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.
We also advise you to refer to the Frequently Asked Questions (FAQs), sample documents and the procedure for obtaining consent from research subjects during the COVID-19 restrictions, all available on the UREC website as well.
The following are guidelines for researchers when going through the ethics procedure.
1. Prepare a detailed plan of your research – this should include a reasoned evaluation of the project, a proposal and details of data collection protocols.
2. The Research E&DP Form can be completed online. This should be completed AFTER you have prepared a detailed plan of your research but BEFORE you start data collection or processing. A Word document replica of this form is also available. You are advised to consult both the Word version and relevant FAQs when preparing your submission and before filling in the online form. (see link above).
3. The Research E&DP form consists of four sections:
Part 1: Applicant and project details
Part 2: Self-assessment
Part 3: Detailed evaluation
Part 4: Submission
Students are to fill the form with the help of the supervisor. Go through Parts 1, 2 and 4 and fill in where relevant. Part 3 will show up if a potential ethics issue is marked in Part 2. In cases where Part 3 does not show up, no FREC approval is needed, the form must be submitted to FREC for filing and audit purposes, and any data collection may start immediately following supervisor endorsement. If Part 3 is to be filled in, applicants are to elaborate only on the issues flagged in Part 2 and seek FREC’s permission before starting any data collection. (See 5. For details.)
4. If your research raises matters relating to data protection, you may wish to refer to the UREC-DP checklist (see UM documents link above) for guidance. Any research that raises data protection issues will be reviewed by both the FREC and UREC-DP.
5. Once all the required forms have been filled in and submitted, the researcher receives a pdf version of the E&DP form, with a unique ID. Keep note of this unique ID. The researcher must send the pdf version to the FREC administrator with the unique ID and either 'For FREC Review' or 'For FREC Records’ in the subject line on the email together with any relevant assisting documentation such as project proposals, consent forms, non-disclosure agreements, recruitment letters and/or information sheets, data collection tools (interview questions, questionnaires and/or research tools) AND full trail of emails. Refer to sample documents link above for model documents. In the case of students, the main supervisor must be copied in the email and must endorse the E&DP form (done through an email to address above), and supervisor carries SHARED responsibility with student researcher for the content of the forms submitted. Submission is not considered complete until endorsed by the supervisor. Furthermore, any consent forms should reflect the requirements indicated in Section 3.1.3 of the University of Malta Research Code of Practice (see link above).
6. In the scenario where research requires FREC review, the initial response shall normally take no more than 30 working days from the time supervisor gives endorsement of the submitted application form to FREC. The response can be one of the following: (i) Approval – the researcher may proceed with the study proposed; (ii) Conditional Approval – the researcher may proceed with the study proposed on condition of certain amendments to the satisfaction of FREC; (iii) Approval Withheld – pending clarifications or major amendments to the documents, where in the latter case these need to be resubmitted. If the proposal also needs to be submitted to UREC-DP, then the initial response shall normally be given within an additional 30 working days. Should a reply not be received within the stipulated time, kindly contact the FREC chair, Dr. David Suda, to pursue progress on your application further.
7. Please note that if new data is required for the research project, it is necessary to go through the ethics procedure (described above) again, as this procedure is only valid for the project details submitted. Furthermore, if, after following all the points above, there are still issues that require clarification, please contact your department FREC representative for further guidance.