1. International standards and national codes, statements and guidelines for conducting research

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects.

The National Statement on Ethical Conduct in Human Research (2015) sets national standards to inform human research. Compliance is required for any NHMRC funded research.

The Australian Code for the Responsible Conduct of Research provides guidance on responsible research practice.

The Royal Australasian College of Physicians Guidelines for the Ethical Relationships between Physicians and Industry 2006

2. Ethics processes and applications

To conduct any research in Australia with human participants, approval must be received from a NHMRC registered Human Research Ethics Committee (HREC). Ethics committees are usually affiliated with universities, hospitals and public sector research institutions.

A list of all HRECs registered with the National Health and Medical Research Council (NHMRC) are listed on its website.

Unfortunately ethics applications and processes are not uniform between and within each state and territory. If you are conducting multi-site research more than one ethics application may be required. Some states (such as NSW, Vic & Qld) have developed single review systems for multi-centre research. It is best to contact the HREC that you will be applying to so as to confirm the ethics processes and application required.

An ethics application that is accepted widely in Australia is the Human Resource Ethics Application (HREA) which replaced the National Ethics Application Form (NEAF) in June 2017. You will need to check if this form is accepted with the HREC that you are applying to.

Fortunately the NHMRC are trying to overcome this complexity and have established the Harmonisation of Multi-centre Ethical Review (HoMER) project. This project aims to implement a national system enabling the recognition of a single scientific and ethical review process within and across all Australian jurisdictions. This system is expected to be functioning in 2011.

3. Obtaining informed consent [6]

A participant must be asked for their written consent if they, their tissue or their data is to be used in human research

Consent to take part in the research project must be gained before ANY study procedures take place.

The Consent Form is usually found at the end of a Patient Information Statement and Consent Form (PICF) document. This document details all the necessary information regarding a research project that a participant will need to know in order to decide whether or not to participate in said research project

Participants and/or their parents/guardians that provide consent must have thoroughly read the PICF and then sign the Consent Form, indicating their understanding of the study and willingness to adhere to the study requirements.

The person conducting the informed consent process must have suitable expertise and adequate training in order to conduct the consent discussion with each subject and obtain fully informed consent. They must also be the one to sign the consent form and in doing so declares that he or she has explained the project to the participant (who signs above) and believe that the participant understands the purpose, extent and possible effects of their involvement in this project.

Participants (under 18 years of age) who are evaluated by the investigator (or member of research team) as having sufficient maturity and understanding to grasp the nature and consequences of the project should be provided with a Participant Information Statement and Consent Form to allow them to give or refuse their consent.

Signing the Consent Form does not prohibit the patient from withdrawing from the trial at any time. Participants can withdraw their consent at any time without adversely affecting their relationship with the study team or affiliated institutions.

All participants must be provided with a copy of the complete Information Statement and Consent Form (of the version they consented to) to keep at the time of consent. A copy of each signed Information Statement and Consent Form must also be kept and filed at the study site.

The consent process should be documented in the participant's medical record (medical progress notes) where necessary. That is, if the research impacts the ongoing clinical care of the patient, i.e. if the treating team needs to be aware that the patient involved in research, then the consent process must be documented.

Refer to the HREC website of the institution to which you’re applying for ethics approval for instructions and templates on writing a consent form. The HREC may also have specific wording to include in the PICF.

[6] Informed Consent in Research Procedure; Doc no. RCH0499, 22-Mar-2010
The Royal Children's Hospital, Melbourne