Ethical review for nWMO studies templates
In the UMCG all nWMO studies are required to be reviewed. This ethical review is performed by the CTc (Centrale ethische Toetsingscommissie van het UMCG).
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Below you find the 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 protocol'. These should be presented using Word and in track and change format. Note that:

  • A protocol (or Biobankprotocol) without the signature of the head of department will not be processed;
  • For some documents that may be required, no templates are available yet;
  • Use of the most recent version of the templates is obligatory. An exception is made in case of Local Feasibility. Please see the dedicated section on the page nwmo.umcg.nl for guidance;
  • 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.

Overview standard Research File and Templates per category of assessment:

  • UMCG nWMO: Local feasibility addendum

    Local feasbility addendum

    REQUIRED
    - As an addendum for implementation in the UMCG.

    - Please also add the original protocol of the overarching study and the approval letter from the recognized.
    Medical-Ethical Review Committee Submit this in the usual way.

  • UMCG nWMO: Start De novo Bio-/Databank (incl secondary use with Informed consent): participants include: adults (≥16yrs)
    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/
    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/
    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/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.