NATIONAL ETHICS APPLICATION FORM Version 2 (2007 National Statement) NHMRC - Health & Research Ethics.

NATIONAL ETHICS APPLICATION FORM

Version 2

(2007 National Statement)

NHMRC - Health & Research Ethics

NEAF v2Consistent with the 2007 National Statement on Ethical Conduct in Human Research (NHMRC, ARC, AVCC)

Outline of presentation • What is NEAF?• Major changes in the 2007 National Statement• Major changes in NEAF v2• Future possibilities and directions

NEAF v2What is NEAF?

•NEAF is a web based tool that allows researchers develop and submit ethics applications.•It provides a minimum acceptable consistent set of questions that address the ethical considerations in the National Statement.•It is intuitive; based on the types of research and participants selected requires different sections of the National Statement to be addressed.•Is applicable across all HREC in Australia.•NEAF can facilitate multi-centre research.

NEAF v2Major changes in the 2007 National Statement on Ethical Conduct in Human Research

New structure: (1) Values & principles (2) Risk, benefit & consent (3) Considerations relating to methods or fields (4) Considerations relative to participants (5) Processes of governance and reviewInclusion of guidance from Supplementary Note 5Removal of some sections, including

‘collectivities’

Administrative Section

Ethical Review Section

Limited DisclosureWaiver of Consent

Limited Disclosure

Invite user – editing marks for online version only

Editing mark-up

NEAF v2Transitional arrangements

• v2.1 is the default template for applications (2007 National Statement) as of 28 August 2008.• Applications made in the previous version (v1.1) up until 28 August 2008 will remain open for editing until 31 December 2008. These will be locked after this time, but can still be opened, printed or exported.• All existing accounts and completed applications as of 28 August 2008 will remain active and accessible.

NEAF v2Questions and discussion

• Future options• Questions about NEAF 2

• NHMRC welcomes your feedback on NEAF 2• [email protected] • 1800 823 993