Contracts and agreements

This page provides advice on the following:

  • Research agreements
  • Indemnity
  • Insurance
  • Material Transfer Agreements
  • Memorandum of Understanding

 

Research agreements

Why do I need a research agreement?

The Australian Code for the Responsible Conduct of Research states that:

"Organisations involved in a joint research project should ensure that an agreement is reached with the partners on the management of the research. Such an agreement should follow the general principles of this Code, including integrity, honesty and a commitment to excellence.

The agreement should be in writing. It must cover intellectual property, confidentiality and copyright issues; sharing commercial returns, responsibility for ethics and safety clearances; and reporting to appropriate agencies. It should address the protocols to be followed by the partners when disseminating the research outcomes, and the management of primary research materials and research data.

The agreement may take various forms, including a legal contract signed by the Chief Executive Officer, an exchange of letters, or a research management plan signed by all parties, or management plans signed by appropriate representatives from all parties." (p81)

Which research agreement should I use?

The NSW, QLD, VIC and SA Health Departments (the SEBS States), together with Medicines Australia, have developed four Clinical Trial Research Agreements (CTRAs), in order to provide template agreements that are fair and reasonable for both sponsors and institutions. The current versions of the CTRAs are available below.

The CTRA to be used depends upon the type of organisation listed as the sponsor in the CTN form and the organisation providing the Medicines Australia Form of Indemnity for Clinical Trials. Therefore, if the sponsor in the CTN form is a commercial sponsor, the CTRA for Commercially Sponsored Trials is to be used, whereas if the sponsor on the CTN is a CRO, the CTRA for CROs is to be utilised, see below.

Standard Clinical Trial Research Agreements

There are four different CTRA templates available from Medicines Australia for use in clinical trials:

  • Clinical Trial Research Agreement - Medicines Australia Standard Form (e.g. sponsored by a pharmaceutical company)
  • Clinical Trial Research Agreement - CTRA: Contract Research Organisation (CRO) acting as the local sponsor (e.g. sponsored by a local CRO on behalf of a global pharmaceutical company)
  • Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies - Standard Form (also known as Collaborative Research Agreement (CRA)) (e.g. sponsored by a not for profit organisation or an academic or non-commercial institution) - note you may also need a legal agreement between the CRG members - this will details things like who signs off on behalf of the CRG, how the CRG makes decisions and how IP will be shared between CRG members
  • Clinical Trials Research Agreement - Phase 4 Clinical Trial (Medicines)

A separate research agreement is required for each site collaborating in a research project. For example, if Barwon Health is acting as Sponsor on a multi-site research project, a research agreement/collaboration is required with each participating site.

Non-standard Clinical Trials Research Agreements

The standard research agreements have been the subject of long and careful negotiation. The template CTRAs can be executed without the need for any amendments via Schedule 7 (or Schedule 4 in the case of the CRG and Phase IV templates).

Where researchers or sponsors alter standard templates or choose to use non-standard research agreements, a legal review is required, which is both costly and can cause long delays in approval times. The Research Ethics, Governance & Integrity (REGI) Unit can organise a legal review of non-standard research agreements, however the costs associated with this review (which range from $1.5K to $2.5K) will be incurred by the research team or sponsor.

Guidance for seeking amendments to the CTRAs is available from Medicines Australia.

For research involving a medical device:

For investigator initiated drug trials:

 Regional collaboration

Barwon Health has arrangements in place to provide human research ethics review for the following sites, however, for the purpose of research governance, each of the following should always be treated as a separate site:

  • South West Health Care (SWHC), Warrnambool & Camperdown - please note that SWHC, Warrnambool, has a HREC and refers some projects to Barwon Health for review (SWHC also provides ethics review for Portland District Health)
  • St John of God (SJOG), Geelong
  • Geelong Private Hospital
  • Colac Area Health

Each site is responsible for its own research governance. Researchers are required to submit a Site Specific Assessment (SSA) to each site for sign off. Signatories are as follows:

  • SWHC, Warrnambool & Camperdown - Mr Stephen O'Leary (Medical Admin Operations Manager) - Email: soleary@swhc.net.au - Ph: (03) 5563 4020
  • SJOG, Geelong - Ms Jenny Ficca (Executive Assistant) - Email: jenny.ficca@sjog.org.au - Ph: (03) 5226 1367
  • Geelong Private Hospital - Ms Janine Haigh (General Manager) - Email: janine.haigh@healthscope.com.au - Ph: (03) 5226 1691
  • Colac Area Health - Mr David Walters (Director Clinical Admin and Pharmacy) - Email: dwalters@cah.vic.gov.au - Ph: (03) 5232 5156

Please note that Barwon Health does not provide ethics or governance review for the following sites:

  • Portland District Health - Ms Christine Giles (CEO) - Email: cgiles.pdh@swarh.vic.gov.au - Ph: (03) 5521 0333
  • Western District Health Services (WDHS) - please note that ethics review for WDHS is coordinated by the SWHC HREC, and governance review is overseen by the Board of Directors - Education Centre - Ph: (03) 5551 8343

Where any of the above is participating in a research project as a separate research site, a Collaborative Research Agreement may be required where financial transactions are involved.


Indemnity

Commercially sponsored applications are usually accommpanied by an indemnity statement, an insurance certificate and a CTRA.

For all commercially sponsored trials, indemnity must be provided by the Commercial Sponsor on the standard Medicines Australia Form of Indemnity for Clinical Trials for each and every participating site. Medicines Australia also provides guidelines for compensation for injury caused by participation in clinical trials.

Note: Listing Barwon Health as a site overs all Barwon Health sites e.g. Mckellar Centre, community health centres, Barwon Health community centres, etc.


Insurance

For all commercially sponsored trials, the sponsor must hold insurance throughout the study. In Victoria, there are specific requirements regarding the level of insurance cover.

The VMIA insurance coverage for all Victorian Government Departments and Public Health Institutions and provides guidance on minimum insurance requirements. For all commercially sponsored trials, an insurance certificate must be submitted to accompany the indemnity. Please note the insurance certificate should be on an insurer's letterhead rather than on a broker's letterhead.

It is important to note that the insurance certificate must meet ALL of the following VMIA Minimum Insurance Requirements:

  1. Cover clinical trials e.g. "Public and Products Liability (or equivalent)", and include a description or title of the named trial
  2. Include as named the full, legal name of the Australian entity (not a parent or a subsidiary) acting as a sponsor
  3. Be through an insurer either approved by the Australian Prudential Regulation Authority, or a foreign insurer - all insurers are required to hold a Standard & Poor's financial rating of not less than 'A-'
  4. Be current throughout the entire period of the clinical trial, either by detailing the end date of the trial or 'until end of trial' being listed as the period of insurance
  5. Provides insurance coverage for a minimum of AU$10 million for any one occurrance and in the annual aggregate
  6. Contains an excess/deductible amount not greater than AU$25,000 for each and every claim or series of claims arising out of one original cause.

Note: If any of the above are not clear on the insurance certificate, confirmation is required from the sponsor (e.g. letter or email) that the above are true and correct.


Material Transfer Agreements

A Material Transfer Agreement (MTA) is a contract between the provider of material and the recipient. It grants the recipient a licence to use the proprietary material and ensures that both parties understand how the materials can be used. MTAs govern issues such as ownership of derivatives and modifications of the materials, the transfer of risk, limits on use, confidentiality of information in relation to the materials and rights to inventions, and research results arising out of use of the materials. Just as research sponsorship agreements and confidentiality agreements can affect the ownership and dissemination of research results, so too can MTAs.

Biological materials such as reagents, cell lines, blood and tissues, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compunds, equipment, data and scans.

If your research involves a transfer of materials or samples and does not require a CTRA or other collaboration agreement, the following agreements are required:


Memorandum of Understanding

Barwon Health has an ongoing Memorandum of Understanding (MOU) with Deakin University which acknowledges our close research relationship and the need to collaborate on research projects. This may entail the sharing of resources, staff, facilities and infrastructure.

The MOU between Deakin University and Barwon Health requires documentation of specific project details including funding arrangements, intellectual property and contribution to be made by each institution in the Annexure A of the existing MOU, which must be completed and submitted for each Barwon Health/Deakin University collaboration.

For projects that involve a collaboration with other not for profit organisations, or universities, a Collaborative Research Agreement (CRA) is required.


All research agreements must be submitted to the REGI Unit along with applications for HREC/RGO approval. REGI facilitates sign off by the appropriate Barwon Health executives.

For any questions or advice regarding research agreements, please contact the REGI Unit by phoning (03) 4215 3373 or emailing REGI@barwonhealth.org.au.  

Traditional Owners

We, Barwon Health, acknowledge the Traditional Owners of the land, the Wadawurrung people of the Kulin Nation. We pay our respects to the Elders both past and present.