CoROM IREC Submissions

To apply for ethical review, please follow the steps below:

1. Complete the Application Form: You must use the official CoROM IREC application form here (right side. Click “Fill out Form” to start the application)

2. Compile Your Submission Package: Your application must be submitted electronically to the IREC administration and needs to include a comprehensive set of documents. An initial screening for completeness will be conducted by the IREC administrator. Incomplete applications will be returned. Please ensure your submission includes all of the following:

- Completed CoROM IREC Application Form
- Full Research Protocol
- Participant Information Sheet(s)
- Informed Consent Form(s) and, if applicable, Assent Form(s) for participants not of legal age to consent
- Data Collection Instruments (e.g., questionnaires, interview guides)
- A detailed Data Management Plan
- Professional CV(s) of the Principal Investigator(s)
- Any recruitment materials you plan to use
- If applicable, copies of local ethics approvals from other research sites or countries.

3. Please send an email to the IREC office to notify us of your recent submission.

Research Ethical Approval Request Form College of Remote and Offshore Medicine

This form is designed to efficiently collect the essential information required for ethical review of your research project, in accordance with CoROM’s IREC Policy and SOPs, and relevant EU and Maltese regulations.

Please complete all sections accurately and attach your Research Plan and other required supporting documents as listed in Section 5. This streamlined process is tailored for projects with an existing approved research plan and should take approximately 30 minutes to complete, in addition to preparing your attachments.

Research activities involving human participants, their biological samples, or identifiable personal data cannot commence until formal ethical approval has been granted by the CoROM IREC.

If you have any questions regarding the ethical review process or this form, please consult the CoROM IREC Standard Operating Procedure (SOP) or contact the IREC administration.

Submitting amendments, changes in the protocol, and yearly progress reports

Any amendments, changes in protocol and yearly progress report shall be submitted as separate email. Please attach the copy of the original IREC decision letter and add the IREC reference number to the subject of the email.

Please note: Any changes in the protocol would require an immediate review of the ethical decision. Any previous ethical approval decision only applies to the protocol submitted.