Submitting new project for ethics review

Peter Mac as Sponsor 

We have implemented a review process for clinical research in which we act as the study sponsor. The sponsor of a clinical research project assumes the overall responsibility for the initiation, management (including ongoing oversight) and financing (or arranging the financing) of a study, as well as the overall scientific integrity of the data derived, and results reported. 

If we will be the sponsor of a clinical research project, you must consult the Clinical Research Development & Operations (CRDO) within the Office of Cancer Research for assistance when developing your study concept. For further information, contact the CRDO: This email address is being protected from spambots. You need JavaScript enabled to view it.. 

Note that for clinical research where we are acting as the sponsor, approval from the Clinical Research Sponsorship Committee must be submitted to our Ethics Committee along with the application for ethical review.

First Time in Human Clinical Trials 

Clinical trials that will be administering an investigational medicinal product to humans for the first time may require a First Time in Human by an expert reviewer. An expert review may be required for all or some of the following areas:  

• Medicines 
• Toxicology 
• Immunology 
• Biologicals 
• Biologicals Biodynamics & Kinetics 
• Medical Devices

To assess whether your project requires First Time in Human review, complete the FTIH Review Required Questions. This expert review must be completed before submission of the clinical trial application to the Ethics Committee. Please consult the Human Research Ethics & Governance office for advice.

Institutional Biosafety Committee 

Clinical research involving the use of genetically modified organisms (GMOs) at Peter Mac WILL require review by the Peter Mac Clinical Trials Institutional Biosafety Committee (PMCT IBC). This includes exempt dealings and new Trials already covered by a DNIR Licence issued by the Office of the Gene Technology Regulator (OGTR). To ensure your project is appropriately classified, and that it complies with all OGTR Regulations To assess whether your project requires IBC review, complete the Clinical Trials with GMOs Questionnaire and consult the OGTR Guidance on the requirements for clinical trials involving GMOs. Please note that all services provided by the PMCT IBC will incur a fee; the fee schedule can be provided on request. The PMCT IBC review for the Peter Mac site should be completed before submitting it to the Ethics Committee. For any questions regarding the IBC and for submission requirements, please contact the IBC secretary: This email address is being protected from spambots. You need JavaScript enabled to view it.

Multisite Ethical Review - Sites 

The Peter MacCallum Cancer Centre Human Research Ethics Committee (Peter Mac HREC) can provide ethical review for clinical trials and other human health and medical research projects, including low risk and negligible risk research projects, for multiple sites across Australia under the National Mutual Acceptance scheme. 

• Clinical trials that were granted approval from November 2013 onwards can add sites from across Australia. IMPORTANT NOTE: Some jurisdictions do NOT accept review under National Mutual Acceptance of First Time in Human (FTIH) and Phase 1 clinical trials. For sites in other states and territories: Please consult the research governance office at the site before submission to Peter Mac HREC. 
• All types of human health and medical research, including low and negligible risk research that were granted approval form December 2015 can add sites from across Australia. IMPORTANT NOTE: Some jurisdictions do NOT accept review under National Mutual Acceptance for research involving: Aboriginal and Torres Strait Islanders; persons in custody; access to coronial material; access to state, territory or commonwealth data collections. For sites in other states and territories: Please consult the research governance office at the site before submission to Peter Mac HREC. 

Advice on managing your ethics and governance applications, including the participating 'HRECs, RGOs and organisations' document can be found at National Mutual Acceptance. 

The Peter Mac Ethics Committee can also provide multisite ethical review for all Research Excellence (REx) partner institutions. The REx partner organisations are Austin Health; Melbourne Health; Peter Mac; Royal Children's Hospital; St Vincent's Hospital Melbourne; Florey Institute of Neuroscience and Mental Health; Murdoch Children's Research Institute; Northern Health; Royal Women's Hospital; University of Melbourne; Walter and Eliza Hall Institute; and Western Health.

Multisite Ethical Review - Investigator Responsibilities 

For multisite ethical review submissions, the Coordinating Principal Investigator (CPI) is responsible for submitting the Ethics application on behalf of all participating sites. The Ethical Approval will be issued to the Coordinating Principal Investigator and list all eligible sites included in the ethics application. Reports required for ongoing ethical monitoring of the project for all sites - for example, amendments and annual reports, must be submitted to the reviewing HREC by the CPI or project sponsor on behalf of all sites. 

Each participating site is still responsible for providing authorisation for a new project to commence at that site and for an amended project to continue at that site. The Principal Investigator (PI) at each site is responsible for submitting a governance application to the site Research Governance Office to obtain site authorisation to commence or continue. Principal Investigators will need to consult their local Research Governance Office for submission advice.

Level of Risk 

Risk is defined as a potential for harm, discomfort or inconvenience. It involves the likelihood that harm (or discomfort or inconvenience) will occur and the severity of the harm, including its consequences. The risk may be to participants and/or to others, - for example, family members, social group. Both the type of risk and the level of risk must be considered. The types of risks are well described in the National Statement on Ethical Conduct in Human Research (see Chapter 2.1, page 12). 

Research with more than a low level of risk must be reviewed by the full Ethics Committee, for example, any research involving an intervention or requiring tissue/blood samples; research that could raise difficult/sensitive issues for participants and/or others; research requiring tissue or data to be sent offsite. Research with a low level of risk, for example prospective research projects involving surveys or questionnaires and research projects using existing data collections, may be reviewed by other pathways.

All projects must submit: 

• Human Research Ethics Application (HREA). Only one signature is required; for single site submission the Principal Investigator, or for multisite submission the Coordinating Principal Investigator 
• Victorian Specific Module (VSM) (only if project has VIC site(s)) completed and signed. The form is created and submitted in ERM as a sub form of the project HREA  
• CVs (if not already submitted within the last two years): Multisite ethical review -Coordinating Principal Investigator and Principal Investigators CVs for sites included in the ethical review. Single site ethical review – Peter Mac Principal Investigator CV

Some projects may also need to submit: 

• If applying for a waiver of the requirement of consent: A justification for the waiver needs to be provided. See: Guidance Document - Waiver of Consent
• If project has WA site(s): Western Australian Specific Module (WASM) 
• If using unapproved therapeutic goods: TGA Clinical Trial Notification (CTN) or TGA Clinical Trial Application (CTA), listing each site under review. CTN is an online form. Please include a PDF/screenshot of the filled in CTN for review (Peter Mac as sponsor projects please contact Clinical Research Development & Operations to fill out a CTN form This email address is being protected from spambots. You need JavaScript enabled to view it.). Find Peter Mac contact details for use in CTNs (Clinical Trials Notification) here
• If using radiation: If radiation exposure is additional to that received as normal clinical management provide a Medical Physicist Report (contact Medical Physicist at each site) ONLY from site with highest radiation amount. If radiation exposure is part of normal clinical management/care, the site Principal Investigator should complete a HREC Radiation Notification Letter
• If Peter Mac is the sponsor of a clinical research project: Approval from the Clinical Research Sponsorship Committee
• If First Time in Human (FTIH) review was required: FTIH reviewer report(s)
• If Institutional Biosafety Committee (IBC) review for the Peter Mac site was required: Outcome of the IBC review
• If the project is commercially sponsored: HREC Only Indemnity
• If project is commercially sponsored: Copy of the Standard Indemnity for all sites

Project Documents - Interventional or Biospecimen Research 

• Protocol 
• Investigator’s Brochure, if applicable 
• Participant Information and Consent form/s Section 5 and section 8 in this link provide the required template PICFs for different types of research and different consent situations. Multisite ethical review – provide a master PICF. Single site ethical review – provide a PICF on Peter Mac letterhead 
• Other project documents - for example, questionnaire, diary, participant card, information brochures 

NOTE: The PICF is for the use of prospective participants and should be written using clear and plain language appropriate for a general audience. Some tips for writing a PICF: 

• It is simple and straightforward
• The language used is easy to understand and the writing is in conversational (lounge room) style 
• There is little or no technical jargon. Use of acronyms is minimal. If used, they are clearly explained
• The content is written in the second person (you/your)
• Sentences are structured with no more than 15 words; 7-10 words are even better. Mono-syllabic words are used in preference to poly-syllabic 

NOTE: Project documents must have a version/date inserted in the footer of all pages - for example, version X dated day month year. This provides for quick and accurate identification of the current approved documents to be used by the project team.

Project Documents - Low Risk Research 

Low risk research is defined as research in which the only foreseeable risk is one of discomfort. Negligible risk research is defined as research in which the only foreseeable risk is no more than inconvenience. 

• Protocol (template protocol suitable for a simple Low Risk project is provided if required)
• Low Risk Participant Information and Consent form (suggested template suitable for projects with ongoing participation).
  o Multisite ethical review – provide a master PICF.
  o Single site ethical review – provide a PICF on Peter Mac letterhead.
• Invitation/Introduction letters (suitable for single questionnaire/survey where consent is indicated by return of the single questionnaire/survey) 
• Questionnaires/surveys and/or other data collection tools (note: REDCap must be used for surveys)
• If applying for a waiver of the requirement of consent: A justification for the waiver needs to be provided. See: Guidance Document - Waiver of Consent

NOTE: The PICF is for the use of prospective participants and should be written using clear and plain language appropriate for a general audience. Some tips for writing a PICF: 

• It is simple and straightforward
• The language used is easy to understand and the writing is in conversational (lounge room) style
• There is little or no technical jargon. Use of acronyms is minimal. If used, they are clearly explained
• The content is written in the second person (you/your)
• Sentences are structured with no more than 15 words; 7-10 words are even better. Mono-syllabic words are used in preference to poly-syllabic

NOTE: Project documents must have a version/date inserted in the footer of all pages - for example, version X dated day month year. This provides for quick and accurate identification of the current approved documents to be used by the project team.

Submitting your Ethics Application 

• Please ensure that all required documents are completed and that the electronic files are clearly labelled
• Submit all application forms and project documents by the meeting submission deadline
• HREC Only indemnity: Please submit e-signing request

If Peter Mac is a site for your project, don't forget to also submit your governance/SSA application for the Peter Mac site (it can be submitted at any time).

Responding to Committee Queries 

The Coordinating Principal Investigator or Principal Investigator will be advised of the outcome of the review and any further queries or requirements. 

Provide a response to each point in the committee review memo - for example, provide explanation/further information; if revisions have been made in response, state what and where. Provide any revised project documents in tracked and clean format.