Barwon Health Research - Research Agreements, Insurance and Indemnity

Research Agreements, Insurance and Indemnity

Do I need an agreement, or an indemnity or insurance?

Check the BH Agreements Guide to see if an Agreement, or an indemnity or insurance is needed for your project, then read on below for more information:

Agreements

Agreements are needed for every project except when the only site is Barwon Health and all investigators are Barwon Health employees.

The lead site or sponsor usually provides the agreement (and indemnity and insurance if needed).

Agreements are used to define the roles and obligations of each party to a research study, cover potential liability arising from the conduct of the study and set out insurance requirements. In order to manage the risk associated with legal liability that may arise from the conduct of research, and to avoid assuming any liability the organisation would not otherwise be responsible for, Barwon Health uses standard agreements which include clauses on liability and insurance and may require examples of the indemnity and insurance to be inserted into the Agreement.

The most commonly used Agreements are:

Insurance

If needed, minimum requirements for insurance are:

Products/Public liability not less than $10 million per claim and in the annual aggregate.
Professional indemnity not less than $10 million per claim and in the annual aggregate.
Deductible or Self Insured Retention must be less than $25,000.

Indemnity

If needed, an indemnity is a statement by one party to compensate the other party for loss or damage suffered by the other party during agreed works.

Preferred Agreement and Indemnity Templates

Barwon Health has a number of preferred agreement templates available for use. These ensure your and Barwon Health’s interests are protected in conducting research.

Barwon Health Details for Agreements

Institution Name: Barwon Health
ABN: 45 877 249 165
Address: Ryrie Street Geelong VIC 3220
Contact: Director of Research
Email for notices: [email protected]
Signatory: RDU will organise CMO or delegate sign off

Payment details for Barwon Health

Bank: NAB, 49 Malop Street, Geelong 3220
BSB: 083 646
Acc: 515 794 188
SWIFT: NATAAU3303M

Templates for Collaborative and Investigator-Initiated Research

Medicines Australia Templates for Clinical Trials with a Trial Drug

The following Medicines Australia templates are accepted by Barwon Health. These are templates used for clinical trials involving a drug/investigational product.

https://www.medicinesaustralia.com.au/policy/clinical-trials/clinical-trial-research-agreements/

Can I change the templates?

The template can be changed however this voids the legal approval and it becomes a non-standard agreement. It will need to be submitted for legal review.

Please email [email protected] and we will advise regarding the legal review at the sponsor’s cost.

For changes to CTRAs, please see ‘Guidance for seeking amendments to the Clinical Trial Research Agreements’.

Template (click to download)	When to use the template
Standard Clinical Trial Research Agreement	Barwon Health is conducting a study at Barwon Health and the commercial sponsor is providing funds to cover the cost of conducting the study. The company making the experimental drug has an Australian office and Barwon Health are entering into an agreement with the sponsor directly.
Clinical Trial Research Agreement – Contract Research Organisation acting as the Local Sponsor	Barwon Health is conducting a study at Barwon Health and the commercial sponsor is providing funds to cover the cost of conducting the study. The company making the experimental drug does not have an Australian office and is contracting a local Contract Research Organisation to act as the local sponsor. Barwon Health are entering into an agreement with the Contract Research Organisation.
Clinical Trial Research Agreement – Collaborative or Cooperative Research Group Studies	Barwon Health is conducting a study at Barwon Health and the study is being run through a collaborative group such as the Australian and New Zealand Breast Cancer Trials Group. The insurance and indemnity arrangements will vary. In most circumstances, these will be treated as investigator driven and fall under the insurance policy of the Victorian Managed Insurance Authority.
HREC Review Only Form of Indemnity	Barwon Health has reviewed a study for another organisation and the commercial sponsor is providing indemnity to Barwon Health for HREC Review Only.
Standard Form of Indemnity	Barwon Health is conducting a study at Barwon Health and the commercial sponsor agrees to provide indemnity to Barwon Health if a claim is made against Barwon Health.
Clinical Trial Research Agreement – Phase IV Clinical Trials	Barwon Health is conducting a study at Barwon Health and the commercial sponsor is providing funds to cover the cost of conducting the study. The company conducting the study has an Australian office and Barwon Health are entering into an agreement with the sponsor directly. The difference between this and the standard template is the wording in section 8. In the standard template, ‘investigational product’ whereas in this template ‘Study Product’.
Clinical Trial Research Agreement – Phase IV Clinical Trials – Contract Research Organisation acting as the Local Sponsor	Barwon Health is conducting a study at Barwon Health and the commercial sponsor is providing funds to cover the cost of conducting the study. The company conducting the study does not have an Australian office and is contracting a local Contract Research Organisation to act as the local sponsor. Barwon Health are entering into an agreement with the Contract Research Organisation.

Medical Technology Association of Australia Templates for Projects with a Device

Last Modified: Wednesday, 13 March 2024

Template (click to download)	When to use the template
Annexure A	An investigator initiated study that involves Deakin University and Barwon Health
CTRA for Investigator Initiated Company Supported Studies	An investigator initiated study that involves support from a commercial company. The commercial company may be providing study drug and or funds to support the research.
Material Transfer Agreement	When data/samples are being transferred from one institution to another institution.
Research Collaboration Agreement Template	A study involving researchers at another institution which is not Deakin, Monash or Melbourne Universities.
Monash Partners Collaborative Group Template	A study involving researchers at Monash Partners (Monash Health, Alfred Health, Eastern Health, Peninsula Health, Epworth, Cabrini, Monash University, Baker IDI, Hudson Institute) for collaborative driven studies.
MACH Group Research Collaboration Agreement Template	A study involving researchers at MACH Group (Austin Health, Bionics Institute, Eye and Ear Hospital, WEHI, RCH, MCRI, RMH, Florey, Peter Mac, Uni Melbourne, NARI, St Vincent’s Hospital, RMH, RWH, Western Health, Northern Health) for collaborative driven studies.
Multi-Institutional Agreement for NHMRC Funding	This is the template used by the NHMRC when providing funding to multiple institutions for a collaborative research study.

Template	When to use the template
HREC Review Only Form of Indemnity	Barwon Health has reviewed a study for another organisation and the commercial sponsor is providing indemnity to Barwon Health for HREC Review Only.
Standard Indemnity Form for a clinical investigation	Barwon Health is conducting a study at Barwon Health and the commercial sponsor agrees to provide indemnity to Barwon Health if a claim is made against Barwon Health.
Standard Clinical Investigation Research Agreement	Barwon Health is conducting a study at Barwon Health and the commercial sponsor is providing funds to cover the cost of conducting the study. The company making the experimental device has an Australian office and Barwon Health are entering into an agreement with the sponsor directly.

Research Agreements and Fees