Protocol Variation Requests

This page provides information on protocol variation requests for research projects granted ethics approval by the Department of Health Human Research Ethics Committee.

Page last updated: 28 October 2014

For research projects granted ethics approval by the Department of Health Human Research Ethics Committee any protocol variation needs to be assessed by the Committee. The request form available here is to assist the researcher in making this request.

For research projects with multiple ethics approvals, including the Department of Health Human Research Ethics Committee, protocol variation requests should be lodged with the lead Human Research Ethics Committee (HREC). Details of these requests should be provided to the Department of Health Human Research Ethics Committee for information only following approval by the lead HREC.

Requests should be made for any changes which impact on the ethical conduct of the research project, with a list of examples included in the protocol variation request form below. Applicants are required to complete all fields of the request form and include, where necessary, any relevant attachments.

If you are unsure whether you should lodge a protocol variation request for your research project, or require assistance on how to complete the form, please contact the Committee Secretariat at ethics@health.gov.au.

Protocol Variation Form (Word 499 KB)

Protocol Variation Form (PDF 60 KB)