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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 level of risk (only discomfort or inconvenience only). Requires HREC approval.
  • Negligible risk—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 Human Research Ethics Application (HREA) 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 HREA 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, psychological, etc), then it is a standard application and warrants a full HREA.
  • Research that is personally intrusive 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 HREA 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 HREA 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 30 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:

  • the HREC submission and checklist form (XLS, 655 KB) (1 original and 4 copies). NB: A listing of all participating sites involved is required.
  • the Human Research Ethics Application (1 original and 4 copies)
  • your study’s research protocol (this is the formal design or specific plan for the research. When revisions occur during the course of the research you will need to submit a revised protocol as an amendment)
  • participant information sheets and consent forms (if applicable) (1 original and 4 copies)
  • Therapeutic Goods Administration registration (1 original)
  • indemnity arrangements. For industry sponsored studies, Medicines Australia form of indemnity may be required if the HREC is not located at a participating site (3 signed originals)
  • curriculum vitae (CV) of researchers who have not submitted a CV within the past two years (1 original and 4 copies).

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 4 copies)
  • data collection tool(s), e.g. case report form (1 original and 4 copies)
  • master patient information sheet and consent form (PICF) (1 original and 4 copies—for multicentre studies)
  • questionnaires or other instruments (1 original and 4 copies)
  • letter of invitation / letter to GP, etc (1 original and 4 copies)
  • participant diaries (1 original and 4 copies)
  • participant wallet card (1 original and 4 copies)
  • other correspondence, e.g. FDA reviews, correspondence from other HRECs, expert independent reviews, peer reviews, etc. (1 original and 4 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 12.00 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 and will not be progressed.

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

  • Submit the HREA 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 12.00 noon 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 September10 October
19 October7 November
16 November5 December

HREC Meeting Dates Checklist 2017 (PDF, 239.6 KB)

Low 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 for the low risk review pathway:

Is my study appropriate for the low risk review pathway?

To submit your HREA through the low risk review pathway please reference the following table. This may help in deciding whether your project is a low  risk activity. If you are unsure of the most appropriate review pathway, 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). The standard risk review pathway should be undertaken.

Staff are participants

Studies involving staff participation are generally considered more than low risk and the standard risk review pathway 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 standard risk pathway 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 provide 1 hard copy of each of the following:

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

How to submit a low risk application

Application forms

The Human Research Ethics 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 HREA application.
  • Submission of the SSA application for Metro South Hospital and Health Service sites is not mandatory.

Submitting your application

Steps to submitting through the low risk review pathway:

  • Submit the HREA 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 HREA 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 negligible risk projects

Definition

Some projects—such as internal quality assurance or negligible risk activities—may be eligible for a negligible risk review pathway. Projects which qualify for this review pathway 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 follow the negligible risk review pathway?

The following question may help in deciding whether a negligible risk application is appropriate for your project. If you answer yes to any of the questions below, your project may not meet the requirements for this review pathway.  If you are unsure of most appropriate application, please contact the Metro South HREC Office.

Will the project...

  • involve a direct approach to patients and staff (except anonymous surveys)?
  • involve consent to be sought?
  • have identifying information being collected?
  • be personally or culturally sensitive (e.g sexual assault, child abuse)?
  • involve data or analysis from an activity being used for a secondary purpose?
  • render any individuals (or groups) disadvantaged as a result of participation?
  • include information which could have ethical, legal or commercial implications?
  • negatively impact on the confidentiality of participants in publications arising from the activity?

How to submit a Negligible Risk Form

A negligible risk application must include the following:

  • a completed Negligible Risk Form (PDF, 80.51 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 6 November 2017
Last reviewed 12 March 2015

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