Institutional Biosafety - How to Apply

Institutional Biosafety

ABOUT THE INSTITUTIONAL BIOSAFETY COMMITTEE
The Institutional Biosafety Committee (IBC) reviews:

Proposals for laboratory and clinical studies involving the use of Genetically Modified Organisms (GMOs) to ensure the research meets the requirements of the Gene Technology Act 2000 and the Gene Technology Regulations 2001. The IBC assists supervisors, sponsors and Office of the Gene Technology Regulator (OGTR) licence holders with obtaining proper authorisation for their studies.

And

Proposals for laboratory research (not clinical service) involving SARS-Cov-2 virus and organisms that cause Listed Human Diseases under the Biosecurity Act 2015 (regardless of whether or not GMOs are involved). This does not include laboratory research involving samples from persons suspected or confirmed to be positive for SARS-Cov-2 or for organisms that cause Listed Human Diseases under the Biosecurity Act 2015.

GMO DEALINGS
The receipt, preparation, use, transport, storage and disposal of a Genetically Modified Organism (GMO) is known as a GMO dealing. Clinical trials and basic or translational research may involve GMO dealings.

Clinical trials of viral vector gene therapies or gene modified viruses must be licenced by the OGTR. Licence applications are reviewed by IBCs before they are submitted to the OGTR for decision. IBCs also advise on cell therapy clinical trials that do not require a licence, on exempt GMO studies, on laboratory research and on local risk management of clinical trials that already have an OGTR licence.

GMO dealings are divided into classes under the Gene Technology Regulations 2001. The classes of GMO dealings most relevant to medical research are:

Exempt GMO dealings
Notifiable Low Risk Dealings (NLRDs) (PC1, PC2 or PC3)
OGTR licenced Dealings Not Involving Intentional Release (DNIRs)
OGTR licenced Dealings Involving Intentional Release (DIRs)

The Gene Technology Regulations 2001 provide information about each class of GMO dealing. The Regulations may be found on the Office of the Gene Technology Regulator (OGTR) web page (http://www.ogtr.gov.au)

LABORATORY RESEARCH (NOT CLINICAL SERVICE) WITH SARS-COV-2 VIRUS OR WITH ORGANISMS THAT CAUSE LISTED HUMAN DISEASES UNDER THE BIOSECURITY ACT 2015

Laboratory research (not clinical service) with SARS-Cov-2 virus or with organisms that cause Listed Human Diseases under the Biosecurity Act 2015 must be approved by RPAH IBC. This does not include laboratory research involving samples from persons suspected or confirmed to be positive for SARS-Cov-2 or for organisms that cause Listed Human Diseases under the Biosecurity Act 2015.

Research involving human samples requires approval by the Human Research Ethics Committee (HREC) and Governance.

A Listed Human Disease (LHD) under the Biosecurity Act 2015 is a human disease which is communicable and may cause significant harm to human health.

The Australian Department of Health lists the diseases that fall under the Biosecurity Act 2015 at https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-biosec-list-diseases.htm

Current Listed Human Diseases under the Biosecurity Act 2015 are:

-           Human influenza with pandemic potential
-           Plague
-           Severe acute respiratory syndrome (SARS)
-           Middle East respiratory syndrome
-           Smallpox
-           Viral haemorrhagic fevers
-           Yellow Fever
-           Human coronavirus with pandemic potential (e.g. COVID-19)

Researchers should refer to the Australian Department of Health website as the list may change from time to time.

Researchers should contact the IBC if they are planning laboratory research (not clinical service) using such organisms.

HOW AND WHEN TO APPLY TO THE IBC
Early consultation with the IBC is required for all proposals (see above) that may require an assessment by, or an application to, the IBC.

The first step is to contact the IBC Executive Officer for advice about whether or not an application to the IBC is required and, if so, about how to apply.

The aim of the IBC’s assessment is to assist researchers, supervisors, sponsors and OGTR licence holders to ensure proper authorisation, compliance and the safe conduct of the study.

For studies that also require review by ethics committees, depending on the nature of the work and whether or not an OGTR licence is required, to avoid delays it is advisable to contact the IBC well before, or close to, the time of applying to ethics committees.

Please also note the early consultation requirements with RPAH Department of Cell & Molecular Therapies (CMT) Head of Department and R&D Manager and the IBC for Advanced Therapy Medicinal Products (ATMPs) (see below)

OGTR GUIDELINES ON HUMAN CLINICAL TRIALS INVOLVING GMOS
OGTR guidelines on regulatory requirements under the Gene Technology Act 2000 for human clinical trials involving genetically modified organisms (GMOs) can be accessed at: https://www.ogtr.gov.au/resources/publications/guidance-sponsors-clinical-trials-humans-involving-gmos

EARLY CONSULTATION REQUIREMENTS FOR ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs)
There are specific initial consultation requirements that must be met in advance for Advanced Therapy Medicinal Products (ATMPs). These are outlined at: https://www.slhd.nsw.gov.au/rpa/research/atmp.html

FORMS
Forms are provided by the IBC Office for the following:
· Exempt GMO and NLRD applications
· Initial early consultations regarding ATMPs
· Local review of a clinical trial that already has an OGTR licence and has satisfied the initial consultation requirements for ATMPs
· Laboratory research (not clinical service) with SARS-COv-2 virus or with organisms that cause Listed Human Diseases under the Biosecurity ACT 2015.

Please contact the IBC Officer regarding the above. Registration may be required prior to application.

The following forms are available on the OGTR website:
· Forms for OGTR DNIR and DIR licence applications
· Forms for OGTR certification of Physical Containment Facilities (applications for certifications are made directly to the OGTR).

Important: You must contact the IBC Executive Officer before commencing an OGTR licence application.

IBC MEETING SCHEDULE
Please see the IBC meeting schedule for the preview, closing and meeting dates.

RPAH IBC CONTACTS
Chairperson: Professor John Rasko AO

Interim Deputy Chairperson: Dr Charles Bailey

Executive Officer and Primary Contact: Dr Gabrielle O'Sullivan
Email (best): Gabrielle.OSullivan@health.nsw.gov.au
Mobile (next best): 0414 785 471
Telephone: 02-9515 6772

Mailing address: Royal Prince Alfred Hospital Institutional Biosafety Committee (RPAH IBC),
c/- Research Ethics and Governance Office (REGO), Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050, Australia

OGTR Web address: http://www.ogtr.gov.au