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Research Governance and Ethics

Governance and regulatory documents

  • Regulatory documents and Legal Review

    Your research project may require regulatory documents听such as听agreements, insurance and indemnities. For more information see the 听or the .

    Submission pathways

    • RCH (The Royal Children鈥檚 Hospital):
      All contracts must be submitted through the
      If you require a short discussion with a Lawyer, we can book a . Please ensure you discuss and seek advice from your manager first before attending.听
      Please refer to the for more information
    • MCRI (Murdoch Children鈥檚 Research Institute):
      All contracts and legal requests must be submitted through the .听
      MCRI Legal offer Legal Drop In sessions and these can be booked through the 听 听 听
      Please refer to the for more information.

    Support before submission

    If your contract is not straightforward, we recommend booking a drop-in session with the relevant legal office before submitting. These sessions can help clarify requirements early and avoid delays.


    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?

    The research agreement that听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 will听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 (MTA).

    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.听However, we strongly recommend 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). If you are recruiting through the RCH, you should list the RCH as the site (Schedule 1).听You should听include the following information:

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

    Other issues to consider:

    • If you think your agreement should be with the RCH alone, and not MCRI, please contact the office to discuss this.听
    • We encourage you to contact the MCTC for clinical trial support. They can assist with trial set-up, budgeting, protocol development and submission and so on.听
    • Please include a draft contract with your initial ethics submission. You do not need to include听a final contract in the first instance.
    • MCRI legal ultimately signs off on all CTRAs once received by our office. Please liaise with for issues and advice on non-standard contracts.

    Research agreement templates

    Commercially Sponsored Research

    If your clinical trial is听commercially sponsored you听must use the standard research agreements from听:

    • 听

    Collaborative Groups

    If your clinical trial is听run by collaborative groups you must use the Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies听agreement.

    Medical Devices

    If you are conducting medical device research from听Medical Technology Association of Australia听you can use the听.

    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.听 Please contact the MCRI Grants Office for more information about MIA's and NHMRC grant funded research.听

    Other research

    You should use an听 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.

    This type of research should be conducted under MCRI, and researchers should hold an MCRI appointment. Please contact听听for more information.听You听must ensure that your听agreements have been reviewed by MCRI legal before听you provide them to your听research collaborators. These agreements must be signed by the MCRI Chief Operating Officer and MCRI Legal.听We will听arrange the signatures on your behalf.听

    You should use the听 template for individual research collaborations between two or more MACH (Melbourne Academic Centre for Health) Group parties.听This template assumes that there is no particular lead or coordinating party in the research collaboration. It accommodates the parties making听'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 for further information.听

    Material Transfer Agreements (MTA)

    An MTA is required when there is a transfer of data or samples between two parties/organisations.听

    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.听If the PI is the HoD they must obtain sign off from whom they report to, for example, the听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 鈥淪upplier Investigator鈥, 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 . The official signatory is听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.

    Confidentiality Agreements (CDAs)

    If you intend to share MCRI confidential information with an external organisation and/or receive an external organisation鈥檚 confidential information, you should enter into a confidentiality agreement (otherwise known as a confidential disclosure agreement (CDA) or non-disclosure agreement (NDA)).听 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鈥檚 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.听 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.听 If you have already received a confidentiality agreement, please refer to the 听for review.

    To view the MCRI CDA templates and access more information, see the .听

    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)听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听 for each of the other sites. This indemnity should be provided by the commercial sponsor.听

    • Name of Institution:听The Royal Children鈥檚 Hospital
    • Address:听 50 Flemington Road, Parkville VIC 3052, Australia
    • ABN: 35 655 720 546

    RCH HREC may also require to be provided by a private hospital, if reviewing research on their behalf. 听听听听

    Insurance

    For all commercially sponsored trials an听Insurance Certificate听must be submitted to accompany the Indemnity. Please note the Insurance Certificate should be on Insurer's听letterhead rather than on a broker's letterhead. 听

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

    • Cover clinical trials e.g.听"Public and Products Liability (or equivalent)", and include a description or title of the named trial.听
    • Include as a named insured the full, legal name of the Australian entity (not a parent or a subsidiary) acting as a sponsor.听
    • Be听through an insurer either approved by the Australian Prudential Regulation Authority, or a foreign insurer. All insurers are required to hold a Standard & Poor鈥檚 financial rating of not less than 鈥楢-鈥.听
    • 听Be current throughout the entire period of the clinical trial either by detailing the end date of the trial or 鈥榰ntil end of trial鈥 being listed as the period of insurance.听
    • 听Provides insurance coverage for a minimum of AUS$10 million for any one occurrence and in the annual aggregate.听
    • 听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.

    If the above information is not clear on the Insurance Certificate, you will require written confirmation from the sponsor that the听information is听true and correct.

    eCTN听

    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听

    • For MCRI led investigator-initiated clinical trials where the sponsor is MCRI, please contact ( via email - mctc@mcri.edu.au) that a CTN is required and they will liaise with you regarding the information you need to provide.听
    • For clinical trials sponsored by external groups, please advise the sponsor that the site details can be found here.听


    Electronic Signatures

    The Royal Children鈥檚 Hospital Research Ethics & Governance (RCH REG) Office)听support and promote the use of electronic signatures when executing clinical trial governance-related documents听including:

    • HREC and Governance Applications
    • Clinical trial research agreements
    • Clinical trial indemnities

    PLEASE NOTE:听copies of all RCH 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 rch.ethics@rch.org.au 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.听


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