Application and Approval Process

  • Preparation

    Prior to applying for ethics approval you will need to develop a well considered research proposal/protocol.  You may need to:

    • Seek review of the academic merit of your project
    • consult with co-researchers/supervisors
    • read the National Statement
    • understand informed consent
    • obtain necessary institutional approvals, including sign off from your Supervisor
    • develop participant resources such as participant information sheet, consent form, questionnaires, interview guides and recruitment flyers
    • procure any necessary external approvals such as, letters of support, working with children checks and certifications
    • determine a timeline for the commencement of your research after approval. Refer to the meeting schedule.
    • seek application review
  • Determining Level of Risk

    Charles Sturt University has two review pathways for the ethical review for research involving human participants based on the level of risk and in accordance with the National Statement.

    Low-risk research can be considered expeditely by the Human Research Ethics Committee (HREC) Executive. For research involving more than low-risk application, these must be considered by the full HREC.

    Determining level of risk

    Self assess against the table below to determine if your application meets the criteria for low-risk.

    Risk

    NS

    Examples

    Lowest

    Waiver

    (exemption)

    • A waiver of consent involves research participants who will characteristically not know that they, or perhaps their tissue or data, are involved in the research (section   2.3).
    • All waiver related criteria must be met and are listed in sections 2.3.9, 2.3.10 and 2.3.11

    Very Low

    Negligible

    • No foreseeable risk of harm or discomfort1; and any foreseeable risk is no more than an inconvenience, defined in 2.1.7 and detailed in 5.1.18-23.
    • Involves the use of existing collections of data or records that contain only non-identifiable data about human beings.

    Low

    Low

    • The only foreseeable risk is one of discomfort, defined in 2.1.7 and detailed in 5.1.18-23.
    • In regards to consent, limited disclosure is unlikely to affect participants adversely (2.3.1).
    • As a general principle, research including genomics will require review by an HREC; however, if no information that can identify an individual is used and no linkage of data is planned, the research may be determined to carry low risk (3.3).

    What if my application does not meet the criteria for low-risk?

    Ask yourself if it is possible to change what you want to do in a way that remains true to the intention of the research.

    You might have a survey on living in country NSW which involves specific questions about First Nations peoples. Those questions will mean that the low-risk option is not possible. If that is a necessary part of the research, then you cannot apply through the low-risk pathway. But if it’s a ‘nice to have’, but not necessary to the research aims, then dropping those questions will provide access to the low-risk review pathway.

    Self-assessment checklist

    In addition to considering the criteria above the level of risk checklist can be used to assist in determining your application risk level. Complete the form and include it with your application submission to the HREC.

    Low-risk submissions still need to complete the HREA online form and required documents, and in addition, will need to submit the low-risk checklist. Unlike other submissions to the Charles Sturt Human Research Ethics Committee (HREC), all low-risk will be dealt with through an expedited process outside of the HREC meeting schedule.

    All applications higher than low-risk must follow the standard application process and review by the full HREC.

  • Application Process

    Regardless of the level of risk, Charles Sturt University requires that all applications for approval be made via the Human Research Ethics Application (HREA) form. The National Health and Medical Research Council (NHMRC)  site hosts the HREA and has general information on how to complete and submit.

    Note that you are required to create a package of documents within the HREA site, then email this package to the HREC.  The package will include:

    • a project proposal/protocol
    • associated materials as appropriate - where these include surveys or questionnaires, these should be provided in a format as close as possible to that which participants will see including the instructions and any relevant skip logic
    • the completed HREA
    • a completed data management plan

    The following is additional CSU specific information.

    When completing your project proposal template:

    • use this CSU project proposal template rather than the one on the NHMRC website
    • provide your information as concisely as possible and limit the proposal document to no more than 5 pages

    When completing your HREA form:

    • the HREA is a context specific form that will adjust the question it asks based on your responses to earlier questions
    • you must answer yes to question 1.12 and provide verification of review of research merit before the HREC can approve your project.
    • take care that you understand questions 1.17, 1.18, you may need to consult with the National Statement and/or your Supervisor
    • for question 1.19 select groups of people who you will be targeting AND groups of people who could coincidentally be expected to be in your recruiting population
    • select "No" at question 1.9.11 for all researchers named on the application.
    • It is a CSU requirement that all researchers named on the application must provide their signature. Student applicants must have signatures from their supervisors.
    • if you are a student your student ID should be included in the field provided for "staff ID"

    It is helpful if all documents are converted to PDF files before uploading into the package.

  • Submission

    Complete all mandatory sections of the HREA form and upload all the materials you will need to generate a HREA document.  As per the HREA instructions, ensure you have saved a copy of the application for your records and possible future reloading. Submit via email to ethics@csu.edu.au.

  • Applications with Multiple Organisations

    Sometimes more than one institution needs to review a research proposal, for example, when it:

    • will be conducted at more than one institution, either by the same or different researchers;
    • will be conducted jointly by researchers affiliated with different institutions;
    • will be conducted at one institution by a researcher affiliated with another institution, for example, a university-based researcher conducting research at a hospital;
    • has been approved at one institution and transferred to another, for example, when a researcher changes institutions
    • will be conducted in State or Territory schools
    • will be conducted with NSW Health

    These situations are detailed in Chapter 5.3 of the National Statement, as are the guidelines for how CSU approaches research projects with multiple organisations.

    The ethical review process at CSU seeks to eliminates unnecessary duplication, and the decision of another institution's ethical review body will often be accepted. The CSU HREC should be informed of the review via the Projects already approved by another HREC form.

    While this is a brief form the application to CSU should also include;

    1. The original application
    2. The approval letter from the approving HREC
    3. Any documentation which will require revision for use at CSU. For example, plain language Information Sheets and Consent Forms providing CSU contacts and procedures.
    4. If the Review Board is not registered in Australia details of the review board, for example a website, should be included where possible.

    These various attachments are required as the CSU HREC needs to be assured that the review was undertaken in line with the requirements of the National Statement.

  • Applications with Research Conducted in Other Countries

    If you propose to conduct research in another country, you still follow the same application process, however additional ethical considerations may arise. You should consider the beliefs, customs, cultural heritage, legal or regulatory requirements of participants. Sometimes these will be in tension with one or more of the ethical values of the National Statement. Please refer to Chapter 4.8 in the National Statement for advice on negotiating appropriate practice.  These considerations should be detailed in your application.

  • Applications using pre-existing datasets only

    If you propose to conduct research using pre-existing datasets only, you will still need to seek ethical review. However, use the HREC Existing Data Use Request form instead of the HREA.  Please refer to Chapter 2.3 of the National Statement on Ethical Conduct in Human Research before completing the form. Please ensure the following documentation is included with your application:

    • A brief project proposal outlining the research to be undertaken (not more than 5 pages). See the CSU project proposal template for guidance;
    • evidence that the original data was collected ethically in accordance with National Statement requirements;
    • evidence that the original participants provided consent to the secondary use of data;
    • confirmation of permission to use the data by the owner.

    Please note, if a waiver of consent is required then you will need to use the HREA and follow the standard application process.