Definition

Experiments under the law of 7 May 2004 means “Every clinical trial, study or research performed on humans, with the intention to gain knowledge inherent to the execution of healthcare professions as defined in Royal Decree n ° 78 of November 10, 1967 on the execution of health professions”.

In general, this concerns all interventional and prospective observational research on humans with the exception of retrospective research, research on embry’s in vitro, on cadavers or residual biological samples.

Interventional research: this includes every research on humans that deviates from normal standard diagnostics or standard therapeutic care. For example: questionnaires or interviews, extra blood sampling, extra RX, psychotherapy, diet intervention, rehabilitation treatment, supplying a drug in a different dose or formula or supplying the drug for a different indication, testing a medical device.
This also includes:
Clinical trials with medicinal product
Medical Device trials
Prospective observational research: In this study, only healthcare data will be collected in the future, and epidemiological methods are used for the analysis of the results obtained.
Retrospective research: This research is based on previously collected data (i.e. data from existing patient records, medical records or administrative records), without the need to collect new data or having contact with trial subjects.

For every experiment on humans under the law of 7 May 2004, an approval of the ethics committee is mandatory. For clinical trials with medicinal products and trials with medical devices, approval of the Competent Authority (Federal Agency for Medicinal and Health Products – FAMHP) may also necessary.

Also for retrospective research and research on residual biological samples approval of the ethics committee of Ghent University Hospital and Ghent UniversityGhent University is mandatory.

Submission package for Ethics Committee approval for experiments (excluding trials with medicinal product or medical device trials)

  • Cover letter, signed (click here)
  • EC application form, signed (please always use the most recent version as can be found on the website of the Ethics Committee of Ghent University Hospital and Ghent University, click here)
  • Protocol and protocol summary
  • Informed Consent Form(s)
  • All documents provided to the subjects (recruiting materials, flyers, posters, diaries, questionnaires, interviews, …)
  • GDPR register for academic studies
  • (Funding) agreements (if applicable)
  • CVs and GCP certificates of PIs (in case of a multicentric clinical trial)
  • Insurance certificate (provided by HIRUZ when Ghent University (Hospital) is sponsor)

Procedures

Interventional investigator-initiated research excl. questionnaires and interviews (EC application form A)

  1. Preparation of your submission package (see above)
  2. Registration at HIRUZ CTU. Please email the completed submission package in word-version to hiruz.ctu@uzgent.be.
  3. Revision by HIRUZ CTU. HIRUZ CTU will revise all documents and will provide you feedback by email together with an internal reference number (BC-number). As soon as your trial is submitted to HIRUZ CTU, the need for an insurance and Clinical Trial Agreement or another type of scientific collaboration agreement will be evaluated.
  4. Submission to HIRUZ CTU. After HIRUZ CTU has received your final revised submission package, HIRUZ CTU will submit your dossier electronically to the Ethics Committee of Ghent University Hospital and Ghent University.
  5. Allocation of an EC project number. The Ethics Committee of Ghent University Hospital and Ghent University will send you the EC project number by email once your submission package is considered complete.
  6. Questions or remarks? The Ethics Committee of Ghent University Hospital and Ghent University will contact you directly in case of any questions or remarks.
  7. Approval. Your trial can only start when a favorable opinion from the central EC has been received and as soon as all agreements are finalized (if applicable). Please notify both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be) when your study starts (first study specific procedures performed/first ICF signed).
  8. Annual progress report. Please provide an annual progress report yearly to both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be).
  9. End of trial report. At the end of your trial, please provide an end of trial report including date of last trial specific procedure performed, final number of participants and events of special interest to both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be).

Retrospective research (EC application form B) and Prospective observational research incl. questionnaires and interviews (EC application form C)

  1. Preparation of your submission package (see above)
  2. Registration at HIRUZ CTU. Please email the complete submission package in word-version to hiruz.ctu@uzgent.be. As soon as your trial is submitted to HIRUZ CTU, the need for an insurance and Clinical Trial Agreement or another type of scientific collaboration agreement will be evaluated.
  3. Revision by HIRUZ CTU and submission. HIRUZ CTU will revise all documents and will submit your dossier directly to the Ethics Committee of Ghent University Hospital and Ghent University along with their comments and remarks.
  4. Allocation of an EC project number. The Ethics Committee of Ghent University Hospital and Ghent University will send you the EC project number by email once your submission package is considered complete.
  5. Questions or remarks? The Ethics Committee of Ghent University Hospital and Ghent University will contact you directly in case of any questions or remarks.
  6. Approval. Your trial can only start when a favorable opinion from the central EC has been received and as soon as all agreements are finalized (if applicable).
    Please notify both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be) when your study starts (first study specific procedures performed/first ICF signed) (For prospective observational research incl. questionnaires and interviews (EC application form C) only).
  7. Annual progress report. Please provide an annual progress report yearly to both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be). (For prospective observational research incl. questionnaires and interviews (EC application form C) only).
  8. End of trial report. At the end of your trial, please provide an end of trial report including date of last trial specific procedure performed, final number of participants and events of special interest to both HIRUZ CTU (hiruz.ctu@uzgent.be) and the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be). (For prospective observational research incl. questionnaires and interviews (EC application form C) only).

Theses (EC application form D) and theses as part of an approved study (EC application form E)

  1. Preparation of your submission package (see above)
  2. Submission to the EC. Please email the completed submission package directly to the the Ethics Committee of Ghent University Hospital and Ghent University ethisch.comite@uzgent.be.
  3. Allocation of an EC project number. The Ethics Committee of Ghent University Hospital and Ghent University will send you the EC project number by email once your submission package is considered complete.
  4. Questions or remarks? The Ethics Committee of Ghent University Hospital and Ghent University will contact you directly in case of any questions or remarks.
  5. Approval. Your trial can only start when a favorable opinion from the central EC has been received and as soon as all agreements are finalized (if applicable).
    Please notify the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be) when your study starts (first study specific procedures performed/first ICF signed).
  6. End of trial report. At the end of your trial, please provide an end of trial report including date of last trial specific procedure performed, final number of participants and events of special interest to the Ethics Committee of Ghent University Hospital and Ghent University (ethisch.comite@uzgent.be).