Ethics

RMH Sponsorship review and approval is required for studies where RMH will formally act as sponsor of the research, including:

• RMH led investigator-initiated drug and/or device clinical trials (CTN/CTA clinical trials within the scope of the Therapeutic Goods Act); or
• Large/resource intensive multi-site RMH-led research studies

Process to request formal RMH sponsorship:

1. At least six (6) weeks before the intended submission deadline date call the Office for Research on 9342 8530 to confirm whether an RMH Sponsorship Review Meeting is required for your project.
2. If a sponsorship meeting is required, our office will

• organise a meeting time
• forward sponsorship request forms to you complete and submit prior to the meeting.

3. Complete the forms and submit prior to the meeting.
4. The Principal Investigator must attend the sponsorship meeting. Other key research team members may attend the meeting if appropriate.
5. The information will be reviewed, where required additional expert advice will be obtained.
6. Decision on whether RMH will sponsor the clinical trail/study will be forwarded to the Principal Investigator and research team contact person.

This process must be completed before a trial/study application can be accepted for ethics and/or governance review.

Submit a detailed project protocol

Ensure that the protocol template is appropriate for the research to be conducted:

Researchers may elect to use one of the following protocol templates:

1. General research project protocol RMH template for investigator initiated studies
2. Qualitative project protocol RMH template for investigator initiated studies
3. Databank/Tissue bank protocol RMH template
   • Supporting documents for Databanks/Tissue banks
     • RMH Guidelines for the establishment of a Research Databank
     • RMH Databank – Biobank Ethically Defensible Plan Guideline

FAQ. Can I submit a grant application as a project protocol?

No. Abridged protocols included in a grant application, such as NHMRC ideas grants, do not usually contain the degree of detail that is required to review or conduct a research project.

Ensure the protocol includes the following information:

• Clear title
• List of authors and affiliated organisations
• A statement on ownership
• A statement of compliance (to applicable giuidelnes etc.)
• Version number and date
• A list of study sites and what aspects of the protocol that will be undertaken at those sites
• A data management plan (may be a separate document)
• A risk assessment (may be a separate document)

Include data collection tools, such as:

• Questionnaires,
• Assessment tools
• Data collection sheets

Statistical Review

With the exception of commercially sponsored clinical trials, it is expected that researchers obtain appropriate statistical input into the development of a protocol.

The purpose of obtaining statistical input is to ensure that the proposed research is well designed and the methods can answer the research question.

Statistical input should be sought during the design stage of the project and prior to the submission of the project and will assist with development of the research question(s), selection of study design, sample size calculation and statistical analysis plan.

You may wish to seek statistical support. Further information can be found here.

Human Research Ethics Application (HREA)

Applicants must complete the HREA Form for all Research projects including Low Risk Research via Ethics Review Manager (ERM).

For help, download the ERM Applicant User Guide.

Ensure the HREA has been authorised by:

• The Chief Principal Investigator (CPI) for multi-site projects
• Principal Investigators (PI) for single-site projects

Important: The RMH HREC will not accept the Low Negligible Risk (LNR) VIC form.

Help and support for use of ERM

Provide a current copy of the Principal Investigator's Curriculum Vitae (CV) if one has not been submitted in the previous 3 years and email to CVsFolder@mh.org.au by the deadline date.

For Investigators who do not have a CV handy you can complete and submit an Investigator Curriculum Vitae Form instead.

All members of the study team must have sufficient and appropriate education, training, experience and resourcing to undertake their role on the study is a common requirement of:

• NHMRC National Statement on Ethical Conduct in Human Research (2007)
• The Good Clinical Practice Guideline (2016) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) - Annotated with TGA comments
• National Clinical Trials Governance Framework (accreditation requirement for hospitals that conduct clinical trails)

Complete the Ethics Checklist.

The Coordinating Principal Investigator (multi-site projects) or the Principal Investigator (single-site project) should complete the Ethics Checklist when preparing the ethics application.

Submit applicable consent documents for ethical review in MS Word format only

Depending on the study these may include:

• Participant information and consent forms (PICF)
• Plain Language Statement (PLS)
• Opt-out information
• Transcripts for obtaining verbal consent

Participant information and consent forms (PICF)

Complete a Participant Information and Consent Form (PICF) if the study involves participants from whom you are obtaining consent.

Different templates are available on the Department of Health website. Use the template(s) that are appropriate for the type of research you are conducting.

• Download the guide for writing PICFs

Contact details for the PICFs:

Reviewing HREC approving this research and HREC Executive Officer details

For Royal Melbourne Hospital site complaints

Complaints contact person at RMH

Recruitment Tips

Download a guide to Essential considerations for recruiting people into your research study.

Where radiation (including pre-MRI safety screening examinations) is not additional to standard care

For RMH sites: If radiation exposure (including pre-MRI safety screening examinations) in a research project is not additional to standard clinical management/care, an independent assessment report by the RMH Medical Physicist must be included in the ethics application.

For non-RMH sites: If radiation exposure (including pre-MRI safety screening examinations) in a research project is not additional to standard clinical management/care at the site, the site Principal Investigator must provide a confirmation letter. The letter should be based on the template - available on the Department of Health Clinical Trials and Research website - and must be included in the ethics application submitted to the reviewing HREC.

Where radiation (including pre-MRI safety screening examinations) is additional to standard care

If radiation exposure (including pre-MRI safety screening examinations) in a research project is additional to standard clinical management/care, an independent assessment report by a Medical Physicist must be included in the ethics application (one report for each applicable site).

Special Consideration

Where the procedures in which exposure to ionising radiation are considered to be additional to standard care at some sites and standard care at other sites and/or the exposure dose is markedly different from site to site, the Coordinating Principal Investigator must investigate this difference with the respective site Principal Investigators and complete and submit the “Ionising Radiation Variation Form part A”. The Coordinating Principal Investigator must provide the reason for the variation and his/her opinion as to whether the differences are reasonable and acceptable.

Where the Research Protocol allows the Principal Investigator at each site to choose the modality of the investigations eg: CT scan or MRI; Echocardiogram or MUGA, CT scan or plain X-ray, the Coordinating Principal Investigator must complete the “Ionising Radiation Variation form Part B” for all sites where the ionising radiation modality is the chosen procedure and provide the rationale for this decision and his/her opinion as to whether this is reasonable and acceptable.

More information

Find out more about ethical review of research projects involving ionising radiation.

Submit the following documents

Investigator's brochure (IB) - if conducting a drug, biologicals or device clinical trial, submit one copy of the IB.

Data Safety Monitoring Board (DSMB) or other safety monitoring processes- For randomised controlled trials, the protocol or ethics application should enable the HREC to determine the following:

• If a DSMB is to be convened, what its main role and function will be and provide (or confirm if it is provided in the protocol or other documents):
  • The DSMB is constituted and functions in line with the NHMRC Data Safety Monitoring Boards (DSMBs) guidance
  • Provide the Terms of reference
  • List of DSMB members, role and affiliations
• If a DSMB is not to be convened, confirm the alternative mechanism for monitoring trial safety and whether this is justified given the nature of the trial (refer to Section 10 of NHMRC Data Safety Monitoring Boards (DSMBs) guidance)
• That appropriate (risk‑based) processes for monitoring trial safety and data integrity are planned.

Note: if the DSMB has not been established by the submission of the HREC application please confirm this in the cover letter and provide the information in the research governance application.

For drug trials

For multi-site commercially sponsored clinical trials - visit the Medicines Australia (MA) Clinical Trials website to complete and submit the MA HREC Review Only Medicines Australia Form of Indemnity for Clinical Trials.

For device trials

For multi-site commercially sponsored clinical trials - visit the Medical Technology Association of Australia (MTAA) website to complete and submit MTAA Standard Indemnity Form for HREC review only.

RMH information for Indemnity forms

For all indemnities given by sponsors to RMH, please complete the “To” or (“the Indemnified Party”) section on page one as follows:

Submission is a two-step process

Each project needs to be submitted by Email and via ERM by 11:00 AM on the deadline day.

1. Open the following email template and attach all the application documents:
   HRECSubmissions@mh.org.au. If you do not receive email confirmation that the Office for Research has received your ethics submission, contact the Office for Research directly on (03) 9342 8530 to confirm receipt.

and

2. Upload all the application documents onto ERM and ensure you hit "submit";

Final checks when submitting your documents

Ensure that the following advice is adhered to:

• PICF is submitted in MSWord format and not in PDF;
• Submission must include CPI/PI authorisation using any one of three options below:
  • scanned copies of the original wet ink signatures; or
  • HREA digital authorisation function via ERM; or
  • an email from the CPI or PI, that references the Local HREC project number in the email, authorising the submission
• Use the file name convention outlined below for each document - this will allow HREC members to identify documents more easily.

File name convention

As shown in example below, include the following: [Local HREC Project Number] [EMR number] [Document Type] Version [Version Number] [Date]

Examples:

• 2020.999 RMH11111 Protocol Version 1 29082020
• 2020.999 RMH11111 PICF Version 3 30092020
• 2020.999 RMH11111 HREA Version 1 22102020

Projects submitted that do not follow these formats will be returned via email to sender and may not be considered for the meeting if not returned in correct format before the 11:00 AM deadline.

Criteria for Review at the next HREC meeting

Submission of a new research project must be received by the 11am deadline however this does not a guarantee that a project will be accepted for review by the HREC at its next meeting.

Following the submission deadline each month, all projects received will be carefully checked to ensure that projects meet the criteria required to allow a thorough review of the project. Projects not meeting these criteria in full will not be accepted for review and will be returned to the principal researcher for attention.