4.1 Who is authorised to complete an accreditation application form?The accreditation application form can be completed by anyone authorised to act on behalf of the organisation to complete the form.
4.2 Who is authorised to sign the declaration of the organisation submitting the accreditation application?The CEO (or equivalent) or a person with the authority to sign on behalf of the organisation, is authorised to sign the application form.
4.3 What is the role of the organisation’s primary contact officer?The organisation’s primary contact officer is the first point of contact for all matters that the OGTR would like to discuss. This role will involve receiving written correspondence and telephone enquiries from the OGTR.
4.4 Who should be the primary contact of the IBC?The OGTR does not dictate who should take on the role of primary contact for the IBC. The IBC is required to make its own decision regarding who is the most suitable person. The committee should be aware, however, that the OGTR will be contacting the primary contact for matters relating to the IBC, applications and notifications
4.5 How long does an accreditation last?Accreditations are issued without an expiry date; however, the Regulator can choose to issue an accreditation with an expiry date. If an accreditation has an expiry date, the date will be set out in the instrument of accreditation.
4.6 Is there an application fee for accreditation?There is no application fee at the time of issue of these explanatory notes.
4.7 How long does it take to assess an application?Accreditations must be decided within 90 working days of the application being received by the Regulator, plus any time spent waiting for responses to requests for additional information from the applicant.
4.8 What are the functions of an IBC?The function of an IBC is to provide assistance to an accredited organisation in relation to the gene technology dealings that the organisation undertakes. Specifically this involves:
- For Licensed dealings
- confirming that for applications for licensed dealings the information provided to the Regulator is complete;
- confirming that personnel are adequately trained to undertake the dealing; and
- evaluating the proposed project.
- For NLRDs
- assessing the proposal for an NLRD;
- making a record of its assessment, in a form approved by the Regulator;
- assessing that the persons or classes of persons undertaking the dealing have the appropriate training and experience to undertake the dealing;
- assessing that the facilities or classes of facilities in which the dealing is proposed to be undertaken is of the appropriate physical containment level and type for the dealing; and
- giving a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the committee.
4.9 Does the OGTR have specific terms of reference for IBCs?Currently the OGTR does not have any specific model terms of reference for IBCs. In general an organisation setting out an IBC’s terms of reference could include the scope of its responsibilities, relationship to non-affiliated researchers, accountability and mechanisms of reporting.
The terms of reference could generally contain such information as:
- Composition of its membership
- Appointment of members
- Working procedures
- Conflict of interest procedures
- Financial affiliations
- Recording of decisions
- Monitoring of the organisation's research
- Complaints mechanisms
- Procedures for suspension or discontinuation of research
- Annual reporting requirements to OGTR
- Record keeping requirements
4.10 What is the role of the IBC Chair?A member of the IBC should be appointed Chair of the IBC. The Chair of the IBC shall convene meetings of the IBC and provide leadership and direction to the conduct of the business of the IBC. Arrangements should be in place for another member to act as the Chair if the need arises.
4.11 What expertise must the IBC have?IBCs must have the collective expertise to competently assess and provide advice on the identification and management of the risks associated with dealings with GMOs undertaken by the organisation and to advise on the containment of GMOs. The composition of individual IBCs will therefore depend on the dealings with GMOs and the nature of the work being undertaken by the organisation.
4.12 Can an organisation utilise more than one IBC?An organisation may choose to utilise more than one IBC because external IBCs may have more extensive experience in certain aspects of an organisation’s dealings. This expertise can be sought and utilised through any number of internal and external IBCs.
At the time of application, the organisation must notify the OGTR if additional IBCs are to be accessed, using the relevant part of the accreditation application form.
4.13 If an organisation wishes to access an additional IBC or cease to access an existing IBC, what action is required?If an organisation wishes to add/remove an IBC to/from their accreditation, the OGTR requires notification of this change. The organisation should send formal correspondence, including relevant pages of the accreditation application form, to the OGTR requesting that the IBC is added or removed, as appropriate. The OGTR will then amend their records in accordance with the advice.
4.14 How many meetings per year is the IBC expected to hold?The OGTR does not prescribe internal operating procedures for IBCs. The committee should come to an agreement on how many meetings are needed to ensure that all OGTR requirements, in relation to dealings with GMOs and inspections of certified facilities, are met.
4.15 What is the minimum number of members required to attend IBC meetings?The committee can agree on how many members are required at a meeting to make a decision. These rules, however, must ensure that the purpose of the IBC to provide oversight of the organisation’s activities in relation to GMOs and a robust scientific assessment of licence applications, are achieved. The IBC should have sufficient expertise at the meetings to assess the applications and ensure that all risks associated with dealings are considered.
4.16 What constitutes a conflict of interest?A ‘conflict of interest’ in a matter may include:
- a direct financial interest;
- any indirect interest, for example a financial benefit accruing to a close relative or partner of the member;
- a non-financial interest, for example a person may have an interest in a matter as a result of an affiliation or membership of an interest group or organisation;
- any interest that could be viewed as a possible conflict of interest; or
- any combination of the above interests.
- IBC members must declare any such conflict of interest whether direct or indirect, pecuniary or otherwise, and perceived or real.
4.17 Do conflict of interest procedures need to be formal?Procedures for conflict of interest need to be established and formalised in relevant documents. Organisations must have documents and procedures in place that define conflict of interest and require members of the IBC to declare any conflict of interest. Any conflicts of interest must be recorded in the minutes of the relevant IBC meeting along with any measures taken to address the conflicts of interest.
4.18 Where can I get a copy of the Gene Technology Act 2000?A copy of the Gene Technology Act 2000 can be downloaded from the OGTR website or Australian Government ComLaw website.
4.19 If an organisation decides to change its name, what action is required?If an accredited organisation chooses to change its name the OGTR needs to be informed. This is because the organisation’s records need to be updated. The organisation should send correspondence to the OGTR via email or in a letter explaining the change and confirming whether a legal entity change is also occurring. The action taken by the OGTR depends on whether the organisation’s legal entity has also changed. Action taken may be a simple administrative name change, accreditation of the new legal entity and subsequent surrender of the old legal entity or a variation of the accreditation. The OGTR will inform the organisation, in writing, when the process has been completed.
4.20 What are the requirements for an organisation in regards to NLRDs?The requirements for organisations undertaking NLRDs can be found under Regulation 13 of the Gene Technology Regulations 2001.
Top of page