ICH GCP:
Most clinical trials, especially those involving therapeutic products, must adhere to ICH GCP (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines Link to ICHGCP Guidelines. UNSW HREC will not provide approval for conduct of such trials without them conforming to a minimum set or requirements:
• as well as the required two page project lay description as outlined in the ethics application form, a formal clinical trial protocol must be generated, with version control and date. This should include literature review, safety data, hypothesis, detailed methods including power calculations and statistical analyses proposed, inclusion and exclusion criteria, likely outcomes and all outcome measures;
• all subsequent amendments will require a new clinical trial protocol with version number and date;
• formal case reporting forms are mandatory;
• participant information statement and consent forms are to include version number and date in a footer;
• depending on the nature of the trial, an independent data and safety monitoring board will need to be established. The investigator should propose data and safety monitoring activities appropriate for the study, including long term follow-up of outcomes and frequency of reports. DSMB reports should be forwarded to the ethics committee


Clinical Trials Registration:
In addition, 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.


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. HREC application form

Multi-centre research with participants recruited from area health services: NSW Government website.
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 researchprocess. 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): NSW Government website.
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.