FAQs and Definitions
Frequently asked questions
What is MQ Health?
The Macquarie University’s Health Sciences Centre (MQ Health) encompasses the Faculty of Medicine and Health Sciences, Macquarie University Hospital and Macquarie University Clinical Associates.
What is the difference between ethics approval and clinical research governance authorisation?
Clinical research governance authorisation is a separate process from an ethics review and approval.
Ethics approval is granted by a fully constituted Human Research Ethics Committee (HREC). Ethics approval is required for all research involving human participants.
The clinical research governance review at MQ Health focuses on assessment of the clinical research projects feasibility, the resource implications and on ensuring the relevant sign-offs are in place.
Note: At MQ Health, the clinical research governance is a two-step process. Initial governance endorsement, confirming MQ Health support of the project, should be obtained before ethics submission. After receipt of all relevant approvals, the final governance authorisation is granted by the MQ Health Clinical Research Executive, or MQ Health Executive and the research can start.
How does the MQ Health clinical research governance process work?
Stage 1: Initial MQ Health governance endorsement – before ethics submission to HREC;
Stage 2: Final governance authorisation – after relevant services approvals are in place.
Do I need to go through the clinical research governance process?
It depends on the nature of your project. If you are proposing a clinical research project where Macquarie University hospital, clinics or FMHS PC2 laboratory staff, resources or patients will be used, you will be required to go through the governance review and authorisation process before commencing your research. Desktop research concerning MQ Health, but NOT requiring access to MQ patients, staff or facilities is exempt.
I have an existing research project. Do I need to go through the clinical research governance process?
No. If you have an existing research project, you don’t need to apply for clinical research governance authorisation. Only new studies need to go through the process.
What documents do I need to submit for governance endorsement?
For the purposes of feasibility and governance endorsement, you need to submit: MQ Health Clinical Research Governance Application form and project synopsis or full research protocol (if already prepared) including itemised study budget.
Detailed guidelines on completion of the Clinical Research Governance Application form and associated documentation, including decision support tools are available on the webpage Governance for clinical research and investigator-initiated clinical trials.
What is the clinical research governance review fee?
From 2 January 2019, all commercially sponsored clinical trials (full sponsorship) submitted for MQ Health clinical research governance review, will incur a fee of $2000 (incl. GST).
Investigator initiated clinical trials and other clinical research projects will be reviewed free of charge.
How long would it take me to complete the forms?
The Clinical Research Governance application form is very short (18 questions) and the project synopsis template is only 2 pages. If you have all the information, it shouldn’t take you long to complete the forms.
Clinical Innovation and Audit Committee (CIAC)
The CIAC was established to provide organisational oversight of quality assurance activities, audits, surgical innovations and new interventions, including devices to be introduced to Macquarie University Hospital (MUH) and to ensure those are reviewed and supported by evidence of safety, effectiveness and financial governance.
If you determine that your project is an audit, quality assurance, innovation, or new intervention, you need to apply for approval by CIAC. Please complete a CIAC application form, research synopsis and other supporting documents and submit electronically to email@example.com
I have ethics approval from the MQ HREC. Can I start recruitment and data collection at the Macquarie University site before the execution of the collaborative research agreement with the other participating sites?
No. The project cannot commence until you receive final MQ Health governance authorisation, which requires MQ HREC approval, completion of necessary contracts and/or agreements (eg CTRAs or research funding agreements) and meeting any other condition stipulated in the initial governance endorsement.
The general rule is that all approvals and contracts should be in place before the start of the research, for all research, clinical or otherwise.
To ensure contracts or agreements are executed in a timely manner, we and Macquarie Research Services recommend that your Pure application for any industry-sourced funding for the project should be submitted at least six weeks before proposed commencement date of the project. For projects that will be supported by grant applications, of course, the Pure applications will need to be submitted much earlier than that, to fit with the funding body’s timelines for application, peer review and post-award processes. Typical timelines from application to award for most funding bodies range from six to nine months.
I have governance authorisation for my project, but there are some changes to the protocol. Do I need to apply for an amendment to my governance approval?
If the changes to the protocol include any resource implications for MQ Health, eg hospital resources, staff time, use of clinics or laboratories, or increased insurance risk, Yes, you will need to notify the Clinical Research Manager at firstname.lastname@example.org.
If the protocol changes don’t have any resource implications or increased insurance risk for MQ Health, you will just need to submit an amendment to the HREC.
Do I need to register my clinical trial in a clinical trial registry and when?
Yes. Prospective trial registration is an ethical obligation (see The Declaration of Helsinki, clause 35), and is increasingly required by medical journal editors as a precondition of publication.
Your study should be registered if it meets the WHO/ICMJE 2008 definition of a clinical trial. That is, any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes.
The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online registry of clinical trials being undertaken in Australia, New Zealand and elsewhere, available at http://www.anzctr.org.au. For more information about clinical trial registration, please click here: http://www.anzctr.org.au/Faq.aspx
Clinical trials should be registered prior to the enrolment of the first participant. The ANZCTR recommends commencing the registration process at least 3 weeks prior to the anticipated recruitment start date.
If you are unsure if registration is required, please contact the ANZCTR at email@example.com
ClinicalTrials.gov is a US site listing clinical trials in the US and in other countries, including Australia.
Who do I contact if I have any questions about MQ Health Clinical Research Governance?
Any questions related to the MQ Health Clinical Research Governance process, should be directed to the Clinical Research Manager firstname.lastname@example.org or +61 2 9850 2834.
Research is creative and systematic work undertaken in order to increase the stock of knowledge – including knowledge of humankind, culture and society – and to devise new applications of available knowledge.
For an activity to be a Research & Development activity it must satisfy five core criteria:
- To be aimed at new findings (novel);
- To be based on original, not obvious, concepts and hypotheses (creative);
- To be uncertain about the final outcomes (uncertain);
- To be planned and budgeted (systemic); and
- To lead to results that could be possibly reproduced (transferable and/or reproducible).
(Ref. 2017 Higher Education Research Data Collection Specifications for the collection of 2016 data)
Clinical research includes a wide range of matters, such as disease prevention and causation, diagnostic methods, treatments, and effects of and response to illness. Such research can occur in a number of settings, including public and private hospitals and clinics, other institutions or organisations, community settings, and general or specialist medical practices (Ref. Chapter 3.3 National Statement).
Clinical trial is a form of human research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. A clinical trial can involve testing a drug, a surgical procedure, other therapeutic procedures and devices, a preventive procedure, or a diagnostic device or procedure (Ref. Chapter 3.3 National Statement).
Audit or Quality assurance (QA) activity
Activity aiming at identifying and/or quantifying, what is currently being done (or not done), the extent of a problem, practice or behaviour to gain knowledge that may then be used to improve a service or practice.
Innovative surgical procedure
An innovative surgical procedure (technique or device) is any procedure that meets one or more of the following criteria: The technique/ device used is new or differs from the standard technique in one or more of the following ways: altogether new, new to anatomical location, or new to patient group.
Investigator-initiated clinical trial
Investigator-initiated (non-commercially sponsored) clinical trial has the following characteristics:
- The clinical trial addresses relevant clinical questions and not industry needs;
- The principal investigator or the hospital or institution is the primary author and custodian of the clinical trial protocol;
- A pharmaceutical/device company is not acting as the sponsor for the purposes of the CTN application;
- A pharmaceutical/device company is not fully funding the conduct of the study, that is, making payment to the relevant hospital or investigator (Ref. Sponsor Responsibilities in Investigator Initiated Studies).
Clinical trial sponsor
Sponsor is an individual, company, institution, or organisation that takes responsibility for the initiation, management, and/or financing of a clinical trial.
Clinical research governance framework
A clinical research governance framework takes into account good research culture and practice; organisational strategy; role definition and accountabilities; project risk; resource and financial assessment and management, compliance with legal, regulatory and contractual requirements; competencies and training of personnel; scientific review; ethical review and approval; site authorisation; monitoring of research; and management of conflicts of interest, complaints and allegations of research misconduct (Ref: The Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance, NHMRC, September 2016.
Research Governance is a process used by an organisation for the oversight, assessment, authorisation and monitoring of research conducted at one or more of its sites or under its auspices.
Feasibility assessment is a process to determine whether a clinical trial (or clinical research) site has the capacity and capability, including resources, expertise and participant pool to carry out a specific clinical trial (or clinical research).
Site Authorisation is a determination by an organisation that a research project satisfies organisational requirements and may commence at the site/s over which it exercises its authority. Site authorisation is the outcome of the site assessment process (Ref. Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance).
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected (Ref. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments).
References and resources
- National Statement on Ethical Conduct in Human Research, 2007 (last updated July 2018)
- Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (V2.3 September 2016)
- Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (2000)
- Sponsor Responsibilities in Investigator Initiated Studies, Standard Operating Procedure, Office of Health and Medical Research, Queensland Health
- 2017 Higher Education Research Data Collection Specifications for the collection of 2016 data (March 2017)
- Indemnity and insurance arrangements for clinical trials in Australia