Submitting new project for ethics review

Peter Mac as Sponsor 

Peter Mac have implemented a review process for clinical research in which Peter Mac 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 Peter Mac will be the sponsor of a clinical research project, please consult the Clinical Research Development & Operations (CRDO) within the Office of Cancer Research for assistance when developing your study concept. CRDO are able to provide support to researchers for protocol development of an Investigator Initiated Study (IIS). For further information, please contact the CRDO: This email address is being protected from spambots. You need JavaScript enabled to view it..

Note: For clinical research where Peter Mac are acting as the sponsor, you must obtain approval from the Clinical Research Sponsorship Committee prior to submitting to our Ethics Committee. A copy of the approval letter must be included in the ethics application.

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 (FTIH) review by an expert reviewer. An expert review may be required for all or some of the following areas:  

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

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 note that NSW sites may not accept Peter MacCallum Cancer Centre review under the National Mutual Acceptance of FTIH and Phase 1 clinical trials. If your trial includes a site in NSW, please check with their Research Governance Office if they will accept Peter Mac review prior to submission.

Further information regarding early phase trials and scientific expert review can be found at Ethics Application - Clinical Trials and Research.

If your trial will be conducted by the Parkville Cancer Clinical Trials Unit (PCCTU) please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for additional information regarding the FTIH review process, timelines and required documents.

Institutional Biosafety Committee 

All projects involving a "dealing" with a Genetically Modified Organism (GMO) require approval through Peter Mac's Institutional Biosafety Committee (IBC) before work can begin. The IBC assists the organisation by advising on the identification and management of the risks associated with dealings with GMOs undertaken at Peter Mac, including the containment of GMOs, and providing an interface with the Office of the Gene Technology Regulator (OGTR).

A copy of the IBC approval must be included in the ethics application.

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. or visit the CONNECT page Institutional Biosafety Committee (IBC).

Multisite Ethical Review - Sites 

The Peter MacCallum Cancer Centre Human Research Ethics Committee (Peter Mac HREC) is certified by the National Health and Medical Research Council to review human research in oncology.

The Peter Mac HREC can provide ethical review for clinical trials and other human health and medical research projects, including lower 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 from December 2015 can add sites from across Australia. IMPORTANT NOTE: Some jurisdictions do NOT accept review under National Mutual Acceptance for research involving: Participants who identify as 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.

For review of private sites, please see: Addition of sites - ethical review - Peter MacCallum Cancer Centre.

Investigator Responsibilities 

The overall responsibility of a research project falls upon the Principal Investigator (PI)/Coordinating Principal Investigator (CPI). They are responsible for the ethics application and the conduct of a study.

Please note that investigators must:

• Be appropriately qualified and employed
• Cannot be students undertaking research projects unless they are appropriately qualified/employed
• For clinical trials: Have a current Good Clinical Practice certificate (within three years)

For training requirements for personnel involved in clinical research at the Peter Mac site, please see New Governance Application (see Investigator Training Requirements).

Single-Site Ethical Review

For single-site ethical review submissions, the PI is responsible for submitting the Ethics application. The Ethical Approval will be issued to the PI. Reports required for ongoing ethical monitoring of the project (e.g., amendments and annual reports), must be submitted to the reviewing HREC by the PI or project sponsor.

Multisite Ethical Review

For multisite ethical review submissions, the CPI is responsible for submitting the Ethics application on behalf of all participating sites. The Ethical Approval will be issued to the CPI and list all eligible sites included in the ethics application. Reports required for ongoing ethical monitoring of the project for all sites (e.g., 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 (RGO) to obtain site authorisation to commence or continue. Principal Investigators will need to consult their local RGO for submission advice.

Level of Risk 

Risk is defined as a potential for harm or discomfort. It involves the likelihood that a harm or discomfort will occur and the severity of the harm or discomfort, including its consequences. The risk may be to participants and/or to others, (eg. family members or communities). 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).

Research with more than a lower level of risk must first be reviewed by a scientific committee (Clinical Research Committee or Tissue Research Committee) followed by the full Human Research Ethics Committee. This includes 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 lower level of risk, may be reviewed via other pathways. This may include research involving:

• Use of existing data collections.
• Prospective research projects involving surveys, questionnaires or focus groups.

The Human Research Ethics and Governance (HREG) office is responsible for assessing the level of risk for a submitted project. Depending on the HREG's assessment, the project will then be triaged to the appropriate review pathway.

Case Report Advice

A case report involving a single individual is not research and does not require HREC approval. While ethics review is not required, please note that:

1. The privacy of the patient needs to be considered. Is there any possibility that a reader would be able to identify the patient based on the information presented? 
2. Explicit consent from the patient should be obtained.
3. Please ensure that you consult the instructions to authors of the intended journal(s) as they will have their own requirements for publication and obtaining consent from the individual.
4. International best practice guidelines can be found at CARE Case Report Guidelines.

However, please note that a case series requires ethics submission.

All projects must submit:

• Human Research Ethics Application (HREA). Only one signature is required; for single site submission the Principal Investigator (PI), or for multisite submission the Coordinating Principal Investigator (CPI). Please note:
  • You must list an institutional email address for correspondence – personal emails and phone numbers will not be accepted.
  • The HREA is a long form so it is recommended that you begin preparing this as early as possible.
• 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 three years):
  • Multisite ethical review - CPI and PI's CVs for sites included in the ethical review.
  • Single site ethical review – Peter Mac Principal Investigator CV.
  • Please submit CVs in the following format: "SURNAME, Forename CV DATE".
• A cover letter summarising the sites and documents being submitted for review: Example Site and Document Listing.

Some projects may also need to submit: 

• If Peter Mac is the sponsor of a clinical research project: Approval from the Clinical Research Sponsorship Committee (contact This email address is being protected from spambots. You need JavaScript enabled to view it.).
• 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.). See contact details for use in CTNs (Clinical Trials Notification).
• 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 the trial is considered First Time in Human (FTIH): An appropriate FTIH review approval. For example:
  • Scientific expert reviewer report(s).
  • IND Study May Proceed Letter issued by the FDA.
• 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. See contact details for use in Indemnities.
• If project is commercially sponsored: Copy of the Standard Indemnity for all sites. See contact details for use in Indemnities.

Project Documents - Interventional or Biospecimen Research 

• Protocol. Please note:
  • Peter Mac researchers can access templates provided on the CONNECT page Clinical Research Development Tools)
  • Where appropriate, please ensure you consult a statistician prior to submission.
  • External protocols: If the project has an existing protocol developed externally to Peter Mac, and if appropriate, please include an Australian-specific appendix with information that is specifically relavent to the sites in the application.
• Investigator’s Brochure, Summary of Product Characteristics or Product Information if applicable.
• Participant Information and Consent form/s. See contact details for use in PICFs.
  • 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 (Grade 8 reading level or below). 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 first instance they are used in the document.
• 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.
• Use clear headings and sub-headings.

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 - Lower Risk Research 

Lower risk research is defined as research in which the only foreseeable risk is one of discomfort. 

• Protocol. Please note:
  • Peter Mac researchers can access templates provided on the CONNECT page Clinical Research Development Tools.
  • Where appropriate, please ensure you consult a statistician prior to submission.
  • External protocols: If the project has an existing protocol developed externally to Peter Mac, and if appropriate, please include an Australian-specific appendix with information that is specifically relavent to the sites in the application.
• Lower Risk Participant Information and Consent form (suggested template suitable for projects with ongoing participation).
  • Multisite ethical review – provide a master PICF.
  • Single site ethical review – provide a PICF on Peter Mac letterhead (found on CONNECT).
• 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: Peter Mac projects: consult REDCap).
• 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 (Grade 8 reading level or below). 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 first instance they are used in the document.
• 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.
• Use clear headings and sub-headings.

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.
• Indemnities: Please submit e-signing request to This email address is being protected from spambots. You need JavaScript enabled to view it.. 

If Peter Mac is a site for your project, don't forget to also submit your governance/SSA application for the Peter Mac site (this 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. 

To respond:

• Please 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.
• If additional changes have been made that were not requested by the committee, please indicate what these changes are and why they have been made.
• Please provide any revised project documents in tracked and clean word document format.
• Please submit your response via ERM. To expedite review, please accompany this with an email to This email address is being protected from spambots. You need JavaScript enabled to view it..