Frequently asked questions

1. What is the timeline for Ethics and Governance review and approval?

This is mainly dependent on how well the initial submission is put together, if scientific or ethical issues are identified and the speed at which these issues are resolved. Liaising with the HREC office and seeking statistical support prior to submission frequently shortens review timelines.

Studies are grouped into categories based on risk and complexity. Activity which poses negligible risk such as anonymised surveys or research audits using non-identifiable data may be reviewed via the negligible risk pathway. The KPI for ethical and institutional approval for this activity is 10 working days.

Research which is low risk or more than low risk has an approval timeline of 60* calendar days as required by the NHMRC National Certification Scheme (external site).

*It is important to note this is 60 days of ‘stop clocked’ time, meaning that when an issue or query is raised by the RGO, HREC or one of its subcommittees, the 60 day count is stopped until a valid response is received from the researcher.

 


 

2. What is the difference between the HREA & WAHEAF and which to use?

The Human Research Ethics Application (HREA) form is the national ethics application form and should be used when conducting research in more than one state or territory. It may be used for state specific activity if applicants prefer it, but this may lead to additional administrative effort. Due to its generic nature, state specific legislation is not covered and therefore use of the HREA in WA must be accompanied by the WA specific module.

The WA Health Ethics Application form (WAHEAF) is WA specific and integrated into the RGS. It will partially prepopulate from information provided during set up of an RGS workspace. This form cannot be accepted by jurisdictions outside Western Australia.

 


 

3. Who are the review & complaints contacts for the Participant Information and Consent Form (PICF)?

Local HREC Office contact (Single Site - Research Governance Officer)

Name: Research Governance Office
Email: SCGH.RGO@health.wa.gov.au

Complaints contact person

Reviewing HREC name: Sir Charles Gairdner and Osborne Park Health Care Group
HREC Executive Officer: HREC Executive Officer
Tel: (08) 6457 2999
Email: SCGH.HREC@health.wa.gov.au

Reviewing HREC (if SCGH) approving this research & HREC Executive Officer details.

 


 

4. When should there be a Master Participant Information and Consent Form (PICF)?

When the study has multiple sites a Master PICF is created as the PICF template for the other sites to add in site specific information.

 


 

5. RGS is sending a reminder of a task that has been completed – what now?

This is an automated system. Login to RGS and look under Tasks. Find the relevant task and if it has been completed you can choose to archive it.

 


 

6. Process to add on another site or investigator after approval? 

This is carried out through the RGS amendment process.

 


 

7. When to seek Western Australian Aboriginal Health Ethics Committee (WAAHEC) approval?

Approval by the WA Aboriginal Health Ethics Committee (WAAHEC) is required before you may conduct health and medical research if Aboriginality is a key determinant or explicitly directed at Aboriginal people. For further information refer to the WA Specific Module.

 


 

8. Does my study need a Data Safety Monitoring Board (DSMB)?

This depends on your study. Please read see the DSMB information sheet (PDF).

 


 

9. Is my activity a research project or quality improvement (audit)?

It is often quite difficult to differentiate whether an investigation needs to be submitted as a research project or may be eligible for submission as a quality improvement activity. The aims and methods do not materially differ between these categories. As such, the Department of Research and Safety, Quality and Performance have collaborated to develop a Quality Improvement versus Research tool (external site) to assist those conducting investigations to identify whether their investigation may be categorised as research or quality activity.

Both the Quality Improvement Office and Human Research Ethics Committee Office encourage all applicants to get in touch prior to submission in the event of any uncertainty or for assistance.

 


 

10. Should I register my study?

Is your study a clinical trial? Trial registration is the process whereby key details about the design, conduct and administration of planned clinical trials are made available on a publicly accessible database known as a clinical trial registry. In Australia, registration must occur prospectively, that is before enrolment of the first participant. Prospective trial registration is now widely accepted as an essential part of an overall strategy for improving research transparency.

The Declaration of Helsinki, which is the cornerstone document guiding the ethical conduct of research in humans by physicians, now explicitly states that “every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.” This approach is supported by the International Committee of Medical Journals Editors (ICMJE) which includes many of the world’s leading journals. In 2004, ICMJE declared that they would not consider a trial for publication without evidence that it had been registered in a publicly accessible clinical trials registry prior to enrolment of the first participant.

The World Health Organization (WHO) considers the registration of all interventional trials to be “a scientific, ethical and moral responsibility”.

In Australia, you can register on the Australian and New Zealand Clinical Trials Registry (ANZCTR). Or you can register on an alternative ICMJE approved registry.

www.australianclinicaltrials.gov.au/trial-registration (external site)

Last Updated: 03/09/2021