Need for review: The general principle is that any human research project which has a relevant connection with the University should be submitted for appraisal to the HREC or the local HREA Panel. Research has a relevant connection to the University if:
i. it is carried out using equipment, facilities or premises owned by the University or otherwise under the control of the University;
ii. it is carried out by any person (either alone or jointly with others) who is a full-time, part-time or conjoint employee of the University, or a person recognised by the University; or
iii. it involves human participants who are students or staff members of the University, or are otherwise connected with the University in any way.

Commencement of projects: No human research project having a relevant connection with the University should commence without the prior written approval of the HREC or the HREA Panel and relevant Head of School.

Head of School certification: All applications to the HREC should be signed by the Head of School (or Faculty, Unit or Centre) before submission. When the Head of School or equivalent is affiliated with the research, an appropriate senior officer not associated with the research should sign. Applications not so certified will not be considered.

Approvals: A copy of the letter of approval, either from the HREC or HREA Panel, should be retained by the Chief Investigator. A record of the HREC approvals is kept by the Ethics Secretariat and HREA Panel approvals by each Panel administrator.

Approval numbers: The HREC or HREA Panel approval number (when available) must be displayed on each document seen by participants.

Ratification: Projects approved by another HREC which involve UNSW staff, students or facilities should be ratified by the UNSW HREC. The Chief Investigator should forward copies of the original application and the approval letter to the UNSW HREC.

Teaching hospital and conjoint appointments: Each teaching hospital affiliated with the University has its own HREC, and any research project involving patients in a teaching hospital or otherwise connected with the hospital or area health service should be approved by the hospital HREC, which in that case is considered to be the primary HREC. It should also be submitted for ratification to the UNSW HREC (the secondary HREC) when there is a relevant connection with the University. This commonly occurs where an investigator has a conjoint appointment to both a University teaching hospital and to the University itself.

Clinical Trial Registration: There is increasing acknowledgement that every clinical trial should be registered in a publicly accessible database, to allow independent scrutiny of clinical trial data.
Clinical trials may only receive final HREC approval for recruitment of participants on the condition that they are registered with such a database (e.g. Australian and New Zealand Clinical Trials Registry). Link to the ANZCTR website.

Multi-centre research with participants recruited from area health services: If participants in research projects are to be recruited from multiple venues within area health services (including hospitals and community health services), the project is required to undergo review using the NSW Dept of Health’s Single review of multi-centre research process. This involves submission of the ethics application to an appropriate lead committee, with site specific assessment required for individual health service venues. Detailed instructions are available on the NSW Government website.

This process typically applies to multi-centre clinical trials. Once approved, such studies will be ratified by the UNSW HREC. UNSW HREC is not able to function as the primary HREC under such circumstances.

Multi-centre research (not recruiting participants from area health services): If a human research project has a relevant connection with the University and one or more institutions, it will require the approval not only of the University HREC but also of the HRECs at those other institutions. This applies to medical and non-medical research. Similarly, if the team of investigators includes individuals from institutions other than UNSW, then the project will also require approval of the HREC at those institutions.

Investigators should decide which institution has the greatest connection with the research and treat them as the primary institution. This will usually be the institution:
• from which the investigator is employed or is a student
• through which funding will be provided
• from where participants are recruited.

It is important that any such proposal not be submitted simultaneously to all relevant committees. The project should be submitted, in the first instance, to the HREC at the primary institution.

Serious adverse events: A serious adverse event is defined as serious or unexpected harm (physical, psychological, financial, social or cultural) to a researcher or research participant. These must be reported to the HREC within 72 hours using the SAE Proforma. See question 6.1 of the HREC application form and associated hotlinks.

Insurance: The University maintains an insurance policy to cover all HREC or HREA Panel approved projects.

Monitoring: Annual monitoring of the status of each HREC approved project is an absolute requirement for ongoing approval status.

Research accounts: External research funds will only be released by Research Services after appropriate HREC approval or ratification of an HREA Panel approval. Internal research funds (e.g. Faculty Research Grants and Goldstar Awards) relating to HREA Panel approved projects do not require HREC ratification.

Modifications: During the course of an approved research project, modifications to the study design may be required (e.g. changes in protocol, addition of researchers, addition of study sites, etc.). In this circumstance, the Chief Investigator should detail the modifications in a letter to the HREC or HREA Panel and attach relevant documents (e.g. updated Participant Information Sheet and Consent Form). If the proposed amendment is substantial, the HREC or HREA Panel may opt to treat it as a new project. In this event, a new application will be required.

Approval period: The HREC provides approval for five years and the HREA Panels provide approval for one year.