Governance for clinical research

Step 1: Determination of the nature of the project

• You should assess whether the proposed project is a research or an audit, quality assurance, or surgical innovation activity, by using the decision support tool.
• If you determine that the project is an quality assurance, clinical audit and innovation activities or new surgical procedures, you need to apply for approval by the Clinical Innovation and Audit Committee (CIAC).
• If you determine the project is research, please complete a Clinical Research Governance application form and clinical research project synopsis or full research protocol and submit to clinical.research@mqhealth.org.au.
• For research, a further decision is required to determine whether the project is clinical research or a clinical trial. You might find the decision support flowchart (clinical research vs clinical trial) helpful at this point.
• If you are unclear as to the precise nature of your project, please contact the Clinical Research Manager via email clinical.research@mqhealth.org.au or phone: +61 2 9850 2834.

Preparation of documents for clinical research governance review

• Please refer to the detailed guidelines for CRG application form and associated documentation. To organise appointment with the Clinical Research Manager for assistance or advice, please send an email to clinical.research@mqhealth.org.au or call +61 2 9850 2834.
• Please note if you require services from Macquarie Medical Imaging (MMI), it is likely that it will incur a fee. For example, if you are requesting imaging data for a retrospective study, MMI has recently introduced a fee for this service. Please contact the Chief Research Facilitator for MMI via mmi.research@mqhealth.org.au to obtain a quote prior to commencing your application.

Step 2: Initial MQ Health governance endorsement

Clinical Research Manager and Clinical Research Executive undertake feasibility assessment and provide initial governance endorsement after complete submission

The purpose of the feasibility assessment is to:

• determine whether the research team has the capacity and capability (including hospital and other resources, expertise and participant pool) to carry out a specific clinical research within a given budget;
• assess whether the proposed research project is in line with the MQ Health strategic priorities; and
• ensure that the MQ Health Executive team is aware of and supports the proposed clinical research.

How does it work?

Upon receipt of all governance documents from you, the Clinical Research Manager will pre-review and determine the level of MQ Health governance endorsement required, which depends on the level of risk of the project. If any clarifications are required, the Clinical Research Manager will contact you for further details.

After a review by the Clinical Research Executive, a governance endorsement letter will be sent to you by the Clinical Research Manager, specifying the conditions of the governance endorsement.

Timeline: 5-10 working days after complete submission

Note: The MQ Health governance assessment and endorsement confirm MQ Health's support of the project, but are not the final authorisation to start the project.

Upon receipt of the governance endorsement letter you must proceed to Step 3 and seek relevant approvals specified in the letter.

Step 3: Ethics, insurance, contracts and service provider approvals

Following the governance endorsement letter from MQ Health, you prepare and submit documents for ethics review, as well as any other required documents (eg research agreements, service providers’ approvals, etc.)

Ethics review

• All applications must be submitted via the Human Research Ethics Management System - FoRA. For more information about this system, how to submit new applications and the management of existing applications, please refer to the Human Research Ethics Management support page.
• Applicants from the Faculty of Medicine and Health Sciences, or who are conducting data linkage research; clinical trials (this includes research using randomised trials or interventional studies; medical and health research; or the use of human specimens), must complete the HREA form built in the Macquarie University Human Research Ethics Management System - FoRA.

If you have any questions you can contact the MQ Ethics Secretariat at ethics.secretariat@mq.edu.au

Research agreement/contract review and execution

Any research-related contracts and agreements with external organisations must be submitted to the University’s Research Policy and Contracts Team (RPCT) to ensure they are acceptable to both you and the University. Where appropriate, contract negotiation and/or drafting may be referred to the Office of General Counsel by RPCT. Part of the role of RPCT is to ensure contracts comply with the University's Code for the Responsible Conduct of Research and other University policies.

NB: Only the Deputy Vice-Chancellor (Research) or his delegate is authorised to sign research contracts or agreements on behalf of Macquarie University.

A Research Contract:

• Describes the expectation and requirements of each party
• Ensures those involved know what is expected from them
• Is a written ‘expression’ of what has been discussed and agreed
• Protects interests of researchers
• Protects the University’s interest
• Protects collaborator/funder requirements

Detailed information about the process, the timeframes for funded and non-funded research agreements and key contacts can be found on the RPCT webpage.

If you have any questions related to research agreements/contracts, please contact the Research Policy and Contracts Team at researchcontracts@mq.edu.au.

To discuss a research agreement for FMHHS and MQ Health, please contact Dr Brenton Hamdorf (brenton.hamdorf@mq.edu.au).

Indemnity and insurance

For insurance purposes, the critical point is what the Macquarie University involvement in the research is, rather than the person who is conducting the research.

Current clinical trial insurance is a “no fault” insurance with a broad coverage of human research. All clinical research involving human participants (not only clinical trials) is covered under the policy. This includes projects using patient health data and observational studies.

The insurances vary depending on the University involvement in the research.

• For Macquarie University sponsored research, the clinical trial will be insured after obtaining ethics approval from Macquarie University HREC.
• For Commercially sponsored studies– the sponsor must hold appropriate clinical trial insurance policy coverage. NSW Health has published a Policy Directive which require commercial sponsored trials to maintain a limit of liability of no less than $20 million for any one occurrence in the aggregate and maximum $25,000 retention.

If you have any insurance related questions for investigator-initiated clinical trial and other clinical research study, you should contact the Clinical Research Manager, who will liaise with the MQ insurance if necessary.

Service provider approvals

• The governance endorsement letter will specify what approvals need to be obtained. This could be from the MQ Health pharmacy, Macquarie Medical Imaging (MMI), pathology, or the Faculty of Medicine, Health and Health Sciences PC2 laboratory.
• Once approval is received, please email the evidence to the Clinical Research team at clinical.research@mqhealth.org.au.

Timeline: Depending on the complexity of your project, you should allow at least 20-25 working days for obtaining the required approvals.

Step 4: Final governance authorisation

The Clinical Research Executive or MQ Health Executive provides final governance authorisation, so that the project may commence. The Clinical Research Manager will issue the final MQ Health governance authorisation letter when the following is in place:

• Final MQ HREC approval;
• Confirmation of executed research agreement/contract;
• Evidence of required service providers’ approvals (if applicable);
• Any other condition stipulated in the initial governance endorsement is met.

Timeline: 1-2 working days

Step 5: Post Final Authorisation (amendment if required)

An amendment request for CRE review after the final governance authorisation generally is not required.

A notification will be required if there is a significant change in the resources or expenses required to conduct the clinical research and clinical trials.

For example:

• Extra hospital beds or clinical space are required.
• Considerable increase in the number of participants to be recruited at MQ Health.
• Expenses not covered by the sponsor that need to be absorbed by MQ Health.

For further information or clarification please contact the MQ Health Clinical Research Manager.