The Princess Margaret Hospital (PMH) Human Research Ethics Committee (HREC) has been renamed to the Child and Adolescent Health Service (CAHS) HREC. The National Health and Medical Research Council (NHMRC) have been notified of the name change and will be updating the details on their website.
In summary the changes are as follows:
The RGS, the on-line application submission IT system, goes live for all new applications from Monday 5 December 2016. All new applications for the 2017 HREC meetings will need to be submitted using the RGS. For information regarding the system and how to become a user please see https://rgs.health.wa.gov.au/Pages/Home.aspx. Assistance for CAHS users is available via the PMH Ethics office on 9340 8221. Please note that to optimise RGS performance Google Chrome should be used and the RGS automated email address (firstname.lastname@example.org) should be added to your chosen email client as a “safe sender”. For assistance installing Google Chrome or adding the RGS automated email address to your safe senders list, please contact your organisation’s IT service desk.
Transition of Research to Perth Children’s Hospital
The PCH Research Transition team (including the Ethics and Governance offices) has been working with researchers, sponsors and research institutions to relocate research to Perth Children’s Hospital when it opens in 2017. Some of the required documentation is unable to be finalised until a move day is announced but many researchers should have now received their PCH site approval letters. If any amendments are required to projects after PCH site approval is received an amendment should be submitted to the relevant HREC in the usual way.
SSA (Governance) Form: Investigators should ensure the when obtaining signatures from support departments in section 18.2 of the SSA form that the head of department is aware that he/she is approving the research support at both PMH and PCH.
From 1 July 2016 the Business Manager nominated to sign all SSA forms (in section 18.3) is Finance & Business Manager, Clinical Services.
The Child and Adolescent Health Service (CAHS) is required to comply with the WA Health Research Governance Framework (Operational Directive 411/12).
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 Child and Adolescent Health Service 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 were involved in phase 1 of piloting GPP, with PMH the only one in WA. The GPP breaks the approval process for clinical trials into the following stages:
In the first phase of this project (September 2015), meetings were held with the major departments currently conducting sponsored clinical trials or CRG studies to discuss the project and explain the information and support we can provide to departments/ investigators. There was an outline provided as to information to be collected as well as encouraging investigators to involve the RGO early in discussions with sponsors for new trials.
PMH was one of 10 sites selected to continue with phase 2 of the GPP pilot. Average time lines had been calculated from phase 1 data and PMH compares favourably for most metrics. The metrics reported on most recently are shown below. The pilot continues until February 2017.
1c. Date of return of complete feasibility to sponsor TO date of site selection visit.
2. Date of site selection notification by sponsor TO date complete SSA and HREC documentation submitted to institution.
5. Date valid site assessment documentation is finalised TO date site authorisation is granted by Institution Executive.
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.
Low and Negligible Risk Ethical Review Pathway
Child and Adolescent Health Service (CAHS) will be trialling a Low and Negligible Risk (LNR) Ethical Review process for the first few months of 2017. Investigators are asked to assess their projects to determine if they are appropriate for this review pathway before making the submission. To aid in this assessment a pre submission checklist and guidance for investigators notes are available. Please note that Ethics Office Administrative Staff will also review the submission for its suitability and will redirect any projects which do not meet the relevant criteria to the Scientific Advisory Sub Committee (SASC).Submissions for the LNR pathway will be accepted from January 17th onwards and will be reviewed as soon as possible after the receipt of an eligible and complete application. The document, Guidance for Investigators, provides full details of the documents and forms which will need to be completed, this includes a peer review and bio statistical review. If you have any questions about the LNR Ethical Review pathway please contact the CAHS ethics office.
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 via the RGS on a NEAF/HREA and be accompanied by the WA-Specific Module (completed as a form in RGS) together with the appropriate research governance forms. After the 30th June 2017 the NEAF will be decommissioned and multi-centre studies submitted for ethics approval in WA, must be submitted via the RGS on the HREA. The RGS is located at https://rgs.health.wa.gov.au and will allow for the uploading of the NEAF and HREA as a PDF supporting document until the HREA can be built in the system. Until such time, researchers will be required to complete the HREA at www.hrea.gov.au, save it as a PDF and upload it in to RGS. Note the WA Specific Module will still be required to be completed in the RGS if the HREA is being used; as the HREA does not contain the relevant ethical information specific to WA.
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 Child and Adolescent Health Service 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 2017 the PMH Ethics Committee will have 11 meetings. 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 Services for CAHS 2017.
Submissions to the PMH Ethics Committee and RGO should be made via the RGS.
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 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 and documents are mostly held on the RGS. Forms (WA Health Ethics Application form, WA Specific Module, SSA and ARF) are on-line through RGS and are populated from the Project details entered by the Coordinating PI when creating the project. Other documents can be found either under 'Document templates' on the RGS home page or via the alternative links provided below.
WAHEAF and WA Specific Module are termed forms in RGS and can be completed on-line via RGS (not available under Document Templates)
1If 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.
2 The Budget Form requires completion of tables with cost and funding information. Comprehensive Excel template is available on the RGS to help with the completion of this section – this includes salary levels and details of on-costs and overheads. This information can be found under 'Research Information' on RGS home page (go to Research Governance, Additional Governance Information). *Please note* This document will be unavailable until after the 20th December 2016. Should you require this document please contact our office.
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 Child and Adolescent Health Service 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 RGS submission system will not currently be used for post approval applications – this will be in RGS stage 2. 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).
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 may not attract a fee. Please contact the RGO to discuss. The fee structure for commercially sponsored trials is 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.