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Research governance

Key messages

  • Research governance considers the legal compliance, financial management, accountability and risk management associated with research.
  • Research governance authorisation, Site Specific Assessment (SSA), is separate from Human Research Ethics Committee (HREC) review.
  • Both ethical clearance and research governance authorisation are required before a research project can commence at a site.
  • The organisation conducting the research, following ethical clearance, must authorise research governance before a research project can commence at that site.

What's new?

New research governance form

Streamlined processes have been introduced including a RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form).

  • This form acts as a cover letter and contains all relevant background information required for research governance. It also prevents additional work in collecting signatures and administering amendments.
  • The following information is required on the form: research project title, HREC number, sites and facility manager signatures for each site. Metro South Health facility managers as at March 2018 are as follows:
FacilityFacility manager

Princess Alexandra Hospital

Head of Department signature required

QEII Hospital

Mike Kerin, Facility Manager

Redland and Wynnum Hospitals

Susan Freiberg, Facility Manager          

Logan and Beaudesert Hospitals

Felicity Jensen,  A/Director, Medical Services

MSAMHS

Balaji Motamarri, Executive Director, Clinical Services               

  • The Principal Investigator (PI) must sign the form and agrees to abide by all requirements.
  • It’s also important to include the initiating department’s Head of Department signature as a professional courtesy to let them know that the research project will be happening within their department.
  • A research cost centre code must be included and is essential. Please note research cost centres in Metro South Health have a 6 in the middle.
  • Researchers must also indicate which supporting documents are included as part of the Site Specific Assessment (SSA).

Requirements for the research governance process

Research governance is a framework for institutions to use to ensure research is conducted responsibly and safely and is scientifically and ethically sound. Research governance considers the legal compliance, financial management, accountability and risk management associated with at a participating site. Research governance is administered by the process of Site Specific Assessment (SSA). Research governance authorisation is essential in the system for streamlined ethical review of multi-centre research projects, and it is also used for single-site research projects.

Research governance is separate from Human Research Ethics Committee (HREC) review. Research governance must occur at all organisations conducting the health and medical research. Both ethical clearance and research governance authorisation are required before a research project can commence at a site. Ethical clearance and research governance authorisation are separate in that decision-making is distinctly different. The Metro South Health Research Governance Office will base an assessment on some of the same documents that are reviewed by a Human Research Ethics Committee (HREC). The deliberation in each case is different; one is ethical and the other considers risk, the law and management of issues around research at the institution.

Timely responses to queries between the Coordinating Principal Investigator (CPI)/Trial Coordinator (on behalf of participating sites) and the reviewing Human Research Ethics Committee (HREC) are crucial to avoid delay in commencing research. Elements of research governance include:

  • Confirmation ethical clearance
  • Compliance with legislation, regulations, guidelines and codes of practice
  • Legal matters, including contracts, and indemnity/insurance frameworks
  • Financial management, risk management and site-specific assessment
  • Institutional policies and procedures for responsible research conduct and managing research misconduct
  • Management of collaborative research
  • Reporting requirements

Site Specific Assessment (SSA) form

The online Site Specific Assessment (SSA) form available on the Online Forms for Research website is the core document to manage the research governance site assessment requirements. The Site Specific Assessment (SSA) form holds the information on how the research project will be conducted at the site, including mandatory signatures and related supporting documentation. All research submissions require a Site Specific Assessment (SSA), thereby allowing the institution to consider whether the research project is suitable for the site, including whether it has the capacity to conduct the research at the relevant site, and meets all legal criteria. This Site-Specific Assessment (SSA) involves consideration of such matters as physical resources, staff, contractual arrangements, insurance and indemnity requirements and other matters.

You should start your Site Specific Assessment (SSA) form as soon as possible. Sign-off is required from departments or authorities involved in the research project, for example: nursing, health information, pathology, other local requirements, interpreting services, pharmacy, tissue bank(s), radiology/medical imaging, and budget authorisation.

A complete Site Specific Assessment (SSA) form will be considered for authorisation by the Metro South Health Research Governance Office. It is strongly recommended you complete the Site Specific Assessment (SSA) and associated documentation for submission at the same time as the Human Research Ethics Application (HREA) documentation for parallel review by the two departments. Please see Research Governance (Site Specific Assessment) Procedure (PDF, 370.43 KB) and/or continue reading for information regarding research governance and required documentation.

Please note: if submitting a Human Research Ethics Application (HREA) for Low Risk review a completed Site Specific Assessment (SSA) form must accompany.

Metro South Health research governance authorisation processes

The research governance authorisation is a process by which research projects are reviewed to ensure that Metro South Health has the resources to support the research (e.g. personnel, equipment and infrastructure) and whether financial arrangements and legal responsibilities have been met. Not all research projects that are deemed ethically sound can be supported by Metro South Health. It is important that you engage in discussions with all Divisions, Departments and facilities you intend to involve in the research before submitting your application for research governance authorisation to minimise the possibility of research projects not receiving authorisation at this stage.  Once Metro South Health Human Research Ethics Committee (HREC) ethical clearance and any additional approvals have been granted, clinicians and researchers will be required to complete a Site Specific Assessment (SSA) and receive research governance authorisation before commencing the research in Metro South Health.

Once all research governance criteria have been met, recommendation for authorisation of the research project submission will be provided by the Metro South Health Chief Executive Officer or delegate.  The following information applies to all research projects conducted at or by Metro South Health, irrespective of whether the Metro South Human Research Ethics Committee (HREC) has provided ethical clearance for the research project or not.

Research governance process

Preparing for research governance submission

Step 1: Commencing the ethical and research governance review

It is strongly recommended to commence completion and collation of research governance documentation at the same time as the Human Research Ethics Committee (HREC) review process. Please see Ethical and Scientific Review of Human Research Procedure (PDF, 413.65 KB) for more information.

Step 2: Commencing research governance authorisation - Conflicts of Interest (COI)

If any person believes they may have a Conflict of Interest in relation to a Site Specific Assessment (SSA), the conflict must be declared and detailed prior to submission of research governance documentation. The Principal Investigator (PI) must escalate; approval of the Site Specific Assessment (SSA) documents and signing of the RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form) to a relevant line manager or delegate.

Step 3: Preparing the Site Specific Assessment (SSA) – specific components

In order to fulfil Site Specific Assessment (SSA) requirements the following specific components must be prepared.

3.a  RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form)

Researchers must complete RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form) for all research projects occurring within Metro South Health, the authorising signatories must be employees of Metro South Health.

  • For research projects that involve more than one (1) Metro South Health facility, a signature from the authorised representative of the facility (i.e. facility manager) is required.
  • The Metro South Health Principal Investigator (PI) is only required to sign when assuming full responsibility for the conduct of the research project at the site and ownership of the research contract/agreement (if applicable).
  • The Head of Department at the initiating site in which the research project is to be conducted, normally the director of the department.  This delegate must not be a member of the research team. If necessary, researchers must seek authorisation from the Executive Director of the department.  Their signature indicates that they support the conduct of the research project within the department.
  • The Business Manager/Financial Officer of the department in which the research project is to be conducted. Their signature indicates that there are sufficient resources available to conduct the research project.
3.b Site Specific Assessment (SSA) Form

The online Site Specific Assessment (SSA) form, available on the Australia Online Forms for Research internet site, must be completed as it relates to information about research activities that are occurring within a Metro South Health facility. Note: Only 1 (one) Site Specific Assessment (SSA) form is required for research projects that involve multiple Metro South Health facilities.  It is important to note that the online Site Specific Assessment (SSA) form can be saved and updated throughout the preparation process.

All supporting documents must be uploaded electronically against the online Site Specific Assessment (SSA) form. See Step 4: Preparing the Site Specific Assessment – Supporting Documents below for more information on required supporting documentation.

Step 4: Preparing the Site Specific Assessment (SSA) – supporting documents

In addition to the above specific components, the following associated supporting documents may also be required based on research project requirements. All supporting documents must be prepared and uploaded against the research project’s online Site Specific Assessment (SSA) form available on the Australia Online Forms for Research internet site.

For document control purposes, all supporting documents must have version control number and date in the footer.  For example the site specific Participant Information and Consent Form (PICF) must include the following: 

Participant Information and Consent Form (PICF) Version x.x dated xx/xx/xxx

And (if required)

Site Specific Participant Information and Consent Form (PICF) Version x.x dated xx/xx/xxx (include logo)

4.a Metro South Health Human Research Ethics Committee (HREC) ethical clearance letter

The Metro South Health Human Research Ethics Committee (HREC) ethical clearance letter is a mandatory requirement and must be provided prior to research governance authorisation.

4.b Research contract/agreement (as applicable)

Researchers are encouraged consult with the Metro South Health Research Governance Office via email to ascertain if there is a requirement for a research contract/agreement.

Research contract/agreements are typically required when a third (3rd) party entity is involved in the collaboration or when a student is undertaking a research higher degree as part of the research team. Please see Research Contracts and Study Execution Procedure (PR2017/122) (PDF, 275.48 KB) for more information.

4.c Medicines Australia Standard Indemnity

Researchers must complete the Medicines Australia Standard Indemnity, in addition to the Medicines Australia Agreement, for commercially sponsored research projects.

4.d Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Radiation Risk Assessment

A copy of the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Radiation Risk Assessment is required for research projects involving ionising radiation as a specific component of the Research Protocol.

4.e Risk Versus Benefit Letter

The Risk Versus Benefit Letter is required for clinical trials or clinical interventional trials where Metro South Health is acting as the research project sponsor. The letter must be signed by an appropriate delegate.

4.f Quotes and authorisations

Quotes and authorisations from departments providing a service to support the research project, i.e. Pharmacy, Radiology and Pathology etc. must be included.

4.g Clinical Trial Notification (CTN) form

As supplied by the commercial sponsor a copy of Clinical Trial Notification (CTN) form (in pdf) which has been submitted to the Therapeutic Goods Administration (TGA). Additionally, if available, a copy    of the TGA acknowledgement letter in respect of the Clinical Trial Notification (CTN) notification.

4.h Invoicing details

Invoicing details are required for research projects that attract a fee as per Research Fees Procedure (PR2017/123) (PDF, 203.26 KB).

4.i External Human Research Ethics Committee (HREC) ethical clearance

Research projects that are approved by an external Human Research Ethics Committee (HREC) i.e. non-Metro South Health Human Research Ethics Committee (HREC), require the following additional supporting documents:

  • Research Protocol
  • Printed Human Research Ethics Application (HREA)/Low and Negligible Risk Application Form (LNA Form) (if applicable) available on the Australia Online Forms for Research internet site
  • Participant Information and Consent Form (PICF):
    • master Participant Information and Consent Form (PICF) for multi-centre research projects only; or
    • site specific Participant Information and Consent Form (PICF) which contains site contact details and site logo;
  • Current Curriculum Vitaes (CV) of research personnel (if not already supplied within the previous two (2) years)
  • Confirmation of Good Clinical Practice (GCP) certification; for clinical trials - mandatory requirement or for all other types of research - strongly recommended.
4.j Health Support Queensland (HSQ) pathology or coronial material authorisation

Depending on the research project, researchers seeking access to Health Support Queensland (HSQ) resources (e.g. data, equipment, biospecimens, biological materials, tissue blocks and slides, etc.) are required to seek approval from the relevant director or delegate.

4.k Non-Queensland Health employees - Public Health Act 2005 (Qld) Authorisation

Depending on the research project, Public Health Act 2005 (Qld) authorisation is required where confidential identifiable patient medical information is to be obtained without consent.

Please contact the relevant data custodian and complete and submit the Public Health Act 2005 – Application and Information for Researchers form. Researchers must ensure when Public Health Act 2005 (Qld) authorisation is received it is immediately forwarded to the Metro South Health Research Governance Office.

Step 5: Submitting the completed Site Specific Assessment (SSA) form

Once completed online, the Site Specific Assessment (SSA) form is submitted electronically and a Site Specific Assessment (SSA) reference number is generated. Researchers must print the completed Site Specific Assessment (SSA) form from the Australia Online Forms for Research internet site and include the Site Specific Assessment (SSA) reference number on the RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form). Note: No signatures are required on the printed version of the online Site Specific Assessment (SSA) form.

Only research projects approved by a National Health and Medical Research Council (NHMRC) certified Human Research Ethics Committee (HREC) will be considered for research governance authorisation. The following documents must be submitted in hard copy to the Metro South Health Research Governance Office address.

Reference

Document type

Hard copy requirement

a.

Cover Letter and/or ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form

1 copy

b.

RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form)

1 copy

c.

Site Specific Assessment (SSA) form

1 copy

Please note, the original (hardcopy) applications must be submitted as the Metro South Health Research Governance Office cannot process emailed or faxed copies. The supporting documents must be uploaded and submitted electronically via the Online Forms for Research internet site.  Once received, the research project submission will be reviewed by the Metro South Health Research Governance Office.

Authorisation process

Step 1: Review and authorisation

Recommendation of authorisation of the research project will not occur until all regulatory, legislative and institutional (Metro South Health) requirements are met including legal review and acceptance of indemnity provisions.  It is not permissible to commence research until all research governance requirements are met.

The Metro South Health Research Governance Office will review all submitted documentation and request further information if/when required (in line with specifications as set in the Health Service Directive – Research Ethics and Governance QH-HSD-035:2016) via email correspondence.

Step 2: Acknowledgement

Formal acknowledgment/confirmation of receipt will be sent from the Metro South Health Research Governance Office when relevant supporting documents are received. Relevant Site Specific Assessment (SSA) documentation will be uploaded to relevant Centres for Health Research databases and filed for record keeping purposes.

Step 3: Metro South Health Chief Executive Officer or delegate review

All research governance documents requiring Metro South Health Chief Executive Officer or delegate review and/or approval will be forwarded by the Metro South Health Research Governance Office to the nominated delegate as per the Metro South Health Financial Delegations Schedule. This includes Metro South Health sponsored research projects.

Following requires Metro South Health Chief Executive Officer or delegate approval:

  1. Research projects WITHOUT a research contract: The research governance authorisation letter and RGF2 Research Commencement Form will be sent to the Metro South Health Principal Investigator (PI) and nominated contact person as well as the PowerTrials Support Team via the generic email address.
  2. Research projects WITH a research contract: In addition to the above, the Business/Finance Manager of the department and the Metro South Health Central Contract Registration Team must be notified to facilitate uploading of relevant documents onto the central contract register (QContracts) via the generic email address: MSHCentralContractsRegister@health.qld.gov.au as well as the PowerTrials Support Team via the generic email address.

Please see Research Contracts and Study Execution Procedure (PDF, 275.48 KB) and PowerTrials - Electronic Medical Record Research Support Module Procedure (PDF, 233.39 KB) for more information.

Step 4: Authorisation

Researchers will be formally notified of research governance authorisation in written correspondence.  The Authorisation Letter will be sent in a pdf form via email to the Principal Investigator (PI) and nominated contact person. The time to reach research governance authorisation will not take more than National Health and Medical Research Council (NHMRC) benchmark of twenty-five (25) days. Registration of research governance authorisation is documented within AU-RED and the Metro South Health Research Ethics and Governance SharePoint site. Researchers are responsible for ensuring research project activities do not commence prior to receiving research governance authorisation. 

Step 5: Notification of commencement

Metro South Health requires that the Metro South Health Research Governance Office is provided the start date of the research project via the RGF2 Research Commencement Form.

Researchers must complete the RGF2 Research Commencement Form and send to either Metro South Health Human Research Ethics Committee (HREC) and/or Metro South Health Research Governance Offices via email prior to commencing the research project.

Step 6: Commence research/publish

The research project may only proceed upon receipt of advice/confirmation in writing from the Metro South Health Research Governance Office.

Research contract/agreements

Where an external organisation requires access to Metro South Health employees, premises, resources or patients the research project may be subject to a written research contract. Please see Research Contracts and Study Execution Procedure (PR2017/122) (PDF, 275.48 KB) for more information regarding Metro South Health requirements.  Please submit all contracts, agreements and indemnities electronically via email for the Metro South Health Research Governance Office to assess, provide comments and approve prior to obtaining signatures from the external organisation/Principal Investigator (PI). 

Final Signature from Metro South Health for any research project related contract/agreement/indemnity, can only be obtained from the Metro South Health Chief Executive Officer or delegated authority upon receiving recommendation by the Metro South Health Research Governance Office. Please refer to the Financial Delegations Framework. The Principal Investigator (PI) cannot be a party to the agreement; however they may sign to 'acknowledge' the agreement.

University research sub-contracts

Research undertaken by a University employee or student requires an agreement in the form of a sub-contract between Metro South Health via (the name of the relevant Metro South Health site/facility) and the relevant university. If you are a University employee or student, a contract must be made with your University’s legal representative. To request a contractual arrangement please contact the following representative (as applicable):

  • University of Queensland
  • Queensland University of Technology
    • Office of Research (grants or competitively funded projects) - Email: orresearchcontracts@qut.edu.au
    • Office of Commercial Services (other source of funding) - Email: ocscontracts@qut.edu.au
    • N.B: QUT students need to contact their QUT primary supervisor for any assistance regarding agreement.
       
  • Griffith University

Indemnity

An indemnity is a contractual promise by one party to the other party for and against certain specific actions, claims or losses.

External organisations, researchers external to Metro South Health or those undertaking research in private rooms, wishing to utilise the services of the Metro South Health site/facility must provide indemnification by submitting a signed Medicines Australia Indemnity Form. Please see the Research Contracts and Study Execution Procedure (PR2017/122) (PDF, 275.48 KB) for more information.

Recommendation of research governance authorisation of your research project will not occur until all regulatory, legislative and Metro South “institutional” requirements are met including legal review and acceptance of indemnity provisions. 

Ongoing management of research governance authorisation

Researchers are responsible for the maintaining and managing their research project.

Frequently asked questions

How do I make an amendment to my research project?

RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form) – (Part 2) must be filled out and signed at the beginning of the research project and kept on file as master. It can then be used if an amendment is required.

The Metro South Health Research Governance Office only requires amendments to contracts i.e. staffing levels, or number of sites or costing/finances (even if only administrative). In these circumstances signatures must be obtained from the Head of Department and/or Business Manager.

Remember - any amendments to the Research Protocol must be provided to the approving Human Research Ethics Committee (HREC) and is separate to research governance requirements.

No signatures are required on the Site Specific Assessment (SSA) form – only signatures are required on RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form).

Further details on what constitutes an amendment and the documentation required, can be found in the Maintain and manage your research project page.

Is there a fee associated with ethical clearance and research governance authorisation and when do I need to pay it?

A fee may be applicable to an application depending on individual circumstances. A fee is always applied to commercial research projects where there is a named sponsor in the application and they are invoiced directly; so please ensure the relevant invoicing details are included on the ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form.

For non-commercial studies, a fee may still be applicable depending on whether the clinician or researcher is from Metro South Health, Queensland Health or an external party.

For details on the fee structure, please refer to our Research Fees Procedure (PR2017/123) (PDF, 203.26 KB). Should a clinician or researcher have any further questions about whether a fee is applicable please contact the Centres for Health Research to discuss further.

Last updated 18 May 2018
Last reviewed 17 May 2018

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