Clinical research governance

Last date for submission of new applications: Friday, 6 December 2024.
Recommence application submissions: Monday, 20 January 2025.

Learn about our approval process and timelines

All research conducted at MQ Health premises and involving MQ Health patients or staff must have clinical research governance (CRG) authorisation before commencing.

The CRG process at MQ Health applies to research that:

is to be conducted at any MQ Health site (Macquarie University Hospital, MQ Health clinics and/or faculty PC2 laboratories), and
involves direct interaction with human participants at MQ Health and/or use of patient samples and/or data.

Clarifying scope

Desktop research concerning MQ Health but not requiring access to MQ Health patients, staff or facilities is exempt.

Research carried out at health facilities that are not part of MQ Health are subject to that facility’s authorisation arrangements; such research is exempt from MQ Health governance review.

Note: CRG authorisation is a separate process from an ethics review. The ethics review is conducted by the Macquarie University Human Research Ethics Committee (HREC) or a relevant University ethics sub-committee. Learn more about human research ethics.

About the process

Clinical research governance review at MQ Health is a two-step process to provide a responsive and supportive approach to institutional governance. See below for more details.

Process and purpose

The MQ Health governance review and approval process comprises two stages:

governance endorsement after feasibility assessment
final governance authorisation after required approvals are in place.

Our two-stage process helps with early identification of any issues with proposed clinical research, including clinical trials, to enable our investigators to conduct high-quality research.

It also ensures:

the research team has the capacity, capability and financial resources (eg funding, approval to use hospital and other resources, relevant expertise and sufficient participant pool) to carry out the proposed clinical research
the proposed clinical research is in line with the MQ Health strategic priorities
the MQ Health executive team is aware of and supports the proposed clinical research
relevant approvals are in place before research begins.

Governance considerations and timeline

The CRG process at MQ Health will:

assess the feasibility of the proposed clinical research project
consider the resource implications for MQ Health
identify and manage any unusual insurance or other risk(s)
ensure relevant sign-offs are in place to meet institutional obligations.

The MQ Health Clinical Research Executive (CRE) assesses the feasibility and quality of proposed clinical research projects and their alignment with the MQ Health strategic priorities. The expertise of the CRE includes the following areas:

academic
clinical
clinical trials
research practice
management.

Timelines: Depending on the quality of the project, and the time taken by the Principal Investigator to respond to any requested clarifications and to any feedback, the governance endorsement and final authorisation (excluding the time for obtaining other approvals such as ethics approval, contract execution, etc) should take between 5–12 working days. It might take longer if the project is complex, hasn't been adequately planned and/or has significant legal, insurance or resource implications.

Indemnity and insurance

For insurance purposes, the critical point is the nature of Macquarie University's involvement in 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 at clinical.research@mqhealth.org.au, and they will liaise with the MQ insurance if necessary.

Amendments after governance authorisation

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

However, please notify us 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.

Planning your clinical project

There are four project types, each requiring a slightly different governance process. Use the questions, resources and guidelines below, to determine the nature of your project.

Question 1

Is it research or not?

Download and use the decision support tool to assess whether the proposed project is:

research or
a clinical audit, quality assurance, surgical innovation activity or a new surgical procedure.

Research or clinical audit

A clinical audit is a way of finding out whether health professionals are doing what they should be doing in terms of following guidelines and using best practice.

Key differences between research and a clinical audit include:

Research	A clinical audit
creates new knowledge about what works and what is best practice	tells us if we are following current best practice
can involve patients trying an untested treatment method	never involves patients trying new treatment methods
may involve a degree of experimentation on patients	never involves anything happening to the patient that is different from their normal treatment
may involve allocating patients to different treatment groups	never involves allocating patients to different treatment groups
results are generalisable	results are applicable within local settings only
involving staff, patients, their tissue or data and requires approval by a human ethics committee (HREC).	rarely requires ethics approval.

Question 2

If it is research, is it a clinical trial?

Download and use the flowchart to determine whether the project is:

a clinical trial or
another type of clinical research.

Question 3

If it is a trial, is it fully sponsored or not?

A fully sponsored trial will have an external organisation that:

develops the protocol
covers all trials costs
insures Macquarie as a trial site and indemnifies the investigators and trial team.

Fully sponsored trials at MQ Health should run through our Clinical Trials Unit.

If you remain unclear as to the precise nature of your project, please contact the clinical research manager.

Project-specific processes

Having determined the type of project, select the appropriate process explanation and documents below.