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Text Version

Below is the text from the Application for Accreditation of an Organisation form.

Front Page - Application for Accreditation of an Organisation

Organisation for which accreditation is sought: (legal entity or trading name)

Is this application accompanied by an application for a declaration that certain information be treated as Confidential Commercial Information (CCI)?
Yes
No

Time taken to complete this form:
Hours
Minutes

General instructions

Application for Accreditation

The completion of this form indicates your organisation is applying for accreditation of an organisation under the Gene Technology Act 2000 (the Act) and, as applicable, corresponding state legislation. The Gene Technology Regulator (the Regulator) needs the information you provide in this form to assist in determining whether to accredit the organisation. If the information you provide is incorrect or incomplete the Regulators decision about this application may be delayed or may result in the Regulator not granting the accreditation.

The Regulator may require you to provide additional information. If this is necessary you will be notified of the additional information required.

If the Regulator accredits the organisation, the organisation will be obliged to comply with the conditions of accreditation.

Accuracy of information

The information you provide in this application must be true and accurate. The Act (and corresponding state law) provides for imprisonment and fines where a person gives information to the Regulator that the person knows to be false or misleading.

All sections, parts and questions must be completed unless otherwise directed on the form. If the spaces provided are not sufficient to set out the requested information, you should attach additional information and clearly mark on the attachment which section, part and question the information relates to. You should also indicate against the item that there is additional information attached, noting the attachment title/number and the page number(s).

Timeframes

Paragraph 16(1)(a) of the Gene Technology Regulations 2001 (the Regulations) and equivalent provisions in corresponding State law specifies the timeframe within which the Regulator must consider and decide on an application for accreditation. This timeframe is 90 working days after the day the application is received by the Regulator.

Applicants should note that days on which the decision making process cannot proceed because the Regulator is awaiting additional information from the applicant do not count as part of the timeframe given above.

Confidentiality

If you wish to make an application for a declaration that specifies information that is Confidential Commercial Information (CCI) for the purposes of the Gene Technology Act 2000 and corresponding state law, you must complete a CCI application form available from the OGTR website and forward it together with this application.

Privacy

Any personal information is safeguarded by the Privacy Act 1988. This prevents the personal information contained in this form from being used for purposes other than assessing the accreditation, or other purposes permitted by law.

Ethics

The National Framework of Ethical Principles in Gene Technology 2012 (Ethics Framework) has been developed by the Gene Technology Ethics and Community Consultative Committee (GTECCC) to provide a national reference point for promoting ethical conduct in gene technology, consistent with the national regulatory system administered by the Gene Technology Regulator. It replaces the 2006 National Framework for the Development of Ethical Principles in Gene Technology.

The Ethics Framework provides guidance for organisations and individuals and sets out key principles and values to inform and support the consideration of ethical issues relevant to all aspects of gene technology. The Ethics Framework is also intended to provide assurance to the Australian community that not only are any risks involved in gene technology properly managed but that ethical issues are also properly considered.

The OGTR encourages organisations and individuals to refer to the Ethics Framework and to make it available to those involved in the conduct or oversight of gene technology work. The Ethics Framework is available from the OGTR website.

Authorisation

The application must be signed by a person authorised to sign on behalf of the organisation.

For further information

  • The Guidelines for the Accreditation of Organisations and Explanatory Information document which can be found on the OGTR website under Forms and Guidelines;
  • Contact the Office of The Gene Technology Regulator by telephone on 1800 181 030 or e-mail ogtr@health.gov.au.

Lodging the application

The completed application form can be lodged with the OGTR:
  • By mail to the Office of The Gene Technology Regulator, MDP 54, GPO Box 9848, CANBERRA, ACT, 2601; or
  • By e-mail ogtr.applications@health.gov.au; or
  • By facsimile to the Office of The Gene Technology Regulator on (02) 6271 4202; or
  • In person at Level 1, Pharmacy Guild House, 15 National Circuit, BARTON, ACT 2600.
You are encouraged to retain a copy of your completed application.

Acknowledgement of receipt

If you have not received any communication acknowledging the receipt of your application within two weeks, please e-mail ogtr.applications@health.gov.au or telephone 1800 181 030.
Top of page

Section 1:

Organisation and Personnel Information

Part A: Status/type of Organisation

Question 1
Indicate below which of the following describes your organisation.

Note: Your response to this question is necessary to determine whether the Regulator will issue the accreditation under Commonwealth legislation or under corresponding State law. If unsure of the organisations status, you should seek legal or other advice which will accurately identify the legal status of the organisation.

(a) a natural person or
Yes
No

(b) an organisation
Yes
No

If the application if by an organisation, indicate below which of the following in Part A or B below best describes your organisation. You may need to tick more than one box.

A. For an organisation which is a constitutional corporation i.e. a trading, foreign or financial corporation within the meaning or paragraph 51 (xx) of the Constitution

Note: Not all incorporated organisations are constitutional corporations. If in any doubt, applicants should seek legal or other advice.

Is the organisation a:

Higher Education Institution
Yes
No

Hospital
Yes
No

Research Institute or similar
Yes
No

A Commonwealth Authority which is a body corporate established under an Act and/or a company in which a controlling interest in held by the Commonwealth or a Commonwealth authority.
Yes
No

A State instrumentality which is a body corporate established under an Act and/or a company in which a controlling interest is held by that State or by a State instrumentality.
Yes
No

A Constitutional Corporation which is none of the above
Yes
No

None of the above. If you are none of the above, describe your organisation in the space provided below.

B. For an organisation which in NOT a constitutional corporation

Is the organisation a:

Higher Education Institution
Yes
No

Hospital
Yes
No

Research Institute or similar
Yes
No

A Commonwealth Department
Yes
No

A State Government Department
Yes
No

None of the above. If you are none of the above, describe your organisation in the space provided below.

Part B: Contact Information

Please provide contact details for the Organisation, the CEO, and the Primary Contact Officer (The person who will receive OGTR correspondence)

Organisation Information

Organisation name:
ABN:
Postal Address:
Postal Locality:
(City/Suburb/Location)
State:
Postcode:
Country:

CEO or equivalent

Personal title:
(eg Ms/Mr/Dr)
Surname:
First name:
Preferred first name:
Phone number:
Mobile:
Fax:
E-mail Address:
Position title:
Organisation (for postal delivery):
Postal address:
Postal Locality:
(City/Suburb/Location)
State:
Postcode:
Country:

Organisation Primary Contact Officer

(The person who will receive all OGTR correspondence)
Personal title:
(eg Ms/Mr/Dr)
Surname:
First name:
Preferred first name:
Phone number:
Mobile:
Fax:
E-mail Address:
Position title:
Organisation (for postal delivery):
Postal address:
Postal Locality:
(City/Suburb/Location)
State:
Postcode:
Country:
Top of page

Section 2:

Accreditation Information

You may copy this application form where multiple copies of certain parts are required. If the same information is relevant to more than one IBC there is no requirement to repeat the information (and attachments) but you must clearly make reference to this in your answer(s) and clearly identify the relevant information (and attachment).

If there is insufficient space in the boxes provided, please include any additional information as an attachment. Note the attachment title/number and the page number(s) in the space provided and mark on the attachment which Section, Part and question the information relates to.

Part A: Suitability

Question 1
Has the organisation previously been accredited by the Gene Technology Regulator?
Yes - Go to question 2
No - Go to question 3

Question 2
If the answer to question 1 is yes, please state whether the previous accreditation was cancelled, suspended or surrendered, or whether the period for which it was valid has expired.
Cancelled
Yes
Date
No

Suspended
Yes
Date
No

Surrendered
Yes
Date
No

Expired
Yes
Date
No

If you ticked yes for any of the above, please provide details.

Question 3
Has the organisation been convicted, within a period of ten years immediately before making this application, of an offence against a law of the Commonwealth, a State or a foreign country relating to the health and safety of people or the environment which is punishable by a fine of $5000 or more?
Yes
No
If yes, please provide details.

Question 4
Has the organisation ever had a licence or permit (however described) under a law of the Commonwealth, a State or a foreign country relating to the health and safety of people or the environment revoked, suspended or cancelled?
Yes
No
If yes, please provide details.

Question 5
Is there any other information relevant to questions 1 - 4 that may assist the Regulator in making a decision about accreditation?
Yes
No

If yes, please provide details. Top of page

PART B: Institutional Biosafety Committee (IBC)

Question 6
Does the organisation:
(a) have one or more IBCs established by the organisation?
Yes - Complete Part C
No

(b) have arrangements in place to use one or more IBCs that were established by another accredited organisation?
Yes - Complete Part D
No

If you answered Yes to both of the above options, please complete Part C and Part D.

If you answered No to all parts of question 6, please provide an explanation in the space provided below. Note that the Regulator may not be able to accredit this organisation.

PART C: Established IBC

This part asks for information about IBCs established by the applicant organisation.

If the applicant organisation has not established any IBCs, go to Part D.

Question 7
How many IBCs has the organisation established?

Please answer Questions 8 to 12 to provide the Regulator with information about the IBC(s) established by the applicant organisation, and provide contact details for the Chair and Primary Contact for the IBC.

If more than one IBC has been established:
  • answer the questions for the IBCs as a group;
  • where the answer to a question is No for one or more of the IBCs, please indicate which IBC(s) the No applies to in the box provided below the question;
  • copy the IBC Contact Details page and complete for each IBC established
Question 8
Does the membership of each IBC possess the collective technical scientific expertise necessary to assess all the matters that are likely to be put to them by the applicant organisation?

Note: Expertise must include skills and experience to competently assess and advise on the identification and management of the risks associated with dealings with GMOs undertaken by the accredited organisation, and to advise on the containment of GMOs?
Yes
No
If no, please provide reasons.

Question 9
Does the membership of each IBC include at least one independent member?

Note: Unless otherwise agreed by the Regulator, an independent member is someone who could be reasonably regarded as being free of any business or other relationship, including a relationship of employment, with the applicant organisation that could materially interfere with the exercise of unfettered and independent judgement in contributing to decisions made by the IBC.

Yes - Please describe why this member is independent to the organisation.
No - Please provide reasons below. (Here you may choose to describe why you believe a person, who does not meet the requirement for independence in the note above, is nevertheless independent).

Question 10
Does the organisation have appropriate indemnification for all members of the IBCs established by it?
Yes
No
If no, please provide explanation.

Question 11
Do all IBC members consider this indemnification to be acceptable?
Yes
No
If no, please provide explanation.

Question 12
Is there any other information relevant to Questions 7 – 11 that may assist the Regulator in making a decision about accreditation?
Yes
No
If yes, please provide details.

IBC Contact Details

Name of IBC:
If individual contact details have been previously provided in this application, you need only complete the surname and first name (and any other information necessary to clearly identify the person).

Chair of IBC
Personal title:
(eg Ms/Mr/Dr)
Surname:
First name:
Preferred first name:
Phone number:
Mobile:
Fax:
E-mail Address:
Position title:
Organisation (for postal delivery):
Postal address:
Postal Locality:
(City/Suburb/Location)
State:
Postcode:
Country:

Primary Contact for the IBC (if different to Chair)
(The person who will receive all OGTR correspondence relating to the IBC)

Personal title:
(eg Ms/Mr/Dr)
Surname:
First name:
Preferred first name:
Phone number:
Mobile:
Fax:
E-mail Address:
Position title:
Organisation (for postal delivery):
Postal address:
Postal Locality:
(City/Suburb/Location)
State:
Postcode:
Country:

Top of page

PART D: Access to IBC Established by Another Accredited Organisation

This part asks for information about IBCs established by another accredited organisation but will be accessed by the applicant organisation.

Question 13
How many IBCs, established by another accredited organisation, will the organisation be accessing?

(a) Please list the IBCs and their parent accredited organisation (ie. the organisation that has established and maintains the IBC).

IBC Name
Parent accredited organisation (i.e. organisation that established the IBC)

(b) Please provide confirmation that each organisation, whose IBC(s) are proposed to be used, has agreed to the applicant organisation using the IBC(s). This must be done by submitting a completed and signed copy of the declaration (Section 3, Part B, page 20) for each IBC.

If more than one IBC is being accessed
  • answer the questions 14 and 15 for the IBCs as a group
  • where the answer to a question is No for one or more of the IBCs, please indicate which IBC(s) the No applies to in the box provided below the question
Question 14
Does the applicant organisation believe that the membership of the IBC(s) possess the collective technical scientific expertise necessary to assess all the matters that are likely to be put to it by the applicant organisation?

Note: Expertise must include skills and experience to competently assess and advise on the identification and management of the risks associated with dealings with GMOs undertaken by the accredited organisation, and to advise on the containment of GMOs?

Yes
No - If no, please provide reasons.

Question 15
Is there any other information relevant to Part D that may assist the Regulator in making a decision about accreditation?
Yes - If yes, please provide details.
No

Question 16
Does the organisation have the capacity to comply with the conditions of accreditation that will generally be applied to an accredited organisation, as outlined in the Regulators Guidelines for the Accreditation of Organisations?
Yes
No - If no, please advise in what way(s) the organisation fails to comply with the Guidelines and what strategies are suggested to enable/maintain accreditation of the organisation, if granted. Top of page

Attachment list

(All attachments to the application form must be listed here).

Section 3: Declarations

Part A - Declaration of the organisation submitting this application

This declaration must be completed and signed by a person with the authority to sign on behalf of the organisation.

I declare that:
  • I am duly authorised to sign this declaration;
  • the information supplied on this proforma and any attachment is true and correct; and
  • I am aware that the making of a false or misleading statement may be punishable by imprisonment or a fine under the Gene Technology Act 2000 and corresponding state law.
Printed name:
Job title:
Signature:
Date:

Part B - Declaration of the organisation responsible for the IBC

This declaration needs to be completed if the organisation for which accreditation is sought intends to rely on the services of an IBC established by another organisation accredited by the Gene Technology Regulator (the other organisation). The CEO or equivalent of the other organisation (or delegate) must make the following declaration.

(1) Name of applicant organisation for which accreditation is being sought:

(2) Name of the IBC to be used:

(3) I declare that:

I am authorised to sign on behalf of:
(other organisation name)

which is accredited by the OGTR
(Accreditation number:)
  • the information provided regarding the IBC named above (in this form and any relevant attachment(s)) is true and correct;
  • the organisation I represent has agreed that the organisation, named at (1), may access the IBC named at (2);
  • that the IBC named at (2) above has the collective technical scientific expertise to advise upon the work anticipated to be done by the Applicant names at (1) above
  • that there are appropriate indemnification arrangements for all members of the IBC covering the use of the IBC by the applicant organisation, and all the IBC members consider this indemnification to be acceptable;
  • that the membership of the IBC named above includes at least one independent member; and
  • I am aware that the making of a false or misleading statement may be punishable by imprisonment or a fine under the Gene Technology Act 2000 or corresponding state law.
Printed name:
Job title:
Signature:
Date: Top of page