Low and Negligible Risk Research

Page Contents

Low Risk Confirmation | Application Information | Submission Requirements | Notification of Review Outcome | After Approval

Please note that this section does not apply to the following types of studies:

 

All single-site low risk research will be reviewed by the Human Research Ethics Committee (HREC). The HREC reviews all research applications which involve patients, clients, residents or staff of Peninsula Health, whether undertaken by a Peninsula Health staff member or an external researcher. 

All applications must be submitted through the Online Forms website. If you are not a current user you will need to create an account on your first visit to this site.

Negligible and low risk is described in the National Statement as:

  1. Negligible risk – where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience
  2. Low risk – where the only foreseeable risk is one of discomfort.

 The following types of projects are not considered Low Risk:

  • Qualitative research projects by a person without appropriate experience
  • Research being conducted overseas
  • Research investigating illegal activity or research that is likely to discover illegal activity
  • Research investigating issues focusing on Aboriginal or Torres Strait Islanders or the identification of any Aboriginal or Torres Strait Islanders recruited as a separate subgroup of participants
  • Research involving:
    • Collection of tissue (eg blood, urine, biopsy tissue)
    • Collection, use or disclosure of identifiable information without the consent of the individual whose information it is (including waiver of consent requests)
    • Covert observation, deception of participants or concealment of the purpose of the research
    • Human genetics
    • Human stem cells
    • Interventions or therapies including clinical and non-clinical trials and innovations
    • Patient family members
    • Radiation additional to standard care
    • Randomisation or use of a control group
    • Sensitive topics (eg death, significant illness, state of mood, depression and anxiety, sexuality, religion)
    • Vulnerable participants (eg children, those dependent on care, people with a mental illness, elderly people, pregnant women, those who are not competent

Low Risk Confirmation

Submit a protocol (templates below) to ResearchEthics@phcn.vic.gov.au

The protocol will be reviewed by the Manager Office for Research to ensure it meets the criteria for a low risk project.  You will be notified by email of the outcome of this review and the correct application forms required to complete your application. 

Protocol Templates

A Basic template Protocol is available. Refer to the broad outline of the sections expected in a protocol.

Application Information

Below is a list of the documents required for submission. Incomplete applications will not be accepted for review.

All applications must be submitted through Online forms:

  • Contain documents which have a version number and date (no draft documents will be accepted)
  • Comply with the submission instructions

ETHICS APPLICATION FORMS

  • Mandatory for all applications

HREC Coversheet

Must list all documents in this submission and be signed by the Principal Investigator

LNR VIC Application Form

Please note: Do not complete the checklist listed on the online forms website

To be completed through Australian Online Forms for Research website. First time users will need to create an account

ETHICS SUPPORTING DOCUMENTS

  • Depending on the project, some or all of these documents may be required

 

Protocol

  • mandatory for all applications

Must match the protocol submitted as part of the Low Risk Confirmation. 

Participant Information and Consent Forms (PICF)

  • Use the template appropriate for your project

 

Must use the templates available from Department of Health and Human Services. Other formats are not accepted.

Data Collection Tools including:

  • Questionnaires
  • Surveys
  • Focus group questions/themes
  • Telephone questionnaires
  • Data collection forms

This includes a printed version of online surveys and validated assessment tools.

Telephone Script Template available

Advertising / Recruitment Material

  • Letter / Email invitation
  • Posters
  • Brochures / Leaflets etc
  • Content for media (including radio, print and digital / social media)

See Advertising Guidelines

Investigator CV for each researcher (if one has not been submitted in the previous 3 years)

Investigator CV Template available

Full CV is not required

Resource Centre Declaration and Service Request Forms

Forms to be used by the service department to determine the cost of the services requested.  These are not considered as part of the research ethics review but are to be sighted as part of the application.

Submission Requirements

Click here for HREC submission deadlines and meeting dates for 2018.

Research applications will be returned if they do not comply with the submission requirements. 

A maximum of 5 new applications will be reviewed at each HREC meeting. The first 5 completed applications submitted will be accepted. An application is considered complete when it complies with the submission instructions and includes all required signatures.

Pre-Screen Submission (Due by New Study Pre-Screen Deadline)

Ensure electronic files are labelled according to the Requirements for Naming Electronic Documents.

Email completed application to ResearchEthics@phcn.vic.gov.au. Application does not need to be signed at this stage.

The application will undergo preliminary review by the Office for Research who will make recommendations regarding the final submission where required.

Final Submission (Due by Agenda Closure Deadline)

Submit electronic copy of full application (including any documents modified based on feedback from the Office for Research) via the Online Forms website.  

Electronic signatures are preferred on application forms. Scanned signatures are acceptable as long as the original signed documents can be provided on request (such as during an audit). 

Fees

Fees are not applicable for review of Low Risk applications unless the project is commercially sponsored.

Notification of Review Outcome

The outcome of the HREC review will be emailed by the Office for Research to the research application contact person within 7 days of the HREC meeting.  The outcome will detail the decision of the HREC and any modifications/amendments required before the approval to commence letter is issued. 

Research must not commence until a formal signed approval has been received.

After Approval

Researchers must comply with the monitoring and reporting requirements for approved research detailed in the approval to commence letter. 

Requirements and submission templates for post-approval changes and reporting are available from here.