONE PDF document which should also include any gatekeepers’ permissions requested by UREC-DP. FREC This PDF document should be added to the URECA-REDP form which will be sent back to you so that you can resubmit. Therefore, FREC should receive the URECA-REDP form, all supporting PDF documents previously submitted, and this added PDF document. FREC will only receive the application after the supervisor’s endorsement. If track changes are not used, the application will NOT be reviewed and will be sent back to the applicant.

Approved on Condition
The submission is NOT yet fully approved as there are still minor amendments to be carried out AND/OR the gatekeepers’ permissions still need to be submitted to FREC. Therefore, research may NOT commence. A feedback sheet will be sent to you via email. Amendments to the supporting documents should be carried out in Microsoft Word using track changes and saved as PDF documents. If any amendments need to be carried out to the URECA-REDP form, square brackets [ ] should be used to indicate anything that you want to delete, and write in CAPS anything you want to add. The URECA-REDP form will be sent back to you so that you can alter it and resubmit. FREC should receive the URECA-REDP form and all supporting PDF documents including all the gatekeepers’ permissions. FREC will only receive the application after the supervisor’s endorsement. The supervisor (in case of students) or the Principal Researcher/Research Team (in case of academics and research support officers) is/are to ALSO send an email to FREC confirming that the changes have been carried out AND/OR the gatekeepers’ permissions have ALL been obtained. FREC will only send the APPROVAL EMAIL once the supervisor’s/Principal Researcher’s/Research Team’s confirmation email [PDF] is received. Otherwise, the application will remain pending and research cannot commence.

Conditionally Approved
The submission is NOT yet approved as there are still major amendments to be carried out. Therefore, research may NOT commence. A feedback sheet will be sent to you via email. Amendments to the supporting documents should be carried out in Microsoft Word using track changes and saved as PDF documents. If any amendments need to be carried out to the URECA-REDP form, square brackets [ ] should be used to indicate anything you want to delete, and write in CAPS anything you want to add.  The URECA-REDP form will be sent back to you so that you can alter it and resubmit. FREC will only receive the application after the supervisor has endorsed by the set deadlines. If track changes are not used, the application will NOT be reviewed and will be sent back to the applicant.

Refused
Your URECA-REDP form needs amendments and is being sent back to you to be revised. Therefore, research may NOT commence. A feedback sheet will be sent to you via email. Amendments might also be required to the supporting documents. FREC should receive the URECA-REDP form and all the supporting PDF documents. FREC will only receive the application after the supervisor has endorsed by the set deadlines.