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 and if there are submission queries sent to the study team, and how well and how quickly the study team addresses the queries. Once the study is ready for formal review if it is classified as a low risk study, it will go through an expedited approval process or it will be assigned to the next board meeting. Drug studies are reviewed by the Clinical Drug Trial Committee (CDTC) before being passed on review by the Human Research Ethics Committee (HREC) and non drug studies are reviewed by the Scientific Review Subcommittee before being passed on to the HREC. Once HREC has completed their review, the study is reviewed by Research Governance and they have a timeline of 60 days. The process takes about 3 months.

 


 

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

The Human Research Ethics Application (HREA) is a streamlined and contemporary ethics application that uses dynamic content and guidance to assist researchers consider and address the principles of the National Statement on Ethical Conduct in Human Research. 

Please note that WA Health HRECs accept either the WA Health Ethics Application Form (WAHEAF) or, for multi-site (especially interstate) projects, the NEAF/HREA. However, it is preferable to use the WAHEAF for projects to be conducted at a single site within WA Health or for multi-site projects only conducted within WA.

 


 

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. What is the difference between Audit and Research?

Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through: 

  • taking part in surveys, interviews or focus groups; 
  • undergoing psychological, physiological or medical testing or treatment; 
  • being observed by researchers; 
  • researchers having access to their personal documents or other materials; 
  • the collection and use of their body organs, tissues or fluids (e.g. skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath; 
  • access to their information (in individually identifiable, re-identifiable or nonidentifiable form) as part of an existing published or unpublished source or database. 

The term ‘participants’ is therefore used very broadly in this National Statement to include those who may not even know they are the subjects of research; for example, where the need for their consent for the use of their tissue or data has been waived by a Human Research Ethics Committee (HREC).

NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018)

A protocol that has comparative intervention arms such as behavioural, medical, device-related or surgical is considered to be research. A protocol that tests a new procedure or intervention is also generally considered to be research.

Audit is an activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation. Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably.

Protocols that apply an already evidence-based intervention or intervention (i.e. one that has been documented as effective in published research trials) to all patients with a specific condition, are likely to be considered quality improvement. Usually quality improvement is intended to affect only those people who are being treated, whereas research should be generalisable.

ETHICAL CONSIDERATIONS IN QUALITY ASSURANCE AND EVALUATION ACTIVITIES National Health and Medical Research Council | Published: March 2014

 


 

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: 07/04/2021