SSA authorisation process

What is an SSA form?

• The online SSA form is the core document to manage the SSA authorisation 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 MSH 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:

What is considered an acceptable signature?

Metro South Research Governance endorses use of electronic signature platforms, digital signatures OR electronic signature for execution of research agreements including Clinical Trials Research Agreements and the HTQ Passport agreements.

Metro South’s Legal team have stated:

‘Legally binding signatures recognised and accepted by Metro South Health for the execution of Agreements applied to research, are wet ink and, subject to inclusion of an appropriate consent and reliable and appropriate method clause in the Agreement, any combination of wet ink, electronic signing platform, digital signature or electronic signature’.

To accommodate this the following clause will need to be added as special condition to any given agreement, for Medicine Australia Agreements it can be inserted into Special Conditions Schedule 4 and Schedule 7:

Electronic Execution

(a) Each party consents to this document being executed by any other party through an electronic signing platform, digital signature or electronic signature.

(b) The parties agree that the method described in this clause is reliable and appropriate for the purposes of identifying the signing party and executing this document.

(c) By signing this document, all parties confirm that they have given prior consent, in accordance with applicable electronic transactions laws (including the Electronic Transactions (Queensland) Act 2001) for electronic transmission of any documents, notices or information required to be given under this document, for signing purposes or otherwise, so far as such means of communication have been indicated in this document by the provision of an email address.

What elements comprise SSA authorisation?

SSA 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 SSA authorisation 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:

• Site Specific Assessment Procedure
• Ethical and Scientific Review of Human Research Procedure
• Participant Information and Consent Form Procedure

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 MSH (via the name of the relevant MSH 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).

• University of Queensland
  • Faculty of Medicine:
    med.rpms@uq.edu.au  +61 7 3443 7612
  • Faculty of Health and Behavioural Sciences:
    habs.researchcontract@uq.edu.au / +61 7 3365 6015 
     
• Queensland University of Technology (QUT)
  • 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
  • Note: QUT students need to contact their QUT primary supervisor for any assistance regarding agreement.
     
• Griffith University
  • oregrants@griffith.edu.au / +61 7 3735 4105

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 MSH site/facility.

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

• For more information:
  • Australian Clinical Trials Frequently Asked Questions: Indemnity and insurance arrangements for clinical trials in Australia
  • NHMRC - Indemnity and insurance arrangements for clinical trials

Do I need special approval to collaborate with researchers from international government owned entities?

A new Act (Australia’s Foreign Relations (State and Territory Arrangements) Act 2020) is in force that requires government departments to seek approval from Federal and State ministers if they intend to enter into formal arrangements with a government owned or controlled international entity. 

This means that specific approval may be required when collaborating with international researchers.  It is important that you contact the Metro South Research office via MSH-RGO@health.qld.gov.au as soon as possible if you have recently entered into formal arrangements with international researchers (since January 2021) or are considering collaborating with international researchers who are affiliated with an international government owned entity.  Ensuring all legislative compliance requirements are met will enable timely approval of your study, including execution of a contract as applicable. 

Background

• The Act is designed to ensure a consistent, national, approach to Australia’s international engagement by ensuring arrangements entered by ‘state/territory entities’ are not inconsistent with Australia’s foreign policy and do not adversely affect Australia’s foreign relations.
• The Act creates the Foreign Arrangements Scheme, and imposes new obligations on Qld which will impact ‘state/territory entities’ including departments/agencies, local governments and universities.
• Under the Act,  “state/territory entities” are required to engage with the Commonwealth Minister for Foreign Affairs prior to entering negotiations or entering new arrangements:
  • For core foreign arrangements, approval is required from the Commonwealth Minister prior to negotiation of, or entering into, the arrangement.
  • For ­non-core foreign arrangements, Qld has to notify the Commonwealth Minister of any proposals to enter an arrangement.
• The Commonwealth Minister will have discretion to authorise for the negotiation for arrangement to continue, or declare a State/Territory entity cannot enter an arrangement.
•  If the Commonwealth Minister for Foreign Affairs considers an arrangement is a risk to Australia’s foreign relations, it can be declared invalid, unenforceable or no longer in operation. This poses potential legal, reputational and fiscal risks to Qld.

Definitions

• core foreign arrangements- between an Australian State/Territory (including departments) and a foreign nation;
• non-core foreign arrangements- between a State/Territory and foreign sub-national government and any arrangements between local governments and universities and foreign entities; and
• subsidiary arrangements- agreements designed to implement a foreign arrangement (this may include commercial contracts).

Full details are available at the DFAT website https://www.foreignarrangements.gov.au/

Is there a research fee associated with ethical clearance and SSA 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 MSH, 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.

How do I make an amendment to my research project?

• Post approval - amendments, reporting and closure