All research studies must be submitted for ethical review before a study can be given approval to start.
Before starting your submission, do either of the following circumstances apply to your research project?
For first time in human phase 1 clinical trials, to be reviewed under the CTN scheme, the HREC follows the Scientific Expert Review Toolkit – Early Phase Clinical Trials developed by the Department of Health.
All first time in human clinical trial applications for submission for HREC will require the following:
- Notification by the Chief Principal Investigator via email to research@mh.org.au no less than six weeks before the advertised HREC Submission date with the following information:
- Name of Chief Principal Investigator
- Title of study
- Summary of proposed trial
- Study sponsor
- Submission of the application no less than four weeks before the advertised HREC Submission date. The application must be emailed to ethics@mh.org.au uploaded on the ERM website and a courtesy email advising of the submission to research@mh.org.au.
The RMH is able to act in the capacity of Sponsor for investigator-initiated clinical studies to meet the regulatory requirements of the Therapeutic Goods Administration (TGA) and GCP.
If you would like RMH to be Sponsor, contact the RMH Office for Research at research@mh.org.au to schedule a pre-submission sponsorship meeting.
Our office will organise a meeting time to discuss. Ideally a study synopsis or study protocol should be provided at the time of the meeting request.
Complete all sections as they apply to your ethics application
Both sections 1 and 5 are mandatory for all submissions.
Complete sections 2, 3 and/or 4 as applicable.
All components in section 1 are mandatory and must be completed for all ethics submissions.
Complete section 2 if your project involves participant-facing documents such as information and consent forms, plain language statements, transcripts and survey questions.
Complete section 3 if your project involves radiation and/or genetically modified organisms (GMOs).
Complete section 4 only if your project is a clinical trial investigating a drug and/or device.
Section 5 is mandatory and must be completed for all ethics submissions.
Tips for completing components of your application
- Before starting your application, review all of the components as you may be able to undertake items in parallel and save a lot of time
- The order of items is arbitrary
- Try to submit the Site Specific application (SSA) at the same time as the ethics application
- Request budget and departmental/service approvals as soon as possible after the protocol has been finalised to save you time preparing your SSA
- Identify if you require an agreement early in the application preparation process and start drafting
In the context of increasing study design complexity and new or revised regulatory obligations, one of the most common questions the Office receives is “What is the difference between referral, recruitment and study site?” We also get asked about other site definitions such as for a Teletrial, Decentralised or Registry study.
It’s worthwhile reading the below before preparing any submission to our Office.
The below should assist in clarifying the definitions of a site for submission purposes and contracting. In addition, this applies to submissions in general and clarifies the role of different study assessment locations for protocol writing and contracting purposes.
All studies are different. Contact the RMH Office for Research to discuss nuances to your project if needed.
Recruitment Site
A clinical service recruiting participants to a study that is being conducted at their site. The recruitment site will consent and conduct study procedures.
A governance application (Site Specific Assessment) is required at an RMH Recruitment Site.
Study Site
A study site is usually understood to mean the same as a recruitment site.
A governance application (Site Specific Assessment) is required at an RMH Study Site.
Referral Site
Referral sites are generally those which only advertise clinical studies by displaying posters/flyers in their waiting areas and clinics.
Where the protocol describes a Referral Site as that which screens its patient database for suitable potential participants for a study conducted at another location, a Principal Investigator should be nominated at the Referral Site for GCP purposes. The recruitment plan of the protocol should also include a “Letter of Referral” to be provided where patients are interested in the study. The Letter of Referral requires ethics approval.
Where the Referral Site is simply displaying posters/flyers for advertising, a governance application (Site Specific Assessment) is NOT required for that referral site.
Where a patient database is to be screened, the Office recommends contacting the Referral Site to determine their specific SSA process. If RMH is the Referral Site, contact the Office for Research to discuss what specific documentation we require.
Ethics approval for Referral Sites is a requirement. In your submission package, ensure you include:
- The study protocol with referral pathway described
- Any recruitment flyers, poster, letters or other materials to be provided to potential participants for the study.
Registry Site
A Registry Site is a clinical service site where routine clinical information is collected to be added to a Clinical Registry project.
Teletrial Site (TT)
A Teletrial Site is a clinical service conducting study assessments via Telehealth methods. The medical team involved in the trial use digital communication, such as video conferencing, to conduct the study. Teletrials are complex and may involve various locations such as home, GP Clinic and/or health service.
Ensure the Teletrial locations and applicable study responsibilities are clear in your application.
Teletrials usually have “Primary” and “Satellite” site arrangements. Ensure protocols (for ethics) and supervision plans (for SSA) are clear to streamline the review of your application.
Decentralised Trial Site (DCT)
Decentralised Trial Sites have a variety of meanings depending on the research design. Contact the Office if you want to add a DCT site to your study.
Like TTs, DCTs usually have “Primary” and “Satellite” site arrangements. Ensure protocols and supervision plans are clear.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.