Research agreements

Execution of research agreements

• Only the Metro South Health Chief Executive or their delegate (Chief Research and Innovation Officer or Director, Research Development) may execute an agreement on behalf of Metro South Health following completion of the required research governance review and approval processes.
• The Metro South Research Governance Office will coordinate execution of agreements in accordance with Metro South Health's approved financial and delegation framework.
• Agreements are executed in conjunction with the relevant Site Specific Assessment (SSA) authorisation and any other required institutional approvals.
• An agreement may be executed in any number of counterparts, including through separate electronic signature processes. All counterparts, when taken together, constitute one fully executed and legally binding agreement.
• Metro South Health uses DocuSign as its preferred method of execution for research agreements. A copy of the partially executed agreement should be uploaded to ERM for institutional execution.
• Metro South Health accepts agreements executed in counterparts and by electronic signature as valid and legally binding. The inclusion of internal Metro South Health governance documents within the Metro South Health envelope does not alter the agreement executed by the Sponsor.

Confidentiality/non-disclosure agreements (CDA)

A Confidentiality Agreement (CDA), also known as a Non-Disclosure Agreement (NDA), protects confidential information shared between parties during discussions about a potential research collaboration or study.

Metro South Health can provide a standard CDA template to support timely review and execution. To request a Metro South Health CDA template or submit a sponsor-provided CDA, contact the Metro South Research Governance Office.

Multi-institutional agreements (MIA)

The National Health and Medical Research Council (NHMRC) and Medical Research Future Fund (MRFF) funding agreements require that all collaborating institutions awarded a grant must have an MIA in place, even when no funds are to be transferred between the institutions.

MIAs can be forwarded to the Metro South Research Governance Office via MSH-RGO@health.qld.gov.au along with the Metro South Health letter of support, where applicable.

Non-clinical trial agreements

For non-clinical trials, if Metro South Health is leading the study, please request the Metro South Research Governance Office to draft the agreement with your Site Specific Assessment application. The request should be documented via a cover letter or RCASE.

If Metro South Health is not the lead site, please contact the relevant research contracts office at the sponsoring or lead organisation. Please do not submit your Site Specific Assessment (SSA) until you have made contact with the sponsoring organisation.

Non-standard research contracts or contracts containing unapproved special conditions can be submitted to Metro South Research Governance Office as early as possible for pre-review.

Approved templates

• Multi-Jurisdictional Multi-Party Non-Clinical Trial Collaborative Research Agreement
• Health Translation Queensland Research Passport Agreement

Metro South Health has a suite of other agreements that can be used by contacting the Metro South Research Governance Office.

Clinical trial agreements

Metro South Health supports the use of nationally approved standard agreements, including:

• Medicines Australia Clinical Trial Research Agreements
• MTAA Clinical Investigation Research Agreements

Using standard templates helps reduce negotiation time. Any proposed changes must be limited, included in a Special Conditions schedule, and submitted with a copy of the Statement of Purpose for National Clinical Trials Agreement Panel (NaCTA) approval as part of the Site Specific Assessment (SSA) application.

Where Special Conditions are included solely for Metro South Health, legal review is required and a separate legal review/discretionary fee may apply.

Metro South Health details required or clinical trial agreements

Please ensure that the following details are inserted into page 1 of the Clinical Trial Agreement, irrespective of the specific facilities involved in the study.

Note: No abbreviations should be used on page 1.

Study site address requirements

Please ensure that Schedule 1 lists the street address of the Metro South Health facility involved in the study, rather than the legal entity address listed on page 1 of the agreement.

Example

Indemnity requirements

Please ensure that the following details are inserted into the Standard Form of Indemnity, irrespective of the specific facilities involved in the study:

Metro South Hospital and Health Service (ABN 86 834 068 616)
Building 15, Level 3, 199 Ipswich Road
Woolloongabba QLD 4102