Research and Innovation Services Ethics and Research Integrity Clinical Trials Health Service Districts and External HREC Approvals – Clinical Trial
Health Service Districts and External HREC Approvals – Clinical Trial
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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 (HREA) should be used for all multi-centre clinical trials.
Please also see the specific submission guidelines for Health Service Districts in on the HREA web site.
If the study has already received approval from a Health Service District HREC you must submit to Clinical Trials, Research Services the following documents:
- Cover Sheet External Approval HREC: Clinical Trial - signed by 91³Ô¹ÏÍø Investigator and Head of School.
- 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);
- Approval notice from the relevant Health Service District HREC; and
- 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 HREA application should be used.
If the study has already received ethics approval from an external HREC, you must submit to Clinical Trials, Research Services the following documents:
- Cover Sheet External Approval HREC: Clinical Trial - signed by 91³Ô¹ÏÍø Investigator and Dean of College.
- 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);
- Approval notice from the external HREC; and
- Any requested amendments/conditions requested by the Health Service District HREC, your response and any other correspondence.
In accordance with , 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.
Clinical Trials, Research Office - Contact Details
Clinical Trials - Research Office,
Room 128, Science & Engineering Building 17
91³Ô¹ÏÍø
Townsville QLD 4811
Email: ethics@jcu.edu.au
Tel: (07) 4781 5011