Health Service Districts and External HREC Approvals – Clinical Trial

Research Services Ethics & Integrity Clinical Trials Health Service Districts and External HREC Approvals – Clinical Trial

MULTI-CENTRE CLINICAL TRIALS

Health Service Districts

Clinical trials involving multi-centre research with participants recruited from Health Service Districts (in hospital or in the community) should apply in the first instance to the relevant Health Service District for a multi-site research ethics approval.

The National Ethics Application Form (NEAF) should be used for all multi-centre clinical trials.

Please also see the specific submission guidelines for Health Service Districts in New South Wales and Queensland on the NEAF web site.

If the study has already received approval from a Health Service District HREC you must submit to Clinical Trials, Research Services, ethics@jcu.edu.au, (07) 4781 5011, Building, DB17, Room 128, James Cook University, Townsville, Qld 4811.

1. Cover Sheet External Approval HREC: Clinical Trial - signed by James Cook University Investigator and Head of School.

2. One (1) copy of the ethics application submitted to the Health Service District HREC (including signature pages, informed consent forms and information sheets, and all other attachments);

3. Approval notice from the relevant Health Service District HREC; and

4. Any requested amendments/conditions requested by the Health Service District HREC, your response and any other correspondence.

External HREC

If the multi-centre clinical trial involves other universities or research institutions, a NEAF application should be used.

If the study has already received ethics approval from an external HREC, you must submit to Clinical Trials, Research Office, ethics@jcu.edu.au, (07) 4781 5011, DB17, Room 128, James Cook University, Townsville, Qld 4811.

1. Cover Sheet External Approval HREC: Clinical Trial - signed by James Cook University Investigator and Head of School.

2. One (1) copy of the ethics application submitted to the external HREC (including signature pages, informed consent forms and information sheets, and any other attachments);

3. Approval notice from the external HREC; and

4. Any requested amendments/conditions requested by the Health Service District HREC, your response and any other correspondence.

In accordance with Chapter 5.3 of the National Statement on Ethical Conduct in Human Research, 2007, as the study has already been reviewed and granted ethics approval by a HREC, the JCU HREC will accept the decisions of these committees and provide written advice that acknowledges ethics has been obtained.