- How do I apply to the HREC?
- Negligible Risk Research Projects
- Low Risk and More Than Low Risk Research
- Submission Requirements
- Fees
As a result of the introduction of the streamlined ethical review process for multi-site clinical trials in Victoria, the application process for ethical approval from the Peninsula Health Human Research Ethics Committee (HREC) has changed. Please read the information below carefully or contact the Research Program for assistance.
All research which involves patients, clients, residents or staff of Peninsula Health, whether undertaken by a Peninsula Health staff member or an external researcher, must be reviewed by the Peninsula Health Human Research Ethics Committee.
The HREC reviews research projects in accordance with the values and principles of research merit and integrity, justice, beneficence and respect outlined in the National Statement on Ethical Conduct in Human Research (2007).
Research involving humans at Peninsula Health must not commence until it has received approval from the HREC or notification that HREC review is not required. The level of review required for a research project is determined by the level of risk posed to participants of that project.
Risk [as defined by the National Statement (2007)] is a potential for harm, discomfort or inconvenience and involves
- The likelihood that a harm (or discomfort or inconvenience) will occur; and
- The severity of the harm, including its consequences.
There are three categories of risk
Negligible risk: where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.
Low risk: where the only foreseeable risk is one of discomfort (research in which risk for participants is more serious than discomfort is not low risk).
More than low risk: where the foreseeable risk is greater than that of discomfort.
(For more information on risk please refer to chapter 2.1 of the National Statement).
How do I apply to the HREC?
The first step in applying to the Peninsula Health HREC is to register your project with the Research Program either by telephone or via the generic mailbox researchethics@phcn.vic.gov.au. Researchers will need to provide the project title and name of the principal investigator and will need to provide invoice or cost centre details using the fee schedule form.
Negligible Risk Research and Quality Assurance (QA)
Many quality assurance (QA) activities where the primary purpose is to monitor, evaluate or improve the quality of health care delivery by a health care provider can be considered as negligible risk research.
To check if your project qualifies as a QA activity, complete the Quality Assurance Checklist.
The QA checklist along with a brief overview of your project (including planned methodology) and a copy of any questionnaires and/or assessment tools should be sent to the HREC via the Research Program.
The application will be assessed and if deemed to be negligible risk, signed by the Executive Sponsor of Research on behalf of the HREC as not requiring HREC review.
Notification of project completion should be sent to the Research Program for all quality assurance activities.
Low Risk and More Than Low Risk Research
For projects that involve risk that is more than foreseeable discomfort, full HREC review is required.
The new system for assessing research separates ethical and scientific review from research governance and there are specific forms and requirements for each of these two processes.
Cover Letter
All applications submitted must be accompanied by a cover letter from the Principal Investigator which includes the following:
- HREC Reference Number and Submission Code
- SSA Reference Number and Submission Code
- Brief statement explaining reason for conducting this research in terms of the values (research merit and integrity, justice, beneficence and respect) outlined in Section 1 of the National Statement on Ethical Conduct in Human Research (2007).
- A list of attachments.
National Ethics Application Form (NEAF)
As of 1 January 2010 all applications must be submitted using the National Ethics Application Form (NEAF) available via the Online Forms website. It is recommended that researchers access the help information for guidance on using the Online Forms website.
Ethics Checklist for Principal Investigators
Victorian Specific Module
In Victoria there is a requirement to comply with legislation relevant to human research involving information privacy (Information Privacy Act 2000), health information (Health Records Act 2001) and the use of ionising radiation (Radiation Act 2005 and Radiation Regulations 2007).
In addition, consent under certain circumstances where the Guardianship and Administration Act 1986 and the Mental Health Act 1986 apply must meet legislative requirements in Victoria.
The Victorian Specific Module must be submitted with the NEAF as a supporting document and is accessible via the Consultative Council for Human Research Ethics (CCHRE) website.
Single-site clinical trials involving drugs
The Peninsula Health Drugs and Therapeutics Committee advises the Peninsula Health HREC on the approval of applications to conduct clinical studies involving drugs on the basis of therapeutic rationale.
The HREC will not approve a single-site research proposal involving drugs until approval has been granted by the Drugs and Therapeutics Committee.
Please contact the Drugs and Therapeutics Committee Convenor on 9784 7601, or email Ben Leung or Skip Lam for further information.
Participant Information and Consent Forms (PICF)
Researchers must refer to the correct PICF template and guidelines when completing this section.
There are three PICF templates available via the Department of Health (DoH) website. The templates are as follows
- Health/Social Science Research Projects
- Clinical Non-Drug/Device Research Projects
- Clinical Drug/Device Research Projects
It is mandatory for researchers to follow the format and use the preferred language provided by DoH in each of these templates as they contain all relevant insurance requirements. Please note that other formats will be rejected.
The Participant Information and Consent Forms are to include the following:
- Identification of the institution either by the use of letterhead or institution name and logo on page 1
- Clear and simple language aimed at the reading level of a 12 year old. (It is advisable to have someone who is not a member of the research team read the PICF before submission)
- A footer containing the Version No. and Date (Any modifications made to the PICF after original submission, require an update to the Version No. and Date)
- A Peninsula Health contact person in section 11. The required wording to be used is: Convenor, Peninsula Health Human Research Ethics Committee, Telephone 9788 1473. (Variations to this will not be accepted).
Site Specific Assessment (SSA) Form
The Site Specific Assessment (SSA) Form addresses the research governance associated with research applications including resources, study budget details, site-specific policies and declarations from departments. The SSA is used for assessing the suitability of a site at which the research is to be conducted.
The SSA Form is available via the Online Forms Website. It is recommended that researchers access the help information for guidance on using the Online Forms website.
Principal Investigators are required to seek sign off any department(s) providing support or services to the research project. Please access the Checklist for Supporting Department Services if you are unsure what support or services are required.
Project Specific Documentation
A copy of all research project specific documents such as the protocol, Investigator’s Brochure, questionnaires, and surveys, tools, advertising material, research governance documentation (such as CTN/CTX, indemnity, insurance and contracts) is to be provided with the forms above.
Submission Requirements
Submission of research proposals involves both an electronic submission and a hard copy submission.
HREC Meeting and Submission Dates 2012
Electronic Submission
Researchers are required to send an email to the generic mailbox researchethics@phcn.vic.gov.au (do not send to personal mailboxes) with the following information included:
- Study title
- Name of Principal Investigator
- NEAF submission code
- SSA submission code
Researchers should ensure they have uploaded electronic copies of supporting documentation to their NEAF or SSA prior to the electronic submission to HREC. For more information on uploading electronic supporting documentation click here
The application will undergo preliminary review by the Research Program who will make recommendations regarding the final hard copy submission where required.
Hard Copy Submission
Researchers are to submit hard copies of their proposal following electronic review. Hard copies must be received by no later than 3pm on the day of the submission deadline in order to be accepted for review at the next meeting.
Please refer to the table below for submission details
| Document | Total | Type of copy |
| NEAF | 4 | 1 x single-sided NOT stapled 3 x double-sided stapled |
| Victorian Specific Module | 4 | 1 x single-sided NOT stapled 3 x double-sided stapled |
| PICF(s) | 4 | 1 x single-sided NOT stapled 3 x double-sided stapled |
| SSA Form | 1 | 1 x double-sided stapled |
| Protocol (Single-site projects) | 4 | 1 x single-sided NOT stapled 3 x double-sided stapled |
| Protocol (Multi-site projects) | 3 | 3 x double-sided stapled |
| All other attachments (ie questionnaires, advertising material) | 4 | 1 x single-sided NOT stapled 3 x double-sided stapled |
Additional documents which may be required
| Document | Total |
| Investigator Brochure | 1 |
| CTN or CTX signed by sponsor | 1 |
| Indemnity signed by sponsor | 3 |
| Copy of Insurance Certificate | 1 |
| Clinical Trial Agreement signed by sponsor | 3 |
Please note that the researcher must collate the documents prior to sending to the Research Program.
Fees
Please note that the Human Research Ethics Committee charge a fee for consideration of some research projects. Researchers should refer to the fee schedule prior to submitting a research application for review. Researchers are to provide invoicing or cost centre transfer information at the time of project registration.
