In this section
Your research project may require regulatory documents such as agreements, insurance and indemnities. For more information see the Regulatory documents process map or the CRDO website .
A formal research agreement is a requirement of the Australian
Code for the Responsible Conduct of Research (2007). It states:
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.
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.
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."
The research agreement that you need to use depends on:
On this page you will find links to a number of standard research agreements and instructions on
which one to use. You only need one agreement for each research collaboration. For example, you do not need to use both a
Clinical Trial Research Agreement (CTRA) and a Material Transfer Agreement
If you choose to use a non-standard agreement, or are engaged by
a third party who wishes to use a non-standard agreement, you will need a legal
review. Our office can
organise this on your behalf by liaising with the legal counsels for MCRI
and/or RCH. However, we strongly recommend that you use a
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). If you are recruiting through the RCH, you should list the RCH as the site (Schedule 1). You should include the following information:
Other issues to consider:
Commercially Sponsored Research
If your clinical trial is commercially sponsored you must use the standard research
agreements from Medicines Australia:
If your clinical trial is run by
collaborative groups you must use the Clinical Trial Research Agreement - Collaborative or
Cooperative Research Group (CRG) Studies agreement.
If you are conducting medical
device research from Medical
Technology Association of Australia you can use the Clinical Research Investigation Agreement (CIRA).
Investigator-Initiated clinical trials
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.
You should use an MCRI Research collaboration agreement for clinical, public health and non-clinical research projects that:
This type of research should be conducted under MCRI, and researchers should hold an MCRI appointment. Please contact MCRI HR for more information. You must ensure that your agreements have been reviewed by MCRI legal before you provide them to your research
collaborators. These agreements must be signed by the MCRI
Chief Operating Officer and MCRI Legal. We will arrange the signatures on your
You should use the MACH Group Research Collaboration Agreement template
for individual research collaborations between two or
more MACH (Melbourne Academic Centre for Health) Group parties. This template assumes that there is no particular lead or
coordinating party in the research collaboration. 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, it is likely that you will need a more
detailed and tailored collaboration agreement. All parties should involve their respective legal advisers to assist with this. Please refer to the MACH Guidelines for further information.
An MTA is required when there is a transfer of data or samples between two parties/organisations.
RCH have two MTA templates:
As per the RCH delegation of authority manual, Head of Departments can sign MTAs on behalf of RCH, i.e. the PI will need to obtain their HoD
signature. If the PI is the HoD they must obtain sign off from whom they
report to, for example, the Executive Director. The other organisation will
also have to sign. When data is being received by RCH, the person sending the
material, i.e. the “Supplier Investigator”, needs to sign also.
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 the Head of Legal.
*Please note, if a Research
Collaboration Agreement is already in place then a Material Transfer Agreement
is not required provided the agreement covers material transfer.
If you intend to share MCRI confidential information with an external organisation and/or receive an external organisation’s confidential information, you should enter into a confidentiality agreement (otherwise known as a confidential disclosure agreement (CDA) or non-disclosure agreement (NDA)). Confidentiality agreements are particularly important if you are dealing with industry.Confidentiality agreements are usually quick and easy to set up and have signed. PI/CI’s are not authorised to sign confidentiality agreements, they must be signed by the Commercialisation and Legal Office.MCRI has four types of confidentiality agreement templates. The one-way templates should be used if it is just MCRI disclosing confidential information, the mutual templates should be used if both parties intend to disclose confidential information. If you have already received a confidentiality agreement, please send it to the Commercialisation and Legal Office for review.
To view the MCRI CDA templates and access more information, see the MCRI Legal website.
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 sites, use the Form of
Indemnity – HREC Review only 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.
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.
important to note that the insurance certificate must meet ALL of
the following VMIA Minimum Insurance Requirements:
If the above information is not clear on the Insurance Certificate,
you will require written confirmation from the sponsor that the information is true and correct.
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.
The Royal Children’s Hospital Research Ethics & Governance (RCH REG) Office) support and promote the use of electronic signatures when executing clinical trial governance-related documents including:
PLEASE NOTE: copies of all clinical trial research agreements and indemnities require review from the Research Ethics & Governance office prior to the request to the relevant signatory. Please email the document to email@example.com with the HREC application number and state for review prior to requesting signatures. A reply will include whom the electronic signature request should be emailed directly to.