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Human Research Ethics

​The Human Research Ethics Committee (HREC) will undertake an ethical and scientific review of the project and if approved will deem the project ethically and scientifically valid.

CCLHD and ethical review

CCLHD does not have a local or internal Lead NSW Human Research Ethics Committee (HREC) however CCLHD researchers and external researchers wishing to conduct research at a CCLHD site can chose to have their project/s reviewed by any of the current 17 NSW Lead HRECs, or if conducting a multi-centre clinical trial one of the participating mutual acceptance states accredited HRECs.

Prior to commencing a research project it is important to determine what type of application is applicable. There are two types of ethics applications reviewable under the NSW system for single ethical review:

  1. Low/negligible risk research
  2. Research requiring full ethical review

Research projects which satisfy the classification of being a multi-centre low or negligible risk research can be submitted on the NSW Health low/negligible risk research (LNR) form and undergo an expedited review process when submitted to a Lead NSW Human Research Ethics Committee (HREC).

Research projects which are classified as requiring full Human Research Ethics Committee (HREC) review must be submitted on the national ethics application form (NEAF) and undergo full committee review.

Low/negligible risk research

The National Statement on Ethical Conduct in Human Research (2007) describes research as “low risk” where the only foreseeable risk is one of discomfort. Discomforts may include minor side-effects of medication, discomforts related to measuring blood pressure or anxiety induced by an interview. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.

Statement on Ethical Conduct in Human Research (2007) describes research as “negligible risk” where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than inconvenience to the participants. Inconvenience is the least form of harm that is possible for human participants in research. The most common examples of inconvenience in human research are filling in a form, participating in a survey or giving up time to participate in a research activity. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.

External page link National Statement on Ethical Conduct in Human Research (2007)

How to apply

The form to complete for Low/Negligible Risk (LNR) research applications can be accessed through the Australia Online Forms for Research website. The Online Forms website is an online system that enables users to complete their applications for research electronically. The website hosts the NSW Health LNR Form and Site Specific Assessment (SSA).

External page link Australia Online Forms for Research

You will need to create an account and wait to receive a confirmation e-mail before you can access the online system. Once you have done this please generate an LNR Research Form.

The Online Forms website provides guidance on completing the form and supporting documents required for making an application. A copy of the form can be downloaded from NSW Health Ethics forms and resources.

External page link NSW Health Ethics forms and resources

Any queries related to using the Online Forms website should be directed to the helpdesk on:

Tel: +61 2 903 78 404 10am to 4pm AEST Monday to Friday or helpdesk@infonetica.net

If you are completing an LNR research application the completed form and supporting documents must be printed* and submitted to the Executive Officer of the Human Research Ethics Committee (HREC) that will review the application. LNR research applications are considered via expedited review by a sub-committee of the HREC usually consisting of a minimum of the Chair of the HREC and the Executive Officer (this may differ between HRECs/institutions). Contact details for NSW HREC Executive Officers are maintained by NSW Health.

It is recommended that the Co-ordinating Investigator consult with the HREC Executive Officer to determine if the research project can be classified as LNR Research, before completing the form. The Executive Officer has the discretion to request that the research project is submitted for full review using the National Ethics Application Form if they consider the risk to participants to be greater than low risk. You can also discuss this with the CCLHD Research Office.

The HREC also has the discretion to request full review using the National Ethics Application Form following assessment of the application for expedited review if it considers the risk to participants to be greater than low risk.

If you are completing a single site LNR Research Application (a project being undertaken at one or more CCLHD sites only, with no additional sites external to CCLHD) and using de-identified data it is recommended you contact the CCLHD Research Office for advice on the review and approval process. The reason being that there is an exemption in the National Statement on Ethical Conduct in Human Research (2007) that allows institutions to undertake an internal review process for some LNR projects involving the use of de-identifiable data.

In addition to the LNR research form an application for Site Specific Assessment is required.

*It is important to note that submission on the online system will not trigger notification in the relevant Research Office/Executive Officer’s system. It is therefore recommended applicants contact the relevant person/office for specific details on the individual application requirements prior to submission.

Research requiring full ethical review

In accordance with the National Statement on Ethical Conduct in Human Research (2007) and PD2010_055 Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations, the following types of human research must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee (HREC) before they take place in a NSW Public Health Organisation.

External page link National Statement on Ethical Conduct in Human Research (2007)

External page link PD2010_055 Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations(PDF)

Research that involves more than low risk to participants and/or research that includes any of the following:

  • interventions and therapies, including clinical and non-clinical trials and innovations or new treatment modalities
  • active concealment or planned deception of participants
  • exposure of illegal activities
  • research specifically targeting Aboriginal or Torres Strait Islander peoples.

Research that includes any of the following, except where the project uses collections of non-identifiable data and involves only negligible risk to participants:

  • human genetics
  • human stem cells
  • women who are pregnant and the human foetus
  • people who are highly dependent on medical care who may be unable to give consent
  • people with a cognitive impairment
  • people with an intellectual disability or a mental illness
  • people who may be involved in illegal activities.

How to apply

The National Ethics Application Form (NEAF) can be accessed through the Australian Online Forms for Research website. The Online Forms website is an online system that enables users to complete their applications for research electronically. The website hosts a licensed copy of the NHMRC’s NEAF, as well as the NSW, QLD, SA and VIC Health Site Specific Assessment (SSA) Forms.

External page link Australian Online Forms for Research

The reason application is required via this portal is that it links to the IT system utilised by NSW, QLD, SA and VIC HREC Executive Officers to manage and report on HREC applications to each participating states Health department. If you have already made your application via the National Health and Medical Research Council’s (NHMRC) website please contact your nominated HRECs Executive Office for advice on how the form can be exported into the NSW Health system.

You will need to create an account and wait to receive a confirmation e-mail before you can access the online system. Once you have done this please generate a NEAF.

The Online Forms website provides guidance on completing the form and supporting documents required for making an application.

Any queries related to using the Online Forms website should be directed to the helpdesk on:

Tel: +61 2 903 78 404 10am to 4pm AEST Monday to Friday or helpdesk@infonetica.net

The completed form and supporting documents must be printed* and submitted to the Executive Officer of the HREC that will review the application. Contact details for NSW HREC Executive Officers are maintained on the NSW Department of Health website.

It is recommended that the Co-ordinating Investigator consult with the HREC Executive Officer to determine if the research project does require full HREC review prior to completing the form. You can also discuss this with the CCLHD Research Office.

In addition to the NEAF an application for Site Specific Assessment is required.

*It is important to note that submission on the online system will not trigger notification in the relevant Research Office/Executive Officer’s system. It is therefore recommended applicants contact the relevant person/office for specific details on the individual application requirements prior to submission.

Single ethical and scientific review of multi-centre research within NSW

In 2007 NSW Health implemented a system of single ethical and scientific review of multi-centre research, with the aim that every research project conducted within the NSW public health system is scientifically and ethically reviewed once only. The latest policy directive outlining the requirements of this initiative is PD2010_055 Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations.

External page link Research Ethics and Governance

External page link PD2010_055 Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations (PDF)

Lead HRECs are accredited to conduct a single ethical and scientific review of multi-centre research on behalf of all sites within the NSW public health system at which a research project is to be conducted, thereby eliminating the need for each local HREC to conduct its own review. Public health organisations (that is local health districts and statewide and specialist health networks) then retain the responsibility for authorising the research to be undertaken within their institutions via the Site Specific Assessment (SSA) process prior to its commencement.

Mutual acceptance of the ethical and scientific review of interstate multi-centre clinical trials

In 2011, the NSW Ministry of Health and Queensland and Victorian Departments of Health signed a Memorandum of Understanding to introduce the Mutual Acceptance of Ethical and Scientific Review of Multi-Centre Clinical Trials undertaken in public health organisations across the three states.

Under the Interstate Mutual Acceptance initiative, each proposal for a multi-centre clinical trial conducted across the participating states will be ethically and scientifically reviewed once only by a public health organisation HREC that has been certified by the NHMRC to review clinical trials.

On November 1st 2013 the MOU was re-negotiated in order to accommodate the other Australian jurisdictions into a National Mutual Acceptance (NMA) scheme for the review of Clinical Trials.  South Australia signed the new MOU and is from this date a participating state under this model.

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