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Information for Licence Holders

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Licence Holder Responsibilities

Compliance with licence conditions

The licence holder is responsible for ensuring that they comply with licence conditions. The licence holder must ensure that each person who is identified in the licence conditions as an authorised person is at all times fully informed of the requirements of the legislation, any corresponding State or Territory law, and the licence and its conditions.

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Notifying that consent has been obtained

A licence includes a date when the research project may start. However, the use of an egg or an ART embryo, or the creation or use of another embryo, must not begin until:

  • proper consent has been given by each responsible person; and
  • the licence holder has reported in writing to the NHMRC Licensing Committee that such consent has been obtained.

The licence holder should use the Notification of Consent spreadsheet to report consent to the NHMRC Licensing Committee.

» Download: Notification of Consent Spreadsheet (XLS, 41kb)

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Reporting on licensed activities

6 monthly reports

Licence holders are required to report on their licensed use of excess ART embryos or human eggs or the creation and/or use of other embryos to the NHMRC Licensing Committee every 6 months using the 6-monthly report on licensed activities template and the Authorised Use Spreadsheet. The reporting periods are 1 April to 30 September and 1 October to 31 March. The reports are due within 30 days of the end of the reporting period.

» Download: Six-monthly report template (Word, 64kb) Word

» Download: Authorised use spreadsheet for excess embryos (XLS, 120kb) Excel

» Download: Authorised use spreadsheet for SCNT Licences (XLS, 31kb) Excel

Final reports

Licence holders are also required to report to the NHMRC Licensing Committee when a licence expires, or is surrendered, using the Final Report on Licensed Activities template and the Authorised use spreadsheet (see above). The report is required to be submitted prior to the expiry or surrender of the licence.

» Download: final report template (Word, 84kb)

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Training licences

When a licence has been issued to allow training, a separate application for each trainee, as below, is required before training can start. This should be submitted to the Embryo Research Licensing Committee of the NHMRC at embryo.research@nhmrc.gov.au. The Application for approval of a trainee must include all of the following:

Trainee to provide:

  1. Name
  2. Name of employer
  3. Curriculum vitae (This should be limited to 2 pages listing qualifications and all previous employment relevant to the requested training. Lists of publications are not required)
  4. Site of proposed training
  5. Statement of trainee's role in organisation (normally only one sentence required but further details may be needed for unusual circumstances)
  6. A copy of the trainee's laboratory training record which should include:
    • Documentation that the embryologist has adequate skills in micro-manipulation of human gametes such that they can routinely perform ICSI;
    • Documentation (including dates) of previous training using animal embryos;
    • Documentation (including dates) of previous training using dead human embryos;
    • A declaration that the trainee has not previously received formal training in embryo biopsy using live human embryos and has not previously regularly performed embryo biopsies in a clinical setting.

Licence Holder to provide:

  1. A one sentence justification for training an additional embryologist in embryo biopsy. Possible reasons could include:
    • requirement to cover laboratory due to resignation/leave or other staff movements;
    • increasing demand for Pre-implantation Genetic Diagnosis.

The Licensing Committee will strive to ensure that a decision about approval or otherwise of a trainee is provided as soon as possible after receipt of the application and normally within 10 working days. Training may only start once the trainee and licence holder have received notification of approval from the Licensing Committee.

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