Governance
A governance application can be made as soon as an ethics application has been submitted to HREC for review.
Governance applications should be submitted to the Research Governance Office (RGO), via the Research Governance Service (RGS).
There is no submission deadline for governance reviews and the RGO team can review an application while HREC review is underway.
All governance applications follow one of 2 pathways – an Access Request Form (ARF) pathway or Site-specific Assessment (SSA) and budget form pathway. The ARF and SSA are 2 separate WA Health forms. The level of impost on CAHS resources will determine which governance pathway is used. See the expandable tabs for further information.
All governance documentation should be completed and signed within the RGS, including any applicable legal or regulatory papers. Investigators will be notified via RGS or email, should they need to provide further detail or documentation.
CAHS’ Chief Executive will approve a project to proceed only once all research governance requirements – including HREC approval – have been met.
An ARF is completed for research projects that have minimal impact on the resources of an HSP, such as CAHS.
These may include projects seeking to:
- recruit participants through posters, leaflets or letters of invitation where HSP staff have no active role
- survey patients or staff, but where there is no investigator or HSP personnel oversight
- access data or biospecimens held at an HSP site, but where site staff do not process or analyse the specimens or data.
Studies that could have a substantial impact on a site’s resources – due to the retrieval, preparation and and/or transport of participants, data or biospecimens – would need to complete an SSA form.
The sorts of studies that would require an SSA include those involving:
- the enrolment and consent of participants
- research procedures involving participants on site
- the management and analysis of data, biospecimens and/or survey responses at the site
- the administration of surveys requiring oversight by investigators or site personnel.
An SSA must be accompanied by a budget form to enable proper assessment of the impost on the HSP.
An ARF is generated electronically within the RGS.
Projects seeking access to multiple sites – even if all within the jurisdiction of a single HSP – must complete a separate ARF for each site.
Process for projects on the ARF pathway
- Once a project has obtained HREC approval – whether from a WA Health HREC or a HREC certified under the National Mutual Acceptance (NMA) scheme – the following documents should be uploaded and/or submitted to RGS.
- HREC approval (for WA Health HREC-approved projects)
- copy of the HREC application (if NMA approved)
- copy of any materials to be distributed (such as posters, leaflets or surveys), with the CAHS site for which distribution approval is sought
- completed ARF.
- An ARF is generated on RGS via the following pathway: Applications/Site Authorisation/Active/Forms.
Site specific documents are via the pathway: ‘Applications/Site Authorisation/ Active/ Documents’. - Information from the project details tab will populate most of the ARF automatically. The Principal Investigator (PI) or Coordinating Principal Investigator (CPI) is responsible for ensuring all information is accurate.
- On completion of the ARF, the CPI/PI must invite the head of the department (HoD) to sign the declaration at 3.2
- On obtaining HoD sign off, the form – and any supporting documents – should be submitted to the CAHS RGO for review.
- If unsure whether an access request needs departmental approval, the investigator should contact the CAHS RGO.
- For projects approved by an NHMRC-registered HREC that is not a WA Health or NMA-certified HREC (such as a university HREC), further review may be exempted and access granted on an individual basis.
Like the ARF, the SSA is generated within RGS.
It is needed for any study that will have a significant impact on an HSP and should be completed as part of the governance application. It is used to gain site authorisation for the project to proceed. A separate SSA must be completed for every site where study activity will occur.
A budget form must be completed along with the SSA.
Much of the SSA form will autofill, drawing from project details already recorded in RGS.
An SSA must detail:
- how and where recruitment at site will occur
- who will make initial contact with participants
- where the study will be conducted
- whether all research staff are CAHS employees
- any conflicts of interests
- funder details (for projects receiving external funding).
Ensure the SSA includes:
- signatures of the Business Manager and correct Divisional Director (at 18.1)
- PathWest Business Manager’s signature (needed only if PathWest is a supporting department)
- party agencies that are involved in conducting the project
- a budget.
The budget must include:
- costs of all items to be utilised in each department at the site
- funding amounts and sources, including in-kind funding; and
- details of the relevant Research Department, Supporting Department (s) and third-party agencies involved in conducting the study.
On the first page
- Identify the department where most of the research will be conducted. The study’s site PI will usually be associated with this department.
- Add the names of any supporting departments or third-party agencies involved in the project.
- The PI or PI delegate signs off for any ‘third-party agency’.
- Note that in circumstances where the HoD is an investigator on the project, an appropriate person at least at least 1 tier above them (such as their Divisional Director) must sign in their place.
*Note examples of third-party agencies in graphic above.
On the second page
This page should have 3 auto-populated lines in the Research Department Overhead – Charge, Ethics review, and site processing and review.
- Overhead charge is 25 per cent for commercial projects, 10 per cent for collaborative group, and 0 per cent for investigator-led projects.
- Cost type – is auto selected for the first 3 lines as ‘Project Specific’.
- Most research activity conducted within an HSP’s research department would be referred to as ‘shared’ if it involved use of the institution’s resources such as power, computers and equipment. In such cases, you would answer ‘yes’ to ‘overhead charge’.
- For project-specific costs such as courier costs or participant reimbursement you would select ‘no’ to ‘overhead charge’.
- For supporting departments, select ‘project specific’ and ‘no’ to overhead charge because their activity would generally be considered ‘project specific’ and their overhead charges are often already calculated into the costs entered in RGS by the sponsor.
On the third page
- Total costs to each funder must be allocated on the budget form. The amount covered by each funder should be noted as either ‘$ funding by sponsor or funder’ or ‘in-kind’.
- Collaborative group or investigator-led projects might include a combination of both.
- Ensure that total costs on the left are equal to the 2 ‘$’ columns on the right ($ funding by sponsor or funder and $ in-kind support) before you invite the HoD.
- Note that for commercially sponsored projects, no costs can be provided in kind. The sponsor must meet all costs.
- Once the budget is complete – with all research activity captured, costed and balanced – return to page 1 and invite the HoDs to sign for their respective departments.
- If your research activity will involve other departments, you are strongly advised to discuss your research with their respective HoDs so the RGS request for their signature will not come as a surprise.
- Once all departments have been authorised, the PI or PI delegate can authorise the form. Note that the initial application budget should only capture aspects of the project that have secured funding. An amended budget must be submitted for any additional money received later.
- Also note that if the budget indicates it has received external grant funding, a copy of the appropriate grant application and agreement must be submitted to governance as part of the site application.
- For assistance regarding:
- the budget, contact the CAHS RGO
- staff costs and finance queries, contact Research Finance Business Officer.
Understanding the roles
Research responsibilities are delegated to different investigators who fulfill different roles in research governance and GCP. The Investigators are responsible for conducting research at different sites supported by the research team.
Coordinating Principal Investigator or Chief Investigator
The Coordinating Principal Investigator (CPI) or Chief Investigator sits at the top of the pyramid and is responsible for the coordination of investigators at different centres participating in a multicentre project. The CPI has overall responsibility for liaising with the HREC, and the conduct and monitoring of the project, for all sites under the HREC approval.
Principal Investigator
The Principal Investigator (PI) is responsible for project conduct at a site and for supervising the project’s team at that site. The PI is also responsible for liaising with the site Research Governance Office.
Associate or Sub Investigators
Associate or Sub Investigators (AIs), under the supervision of the PI, provide intellectual and/or practical input into the project. Their participation may warrant inclusion of their name on publications.
The RGS allows for one CPI delegate and one PI delegate for each PI. A delegate can assist with the application on RGS and replaces the CPI/PI in unforeseen or emergency circumstances.
Students
For projects involving a student, the student must sign the WA Health Student Research and Confidentiality Declaration Form. The template for this document can be found under the ‘Document templates’ tab on RGS. Submit this form as a supporting document with your application in RGS.
Visit RGS for information on managing Project Members.
Good Clinical Practice (GCP)
All members of a research project are required to have a current GCP certificate which must be uploaded on the member’s profile in RGS. Please note that GCP certification should be renewed every 3 years.
GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials.
Compliance with this standard provides public assurance that data and reported results are credible and accurate. It also ensures trial participants’ safety, well-being and integrity are protected and that their information is kept confidential.
The World Health Organization recognises that all parties involved in a research project are responsible for implementing the elements of GCP, applicable to research governance.
GCP training
GCP training can be completed online via the following websites:
- A-CTEC GCP (Certified) | ACTEC (2.5hrs)
To access this A-CTEC courses, each person will need:- an @health.wa.gov.au email address
- to enter an access key ‘actec@2003’ (if this does not work in the future, then it is found on each person’s home page)
- WA Health Translation Network
- ARCS Australia
- Whitehall Training
- Global Health Trials
Protecting participants and handling their information responsibly is extremely important in human research. Confidentiality and privacy processes must be implemented for all research projects conducted within the WA health system.
Every state-wide health data collection containing health information from WA health system patients must have approval from the relevant data custodian. Data custodians will approve access and disclosure of data only if any of the following circumstances apply:
- consent has been provided by the participant for their data to be used for research purposes
- the empowering legislation governing the relevant data collection(s) allows for participant information to be released for a specific research project in the absence of participant consent
- the information being requested is non-personal health information and the disclosure of information in the absence of consent is not prohibited by legislation.
In the site application consider the following:
- How will data be recorded from the source documents? For example, by electronic case report form (CRF), paper CRF or entered directly into a database such as REDCap?
- If by REDCap, who will host this instance of REDCap and will the data leave WA Health?
- Will data recorded be identifiable, re-identifiable or de-identified?
- If re-identifiable, where will the master contact list be kept and who will have access to it?
- Where will data be stored and, if any data leaves WA Health IT servers, where will it be held?
- Note that if any data leaves a WA Health server, a Data Transfer Agreement (DTA) with the recipient of the data (refer to Agreement Table Guideline) is needed.
- How long will hard and electronic copies of the data be stored and how will they eventually be destroyed?
WA Health follows the WA University Sector Disposal Authority schedule for the retention of research records. Research records must be destroyed as per the WA Health Information Retention and Disposal Policy after the minimum retention period and approval from the sponsor.
Note also that the management of data must be consistent with what is in the PICF because participants must be informed about where and how their data will be used, stored and destroyed.
What constitutes a conflict of interest?
A ‘conflict of interest’ is a situation arising from a potential clash between the performance of a public duty and private personal interest.
Conflicts of interest may be actual, perceived to exist, or potentially exist at some time in the future.
While it is not always possible to avoid a conflict of interest, appropriately identifying and dealing with the situation can mitigate potential problems.
All non-WA Health staff must sign a declaration of confidentiality. When you accept an invite to a research project on RGS, you will be asked if you are a WA Health employee. If you answer ‘no’, you will be prompted to sign an electronic Declaration of Confidentiality form.
WA Health employees with a dual appointment, such as an honorary or paid appointment at another organisation that will be collaborating on the project, should consider the ‘hat’ they are wearing. If the hat for that project is not WA Health, they should answer ‘No’ to this question and complete the ‘Declaration of Confidentiality’ when accepting the project invite.
Investigators wearing 2 or more hats, should consider how potential or actual conflicts of interest will be managed. These investigators should complete the RGS conflict-of-interest form in the ‘Declarations’ tab on RGS and the ‘Conflict of Interest’ form that is required by WA Health and the external Organisation in these instances.
The WA Health Managing Conflicts of Interest Policy offers further guidance with scenarios which may help you decide if a conflict is actual, perceived, or potential.
If there is an investigator who is a student on a project, a ‘Student Research and Confidentiality Declaration’ must also be submitted with the project application on RGS. The template is available on RGS under the ‘Document Templates’ tab. The student declaration includes clauses to protect both the student and WA Health.
Clinical trial and public liability insurance refers to a policy taken out to cover a trial’s risks and liabilities.
The party providing indemnity must have and maintain appropriate insurance.
In commercially sponsored projects, the sponsor is responsible for this insurance.
For non-commercially sponsored projects, the WA Health System entity is responsible.
Commercially sponsored projects must include details of the insurance at Schedule 4 of the Research Agreement. Evidence of a current Clinical Trial Insurance certificate of currency is required for all commercial projects. The RGO will also request a copy of the policy document to ensure the cover is adequate and does not have exclusions that could prevent a claim.
Public liability insurance is required if independent study monitors will be coming onsite to monitor the project.
The Sponsor and/or the Contract Research Organisation (CRO) must indemnify the institution and members of the responsible HREC against claims arising from a project (on the terms and conditions set out in the relevant Medicines Australia Form of Indemnity for Clinical Trials) in all projects involving the following Clinical Trial Research Agreements (CTRA):
- CTRA - Medicines Australia Standard Form (Form A)
- CTRA - Medicines Australia Form - Contract Research Organisation acting as the Local Sponsor (Form D)
- WA CTRA Standard Form B – involving a Sponsor and a Contract Research Organisation.
Projects conducted under the Clinical Trial Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Form C) do not require the CRG to provide the institution and HREC with an indemnity.
If a CRG offers to provide indemnity it should be via the Medicines Australia form. There are 2 versions of the Medicines Australia form of indemnity for clinical trials:
- Standard Form of Indemnity (for use where the indemnified party (CAHS) is providing premises for the conduct of the project and HREC Review or is providing premises only)
- HREC review only (this form should be used if the indemnified party – CAHS – is providing HREC review of the project only).
For most projects, the Standard Form of Indemnity will be submitted. The current version can be downloaded from the RGS or Medicines Australia.
As the Form of Indemnity is a legal document, the indemnifying party (e.g. the Sponsor) must ensure that the correct legal name appears for both ‘the indemnified party’ and ‘the sponsor’. CAHS RGO can assist with these details.
Indemnity forms
- Medicines Australia Standard Form of Indemnity for Clinical Trials
- Medicines Australia HREC Review Only Form of Indemnity for Clinical Trials
- Medicines Australia Compensation Guidelines for Clinical Trials
- Medical Technology Association of Australia Standard Indemnity Form for a Clinical Investigation.
Research involving WA Health System employees, participants, data or biospecimens – and that is undertaken in collaboration with an external entity – must be subject to a written agreement.
The type of the agreement required will depend on the nature of the project. Research agreements are legally binding between 2 or more parties and establish the respective responsibilities and obligations of the parties involved.
The type of research agreement required will depend on the type of research activity and entities involved. Several WA Health Research Agreements are available on the RGS website, under the documents tab.
Sponsors sometimes prefer to use their version of the Medicines Australia Clinical Trial Research Agreement (CTRA). This is acceptable provided they include WA Health Special Conditions. These special conditions can be found in our templates on RGS under ‘Document Templates’. If using a non-standard agreement, contact the RGO early so its team can start the review process early.
Clinical trials involving an investigational agent or device, must submit a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA).
The sponsor is responsible for managing the submission and payment of the CTN which must be finalised prior to starting the project.
CAHS-sponsored trials should contact the RGO for drafting rights and to liaise regarding submission and payment of the CTN.
The TGA administers 2 pathways for clinical trials – Clinical Trials Notification (CTN) and Clinical Trials Approval (CTA). Both, provide an avenue through which 'unapproved' therapeutic goods may be supplied lawfully for use solely for experimental purposes in humans.
The Australian clinical trial sponsor and HREC decide which pathway will be taken, with HREC responsible for approving the study protocol.
Within WA Health, the majority of clinical trials involving a drug or device follow the CTN route.
The CTA pathway is designed for high-risk or novel treatments where there is limited or no knowledge of safety. The CTA pathway may be more appropriate for a study trialling an experimental device that introduces a new technology, material or new treatment concept that has not been evaluated previously in clinical trials in any country. Where a device poses a risk of serious patient harm, the CTA pathway would be a more appropriate route.
Budget
Projects that will use Clinic D must capture this in the budget on RGS.
The Research Department must be identified as a separate department on the budget, with Clinic D added as a line item under the department.
The cost of clinic D is $40 an hour which can be provided in-kind for projects led by CAHS Principal Investigators. Clinic D’s HoD must be invited to sign off on the budget
Access hours
Clinic D is accessible weekdays from 8am to 5pm.
Clinical research resources may be accessed for after-hours research activity if deemed appropriate by the Director, Department of Research or delegate. Contact the RGO to discuss potential after-hours arrangements.
Interventional Research
If blood draws or other interventional procedures are to be conducted in Clinic D, a signed ‘Participant Safety Checklist for Interventional Research’ should be provided to the RGO for review.
CAHS staff can access the Safety Checklist form on HealthPoint (internal WA Health only).
Compliance
Staff, students and visiting researchers must comply with requirements of the approving HREC, all other applicable regulatory bodies and policies and procedures.
They also have a responsibility to report all hazards, incidents and injuries.
PathWest involvement in a research project must be captured in RGS in the following circumstances:
1. When PathWest is involved in screening for the project, for example when its data is used to identify participants or prospective participants.
If using ULTRA or Soft LIS (PathWest data sets) research staff must:
- list PathWest as a site in RGS and get approval from the lead HREC
- complete an Access Request Forum (ARF) in RGS
- complete a Data Request Form which must be signed by the Data Custodian
- obtain an HREC-approved waiver of consent for projects where the hospital is not involved in consenting participants for access to their data for pre-screening.
2. Where PathWest data is being accessed:
- list PathWest as a site in RGS and get approval from the lead HREC
- complete an ARF in RGS
- complete a Data Request Form signed by data custodian
- it is likely a Data Transfer Agreement will also be needed.
3. Where PathWest archival or salvage tissues or biospecimens (such as blood or tissue) will be accessed:
- list PathWest as a site in RGS and get approval from the lead HREC
- complete SSA Form and Budget Form in RGS
- it is likely a Material Transfer Agreement will be needed.
4. Where there is collaboration with pathology/scientists (for example where a PathWest employee is named as member of the research team):
- list PathWest as a site in RGS and get approval from the lead HREC
- ensure a PathWest PI is listed for the site
- complete SSA Form and Budget Form in RGS for PathWest
- an agreement may be required.
For queries email PathWest.RGO@health.wa.gov.au
Questions to consider when sending biospecimens to another laboratory
- Why are the samples being sent to another institution? Is it for quality assurance, banking or specific tests that cannot be performed by PathWest?
- How long will the samples be stored at the Institution and how will they be destroyed?
- Who will have access to the samples?
- Will the specimens be de-identified?
- What sort of agreement is in place for the third-party institution to perform any testing?
- How will you confirm and manage payments made to the third-party institution.
- Who will be responsible for packaging samples for transfer? Are these individuals International Air Transport Association (IATA)-trained?
Note that if a participant’s samples will be sent for testing to an institution outside of WA Health, this must be disclosed in the PICF and include precise details of what will happen to the specimens.