1. Submission of a new thesis (Bachelor/Master/MaNaMA)
1.1. Submission package
- Protocol (if applicable)
- Informed Consent Form(s)
- All documents provided to the subjects (e.g. recruitment material, flyers, posters, diaries, questionnaires, interview topic list…)
- Data processing register (Ghent University Hospital studies | Ghent University studies)
- CV of the student
- CV (obligated) and GCP certificate (if applicable) of the PI at Ghent University (Hospital)
- Agreements (if applicable, a draft version is sufficient)
- Insurance certificate (only if Ghent University (Hospital) does not act as the sponsor of the study; otherwise provided by HIRUZ CTU)
Please note: Since February 2022 the Medical Ethics Committee (MEC) application forms have been replaced by a set of questions in the Research Portal.
1.2. Submission procedure
1.2.1. Preparation of the submission package
In case of questions, please contact ethisch.comite@uzgent.be.
1.2.2. Submission through the Research Portal
Since February 2022 all studies must be submitted through the Research Portal of Ghent University (Hospital): https://onderzoeksportaal.uzgent.be/
More information can be found here.
Once the applicant submits the study in the Research Portal, approval of the Principal Investigator (PI), Head of Department (if applicable) and promoter will be asked. When all approvals are given, the study is directly submitted to the MEC of Ghent University (Hospital). All further communication with the MEC (remarks/approval MEC) will go via the Research Portal.
Please note: If applicable, please contact HIRUZ Contract Unit (hiruz.contracten@uzgent.be) or Techtransfer (contracten@ugent.be) by email for review of draft agreement proposals or to set-up an agreement if needed. In the near future, agreements will need to be submitted through the Research Portal.
1.2.3. MEC approval
Information on the legal periods for advice by the MEC can be found here.
The study can only start when a favourable opinion from the central MEC has been received and as soon as all agreements are finalized (if applicable).
1.2.4. Start study – During the study
Please register the date of start of recruitment and the date of first inclusion in the Research Portal.
Don’t forget that the sponsor needs to register the study on a publicly accessible website before inclusion of the first participant. For the public database ClinicalTrials.gov, HIRUZ CTU can provide you with the login details if Ghent University (Hospital) is sponsor. For more information, see FAQ.
1.2.5. End of study
Please register the end of the study in the Research Portal and upload the study results within one year after the end of the study (as legally required).
2. Submission of a thesis as part of an approved study
2.1. Submission package
- CV of the student
2.2. Submission procedure
2.2.1. Preparation of the submission package
In case of questions, please contact ethisch.comite@uzgent.be.
2.2.2. Submission through the Research Portal
Since February 2022 all studies must be submitted through the Research Portal of Ghent University (Hospital): https://onderzoeksportaal.uzgent.be/
More information can be found here.
Once the applicant submits the application for a thesis as part of an approved study, approval of the Principal Investigator (PI) and promoter will be asked. When all approvals are given, the application is directly submitted to the Medical Ethics Committee (MEC) of Ghent University (Hospital). All further communication with the MEC (remarks/approval MEC) will go via the Research Portal.
Please note: If applicable, please contact HIRUZ Contract Unit (hiruz.contracten@uzgent.be) or Techtransfer (contracten@ugent.be) by email for review of draft agreement proposals or to set-up an agreement if needed. In the near future, agreements will need to be submitted through the Research Portal.
2.2.3. MEC approval
Information on the legal periods for advice by the MEC can be found here. The amendment can only be implemented when a favourable opinion from the central MEC has been received and as soon as all agreements are finalized (if applicable).