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Child and Adolescent Health Service

Health Professionals

 

Princess Margaret Hospital

Ethics & Research Governance

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.

Research Governance Service (RGS)

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 or Internet Explorer 10 (or above) should be used.

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:

Ethics committee

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.

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Research governance

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.

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NHMRC Good Practice Process for the Site Assessment and Authorisation of Clinical Trials

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.

Background

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:

  • Introduce efficiencies in the site assessment and authorisation process;
  • Identify roles and responsibilities relating to the site assessment and authorisation process;
  • Outline planning and preparation activities that could make the site more responsive to clinical trial sponsors;
  • Facilitate and streamline multi-centre research across Australia; and
  • Outline a set of principles for research governance that, when applied, should lead to improvements.

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:

  • Feasibility Assessment (sponsor contact to PI through to sponsor site selection notification)
  • Document Preparation and submission (Preparation and submission of both HREC and governance applications)
  • HREC Review / Site assessment (Ethics review, including SASC, and Governance review)
  • Site authorisation (Finalisation of review to Institutional sign off)

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Phase 1

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.

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Phase 2

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.

Metrics

National average
(days)

CAHS average
(days)

1c. Date of return of complete feasibility to sponsor TO date of site selection visit.

78.8

57.7

2. Date of site selection notification by sponsor TO date complete SSA and HREC documentation submitted to institution.

156.2

86.15

5. Date valid site assessment documentation is finalised TO date site authorisation is granted by Institution Executive.

30.3

1.4

 

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Contacts and More Information

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.

PLEASE NOTE: Two (2) letters of approval are required before your research project can commence - an ethics approval letter from the approving HREC and an authorisation letter from the Child and Adolescent Health Service. For single centre research, the approving HREC will be the PMH Ethics Committee.

Contact details

All these offices are located in the Children’s Clinical Research Facility, PMH (cnr Roberts Rd and Hamilton St)

Ethics Office
Rose Leonard
Ethics Committee Secretary
(08) 9340 8221
pmhethics@health.wa.gov.au
Monday - Friday

Research Governance Office
Jenny Westgarth-Taylor
Research Governance Officer
(08) 9340 7108
pmh.rgo@health.wa.gov.au
Tuesday - Thursday

   
Research Compliance Office
Helen Hughes
Research Compliance Officer
(08) 9340 8405
Helen.Hughes@health.wa.gov.au
Monday - Friday
Biostatistics Office
Natasha Bear
Senior Biostatistician
Natasha.Bear@health.wa.gov.au
Monday, Tuesday and Thursday

Quality improvement or research

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.

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Application approval process

Single-centre research

The approval process for a local single-centre research proposal is as follows:

  • A completed, signed application is submitted to the HREC Secretary via the RGS.
  • Provided all the necessary documentation has been provided, the study is included on the agenda for the Scientific Advisory Sub-Committee (SASC) meeting where the scientific content is reviewed. These meetings are held as per listed schedule.
  • The SASC gives feedback to the investigators as to any amendments required.
  • If approved by the SASC, the study, together with any amendments following SASC recommendations, is included in the next PMH HREC agenda.
  • If the SASC requires extensive changes to be made the study may have to be resubmitted for further review by SASC before proceeding to the HREC.
  • The study is reviewed at the HREC meeting and is either
    • approved with no changes,
    • approved subject to specific amendments being made,
    • to be resubmitted to HREC for further review following receipt of requested amendments; or
    • rejected.
  • On or after the application is submitted to the HREC Secretary, a completed, signed Site Specific Assessment or Access Request form (together with other regulatory/legal documents if applicable) should be submitted to the Research Governance Office (RGO) via the RGS.
  • While ethical 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 if inadequate or insufficient documentation regarding the proposed study is received.
  • All research governance requirements must be met before the application receives final approval from CAHS Chief Executive for the project to proceed within CAHS.
  • Upon ratification of the recommendations of the HREC and RGO by the Chief Executive, formal authorisation is sent to the investigators of approved studies.

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.

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Multi-centre research

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.

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TGA CTN Requirements

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.

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Frequently Asked Questions

Meetings dates and submission deadlines

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.

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Application submission requirements

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.

Ethics applications

Submissions to the PMH Ethics Committee and RGO should be made via the RGS.

  1. WA Health Ethics Application form,
    OR
    NEAF/HREA plus Western Australian-Specific Module (for multi-centre studies only)
  2. Protocol that includes all relevant information requested in the relevant Protocol template (Protocols submitted without all required information will be returned to the investigator and the review will be delayed)
  3. Investigator Brochure (if applicable)
  4. We accept the NHMRC Participant/Parent information sheet and consent form templates or you may use the templates more specific to PMH (select the template relevant to your project) – Interventional or Non Interventional research project. It is advised that children considered to be mature enough to understand the project and provide consent are provided with the equivalent of the parent information sheet and can co-sign the consent form with the parent. Those children not considered mature enough to fully understand and consent should be involved in the discussion about the project and provided with a simplified information sheet but do not sign any form. The discussion should be documented in the participant notes, particularly the degree of involvement of the child.
  5. Checklist for Management of Adverse Events
  6. Diary, questionnaire(s), brochure, advertising material etc. (if applicable)

Governance applications:

  1. WA Health Site-Specific Assessment form (SSA), or WA Health Access Request form
  2. Any other required documents1 (signed if appropriate)

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.

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Application forms and documents

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.

Ethics forms and documents

  1. WA Health Ethics Application form (for single centre or WA only projects),
    OR
    HREA (non RGS link) plus Western Australian-Specific Module (for multi-centre studies involving sites outside WA)

WAHEAF and WA Specific Module are termed forms in RGS and can be completed on-line via RGS (not available under Document Templates)

  1. Protocol Template for Clinical Trials / Protocol Template for Non-Clinical Trials (these templates are to assist investigators with little experience in protocol drafting)
  2. We accept the NHMRC Participant/Parent information sheet and consent form templates or you may use the templates more specific to PMH (select the template relevant to your project) - Interventional or Non Interventional (Non RGS link) research project.
    Please note that a Withdrawal Form should be separate from the information sheet and consent form and is not compulsory for a participant to complete if they wish to withdraw from a project.
    For multicentre projects, particularly where more than one WA Health site, please refer to the WA Health PICF Template to allow for all WA Health sites to be appropriately badged and have consistent footers.
  3. Checklist for Management of Adverse Events (Non RGS link)
  4. Recruitment Letter (Non RGS link)

Research Governance forms and documents

  1. WA Health Site-Specific Assessment form (SSA), OR WA Health Access Request form1 and Budget form2. These are termed forms in RGS and can be completed on-line via RGS (not available under Document Templates)
  2. Clinical Trial/Investigation Research Agreement templates are available on the RGS home page under Document templates. With the creation of the Child and Adolescent Health Service as a separate legal entity, the information to be included on CTRAs and Indemnities:
    Institution (front page): Child and Adolescent Health Service a body corporate established under section 32 of the Health Services Act 2016
    ABN (front page): 37 180 581 224
    Under CAHS Signatory: for and on behalf of Child and Adolescent Health Service in accordance with section 41 of the Health Services Act 2016
  3. WA Health insurance requirements are contained within the schedules of the clinical trial research agreements and outlined in the OD 0411/12 WA Health Research Governance Policy and Procedures 2012
  4. Indemnity documents (primarily for commercial clinical trials)
  5. Clinical Trial Notification form (where CAHS is the trial sponsor for this site please contact the RGO if require drafter access to the on-line TGA system)
  6. WA Health Student and Confidentiality Declaration to be completed by all student research personnel (irrespective of whether they are WA Health employees)

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.

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Other Approvals

Aboriginal or Torres Strait Islander Peoples

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:

  • Aboriginality is a key determinant;
  • data collection is explicitly directed at Aboriginal people;
  • Aboriginal people, as a group, will be examined in the results;
  • the information has an impact on one or more Aboriginal communities; or
  • Aboriginal health funds are a source of funding.

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.

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WA Health Data Collections

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/

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Waiver of Consent and Opt-out Consent

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.

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University HRECs

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.

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Post approval

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).

  1. Ethics amendment and monitoring forms
  2. Governance amendment and monitoring forms

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Application fees

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:

  1. The IP arising from the study is not restricted by the commercial agency
  2. The data arising from the study is not provided to the commercial agency for marketing or publicity purposes, and
  3. The investigator retains full publication rights. There should not be a right-of-review restriction by the commercial agency. Applications by individual researchers for non-sponsored projects or for competitive grant applications will not attract a fee.

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.

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Other matters requiring Ethics approval

  1. Access to unapproved therapeutic goods - Authorised Prescribers
  2. Case report:  To obtain HREC approval for a case report please submit a copy of the report together with a completed declaration.   Authors should obtain consent from the case report subject(s) - a template for documenting such consent can be found here.

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.

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Important publications for researchers

 
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