Preparing an Ethics Application

All human research ethics submissions to the NCNSW HREC are to be submitted using a Human Research Ethics Application (HREA) via the online forms website. Please be aware that there is no requirement to upload supporting documents onto the Online Forms Website. When preparing the ethics application you may wish to consider the following key resources:

Ethics Application Requirements

Once the HREA is complete, generate and save a copy of the application in PDF format for submission along with all supporting documentation by email to the Executive Officer, North Coast NSW Human Research Ethics Committee by the agenda deadline. All supporting documents must have a document title with version control on each page in the document footer, and may include documents such as:

  • A Protocol or Research Proposal/Plan
  • Applicable Brochures / Manuals / Product Information
  • Participant Information Statement/Sheet/s
  • Participant Consent Form/s
  • Data Collection Tool/s
  • Advertisements/Flyers etc
  • Surveys / Questionnaires / Interview Schedules / Semi-structured Interview/Focus Group Questions
  • Other relevant information – as/if required

Please be aware that only “complete applications will be accepted for review. Incomplete applications will be returned to the researcher for rectification and re-submission.

Reseach Risks and Ethical Considerations

The National Statement provides different risk categories of research, as follows:

Negligible Risk Research is 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.

Low Risk Research is 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.

Examples of research with low and negligible risk include:

    • Research involving questionnaires and general surveys on non-controversial, non-personal issues that also include only basic demographic data and where, in all instances, respondents are not identified
    • Research involving the use and/or disclosure of information from existing data collections, where the identity of the person cannot reasonable be ascertained from the information to be disclosed to researchers
    • Research involving human tissue where participant consent is not required because broad consent has been provided for use of the tissues in research and specific individuals cannot be identified from specimens used eg: where specimens have never been labelled with individual identifiers or individual identifiers have been permanently removed
    • Research requiring access to individual medical records or to information stored electronically, through the site’s medical records department or other department/speciality, but where participant consent is not required because, in all instances, individuals cannot be identified from data extracted or provided.

Greater than Low Risk Research inlcudes 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 pertaining to human genetics
    • Research pertaining to 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
    • In addition, research projects involving people with sexually transmissible infections or blood-borne virus infections are not eligible for low or negligible risk review, except where the research uses collections of non-identifiable data and involves only negligible risk.

Research projects specifically affecting the health and wellbeing of Aboriginal people and communities

Approval from the Aboriginal Health and Medical Research Council Ethics Committee (AH&MRC) is required where a research project involves research in, or concerning, NSW and any one of the following applies:

  • The experience of Aboriginal people is an explicit focus of all or part of the research
  • Data collection is explicitly directed at Aboriginal people
  • Aboriginal peoples, as a group, are to be examined in the results
  • The information has an impact on one or more Aboriginal communities or
  • Aboriginal health funds are a source of funding

While applications to the NCNSW HREC and AH&MRC may be submitted concurrently, AH&MRC approval is required before final approval will be issued by the NCNSW HREC.

Further Information: