Licence Holder Responsibilities
Compliance with licence conditions
Licence holders are responsible for ensuring that their organisations 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.
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 Embryo Research Licensing Committee that such consent has been obtained.
The licence holder should use the applicable page of the Notification of Consent spreadsheet to report consent to the NHMRC Licensing Committee.
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 March to 31 August and 1 September to 28 (or 29) February. The reports are due within 30 days of the end of the reporting period.
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.
Varying a licence
Section 25 of the Research Involving Human Embryos Act 2002 allows the NHMRC Licensing Committee to vary a licence if it is necessary or desirable to do so. Variations can be initiated by the licence holder or by the NHMRC Licensing Committee (see Chapter 3 of the Information Kit). Details about the information required for different types of variations can be found here