Research at the WCHN
Institutional Biosafety Committee (IBC)
The IBC's responsibilities are outlined in its Terms of Reference. It is responsible for administering the guidelines of the Office of the Gene Technology Regulator (OGTR) which includes monitoring and surveillance of all genetic manipulation work carried out within the precincts of WCHN. The IBC reports to the WCHN Executive and to the OGTR annually.
Membership includes people with the requisite knowledge and expertise to assess, evaluate and oversee biological work carried out at WCHN, an engineer experienced in testing biological safety facilities and equipment, and at least one lay person not associated with the Hospital. Meetings are held two monthly and protocols for consideration by the committee must be received by the secretary 21 days before the meeting. The IBC is responsible for the certification and annual inspection of PC2 containment facilities within the hospitals and for the consideration of research protocols which are generally categorised as: exempt dealings, notifiable low risk dealings, or licensed dealings, depending on the level of associated safety implications. Enquiries about the committee should be directed to the IBC Executive Officer on 8161 6390.
The OGTR produces Guidelines which describe each of the categories of protocol listed below. Each application to the IBC must be accompanied by the relevant WCHN form (see below):
FACILITY Application Evaluation Form (Please note - from March 2013 the OGTR have issued new guidelines for Certification of a Physical Containment Level 2. Version 3.2 effective 1 March 2013 ).
Unsure whether your application involving viral vectors is a DNIR or NLRD?
Please contact the IBC Executive Officer on 8161 6390 if you have any queries when completing the above forms. Refer to Research Secretariat page for e-mail contact details.
NB: Effective from 1 July 2019, please note the following advice about Record of Assessment (RoA) requirements from the OGTR (this includes but not limited to the addition of staff to dealings, title addition/changes and facility alterations).
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).
Responsibility of Department Heads
Records of training
OGTR requires that all personnel (staff, students or visitors) working in an OGTR-certified facility be appropriately trained. It is the responsibility of Department Heads to ensure that relevant personnel have completed a Record of Training and to retain originals of these records and to make them available to OGTR on request. Additionally, Department Heads or Supervisors must ensure that all laboratory staff are provided with adequate "Induction Training".
Genetically Manipulated Organisms (GMO) Storage and Transport Register
Department Heads have a responsibility to ensure that stored GMO details are recorded on
Other documents of interest:
last modified: 21 Aug 2019