JCU Connect Ethics and Research Integrity Human Ethics Low/Negligible Risk Applications

Low/Negligible Risk Applications

Please read the National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research, 2007 before you begin a human ethics application.

The Human Research Ethics Committee's (HREC) Executive reviews low risk and negligible risk applications on a continuous basis.

Low risk research is defined as research in which the only foreseeable risk is one discomfort. Discomforts include, for example, minor side-effects of medication, the discomfort of associated with measuring blood pressure or the anxiety induced by an interview.

Negligible risk research is defined as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Examples of inconvenience may include filling in a form, participating in a survey, or giving up time to participate in research.

The following types of research cannot be granted Executive low or negligible risk and require a full Human Research Ethics Committee (HREC) review.

  1. All research that involves more than low risk
  2. Research falling under the following chapters of the National Statement:
    • Chapter 3.2: Human biospecimens in laboratory based research;
    • Chapter 3.3: Genomic research
    • Chapter 3.4: Animal-to-human xenotransplantation
    • Chapter 4.1: Women who are pregnant and the human foetus
    • Chapter 4.4: People highly dependent on medical care who may be unable to give consent
    • Chapter 4.5: People with a cognitive impairment, an intellectual disability or mental illness
    • Chapter 4.6: People who may be involved in illegal activities (except for those projects that only involve the collect ion of non-identifiable data and involve negligible risk)
    • Chapter 4.7: Aboriginal and Torres Strait Islander Peoples
    • Chapter 4.8: People in other countries (except where the risk to participants is low/negligible risk and/or the project does not involve participants who could be considered a vulnerable group in the context of the project)

    Click here requires a review by the HREC.

  • A HREC Application Form or Human Research Ethics Application online form
  • An Information Sheet (if applicable)
  • A Consent Form (if applicable)
  • Attachments (draft or final copies of surveys, questionnaires, letters of support/approval, advertisement flyers).
  • A complete application ready for submissions needs to include a signed original application (signed by Principal Investigator, Supervisor/s (if applicable)), Dean of College/Delegate and Human Ethics Advisor.

Refer to the Application Guidelines before you draft your Human Research Ethics Application.

  • Send your draft to a  Human Ethics Advisor
  • Once the Human Ethics Advisor has signed and approved the application ready for submission, send the completed application to the appropriate Dean of College/Delegate for signing.

NOTE: The pdf file should include the ethics application and any attachments as one document. If the application and attachments are not submitted as one pdf file it will not be accepted and you will be asked to resubmit.

  • HREC will review the low/negligible risk application as soon as possible after submission. Notifications will be released five to seven working days after the HREC review.
  • Incomplete applications or applications submitted without the appropriate signatures will not be submitted to HREC for review.
  • HREC does not grant retrospective approval.

Human Ethics Advisors are academic employees of James Cook University who review ethics applications for teaching and research involving human participants in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research, 2007. The Advisors are nominated for appointment by the Dean of College and review ethics applications in broad discipline areas and provide advice to academic staff and students on ethics matters.

The Advisor’s role is to offer advice on a draft of your application in relation to the National Statement and assist you to understand what is required before your application is submitted to the Human Research Ethics Committee (HREC) for review. The Advisor provides a recommendation to the HREC on the application. Advisors also review amendments to ethics applications for approval by the HREC.