Staff/Postgraduate Research Students

Applications can be considered for either the lower risk review route or high risk review depending on the risk level of the project, allocated through OREM.

Medium Risk Applications

Applications with minimal ethical issues are undertaken via Lower Risk Review. Once submitted on the Online Research Ethics Management System (OREM), the Research Ethics Officer will assign the application to a Designated Reviewer and, subject to availability, the application will be reviewed within 10 working days.

High Risk Applications

Research studies with more material ethical issues will be considered by the full Faculty REC. The application must be submitted on  OREM for review at the next available meeting. Meetings dates and corresponding submission deadlines can be found here.

Undergraduate/Postgraduate Taught Students

For all lower risk undergraduate (UG) or postgraduate taught (PGT) research an application is submitted on the Online Research Ethics Management System (OREM). The application must be reviewed by the Supervisor and another member of Staff from the School (who is independent of the research) to confirm they have conducted the ethical reviews and approved the submission. The REC will then confirm the approval on the basis of these two reviews/approvals. In the unlikely event an UG/PGT project is deemed high risk on the basis of the OREM application questions, a high risk application to MHLS Faculty REC must be submitted.

The relevant  documents as listed below should be uploaded with the application on OREM:

• Research protocol
• Recruitment material eg invitation letter/e-mail/message, posters/flyers, social media posts or recruitment script
• Participant Information Sheet(s) eg participant/child/parent information sheet. If there are multiple cohorts of participants or multiple methods are used the information sheets catered for each cohort/methodology must be submitted
• Participant consent form(s) including assent form if children under 16 years of age are recruited. If multiple methods are to be used the consent form for each methodology should be submitted.
• Any questionnaires/surveys (including all questions/measures/scales/demographics etc.)
• Interview Schedule(s)
• Focus Group Schedule(s)
• Workshop Schedule(s)/Agenda
• Confirmation of Peer Review ( ie 2 completed Gov 4 Forms are required for full submission to MHLS Faculty REC or if peer review has taken place as part of an external funding award process confirmation of the funding award)

The following may also be relevant for particular projects:

• Debrief (eg including detail of any deception involved, any signposting information for participants who may be impacted by the topics/themes raised in the study).
• Distress Protocol
• Disclosure Protocol
• Lone Working Protocol
• Any relevant permissions, eg to access participants, letter of support etc.
• This list is not exhaustive, any other documents/information deemed relevant should be uploaded to the application and submitted for review.

Once a project has received a favourable ethical opinion, any amendments or changes to the study procedures or documentation must be submitted to the Faulty Research Ethics Committee for consideration prior to implementation.

If the application was submitted via OREM the amendment process on OREM should be followed. Guidance on the process can be found here.

For all studies approved prior to the implementation of OREM, the Notification of Amendment Form should be submitted with all revised or new study documents.

Please ensure any revisions to the previously approved documents are clearly marked by using track changes. Also, ensure the version number and date in the header/footer of documents is updated.

Review of amendments is dependent on the availability of reviewers. If the revisions to the study are substantial they may require review at the next available REC meeting.

If the proposed changes significantly alter the study objectives or increase the risk level of the study then a new application will be required.

Where your study has received ethical approval from another recognised Research Ethics Committee (or Institutional Review Board) the QUB Faculty REC Affirmation of Existing Ethical Approval process may be applicable. This is used to acknowledge the approval issued by another institution, meaning that multiple ethical reviews are not conducted.  Guidance on the process for Acknowledgement of Existing Ethical Approval can be found here.

The completed Acknowledgement of Existing Ethical Approval form, along with the approval letter and all approved study documents from the external institution, which are to be used by QUB researchers in the study must be submitted to the MHLS Faculty REC. The MHLS Faculty REC will issue an acknowledgement of the external review. Please note in these circumstances the MHLS Faculty REC is only acknowledging the ethical opinion from another institution and is not conducing an ethical review or granting ethical approval. It is the researchers’ responsibility to ensure the work they are undertaking is covered by the external ethical approval.

For studies reviewed by the Faculty REC, Annual Progress Reports must be submitted to the Research Ethics Officer on an annual basis.  The first report is due 12 months after the date ethical approval was granted.  Annual reports will be reviewed by the Research Ethics Officer and any issues reported will brought to the attention of the Faculty REC Chair to determine if further action is required.  Similarly, the end of study report should be completed once the project has ended.

For studies approved prior to OREM system then complete the Annual Progress Report Form (Word). 

The Research Ethics Officer will acknowledge receipt of the Notification of End of Study and close the Faculty REC file for archiving.

If the study was approved via the OREM system, you will receive a reminder to complete the annual progress report within OREM.  This can also be used to notify when the study is complete.