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FAQ: Single-site research

How do I get ethical approval for a single-site study?
Do I have to use the National Ethics Application Form (NEAF)?
When can my research project commence?
How do I add another site to my study?
Where can I get more information/advice?

How do I get ethical approval for a single-site study?

For single-site studies within the NSW public health system, an application for ethical and scientific review must be submitted to the local HREC i.e. the HREC associated with the site at which the research is to be conducted. In addition, a Site-Specific Assessment (SSA) Form must be completed and submitted to the local Research Governance Officer. The ethical review and site-specific assessment may occur in parallel, however the decision to authorise or not authorise the conduct of the research will only be made once the HREC has granted approval and the site-specific assessment has been satisfactorily completed.

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Do I have to use the National Ethics Application Form (NEAF)?

Multi-centre research proposals must be submitted on the NEAF. For single-site studies, HRECs may accept research proposals submitted on the HREC's own application form. Where the NEAF is not used, the investigator must also complete the privacy questions outlined in the NSW Health policy 'Human Research Ethics Committees: National Ethics Application Form - Application within NSW Health', which can be accessed at:

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When can my research project commence?

The decision to authorise or not authorise the conduct of a research project is made by the public health organisation once the HREC has granted approval and the site-specific assessment has been satisfactorily completed. The research can only commence once the investigator has received written approval from the Chief Executive (or their delegate).

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How do I add another site to my study?

The procedure for adding sites depends upon a number of factors, including:

  • Whether or not the study has been approved/has commenced;
  • Whether or not the additional site(s) are within the same jurisdiction as the original site;
  • Whether or not the HREC that originally approved the study is a lead HREC; and
  • Whether or not the study was originally approved prior to the implementation of the single ethical review model on 01 July 2007.

Consequently, the procedure may differ between individual studies. Investigators should consult the NSW Health policy 'Research - Model for Single Ethical & Scientific Review of Multi-Centre Research', which describes the different procedures in detail. The policy can be accessed at: www.health.nsw.gov.au/policies/pd/2007/PD2007_072.html

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Where can I get more information/advice?

For specific advice on ethical issues relating to your single-site research project, you should approach the local HREC and/or the local Research Governance Officer.   Contact details are available on the NSW Department of Health website at: www.health.nsw.gov.au/ethics/research/contacts.asp

You should also review the NHMRC National Statement on Ethical Conduct in Human Research (2007) available at: www.nhmrc.gov.au/publications/synopses/e72syn.htm

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