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Obtaining ethics approval

Approval from a Human Research Ethics Committee (HREC) is required if your project involves research on humans. This includes questionnaires, medical record reviews and the use of databases.

The Metro South Hospital and Health Service HREC is able to review and approval research projects conducted in any of our facilities.

You should submit your application with all supporting documents both on paper to the Human Research Ethics Committee Office and via the Online Forms for Research website. The Metro South HREC and Research Governance offer a monthly Drop In Session (PDF, 182.31 KB) to provide initial overview of your submission with the provision of advice to ensure the submission package is complete and all administrative requirements are complete based on the projects requirements.

There are three types of applications based on the level of risk to participants in the study:

  • Standard risk—more than a low level of risk. Requires HREC approval.
  • Low risk—low or negligible level of risk (only discomfort or inconvenience only). Requires HREC approval.
  • Exemption from HREC Review—negligible level of risk (inconvenience only), involving the use of existing collection of data or records that contain only non-identifiable data. Currently requires ethical oversight to determine if there are any ethical implications.

Standard risk applications

Definition

A ‘standard risk’ application is, by virtue of its form and content, an activity which constitutes something more than discomfort or inconvenience for study participants. The National Statement on Ethical Conduct in Human Research (2007) defines ‘discomfort’ as a low level risk activity such as a participant having their blood pressure measured or attending a study interview (NS Chapter 2.1).  A standard, full NEAF application, may need to be submitted when the risk involved is greater than this.      

Is my study standard risk?

If any of the following activities are involved, then your study may warrant a standard, full NEAF application. If you are unsure of most appropriate application, please contact the Metro South HREC Office.

  • Risk which constitutes more than low or negligible risk (NS 2.1)
    The level of ethical review required should be commensurate with the level of risk involved.  If a research activity involves more than ‘discomfort’ (emotional, physical, spiritual and psychological), then it is a standard application and warrants a full NEAF.
  • Research that is personally instrusive or confronting or involves potentially embarrassing questions
    The study looks at and/or involves subject matters (e.g. in a survey, questionnaire or interview) that participants may be uncomfortable discussing or find distressing (e.g. anxiety, depression or sexuality).
  • Staff are participants
    Studies involving staff participation generally require a standard, full NEAF application.  This is to best ensure that the right of the participants in the workplace are protected,  and that any participation or refusal to participate does not have a negative impact on the participants’ workplace relations, both now and in the future.
  • Any of the following participants groups are specifically targeted:
    • women who are pregnant and the human foetus
    • children and young people
    • people in dependent or unequal relationships
    • people highly dependent on medical care who are unable to consent for themselves’
    • people with a cognitive impairment, an intellectual disability or a mental illness
    • people who may be involved in illegal activities or residents of custodial institutions
    • Aboriginal and Torres Strait Islander Peoples
    • people who are unable to give informed consent because of difficulties understanding an information sheet (e.g. non English speakers).
  • The study involves genetic research
    The application requires review by the full HREC.  A standard NEAF application to the HREC is required (National Statement Chapter 3.5).
  • An intervention
    The study involves an intervention to routine care (e.g. clinical trial of a device or drug, an educational intervention or an alternate treatment option)(National Statement S2.1.6).
  • Time commitment
    Participants are required to commit more than 20 minutes of their time (either in one or multiple sessions).

What should my application include?

If your study warrants a standard, full NEAF application, you will need to submit the following:

In addition, you should submit any of the following documents that are relevant to your research project:

  • any advertising or marketing material that is to be given to participants (1 original and 7 copies)
  • data collection tool(s), e.g. case report form (1 original and 7 copies)
  • master patient information sheet and consent form (PICF) (1 original and 7 copies—for multicentre studies)
  • questionnaires or other instruments (1 original and 7 copies)
  • letter of invitation / letter to GP, etc (1 original and 7 copies)
  • participant diaries (1 original and 7 copies)
  • participant wallet card (1 original and 7 copies)
  • other correspondence, e.g. FDA reviews, correspondence from other HRECs, expert independent reviews, peer reviews, etc. (1 original and 7 copies).

For research using radiological procedures that are performed specifically for research:

  • independent assessment report or verification by a medical physicist (or radiation safety officer) or the total effective dose and relevant organ doses for those radiological procedures that are performed specifically for the research protocol (1 original and 7 copies).

How to submit a standard risk application

  • You should submit your application in conjunction with an advertised HREC submission deadline. There are 11 meetings a year; see the closing dates below.
  • One original and the appropriate number of copies of your application documentation should reach the HREC office by 12 noon on the deadline date.
  • Please note, applications posted to the Metro South HREC Office on the day of the deadline, which arrive at a later date, do not meet our deadline requirements.

Ensure all supporting documents, including CVs are uploaded to the Online Forms website:

  • Submit the NEAF Qld and SSA (if applicable) via the Online Forms website to obtain a submission code. This is to obtain a submission code only.
  • Please note, submission, via the Online Forms website, does not constitute receipt of the application in the Metro South HREC Office.

Submit a hard copy of all documentation to the following address:

  • Metro South HREC
    PAH Centres for Health Research
    Level 7, Translational Research Institute
    37 Kent Street
    Woolloongabba QLD 4102

Please note, all documents must:

  • include a version number and a date in footer
  • be copied double sided and collated
  • not be bound.

Closing dates and times

You must submit all required forms and documents by 12 midday on the closing date listed below. Unfortunately we are unable to make any exceptions.

Closing date – 2017 (submit by 12pm)Meeting date – 2017
19 January7 February
16 February7 March
16 March4 April
20 April9 May
18 May6 June
15 June4 July
13 July1 August
17 August5 September
14 September3 October
19 October7 November
16 November5 December

HREC Meeting Dates Checklist 2017 (PDF, 239.6 KB)

Low or negligible risk applications

Definition

“Research is ‘low risk’ where the only foreseeable risk is one of discomfort.  Where the risk, even if unlikely is more serious than discomfort, the research is not low risk” – National Statement on Ethical Conduct in Human Research (2007) (S2.1.6)

Find out whether or not your project may be considered low or negligible risk research:

Is my study low or negligible risk?

The following table may help in deciding whether a low or negligible risk (LNR) application is appropriate for your project. If you are unsure of most appropriate application, please contact the Metro South HREC Office.

Are any of the following relevant to your study?Yes
The study involves a risk to participants, even if unlikely, that is more than discomfort.  Risks can include physical,  psychological, social, economic or legal harms or devaluation of personal worth (National Statement Chapter 2.1)

The study would not fit the definition of low risk research (National Statement S 2.1.6). A full NEAF application to the HREC is required.

Staff are participants

Studies involving staff participation are generally considered more than low risk and a full NEAF application is required.  This is to best ensure that the right of the participants in the workplace are protected, and that any participation or refusal to participate does not have a negative impact on the participants’ workplace relations, both now and in the future.

Please contact the Metro South HREC Office for advice.

Any of the following participant groups are specifically targeted:

  • Women who are pregnant and the human foetus
  • Children and young people
  • People in dependent or unequal relationships
  • People highly dependent on medical care who are unable to consent for themselves
  • People with a cognitive impairment, an intellectual disability or a mental illness
  • People who may be involved in illegal activities or residents of custodial institutions
  • Aboriginal and Torres Strait Islander Peoples
  • People who are unable to give informed consent because of difficulties understanding an information sheet (e.g. non English speakers)

It is unlikely that the study will be able to be reviewed by the Low Risk Review Panel.

Please contact the Metro South HREC Office for advice.
The study involves genetic researchThe application cannot be reviewed by the Low Risk Review Panel.  A full NEAF application to the HREC is required (National Statement Chapter 3.5).
The study involves an intervention to routine care (e.g. clinical trial of a device or drug, an educational intervention or an alternate treatment option)

It is unlikely that the study will fit the definition of low risk research (National Statement S 2.1.6).

Please contact the Metro South HREC Office for advice.
Participants are required to commit more than 20 minutes of their time (either in one or multiple sessions)Please contact the Metro South HREC Office to discuss the details of the project and whether it may be considered low risk research.
The study looks at and/or involves subject matters (e.g. in a survey, questionnaire or interview) that participants may be uncomfortable discussing or find distressing (e.g. anxiety, depression or sexuality)

The study may not fit the definition of low risk research (National Statement S 2.1.6).

Please contact the Metro South HREC Office for advice.

What should my application include?

*Please note that all documents should include version and date control in the footer.

How to submit a low or negligible risk application

Application forms

The Queensland Low or Negligible Risk (LNR) application form can be accessed through the Online Forms website.

Single or multi centre studies

For single-site studies conducted within Metro South Health facilities:

  • The completed Site Specific Assessment (SSA) must be submitted with the LNR application.  To be considered complete, the following must be included on the SSA:
    • business Manager sign-off
    • research cost centre details
    • head of department sign-off (if any investigator is the head of department, please ensure that appropriate line manager signs as head of department).

For multi-site studies:

  • The application should be booked into the Metro South HREC through the Queensland Centre Coordinating Service (CCS) who will assign an HREC reference number for the application.
  • Please ensure that the HREC reference number is included on the LNR application.
  • Submission of the SSA application for Metro South Hospital and Health Service sites is not mandatory, however it is highly encouraged.

Submitting your application

Steps to submitting a low to negligible risk application:

  • Submit the LNR Qld and SSA (if applicable) via the Online Forms website to obtain a submission code.  Please note that this is to obtain a submission code only—this will not submit your application to the Metro South HREC.
  • Submit 1 original copy* of all documentation to the following address:
    • Metro South HREC
      PAH Centres for Health Research
      Level 7, Translational Research Institute
      37 Kent Street
      Woolloongabba QLD 4102
    • Ensure all supporting documents, including CVs are uploaded against the LNR Qld form via the Online Forms website.
  • Please note, the original (hardcopy) application must be submitted as the Metro South HREC Office cannot process emailed or faxed copies.

There are no deadlines for submission of LNR studies to the Metro South HREC.

Application for exemption from full ethical review

Definition

Some projects—such as internal quality assurance or quality type activities—may be eligible for exemption from full ethical review. Projects which qualify for an exemption of HREC review are of a negligible level of risk (inconvenience only) and involve the use of existing collections of data or records that contain only non-identifiable data (National Statement on Ethical Conduct in Human Research 2007 S5.1.22).

Can my study be exempt from HREC review?

The following question may help in deciding whether an application for exemption of full HREC review is appropriate for your project. If you answer yes to any of the questions below, your project may not meet the requirements to be exempt from full HREC review.  If you are unsure of most appropriate application, please contact the Metro South HREC Office.

Will the project...

  • Be hypothesis driven?
  • Seek to gather information about the patient beyond that collected in routine care?
  • Seek to identify new knowledge?
  • Pose any risk for the staff or patient beyond those of routine practice or care?
  • Potentially breech the confidentiality of any individual/s personal information, beyond that experienced in the provision of routine care?
  • Involve the use data that is not from an existing collection of data or records that contain only non-identifiable data?
  • Be conducted by a person (or have a project team member) who does not normally have access to the health records for clinical care?
  • Involve any clinically significant departure from the routine clinical care provided?
  • Involve randomisation or the use of a control group or placebo?
  • Potentially infringe the rights, privacy or professional reputations of carers, health professional or institutions?
  • Be conducted externally to the Metro South Hospital and Health Service?
  • Involve any staff or patients external to Metro South Hospital and Health Service?
  • Be a component of a higher degree (i.e. Honours, Masters of PhD)?
  • Involve a comparison of cohorts?

How to submit an application for exemption from HREC review

An application of exemption of HREC review must include the following:

  • a completedApplication Form for Exemption of HREC Review (XLS, 655.5 KB). This form must be signed by both the applicant and the head of department.  In the case where the applicant is the head of department, the form should be signed by their line manager.
  • Any supporting documentation as required.
  • Submit 1 original copy of all documentation to the following address:
    • Metro South HREC
      PAH Centres for Health Research
      Level 7, Translational Research Institute
      37 Kent Street
      Woolloongabba QLD 4102
Last updated 24 November 2016
Last reviewed 12 March 2015

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