Low and Negligible Risk Research

 

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

 

Important information for researchers 

As from 16 July 2018 the Ethics and Governance database and submission process has changed.  All applications and post approval documents will need to be created and submitted through the newly released Ethics Review Manager (ERM) Database for approval.  ERM replaces Online Forms.

New Applications

Instead of using Online Forms you will need to create and submit through ERM.  If you already have an Online Forms login and password it will transfer to ERM.  If your Online Forms login and password does not work, contact Helpdesk@infonetica.net

If you have not previously used Online Forms you will need to register in ERM.

The instructions on our website will be updated to reflect these changes.  

Where do I find ERM?

https://au.forms.ethicalreviewmanager.com/

The staff from the Office for Research will be able to assist you.  Call Kim Sherry on 9784 2680 to make a time to call in or email Kim, KimSherry@phcn.vic.gov.au with your questions.

 

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 ERM Applications 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 HREC@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.

Show Content

 

Application Information

All applications must be submitted through ERM Applications.

Guidance for completing your application through ERM is available from here

A list of documents required for submission is available from here.  Please note this document also contains details of the documentation required for post-approval submissions.

 

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 

Submit completed application via ERM Applications by the New Study Pre-Screen Deadline.  This will allow time for the Office for Research to undertake a preliminary review of the application.  Recommendations regarding the final submission will be made where required.

Final Submission 

If there have been any modifications to the application after the Pre-Screen Submission, the revised application (including any documents modified based on feedback from the Office for Research) will need to be re-submitted via ERM Applications by the Agenda Closure Deadline .  

ERM’s electronic signature process is to be used for all required signatures, including Head of Department and Heads of Supporting Departments.

 

Fees

Fees are not applicable for review of Low Risk applications unless the project is commercially sponsored. Please ensure you are aware of any applicable fees and payment requirements prior to submitting. 

 

Notification of Review Outcome

The outcome of the HREC review will be sent via ERM by the Office for Research 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 for post-approval changes and reporting are available from here.