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Ethical review for nWMO studies checklists and templates
The UMCG plans to have all nWMO studies reviewed starting 2022. This ethical review is performed by the CTc (Centrale ethische Toetsingscommissie van het UMCG).
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Below you find the checklistst and templates required for your application for ethical review for nWMO studies. Please always attach documents in PDF in your first submission. With the exception of the 'Biobank Reglement' and 'biobank protocol'. These should be presented using Word and in track and change format. Note that:

  • a protocol (or Biobank Reglement) without the signature of the head of department will not be processed;
  • for some documents that may be required, no templates are available yet;
  • you are not obliged to use the templates, for example when required documents are available from the sponsor. If you decide not to use a template, make sure all information needed for ethical review is included in the document you submit. Use the nWMO templates as a checklist, or as an addendum for UMCG information;
  • if you want to collect survey data from participants other than from the EPD, add these documents to your submission (e.g. questionnaire, survey, interview questions) If you wish to make use of a given informed consent from a previous study, please add the relevant participant information letter and informed consent form.

  • UMCG nWMO: study without informed consent (none of the participants will be asked IC)
    Study protocol REQUIRED to use the UMCG's template nWMO protocol (see link).
    - As the protocol for the study
    - As an addendum for implementation in the UMCG, in the case of multicentre research. Please also add the original protocol of the initiating centre.
    Data management plan REQUIRED to complete the data management section in the UMCG's template nWMO protocol.
    MDTA and/or Data processing Agreement
    contact: mail    		 You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review
     

  • UMCG nWMO: Study with informed consent: participants include: adults (≥16yrs)
    Study protocol REQUIRED to use the UMCG's template nWMO protocol (see link).
    - As the protocol for the study
    - As an addendum for implementation in the UMCG, in the case of multicentre research. Please also add the original protocol of the initiating centre.
    Data management plan REQUIRED to complete the data management section in the UMCG's template nWMO protocol.
    Information letter for participant REQUIRED
    MDTA and/or Data processing Agreement contact: mail You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review
     

  • UMCG nWMO: Study with informed consent: participants include: children (12-16yrs)
    Study protocol REQUIRED to use the UMCG's template nWMO protocol (see link).
    - As the protocol for the study
    - As an addendum for implementation in the UMCG, in the case of multicentre research. Please also add the original protocol of the initiating centre.
    Data management plan REQUIRED to complete the data management section in the UMCG's template nWMO protocol.
    Information letter for child (study) REQUIRED
    Informed consent form for child(study) REQUIRED
    Information letter for parents / guardians REQUIRED
    MDTA and/or Data processing Agreement

    contact: mail

    		 You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    Decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review
     

  • UMCG nWMO: Study with informed consent: participants include: children (<12 yrs)
    Study protocol REQUIRED to use the UMCG's template nWMO protocol (see link).
    - As the protocol for the study
    - As an addendum for implementation in the UMCG, in the case of multicentre research. Please also add the original protocol of the initiating centre.
    Data management plan REQUIRED to complete the data management section in the UMCG's template nWMO protocol.
    Information letter for legal representative REQUIRED
    Informed consent form for legal representative REQUIRED
    MDTA and/or Data processing Agreement contact: mail You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    Decision letter other ethical/ scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review

  • UMCG nWMO: Study with informed consent: participants include: otherwise incompetent persons (eg Alzheimer disease)
    Study protocol REQUIRED to use the UMCG's template nWMO protocol (see link).
    - As the protocol for the study
    - As an addendum for implementation in the UMCG, in the case of multicentre research. Please also add the original protocol of the initiating centre.
    Data management plan REQUIRED to complete the data management section in the UMCG's template nWMO protocol.
    Information letter for legal representative REQUIRED
    Informed consent form for legal representative REQUIRED
    MDTA and/or Data processing Agreement contact: mail You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    decision letter other ethical/ scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review
     

  • UMCG nWMO: Start De novo Bio-/Databank (incl secondary use with Informed consent): participants include: adults (≥16yrs)
    Data/Biobank reglement 'De novo' REQUIRED
    Data/ Biobankprotocol 'De novo' REQUIRED
    Information letter for participant (bio-/databank) REQUIRED
    Informed consent form for participant (bio-/databank) REQUIRED
    Withdrawal form for participant (bio-/databank) REQUIRED
    MDTA and/or Data processing Agreement contact: mail You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review

  • UMCG nWMO: Start De novo Bio-/Databank (incl secondary use with Informed consent): participants include: children (12-16yrs)
    Data/Biobank reglement 'De novo' REQUIRED
    Data/
    Biobankprotocol     'De novo'    		 REQUIRED
    Information letter for child (bio-/databank) REQUIRED
    Informed consent form for child (bio-/databank) REQUIRED
    Withdrawal form for child (bio-/databank) REQUIRED
    Information letter for parents / guardians REQUIRED
    Informed consent form for both parents / guardians REQUIRED
    Withdrawal form for parents / guardians REQUIRED
    MDTA and/or Data processing Agreement contact: mail You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review

  • UMCG nWMO: Start De novo Bio-/Databank (incl secondary use with Informed consent): participants include: otherwise incompetent persons (eg Alzheimer disease)
    Data/Biobank reglement 'De novo' REQUIRED
    Data/
    Biobankprotocol     'De novo'    		 REQUIRED
    Information letter for legal representative REQUIRED
    Informed consent form for legal representative REQUIRED
    Withdrawal form for legal representative REQUIRED
    MDTA and/or Data processing Agreement contact: mail ou should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval
    decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review

  • UMCG nWMO: Start/management Secondary use Bio-/Databank 'No objection': secondary use Bio-/Databank 'No objection'
    Data/Biobank reglement 'Secondary use' REQUIRED
    Data/Biobankprotocol 'Secondary use' REQUIRED
    MDTA and/or Data processing Agreement contact: mail You should have this agreement if data/material will be shared with other parties (outside the UMCG). You don't need to submit the agreement for ethics approval.
    decision letter other ethical/scientific committee REQUIRED if the project has been reviewed by an ethical/scientific committee outside the UMCG OR EXPLAIN in cover letter why it is not submitted for review.