Human Research Ethics Committee (HREC)
Grants Management Office
Researchers may submit their ethics application using either the UNSW HREC application form or the web-based National Ethics Application Form (NEAF). Each question on these forms has instructions and links to relevant documents for guidance and information.
- 1 copy of the signed application plus attachments all as one PDF document emailed to Annamarie D'souza
- 12 printed (double-sided only) copies of application and attachments stapled as 12 complete packs sent to the Grants Management Office (address above).
- Please do not put application or copies in envelopes or folders.
- With Grant: Include 2 copies of the grant application
- Cover letter giving details and justification of the change.
- A copy of any amended documents** with the changes highlighted either in italics or bold.
- For the addition of personnel to the project please fill in the Personnel Modification Form.
- All documents should be saved in PDF format and emailed to Annamarie D'souza.
- Please refer to the Suggested Naming Standards below for naming your modification attachments
HREC Application: Ratification from another Ethics Committee/ Panel*
UNSW HREC no longer ratifies external HREC approvals. For applications already approved by a NHMRC-registered Australian HREC, no further action is required. For applications approved by an overseas ethics committee, a formal application to UNSW HREC (or Panel, if low ethical risk) must be made. For projects approved by an Australian HREC, e.g. at a hospital, but for which the approval is limited to that site or for only part of the activities to be undertaken, UNSW HREC will review the existing application and approval paperwork (send to Annamarie D'souza), along with an appropriately amended participant information statement and consent form (e.g. including the UNSW complaints clause), to provide approval that includes the remaining sites and activities.
* Panel approvals require HREC ratification only if the research is associated with the Department of Education and Training. All other Panel approvals no longer require ratification by the HREC before funds will be released.
**eg: questionnaires, letters of support, Participant Information Statement and Consent Forms
HREC Applications from Non-UNSW Researchers
The UNSW Human Research Ethics Committee (HREC) will consider ethics applications from non-UNSW researchers.
The application should be made using the standard HREC Application Form. This form should be completed and submitted to the Ethics Secretariat as per the instructions above.
Non-UNSW applications will incur a fee for the initial review and for any modifications to the project. The fee must be paid at the time of submission and prior to consideration, whether or not approval is given. The fees are outlined in the Agreement.
An Agreement between UNSW and the researcher must be signed prior to UNSW HREC review. This Agreement will set out the HREC Terms and Conditions for consideration, approval and indemnification arising from the review of such projects.
All such projects will be reviewed by the HREC and any outstanding issues must be addressed to the satisfaction of the Committee prior to finalisation of the approval. The Risk Management Unit of UNSW will be advised of such applications as required for indemnity and insurance purposes.
As with all research applications continued approval is dependent upon satisfactory annual monitoring reports being provided by the researcher.
Suggested naming conventions for Attachments
Documents being sent to the Ethics Secretariat should be named clearly and informatively. This greatly assists in processing the large volume of attachments received.
|Type of Attachment||Suggested Naming Convention|
|Questionnaire/Survey||Questionnaire_<name of the Questionnaire if relevant><Date>|
|Communication||Correspondence_with <name of person/organisation>_regarding <reason> dated <insert date of correspondence>|
|Response||Response_cover_letter_<name of CI>_<date>|
|Application form submitted after making the changes requested by the HREC||Amended_ethics_application_form <date amended>|
|Participant Information Statement and Consent Form||Amended_PIS_CF<if relevant state who is the target eg parent/child/gaurdian><date amended>|
|CF||Amended_CF<if relevant state who is the target eg parent/child/guardian><date amended>|
|Letter of support||LOS<Name of Organisation><Date>|
|Approval from another HREC||Approval_from<name of organisation/ethics Committee><Date of approval>|
|Study protocol||Amended_Protocol<version number><Date>|
|Modification cover letter||Modification_cover_letter_<name of CI>_<date>|
|Clinical Trial Notification||CTN<Date>|
|Medicines Australia Form of Indemnity for Clinical Trials||Indemnity_CT<Date>|