These frequently asked questions (FAQs) have been compiled from observations and common queries received in the office. The information will be updated periodically.

If you have any questions relating to Accreditation, IBCs or the administration of NLRDs, which are not addressed on this page, please email ogtr.applications@health.gov.au.

What are Primary and Secondary contacts? Are they authorised to request changes to a certification or licence?

The Primary contact is the person an organisation has nominated as the first point of contact for all communications from the OGTR. The Secondary contact is intended to be a back-up for the Primary contact. Both will be included in communications from the OGTR. Under the conditions of Accreditation, the OGTR must be advised of any changes to the contact persons, or their details.

Primary and Secondary contacts cannot request changes to a certification or licence unless they are also Authorised Persons. An Authorised Person form can be completed by organisations to authorise persons to act on behalf of the organisation. Authorised persons can be Primary or Secondary contacts, or neither. If no authorised persons form has been provided to the OGTR, or if a person submitting an application is not listed as an authorised person in our records, they must state in their application that they are duly authorised to do so (if they indeed are). Authorised persons are not included in regular communications from the OGTR, unless they have another contact role i.e. Primary or Secondary contact

There are different levels of “authorisation” that can be requested:
  • Authorisation for Secondary Applications for all instruments (Accr/Cert/DIR/DNIR)
  • Authorisation for Secondary Applications relating to an organisation’s Accreditation
  • Authorisation for Secondary Applications relating to all Certifications
  • Authorisation for Secondary Applications relating to all DNIRs
  • Authorisation for Secondary Applications relating to all DIRs
Note: Secondary Applications refer to requests to modify existing primary applications (i.e. Accr, Cert, DNIR, DIR), and include variation, suspension, lift of suspension, transfer and surrender applications.

The forms to advise the OGTR of any changes to Primary, Secondary Contacts or Authorised persons are available on the Accredited organisation responsibilities page of the OGTR website.

Who notifies the Regulator of NLRDs assessed by an IBC?

  • Regulation 13C(1) requires a person or accredited organisation to provide the Regulator a record of any proposed dealings assessed by an IBC to be a NLRD.
  • The record/s must be provided to the Regulator in a report for the financial year. For accredited organisations, this is submitted as part of the organisation’s Annual Report.
  • The notification of NLRDs should come from the person or organisation who submitted the proposal, not from the IBC that assessed it.
  • The role of the IBC is to assess whether or not proposals submitted by a person or organisation are NLRDs, assess the suitability of people and facilities proposed for the dealings, and to give a copy of the record of assessment to the person/organisation who submitted the proposal.
  • Generally, notifications of NLRDs by an IBC on behalf of another organisation will not be accepted by the OGTR.

What if we haven’t reported new NLRDs from previous financial years?

  • The person or organisation must notify the Regulator of the NLRD from a previous financial year as soon as possible.
  • If it is during the annual reporting period (1 July to 30 September) for accredited organisations, then notifications of NLRDs can be submitted with their annual report. Be sure to alert the OGTR to the fact that the NLRD notifications include those from previous years.
  • It is the responsibility of the person or organisation to ensure that all NLRDs are notified at the end of the financial year that the NLRD was assessed.

Can we extend, transfer or amend a NLRD in any way?

The existing record of assessment (RoA) for a NLRD cannot be changed i.e. varied, extended, transferred or amended. A new assessment must be conducted and a RoA prepared to include elements not in the original assessment. This ensures there is clear understanding between NLRD proponents, IBCs and the Regulator about the scope of each NLRD, which supports organisational oversight of research and OGTR’s monitoring and compliance activities. When preparing a RoA, consideration should be given to what is included in the RoA so as to accommodate changing circumstances. Guidance on making a RoA to achieve this, such as the use of class of person or facilities, is available (see the NLRD and Documents and Forms page).

Specific examples of amendments that would require a new RoA include:
  • Changes to person(s) considered appropriate to undertake the dealings, if not defined by a class of person;
  • Changes to the class of persons, if defined by class;
  • A change to the person(s) or accredited organisation undertaking the dealings;
  • Transfer of researcher or person(s) to another organisation;
  • Changes to the certified facilities considered appropriate in which to undertake the dealings, if not defined by a class;
  • Changes to class of certified facilities, if defined by class; or
  • Changes to the dealings (e.g. addition of transport and storage if not previously considered).
  • More information about NLRDs can be obtained from the What are Notifiable Low Risk Dealings (NLRDs)? page on the OGTR website.

How do I surrender my Accreditation?

If an accredited organisation no longer requires accreditation, they may apply for a surrender of accreditation. Organisations may wish to seek a surrender of accreditation if, for example, they no longer undertake licenced work with GMOs.
  • Applications for surrender should be made in writing, by an authorised person, to the Regulator. Unless the person submitting the application is listed as an authorised person for this purpose, they will need to state in their application that they are authorised to submit the request on behalf of their organisation. Alternatively, if the person submitting the application is not authorised for this purpose; they can ask a person who is authorised to submit the request.
  • If the organisation has established any IBCs the OGTR should be advised whether or not the IBC/s are being disbanded.
  • The conditions of accreditation continue to apply until the applicant receives written confirmation from the Regulator that the surrender process has been completed.
  • It is a condition of a licence (DIR/DNIR) for an organisation to maintain Accreditation. Holders of accreditation should note that the surrender of accreditation will have implications for any licences which require ongoing accreditation as a condition of the licence
  • Organisations may consider suspending their accreditation (instead of surrendering), if it is clear that it may be needed in the foreseeable future.

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