Applying for Research Governance Approval

The Research Governance Office (RGO) provides an independent and systematic evaluation of research applications to minimise the risk and ensure the safety of the patient, the researcher and the institution.

The RGO reviews matters relating to research staff qualifications, intellectual property, insurance, indemnity, study agreements and monitoring of research projects. This ensures the research projects comply with the guidelines set down by the National Statement on Ethical Conduct in Human Research (2007) and in accordance with the WA Health Research Governance Policy and Procedures.

A project cannot be initiated until approval from the KEMH Chief Executive (or delegate) is granted. Approval relies on recommendations from both a WA Health / NHMRC Certified Ethics Committee (such as the CAHS Human Research Ethics Committee) and the KEMH RGO.

All projects conducted at KEMH require approval via WA Health’s Research Governance Service (RGS) (external site). The RGS is the online application submission service. All new HREC applications and all governance applications must be submitted using this service.

For assistance with using the system and to find more information please visit the RGS website (external site) (please be aware that for optimum RGS performance use Google Chrome or Internet Explorer 11).

For information on RGS and guidelines for researchers please refer to the RGS help wiki (external site).

Help with RGS is available from the administrative team at CAHS and RGS.Support@health.wa.gov.au.

Research Governance Review Process

After the ethics application is submitted via RGS for HREC review the governance application should be submitted to the Research Governance Office (RGO) via the RGS. There is no submission deadline of meeting schedules related to governance review. This governance application may include either a Site Specific Assessment and budget form or an Access Request form, completed and signed within RGS, together with other regulatory / legal documents if applicable.

While ethical (including scientific) review takes place, the Research Governance Office (RGO) reviews all application documentation to ensure it complies with the RGO Guidelines.

The RGO will liaise with the investigators, via RGS or separately via email, if inadequate or insufficient documentation regarding the proposed study is received.

All research governance requirements must be met, including HREC approval, before the application receives final approval from KEMH Chief Executive for the project to proceed at KEMH.

Submission requirements and fees

Applications for the KEMH Research Governance office should be submitted via the RGS. Researchers should ensure they contact and seek the support of the relevant KEMH departments that may be involved or impacted by their project prior to preparing their governance (site authorisation) application. Submissions should include the following:

  1. Site Specific Assessment (SSA) / Access Request form - online forms completed in RGS
  2. Budget form to accompany the SSA - online form completed in RGS
  3. If applicable, copy of draft agreement, indemnity, insurance certificate / policy - document templates available from the RGS
  4. If applicable, Conflict of Interest form or Declaration of Confidentiality form - online forms to be completed in RGS
  5. Checklist for management of adverse events - if applicable for research at CAHS, attach as supporting document in RGS.

WA Health employees can access further guidelines and document templates via the CAHS intranet (external site) (internal WA Health only).

For multi-centre projects that have been reviewed by a non-WA Health HREC (under the National Mutual Acceptance, NMA, scheme) please refer to the relevant submission requirements outlined on the RGS Multi-centre Research website (external site).

Please note that a Project Workspace must be created and a WA Specific Module drafted in the RGS (to accompany the HREA to the reviewing HREC) prior to HREC approval being sought for a project to be conducted at KEMH.

Two letters of approval are required before your research project can commence at KEMH - an ethics approval letter from the approving HREC and an authorisation letter from the Women and Newborn Health Service. For single centre research, the approving HREC will be the CAHS HREC.

View the fee schedule (external site).

Clinical Trial Registration

Trial registration involves posting the details of a trial’s design, conduct and administration on a publicly accessible database known as a clinical trial registry. The National Statement (external site) obligates researchers to ensure that their clinical trial is registered in a publicly accessible database before recruitment of the first participant.

The International Committee of Medical Journal Editors (ICMJE) (external site) also has a policy requiring trial registration prior to publication. The Declaration of Helsinki now also states that “every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”

Trial registration is also important for participant recruitment because it allows people interested in participating in a clinical trial to search for relevant clinical trials on a single website. Registration also assists health professionals to identify relevant trials for their patients.

Researchers should register trials as early as possible and ensure information such as contact details and trial status is kept up to date. The details of trial registration are required in RGS.

Amendments and monitoring

To amend an authorised research project or to meet the requirements of research monitoring (such as safety reporting and progress reports) please complete the required submission within RGS. Information is available in RGS under the Governance Monitoring Forms (external site).

Additional information is available in our Standard Operating Procedures for the Approval of Research (PDF).

All Safety Reporting should adhere to the NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods (2016). NHMRC has also developed other documents to supplement the Guidance and to provide further advice for non-commercial and commercially-sponsored clinical trials involving therapeutic goods.

This supplementary guidance covers the following topics:

  • Data Safety Monitoring Boards (DSMBs)
  • Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods
  • Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.

These documents can be accessed on the NHMRC website (external site).

To report an adverse event or Serious Adverse Event to CAHS as the sponsor of research please refer to HealthPoint (internal WA Health only).

Intellectual property

Please refer to WA Health website (external site) for information on intellectual property.

Essential reading and reference

The documents below are essential for any medical researcher working in Australia, WA and within the WA public health sector. It is also a requirement for researchers at KEMH to complete Good Clinical Practice Training prior to conducting any research activity.

Understand your broad responsibilities as a researcher in Australia

Understand how to design and conduct ethically acceptable research

Understand the fundamentals of conducting clinical trials and all human research

Read about how research is governed within WA Health

The updated Research Governance Policy (external site) from WA Department of Health is now in effect and has been updated to reflect current policy requirements.

The Department of Health is currently progressing 2 sequential reviews of ethics and governance across WA Health. The ethics review is being finalised and the governance review is planned to commence as soon as possible after the HREC review is finalised. The purpose of these 2 reviews is to ensure that WA Health processes of research governance are contemporary and consistent with best practice. The policies maybe further revised once the review processes are complete.

Understand the principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities

Follow available guidance on NHMRc requirements on safety reporting and monitoring requirements

For information on the difference between quality improvement (QI) and research, and the requirements for QI ethical review

Don’t forget to sign-up to get an ORCID (Open Researcher and Contributor ID) (external site) – be found, build your profile as a researcher.

 

WAHTN Research Education and Training Program (RETProgram)

The RETProgram aims to provide busy health practitioners with open access to comprehensive research skills training across the entire research process. The benefits of a well-trained health research work force include a higher standard of meaningful research projects, a greater likelihood of successful completion and most importantly, better health outcomes for study participants and the broader WA community.

The RETProgram provides online training modules, research skills training and events and a research skills seminar series.

For more information visit the Research Education and Training Program website (external site).

WAHTN Partner Institutions: Seminars, Events and Training for Science and Health

To view the upcoming list of seminars, events and training across all WAHTN partner institutions, visit the WAHTN seminars / events / training page (external site).

 

National Health and Medical Research Council (NHMRC) Clinical Trials eLearning

The Australian Clinical Trials NHMRC eLearning modules (external link) provide an introduction to clinical trials, clinical research ethics and ethics and governance review processes.

 

Good Clinical Practice

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. All researchers conducting human research at KEMH must have undertaken good clinical practice training.

GCP was developed to provide a unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities across international jurisdictions. This means it provides a set of standard operating procedures for clinical trial however much of the information is also relevant to any human research. The CPI / PI must ensure their study team is appropriately trained. The level of training may depend on the roles and responsibilities that are delegated to team members for each specific research project and should be determined by the CPI / PI.

Please review: The ICH Guideline for Good Clinical Practice – Annotated with TGA comments (external site).

There are many Australian providers of GCP training and refresher courses:

There are a number of organisations that provide accessible online GCP modules at no cost:

Last Updated: 12/11/2024