How to Submit a Human Research Ethics Application: Full HREC review

Please read the National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research, 2007 before you begin a human ethics application.

The following types of research require review by a Human Research Ethics Committee (HREC):

1. All research that involves more than low risk:
2. Research falling under the following chapters of the National Statement:
   • Chapter 3.2: Human biospecimens in laboratory based research;
   • Chapter 3.3: Genomic research
   • Chapter 3.4: Animal-to-human xenotransplantation
   • Chapter 4.1: Women who are pregnant and the human foetus
   • Chapter 4.4: People highly dependent on medical care who may be unable to give consent
   • Chapter 4.5: People with a cognitive impairment, an intellectual disability or mental illness
   • Chapter 4.6: People who may be involved in illegal activities ( (except for those projects that only involve the collect ion of non-identifiable data and involve negligible risk)
   • Chapter 4.7: Aboriginal and Torres Strait Islander Peoples
   • Chapter 4.8: People in other countries (except where the risk to participants is low/negligible risk and/or the project does not involve participants who could be considered a vulnerable group in the context of the project)

A human research ethics application consists of:

• JCU Human Research Ethics Application Form
• JCU Information sheet (if applicable)
• JCU Informed consent form (if applicable)
• Attachments (draft or final copies of surveys, questionnaires, letters of support/approval)
• See Forms and Downloads for the most recent versions of the forms and templates

You can also use the National Health and Medical Research Council’s Human Research Ethics Application Form for submission to the James Cook University HREC. It is recommended that this form be used if you are conducting any research that requires multi-institutional/multi-health service district approvals.

Please read the Human Research Ethics Application Application Guide, which can be found in Forms and Downloads before you attempt to draft your application. Once you have a draft ready and your Supervisor/s (if applicable) is satisfied with the document, you need to forward the application to a Human Ethics Advisor for review. This review can take time, so please take note of the Closing Dates for submission of Ethics Applications.

Once the Human Ethics Advisor has signed and approved the application ready for submission.

A complete application ready for submission consists of:

• A fully signed application (signed by Principal Investigator, Supervisor/s (if applicable), Dean of College/Delegate and Human Ethics Advisor) including any attachments outlined above.

Submission details:

Email one electronic copy in one PDF file to [email protected]

The pdf file should include the ethics application and any attachments such as checklists, information sheet, consent form, etc. If the application and attachments are not submitted as one pdf file it will NOT be accepted and you will be asked to resubmit in one pdf file.

PLEASE NOTE: THE HREC DOES NOT GRANT RETROSPECTIVE APPROVAL