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Research governance authorisation

Research governance considers the legal compliance, financial management, accountability and risk management associated with research. Research governance provides a separate review and is distinctly different from the ethical clearance process, however it is recommended that research project/s can be submitted for review to both departments for review in parallel.

The online Site Specific Assessment (SSA) Form, used is developed via the ERM Applications portal. Only one SSA form needs to be submitted for multiple Metro South sites.

Research governance authorisation process

 

Steps

More information

1.

Complete ethical clearance process

Ethical clearance

2.

Complete the site finance budget (mandatory)

Research Funding, Budgets and Infrastructure Support Procedure

3.

Prepare research contracts and agreements (as applicable)

  • A research agreement is not required if your research only involves researchers or resources within MSH

Research Contracts and Study Execution Procedure

4.

Prepare any relevant site specific supporting documents

Research Governance (Site Specific Assessment) Procedure

5.

Complete the Research Contracts and Study Execution Form to obtain ‘wet ink’ signatures from Head of Department, Business Finance Manager (if funds are over $10k) and MSH Facility Managers. Authorisation can also be obtained electronically via email and then uploaded via the ERM website.

Research Contracts and Study Execution Form

6.

Review research fees

Research Fees Procedure

7.

Complete SSA form via the ERM Applications portal – declare conflicts of interest

Research Integrity Procedure

8.

Upload supporting documents, sign and submit application via the ERM Applications portal

Please note: Submission processes differ if you conduct multi-centre research and MSH is not the reviewing HREC. If any documentation has been updated after HREC review, forward it to our Research Governance Office available on the contacts page. Research governance authorisation cannot occur until HREC approval is granted.

ERM Applications

9.

  • Receive outcomes from:
    • HREC – ethical clearance
    • Research governance authorisation
  • Commence research

 

 

 

 

Note: If you are conducting a clinical trial, please view our specific information about clinical trials.

Frequently asked questions

What is an SSA form?

  • The online SSA form is the core document to manage the research governance site assessment requirements.
  • The SSA form holds the information on how the research project will be conducted at the site/s, including mandatory signatures and related supporting documentation. 
  • All research submissions require an SSA, allowing the institution to consider whether the research project complies legally (ie contractual arrangements, insurance and indemnity requirements are being addressed) it has sufficient physical resources and staff,  site is capable of conducting the research, financial management is in place, accountability is addressed and risk management is in place for the associated Metro South Health participating site/s and any other relevant requirements are met.

How do I submit my forms online?

All new SSA applications need to be submitted via ERM Applications

1. Login to ERM Applications or create an account if you do not already have one

2. Select the tile Create Sub-form from the list of Actions on the left-hand side

  1. On the Create Sub-form page, select Queensland Health as your jurisdiction and SSA Form QLD as the Main Form type, then select Create

​3. Complete the SSA and attach relevant supporting documents, including your site finance budget

Training material and Instructions on how to use the system can be found here. An SSA form can be generated after the HREA has been created.

Who is my facility manager?

Signatories Metro South Health facility managers as at June 2020 are as follows:

Facility

Name/position

Email

Princess Alexandra Hospital

Relevant Head of Department

Various

QEII Jubilee Hospital

Adrianne Belchamber, Executive Director

qeii.medicaladmin@health.qld.gov.au

Redland and Wynnum Hospitals

Susan Freiberg, Facility Manager          

baysidehealthresearch@health.qld.gov.au

Logan and Beaudesert Hospital 

Felicity Jensen A/Director, Medical Services

Felicity.Jensen@health.qld.gov.au

Metro South Mental Health and Addiction Services

Kieran Kinsella, Executive Director

MSAMHS_Research@health.qld.gov.au

Community and Oral Health

Dr Helen Boocock

EDCOHSMetroSouth@health.qld.gov.au 

Inala Indigenous Health Services

David Eastgate, Director, Health Equity & Access Unit

David.eastgate@health.qld.gov.au

 

What is considered an acceptable signature?

Acceptable signatures in the ERM Applications portal required by the SSA form includes:

  • electronic signature
  • wet ink signatures uploaded on a PDF form
  • letter/s and
  • email/s.

What elements comprise research governance authorisation?

Research governance requirements include:

  • confirmation of ethical clearance
  • compliance with legislation, regulations, guidelines and codes of practice
  • legal matters, including contracts and indemnity/insurance frameworks
  • financial management, risk management and SSA
  • institutional policies and procedures for responsible research conduct and managing research misconduct
  • management of collaborative research
  • reporting requirements.

How long does the research governance process take?

  • Timely responses to queries between the principal investigator/trial coordinator (on behalf of participating site/s) and the reviewing Research Governance Office is crucial to avoid delay in commencing research. 

Where do I find more information regarding the site specific supporting documents?

Please see the following procedures for more information:

I am University employee/student, what agreements or contracts are required?

  • Research undertaken by a University employee or student requires an agreement/contract or sub-contract between Metro South Health (via the name of the relevant Metro South Health site/facility) and the relevant university.
  • You must request a contractual arrangement by contacting your University’s legal representative, see the following listed University contacts (as applicable).

 

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

  • A research 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.
  • 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.
  • Should a clinician or researcher have any further questions about whether a fee is applicable please contact us to discuss further.

What are the indemnity and insurance requirements and how does it apply to me?

  • The indemnity protects a party for and against certain specific actions, claims or losses, and is required when an external organisation/researcher undertakes research in private rooms or wishes to utilise the services of the Metro South Health site/facility.

Note: If you are conducting a clinical trial, please view our specific information about clinical trials.

How do I make an amendment to my research project?

Last updated 24 September 2020
Last reviewed 22 July 2020