How to submit a human ethics application: Expedited Low or Negligible Risk

Research Services Ethics & Integrity Human Ethics How to submit a human ethics application: Expedited Low or Negligible Risk

How to submit a human ethics application: Expedited Low or Negligible Risk

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 (HREC) 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 of discomfort. Discomforts include, for example, minor side-effects of medication, the discomfort of 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 street survey, or giving up time to participate in research.

Types of research than CANNOT be granted expedited low or negligible review

The following types of research 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 fetus
    • 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)

A low/negligible risk human research ethics application consists of:

These forms can also be found under Forms and Downloads.

How to submit an application

Please see Overview of Application Submission Process for an overview of submission requirements.

Please also read the Guidelines to Complete a Human Research Ethics Application (PDF, 97 KB) before you attempt to draft your application. Once you have a draft ready and your Supervisor/s (if applicable) is satisfied with the document, you need to forward the application to a Human Ethics Advisor for review.

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.

A complete application ready for submission consists of:

  1. A signed original application (signed by Principal Investigator, Supervisor/s (if applicable), Dean of College/Delegate and Human Ethics Advisor) including any attachments.

Submission details:

  1. Email electronic copy to ethics@jcu.edu.au
  2. Mail or deliver one hardcopy of the completed and fully signed applications to:
    Human Ethics, Research Office
    Room 128, Faculty Science & Engineering Building 17
    James Cook University QLD 4811

Please note: The HREC will review the low/negligible risk application as soon as possible after submission and notifications will be released between 5-7 working days after the HREC review.

Any incomplete applications or applications submitted without the appropriate signatures will not be submitted to the HREC for review.

THE HREC DOES NOT GRANT RETROSPECTIVE APPROVAL