Low and Negligible Risk Research

Page Contents

Registration of Projects | Application Information | Submission Requirements | Notification of Review Outcome | After Approval

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

 

The Low Risk Research Subcommittee (LRRS) is a subcommittee of the HREC and reviews research applications which involve low or negligible risk to patients, clients, residents or staff of Peninsula Health, whether undertaken by a Peninsula Health staff member or an external researcher.  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.

Research in which the risk for participants is greater than discomfort is not low risk and must be reviewed by the full HREC. This includes research projects involving one or more of the following:

  • 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

 

Registration of projects

Register your project with the Office for Research  by submitting 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 LRRS review.  You will be notified by email of the outcome of this review and will be allocated a registration number.

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:

  • Include the LRRS reference number
  • 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

LNR Research Coversheet

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

LNR Application Form

To be completed in full (including the eligibility checklist) and contain all signatures.

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 project registration. See ‘Registering a project’ section above

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 all researchers  who have not previously submitted a research CV.

 

Investigator CV Template available

Full CV is not required

Submission Requirements

Submission of research applications involves both an electronic submission and a hard copy submission. Click here for LRRS submission deadlines and meeting dates for 2017.

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

Electronic Submission

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

Email completed application to ResearchEthics@phcn.vic.gov.au. Include LRRS reference number in email subject line.

Hard Copy Submission

Submit one hard copy of the completed application to the Office for Research by the submission deadline. 

Hard copy must include all relevant signatures. 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 LRRS review.  A fee may be applicable if referral to the full Human Research Ethics Committee is required.

Notification of Review Outcome

The outcome of the LRRS review will be emailed by the Office for Research to the research application contact person within 7 days of the LRRS meeting.  The outcome will detail the decision of the LRRS 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 are available from here