Experiments under the law of 7 May 2004

Experiments under the law of 7 May 2004 are defined as “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”.

This includes: 

  • Interventional research: 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, …
  • Prospective observational research: research in which only healthcare data will be collected in the future, and epidemiological methods are used for the analysis of the results obtained.

For every experiment on humans under the law of 7 May 2004, an approval of the Medical Ethics Committee (MEC) is mandatory. 

For research involving medicinal products (e.g. supplying a drug in a different dose or formula or for a different indication) or medical devices, please refer to the section Clinical Trials or medical device.

Exceptions on the law of 7 May 2004

The following studies do not fall under the law of 7 May 2004:

  • Retrospective research: Research 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.
  • Research on embryos in vitro
  • Research on cadavers
  • Research on residual biological samples

For academic retrospective research and research on residual biological samples, approval of the MEC of Ghent University (Hospital) is mandatory as well.

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 (obligated) and GCP certificate (if applicable) of the PI at Ghent University (Hospital)
  • CVs (obligated) and GCP certificates (if applicable) of all local PIs (if applicable, in case of a multicentric study)
  • 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)
  • Approval letter of the central Medical Ethics Committee (MEC) (only if Ghent University (Hospital) is added as participating centre to an approved study)

    Please note: Since February 2022 the EC application forms are replaced by a set of questions in the Research Portal.

Submission procedure

  1. Preparation of the submission package
    In case of questions regarding academic studies, please find the HIRUZ CTU contact person for your department here.

  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.

    For commercial studies:
    Once the applicant submits the study in the Research Portal, approval of the Principal Investigator (PI), Head of Department (if applicable) and Medical Manager of the biobank (if applicable) 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: Agreements should be submitted to hiruz.contracten@uzgent.be by email for review. In the near future, agreements will need to be submitted through the Research Portal.

    For academic studies:
    Once the applicant submits the study in the Research Portal, approval of the Principal Investigator (PI), Head of Department (if applicable) and Medical Manager of the biobank (if applicable) will be asked. When all approvals are given, the study is submitted to HIRUZ CTU for review.

    After admissibility check, HIRUZ CTU will revise the information given in the Research Portal, as well as the documents that were submitted. Once the study is reviewed, you will be informed (by email) that the review can be found in the Research Portal (in the tab ‘HIRUZ Remarks’). HIRUZ CTU aims to provide feedback within two weeks after submission of the study to HIRUZ CTU. 

    Complete applications (if applicable, after the review by HIRUZ CTU was implemented) are submitted by HIRUZ CTU to the MEC of Ghent University (Hospital) (also through the Research Portal). All further communication with the MEC (remarks/approval MEC) will go via the Research Portal.

    Please note: When the study is submitted to the MEC, HIRUZ Contract Unit or Techtransfer will be notified to review the draft agreement proposals or to set-up an agreement if needed.  
  1. 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. 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 of the study. For more information, see FAQ

    Please provide an annual progress report yearly to both HIRUZ CTU (hiruz.ctu@uzgent.be) and the MEC of University (Hospital) Ghent (ethisch.comite@uzgent.be). 
    Please note: for the time being, annual progress reports still need to be submitted by email instead of through the Research Portal.
  1. 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). If a study-specific biobank at U(Z)Gent was used for your study, please also inform HIRUZ Biobank (hiruz.biobank@uzgent.be) about the end of the study so that they can notify the Federal Agency of Medicines and Health Products (FAMHP) about the termination of the biobank. Please consult the HIRUZ Biobank website for the ‘terminating a biobank’ template.

Submission package

All substantial changes compared to the original Medical Ethics Committee (MEC) application have to be approved by the MEC of Ghent University (Hospital) through an amendment. This includes substantial changes to the study design, study protocol or other study documents and the addition of other study centers.  

  • All modified study documents in track-changes and clean version
  • All new documents that were created in light of the amendment
  • Approval letter of the central MEC (only if MEC Ghent University (Hospital) does not act as central MEC and if applicable yet)

Submission procedure

  1. Preparation of the submission package
    In case of questions regarding academic studies, please find the HIRUZ CTU contact person for your department here.

  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.

    For commercial studies:
    Once the applicant submits the amendment in the Research Portal, approval of the Principal Investigator (PI) and Medical Manager of the biobank (if applicable) will be asked. When all approvals are given, the amendment 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: New agreements or changes to agreements should be submitted to hiruz.contracten@uzgent.be by email for review.  In the near future, agreements will need to be submitted through the Research Portal.

    For academic studies:
    Once the applicant submits the amendment in the Research Portal, approval of the Principal Investigator (PI) and Medical Manager of the biobank (if applicable) will be asked. When all approvals are given, the amendment is submitted to HIRUZ CTU for review.

    After admissibility check, HIRUZ CTU will revise the information given in the Research Portal, as well as the documents that were submitted. Once the amendment is reviewed, you will be informed (by email) that the review can be found in the Research Portal (in the tab ‘HIRUZ Remarks’). HIRUZ CTU aims to provide feedback within 2 weeks after submission of the amendment to HIRUZ CTU.   

    Complete applications (if applicable, after the review by HIRUZ CTU was implemented) are submitted by HIRUZ CTU to the MEC of Ghent University (Hospital) (also through the Research Portal). All further communication with the MEC (remarks/approval MEC) will go via the Research Portal.

    Please note: When the amendment is submitted to the MEC, HIRUZ Contract Unit or Techtransfer will be notified to check whether new agreements are needed or if changes to existing agreements are needed. 
  1. 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 MEC has been received and as soon as all agreements are finalized (if applicable).