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

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 3.3: Interventions and therapies, including clinical and non-clinical trials and innovations;

Chapter 3.5: Human genetics

Chapter3.6: Human stem cells

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 collection of non-identifiable data and involve negligible risk)

Chapter 4.7: Aboriginal and Torres Strait Islander Peoples

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

JCU Human Research Ethics Low/Negligible Risk Application Form

JCU Information sheet (if applicable)

JCU Informed consent form (if applicable)

Attachments (draft or final copies of surveys, questionnaires, letters of support/approval

These forms can all be found under Forms and Downloads:

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

Please also read the Guidelines to Complete a Low/Negligible Risk Human Research Ethics Application 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:

A complete application ready for submission consists of:

A signed original application (signed by Principal Investigator, Supervisor/s (if applicable), Dean of College/Delegate and Human Ethics Advisor and one electronic copy in pdf format (application form and attachments in one pdf document)

Submission details:

Human Ethics (ethics@jcu.edu.au)

Research Office

Room 128

Faculty Science & Engineering Building (DB017)

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.

PLEASE NOTE: THE HREC DOES NOT GRANT RETROSPECTIVE APPROVAL