National Ethics Application Form and the Victorian Specific Module

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Overview

The National Health and Medical Research Council (NHMRC) have developed the National Ethics Application Form ('NEAF') which meets the requirements of relevant national legislation and guidelines, including the National Statement on Ethical Conduct in Human Research (2007).

The NHMRC NEAF website must be used to prepare applications for submission to organisations not participating in the Consultative Council for Human Research Ethics (CCHRE) initiative. Participating sites are listed on the CCHRE website.

In Victoria there is an additional requirement to comply with legislation relevant to human research involving

• information privacy (Information Privacy Act 2000)
• health information (Health Records Act 2001)
• the use of ionising radiation (Radiation Act 2005 and Radiation Regulations 2007).

In addition, consent under circumstances where the Guardianship and Administration Act 1986 and the Mental Health Act 1986 apply must meet legislative requirements in Victoria.

See the Links page for more about legislative requirements.

Sections of the Victorian Specific module

The Victorian Specific Module has specific sections for human research in Victoria and these have been designed to be compatible with the use of the NEAF. This Module must be submitted with the NEAF application to Victorian Human Research Ethics Committees (HRECs) where relevant to the research project. The Module may be modified and updated from time to time.

Please access the Victorian Specific Module from the CCHRE website each time you make a new application, to ensure that you have the latest version.

Section 1 – Projects involving drugs & therapeutic devices

Section 2 – Recruitment of adults who may be incompetent to consent

This Section refers researchers to the requirement for gaining consent where the Guardianship and Administration Act 1986 and Mental Health Act 1986 apply.

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Section 3– Research Involving the Collection/Use/Disclosure of Information

The Statutory Guidelines on Research (the Guidelines; Health Records Act 2001) must be read and referred to when completing this section.

Investigators have a legal as well as an ethical obligation to consider privacy and health information issues. Investigators and HRECs are required to fulfil their obligations under Victorian privacy and health records legislation. Privacy under Commonwealth legislation (National Privacy Principles) is addressed in the National Ethics Application Form (NEAF) and refers to the Privacy Act 1988, Sections 95 and 95A.

In addition, applicants in Victoria submitting research projects involving collection, use and disclosure of information must complete Section 2 of the Victorian Specific Module.

Section 4 – Use of Ionising Radiation

The Radiation Act 2005 and the Radiation Regulations 2007 control the use of ionising radiation in Victoria. The responsible body in Victoria is the Radiation Safety Section (RSS) in the department.

Applicants if necessary should obtain further information from their institution’s Radiation Safety Officer, Medical Physicist or the Radiation Safety program at the department by emailing radiation.safety@health.vic.gov.au.

Section 5 - Research Involving the Use of Human Tissues or Blood, or Performance of Post Mortem

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Related information

Medicines Australia Standard Indemnity Forms

To download these forms, see the Indemnity and Compensation Guidelines on the Medicines Australia website.

Clinical Trial Research Agreement

This is a legally binding Agreement between the Sponsor responsible for the initiation, management and financing of a clinical trial and the Institution responsible for the conduct of a clinical trial at a site.

This Clinical Trial Research Agreement is an industry standard. The Agreement can be downloaded from the Medicines Australia website.

First Time In Human protocol

The First Time In Human protocol has been developed to assist preparation of early phase clinical trials. This can be downloaded from the Victorian Managed Insurance Authority (VMIA) website. See Clinical trial notification guidelines on the VMIA website.

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