Applications

 

Project Number | Application (low/negligible risk) | Application (standard) 

Forms | External Applicants | Minimising Duplication | Fees | How to Submit | Dates

Legal and Regulatory Requirements | Dangerous Goods Courses

 

Project Number

All projects are identified with a unique number that remains for the life of the project. Please request a project number before submission stating:

  • Principal researcher
  • Research team members (if available)
  • Full title
  • Project type eg clinical trial, audit

by email:

hrec@barwonhealth.org.au 

lynsc@barwonhealth.org.au (Community and Mental Health only)

 

If you have any queries, please contact the Research and Ethics Office.

  

Application (Low/Negligible Risk) 

If the project is negligible (definition: research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk. Source: National Statement on Ethical Conduct in Human Research (2007)) or low risk (definition: research is ‘low risk’ where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk. Source: National Statement on Ethical Conduct in Human Research (2007) full ethical review may not be required. Please complete both:

This might also apply to any projects which while not strictly research also require ethics approval (for example if you intend to publish).

 

Application (Standard)

If the project is greater than negligible or low risk, full ethical review is required. Please complete either:

or

Forms

Click on the links to view specific forms.

 

Common Application Forms (CAF) Modules (Please note - you may download the Victorian Common Application Form modules or complete these modules online.)

 

NEAF - is a web-based tool that has been developed to assist researchers of all disciplines to complete research ethics proposals for submission to Human Research

Ethics Committees (HRECs), and to assist HRECs to consistently and efficiently assess these proposals. It has been designed to meet the requirements of relevant guidelines with the aim of increasing the efficiency and quality of the ethical review process for all parties involved. **NEAF is currently under development and a new version is about to be released

 

External Applicants

If you are an applicant who is not a staff member of Barwon Health you must include at least one senior member of staff on the research team.

 

Minimising the Duplication of Review

The National Statement on Ethical Conduct in Human Research (2007) requires that organizations minimize the duplication of ethical review of research proposals (National Statement 5.3). Research which has received ethics approval by a Human Research Ethics Committee constituted in accordance with the National Statement (Sections 5.1.26 – 5.1.37), may not require additional ethical review. However application must be made to the RRC for consideration prior commencement. The RRC determines if further review is required.

 

Fees

Fees apply for certain categories of applications. For full details, see 'Fees'.

 

How to Submit

The Barwon Health research review process involves three committes with different focuses and approval powers.

 

CMH Research Governance Committee Community & Mental Health projects only

All projects involving Community and Mental Health sectors must be approved by this committee, which has been established to monitor research, quality assurance and audit projects proposed and conducted within Community & Mental Health. It makes recommendations to RRC, including approval of negligible risk projects.

 

This is an electronic process. Please complete appropriate Modules or NEAF and submit electronically to: lynsc@bawronhealth.org.au or hrec@barwonhealth.org.au. Responses from the committee are made by email.

 

Research Review Committee (RRC) All research applications

All research must be reviewed by the RRC, which has been established to review projects from a technical, scientific and governance perspective and make recommendations to the REAC. The RRC may approve low or negligible risk projects.

 

This is an electronic proces. Please complete appropriate Modules or NEAF and submit electronically to: hrec@barwonhealth.org.au. Responses from the committee are made by email.

 

Research and Ethics Advisory Committee (REAC)

The Barwon Health Research and Ethics Advisory Committee (REAC) is constituted and operates in accordance with the NHMRC Statement on Ethical Conduct in Research Involving Humans (2007).

 

This is a hard copy process. Please complete appropriate Modules or NEAF and submit one original and seventeen (17) hard copies and the final copy electronically to ensure delivery to the Research and Ethics Office by the due date. Responses from the Committee may be made by email but the approval letter is a hardcopy. Before the project may start, the investigator must be in possession of written approval stating the date of approval and any conditions under which approval is granted.

 

Dates

Committee Dates

The RRC and REAC meetings are held monthly with agenda closing two weeks prior. Please note that due to administrative pressures, it may be impossible to accept late submissions. Click on the link below to download a copy of the key committee dates.

 

Committee Dates 2008

 

Legal and Regulatory Requirements

Commercially sponsored applications are usually accompanied by an indemnity statement, a current insurance certificate and a Clinical Trial research Agreement.

 

VMIA CTN guidelines with the updated attachment B Form of Indemnity for Clinical Trials and updates incorporating amendment to the Guardian and Administrative Act 1986.

 

Guidelines for compensation for injury resulting from participation in a company-sponsored clinical trial


Medicines Australia - Guidelines for Compensation (85kb, PDF)

Clinical Trials Research Agreement - Medicines Australia

 

Form of indemnity for clinical trials
Form of Indemnity for Clinical Trials (76kb, MS Word)

Form of Indemnity: HREC review only

 

Clinical Trial Notification (CTN) Scheme Form
CTN Form (55kb, PDF)

 

Registration of Clinical Trials

The International Committee of Medical Journal Editors (ICMJE) has adopted a policy that the member journals will only consider publication of clinical trials if the trial has been registered in a World Health Organisation (WHO)-accredited clinical trial registry. Click on the link below for more information.

 

Registration of Clinical Trials

 

Trials can be registered with:

Dangerous Goods Causes

Who should do a dangerous goods course?

 

Shippers: people employed to send dangerous goods by air must do an approved course. This covers employees who do any of the following:

  • enclose the goods in packaging
  • mark or label the consignment
  • prepare a shipper's declaration

Training Requirement

Readers should note that Part 92-120 of Civil Aviation Safety Regulations 1998 requires that shippers of ALL dangerous goods be trained. This includes UN3373 prepared in accordance with Packing Instruction 650, whether or not it is packed with a medium or another substance that is dangerous goods. Training is also required for shippers who ship “exempt” material on or with a medium or substance that is dangerous goods; these include dry-ice, formaldehyde, alcohol etc. For further information contact a CASA Dangerous Goods specialist on 131 757.