This website is currently under review so please check regularly to ensure you have the latest information and guidance. If you would like to provide feedback about the website or have suggestions regarding any of the forms/guidelines please email us at PMH.ResearchWebsite@health.wa.gov.au.
Currently approved projects being undertaken within CAHS that will continue beyond March 2016 should start to plan for the move to the Perth Children’s Hospital in 2016. The Ethics and Research Governance offices will be contacting investigators to begin working through the various processes and changes that will be required for research to transition from Princess Margaret Hospital to the new Hospital.
All human research that takes place in WA Health will be reviewed, authorised, conducted and monitored in accordance with the WA Health Research Governance Policy and Procedures and undergo review by a Human Research Ethics Committee and Research Governance:
The primary function of the Princess Margaret Hospital for Children Ethics Committee is to advise upon and carry out the ethical review of all research involving the staff, patients or resources of the Child and Adolescent Health Service (CAHS), primarily encompassing research conducted at PMH and affiliated organisations. The Committee’s Terms of Reference is available here.The PMH Ethics Committee operates under the Guidelines of the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007) and the WA Health Research Governance Framework. Scientific content and clinical implications of projects are considered by the Scientific Advisory Sub-Committee (SASC) prior to review by the Ethics Committee.
The Research Governance Office (RGO) provides an independent and systematic evaluation of research applications. This evaluation ensures the safety and minimises the risk for 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 to ensure 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.
CAHS is participating in a NHMRC pilot project which will enable us to work with departments and investigators to standardize the information we provide to potential clinical trial sponsors/collaborative groups who approach CAHS departments or investigators to discuss the feasibility of conducting clinical trials on this site. This is an opportunity to streamline the information provided to sponsors during the initial discussions about conducting potential trials and may help to overcome many common delays or hurdles that occur during the preparation, submission and review of ethics and research governance applications for these trials. The project scope at CAHS will cover industry sponsored clinical trials and multi-centre Collaborative Research Group (CRG) studies.
The NHMRC has developed the Good Practice Process (GPP) with the aim of increasing the efficiency of the site assessment (ethics and research governance) and authorisation process of clinical trials. More specifically, the GPP aims to:
Sixteen institutions around Australia have nominated to be a pilot site for the GPP and PMH is the only one in WA. The Research Governance office (RGO) is coordinating the pilot at PMH and will be implementing the GPP for at least the next 6 months. The GPP breaks the approval process for clinical trials into the following stages:
In the first phase of this project (September 2015), we will be approaching the major departments currently conducting sponsored clinical trials or CRG studies to discuss the project and explain the information and support we will be providing to departments/ investigators. We will also outline what information we will need to collect. In addition, any investigators who might be approached by potential sponsors (e.g. with a confidentiality agreement prior to the first feasibility discussions) should feel free to contact us for assistance. If a sponsor should ask an investigator to complete a confidentiality disclosure agreement (CDA) this should be forwarded to the Research Governance Office to organise signing by CAHS Executive.
Data will be collected about the 4 stages of the approval process (Feasibility; HREC/Governance submission; HREC/Governance review and Site Authorisation), as well as additional information regarding time to first participant recruitment and total vs expected recruitment. Researchers should be aware that as part of the implementation of the GPP they may be approached by the RGO to obtain information as outlined above – this is a change, particularly in relation to the Feasibility Assessment phase. It is also intended that the RGO or Project officer will meet with research teams/departments to provide further information about the pilot and help identify any approval procedural issues that could be addressed to streamline the process.
As a pilot site PMH also needs to collect historical data for approved clinical trials for the 4 approval process stages. Researchers may be asked to provide information in relation to recruitment – time period from approval to first participant recruited and what the total vs expected recruitment has been. Information regarding the Feasibility Assessment stage will not be sought for projects that are already approved.
Please refer to Contact details (Research Governance Office) below for the PMH contact for this project.
For more information about the Good Practice Process please refer to the NHMRC outline.
All these offices are located in the Children’s Clinical Research Facility, PMH (cnr Roberts Rd and Hamilton St)
Research Governance Office
|Research Compliance Office
Research Compliance Officer
(08) 9340 8405
Monday - Friday
Monday, Tuesday and Thursday
Applicants should refer to section 3.1 (page 42) of WA Health Research Governance Policy and Procedures to determine whether a project falls under the category of quality improvement or research. Further guidance is available from the NHMRC publication Ethical Considerations in Quality Assurance and Evaluation Activities.
Projects deemed to be quality improvement or audit should be entered into the QI database via the GEKO site for approval. Advice regarding this process can be obtained from the CAHS GEKO page or from the Performance Review and Audit Coordinator on PMH extension 7638.
The approval process for a local single-centre research proposal is as follows:
The application and approval process is summarised in a simple flow diagram.
If you have any questions about the process or requirements please review the Frequently Asked Questions document or contact Ethics Office on (08) 9340 8221.
WA Health is committed to a single ethical review process for all multi-centre human research conducted in WA. WA Health will, as soon as possible, implement National Approach1 and Mutual Acceptance2 (this is not expected to commence until after June 2015). These processes will accommodate the scientific and ethical approval of research by a single lead HREC (which may or may not be in WA), while research governance approval will be required from the relevant RGOs at each WA site.
For multi-centre studies (e.g. large national or international clinical trials) the coordinating principle investigator is responsible for organising submission of documents for scientific and ethical review by an appropriate lead HREC. Principle investigators at each site must submit applications for governance review and will be responsible for local approvals and compliance. Multi-centre studies submitted for ethics approval in WA, whether originating from WA or other states, must be submitted on a NEAF and be accompanied by the WA-Specific Module together with the appropriate research governance forms.
Effective from September 2013, there is a single-ethical review process in place within WA Health whereby multi-centre projects to be undertaken at more than 1 WA Health site need ethics approval from only 1 WA Health HREC. It should be noted that the Princess Margaret Hospital Ethics Committee is the HREC with expertise in paediatric research.
Full details, including exceptions and exclusions to the policies, are outlined in WA Health Research Governance Policy and Procedures.
1 The National Approach to Single Ethical Review of Multi-centre Research is a process to enable the single ethical review of multi-centre research, within or across Australian jurisdictions, utilising the NHMRC’s certified ethical review processes. This process was formerly known as the Harmonisation of Multi-centre Ethical Review (HoMER) initiative.
2 The National Mutual Acceptance of Ethical and Scientific Review of Multi-centre Clinical Trials is a process to enable the single ethical review of multi-centre clinical trials, within or across Australian public health organisations.
For projects where an unregistered drug or device is being used, or where they are being used outside their indications a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA) will be required. As of 1 July 2015 the submission of a CTN to the TGA is done on-line through TGA Business Services.
For information about how the on-line process will operate within CAHS and further details of the on-line process please refer to New CTN process.
In 2015 the PMH Ethics Committee will have 12 meetings and thus meetings are not held in the same week of every month. Please refer to the schedule below for specific dates.The current membership of the PMH Committee is 13, together with an Ethics Committee Secretary. The membership conforms to the requirements set out in the NHMRC National Statement on Ethical Conduct in Research Involving Humans and includes five members from outside the health service.
As of 1 January 2015, separate submissions are to be made to the PMH Ethics Committee and CAHS Research Governance office (RGO). The submission to the RGO can be made at the same time as that to the Ethics Committee, or later if necessary. It should be noted that a project cannot commence on a CAHS site until institutional approval is granted – such approval relies on recommendations from both a WA Health Ethics committee and the CAHS RGO.
You are encouraged to engage a Biostatistician in the early stages of your project. Statistical support for your project is available within CAHS. For details of the process please refer to Biostatistics with diagram.
If a receipt is required please ensure that the submission is handed IN PERSON to Ethics Office.
1 Studies that fall under the category of clinical trials must be registered on a clinical trials registry (e.g. ACT, ANZCTR). For projects where an unregistered drug or device is being used, or where they are being used outside their indications a Clinical Trial Notification (CTN) to the TGA will be required – a hard copy of the CTN form should be submitted as part of the application where CAHS/PMH is the sponsor. A Clinical Trial Research Agreement or similar, plus other documentation may also be required, depending on the nature of the study and its funder/sponsor. Full details are in section 2 of WA Health Research Governance Policy and Procedures.
Application Forms are held on the Government of Western Australia Department of Health website. If the direct link to the form below is not working please review the website directly at: ww2.health.wa.gov.au and review the “Researchers and Educators section” under the title “Research Governance”.
1 The Declaration of Confidentiality, not project specific, needs to be signed and filed once only to cover all research conducted at PMH/CAHS.
2Section 16.3 of the SSA form requires completion of a table with resource and budgetary information. A comprehensive Excel template is provided to help with the completion of this section – this includes salary levels and details of on-costs and overheads. The SSA form also contains detailed guidelines as to what information should be included.
3If the research requires access to WA Health patients or personnel (or their tissues/data) but is not being conducted on-site or on the participants directly (e.g. requires access to participants’ tissues or data, or distribution of letters/leaflets), then a WA Health Access Request form should be submitted instead of the SSA form. See section 2.5 of WA Health Research Governance Policy and Procedures for a more detailed explanation.
The Office of Aboriginal Health of the Department of Health WA in partnership with the Western Australian Aboriginal Community Controlled Health Organisations established the Western Australian Aboriginal Health Information and Ethics Committee in August 1996. This has since been renamed the Western Australian Aboriginal Health Ethics Committee (WAAHEC) and now sits within the Aboriginal Health Council of WA.
WAAHEC is registered with the Australian Health Ethics Committee of the National Health and Medical Research Council and exists to promote and support good ethically based health and medical (or the determinants of health) research, which will benefit Aboriginal people.
In addition to the local or Lead HREC approval it is a requirement of WAAHEC to approve the conduct of health and medical research in WA where the research project involves the following categories:
Refer to the Aboriginal Health Council of Western Australia website for the "Western Australian Aboriginal Health Ethics Committee (WAAHEC) Values and Ethics Statement" and the ethics application form.
Research that require access to WA Health data collections and/or involve data linkage should also be submitted to the Department of Health WA HREC. Information about the committee and necessary forms can be obtained from www.health.wa.gov.au/healthdata/HREC/
Research that is to be undertaken without the consent of those whose data, tissue or DNA is to be used must include a request for a waiver of consent in the application to the Ethics Committee. All sub-sections of section 2.3.10 (a-i) of the National Statement should be addressed in the application – outlined in either section 6.1.2of the WA Health Ethics Application Form or section 6.6 of the NEAF.
Where participant recruitment involves opt-out consent – where information is provided to the potential participant about the research and their involvement and where their participation is presumed unless they take action to decline – a specific request for approval of this recruitment process must be included in the application to the Ethics Committee. All sub-sections of section 2.3.6 (a-i) of the National Statement should be addressed in the application – outlined in either section 6.1.2 of the WA Health Ethics Application Form or section 6.6 of the NEAF.
Where the PI of a project is a staff member of a Western Australian university but the project will recruit CAHS patients and/or involve CAHS staff or facilities ethics approval from the Princess Margaret Hospital Ethics Committee must be obtained. WA Health institutions currently cannot accept the ethical approval granted to a project by a university HREC. University HRECs may choose to accept the ethical review of the PMH Ethics Committee.
The following forms are to be used throughout WA Health to amend an authorised research project and meet the requirements of research monitoring (such as safety reporting and progress reports). Please note the Department of Health HREC has their own specific Ethics Amendment Form (which is used for both Administrative and Substantial Amendments, this should not be used for any other WA Health HREC).
Applications for projects which are sponsored by commercial agencies (e.g. pharmaceutical companies or other industry bodies) will attract a fee. Fees are payable on submission. Further fees may be charged for amendments. Where a fully sponsored project does not undergo a full scientific, ethical or governance review an application fee will be payable but the amount will be determined on a case-by-case basis.
Commercial sponsorship may be financial or in-kind (e.g. provision of drugs or devices). Fees for in-kind support by commercial agencies may be waived for investigator-initiated studies if the following conditions are included in a WA Health approved clinical trial agreement:
Applications by individual researchers for non-sponsored projects or for competitive grant applications will not attract a fee. The fee structure is listed as follows:
|New application (HREC and Governance review)||$5500|
|Research Governance review only||$3500|
|Administrative amendments||No fee|
|Substantial amendments (initial submission)*||$640|
|Further review of substantial amendment/requirement for resubmission of amendment (each occasion)||$320|
|Extension of HREC approval||$640|
Major protocol amendments are substantial amendments that introduce major new aims (i.e. a new primary or secondary objective) or which introduce major new safety considerations and which require extended scientific and/or ethical review may attract a higher fee. This includes new sub-studies.
Industry and non-industry submission of incomplete applications requiring significant additional administrative workload may be subject to additional fees both for sponsored and non-sponsored studies.
In the event that the Ethics Committee and Research Governance Offices are unattended for emergencies and notification of adverse events please contact the office of the Executive Director Medical Services, CAHS, on 9340-8245.