Governance and regulatory documents

Research Agreements

There are a number of regulatory documents that are required as part of a research project, research including agreements, insurance and indemnities. Should you require any further clarification regarding when these documents are required, or appropriate signatories, please refer to the Regulatory documents process map or the CRDO website for more information. 

Why do I need a research agreement?

A formal research agreement is a requirement of the Australian Code for the Responsible Conduct of Research (2007). It states:

"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."

Which research agreement should be used?

There are a number of different styles of agreements. The agreement you need to use depends on:

  • the type of research you are conducting
  • who (if anyone) is funding it; and
  • the nature of the collaboration.

On this page you'll find links to a number of standard research agreements and instructions on which agreement should be used in which situations. Only one agreement is required for each research collaboration i.e. there is no need to use a Clinical Trial Research Agreement (CTRA) and a Material Transfer Agreement (MTA) as the issues covered in the MTA will be covered by the larger, broader CTRA.

If you choose to use a non-standard agreement, or are engaged by a third party who wishes to use a non-standard agreement, legal review will be required. Research Ethics & Governance (REG) can organise this on your behalf by liaising with the legal counsels for MCRI and/or RCH. However, it is strongly recommended that you use a standard agreement.

Who are the entities listed on the agreement?

The RCH and MCRI have a legal agreement that makes MCRI responsible for all clinical trials on campus. As the custodians of research, all agreements should list MCRI as the contracting party (Institution); and if recruitment is being done through the RCH, RCH should be listed as the site (Schedule 1). As such, the following information should be used:

  • Name of Institution: Murdoch Childrens Research Institute
  • Address: The Royal Children’s Hospital, 50 Flemington Road, Parkville VIC 3052
  • ABN: 21 006 566 972

NOTE:

  • If you think your agreement should be with The Royal Children's Hospital alone (and not MCRI) please contact the office to discuss this further. 
  • For Clinical Trial support we encourage all staff to liaise with the MCTC who can assist with trial set-up, budgeting, protocol development and submission etc. 
  • A final contract is not required for submission to REG, please submit a draft in the first instance.
  • MCRI legal ultimately signs off on all CTRAs (once received by REG); please liaise with MCRI legal for issues and advice on non-standard contracts.

Research Agreement Templates

Commercially Sponsored Research

All clinical trials that are commercially sponsored must use the standard research agreements from Medicines Australia:

Collaborative Groups

All clinical trials run by collaborative groups must use the following standard research agreement from Medicines Australia:

Medical Devices

For Medical Device research from Medical Technology Association of Australia: 

Investigator-Initiated clinical trials

Investigator initiated clinical trials

NHMRC funded research

NHMRC grant funded research that involves collaboration between two or more sites must have a Multi-Institutional Agreement (MIA) in place. The MIA is an NHMRC template agreement that details how the NHMRC funds will flow to the parties over the funding period and include details on who the Administering Institution is, intellectual property ownership, publication rights, insurance and indemnity obligations etc.  Please contact the MCRI Grants Office for more information about MIA's and NHMRC grant funded research. 

Other research

For clinical, public health and non-clinical research projects that:

  1. are not funded by NHMRC
  2. are funded from various sources, including partial NHMRC funding or in-kind support
  3. involve complex arrangements around intellectual property ownership. In this case the MCRI Research collaboration agreement should be used. 

This type of research should be conducted under MCRI, and researchers should hold an MCRI appointment – please contact MCRI HR for more information. All agreements must be reviewed by MCRI Legal before being sent on to your research collaborators. These agreements must be signed by James Dromey, MCRI Chief Operating Officer and MCRI Legal. REG will arrange signatures on the researchers behalf. 

The MACH Group Research Collaboration Agreement template is intended to be used for individual research collaborations between two or more MACH (Melbourne Academic Centre for Health) Group parties from time to time. This template Research Collaboration Agreement assumes that there is no particular lead or co-ordinating party in respect of any research collaboration for which it is used.  It accommodates the parties making “Materials” available for research collaborations and for small to medium amounts of funds to be expended by the parties.  However, where more complex collaborations are proposed, especially those involving IP commercialisation, or head funding agreement terms and conditions, a more detailed and tailored collaboration agreement will likely be more appropriate and the parties should involve their respective legal advisers to assist. Please refer to the MACH Guidelines for further information. 

Material Transfer Agreements (MTA)

RCH Material Transfer Agreement (for use when RCH is the owner/custodian of the material/data). As per the RCH delegation of authority manual, Head of Departments can sign MTAs on behalf of RCH. Please note: If the PI is the Head of Department they must obtain sign off from whom they report to (i.e Executive Director). Otherwise the PI will need to obtain their Head of Department signature. 

MCRI have two MTA agreement templates:

As per the MCRI delegation of authority manual, MCRI MTA's require written approval from MCRI legal. The official signatory is Phoebe Macleod, Head of Legal..

Confidentiality Agreements (CDAs)

MCRI Confidentiality Agreements

For further information regarding MCRI CDAs please visit the MCRI Legal website

Indemnity

For all commercially sponsored clinical trials conducted at MCRI and/or RCH, the adapted Medicines Australia Standard Form of Indemnity (MCRI/RCH Standard Wording) must be used. This form has been adapted to reflect that MCRI is now the contracting party of the campus - not RCH.

When the RCH HREC is providing ethical approval for a commercially sponsored trial to be conducted at other site(s), Form of Indemnity – HREC Review only is required for each of the other sites. This indemnity should be provided by the commercial sponsor.

RCH HREC may also require Form of Indemnity – HREC Review only to be provided by a private hospital, if reviewing research on their behalf.     

Insurance

For all commercially sponsored trials an Insurance Certificate must be submitted to accompany the Indemnity. Please note the Insurance Certificate should be on 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:

  • Cover clinical trials e.g. "Public and Products Liability (or equivalent)", and include a description or title of the named trial. 
  • Include as a named insured the full, legal name of the Australian entity (not a parent or a subsidiary) acting as a sponsor. 
  • 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-’. 
  •  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. 
  •  Provides insurance coverage for a minimum of AUS$10 million for any one occurrence and in the annual aggregate. 
  •  Contains an excess/deductible amount not greater than AUS$25,000 for each and every claim or series of claims arising out of one original cause.**

  **Please 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.

eCTN 

Clinical Trial Notifications (CTN) should now be completed and submitted electronically to the Therapeutic Goods Administration (TGA) by the trial sponsor. For additional information about eCTN forms, please click here.

  • For MCRI led investigator-initiated clinical trials where the sponsor is MCRI, please contact MCTC that a CTN is required and they will liaise with you regarding the information you need to provide. 
  • For clinical trials sponsored by external groups, please advise the sponsor that the site details can be found here.