Level of risk

If you are initiating a research project it is important to firstly identify the level of risk to participants during the initiation and planning phase. A risk is a potential for harm, discomfort or inconvenience (discussed below). It involves:

• the likelihood that a harm (or discomfort or inconvenience) will occur
• the severity of the harm, including its consequences.

The Metro South Health Human Research Ethics Committee (HREC) Office is responsible for conducting an assessment of risk for research projects by:

• identifying any risks
• gauging their probability and severity
• assessing the extent to which they can be minimised
• determining whether they are justified by the potential benefits of the research
• determining how they can be managed.

Negligible Risk

Some research projects, such as negligible risk research type activities, may be eligible for a negligible risk review pathway. Research 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) ('National Statement') paragraph 5.1.22).

Low Risk

In keeping with the National Statement Chapter 2.1 low risk research projects involving research in which:

• the only foreseeable risk is one of discomfort; or
• there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience.

Such research must therefore not present any more than what could be considered a low risk and/or burden to participants.  Risks to participants include not only physical risks, but also research that may cause psychological, spiritual, social, economic and legal harms or distress or devaluation of personal worth National Statement on Ethical Conduct in Human Research (2007) Chapter 2.1).  Burdens may include research that involves lengthy time commitments, is intrusive, and causes discomfort, inconvenience or embarrassment for the participants.

More than Low Risk (Standard Risk)

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

Please see the Ethical and Scientific Review of Human Research Procedure (PDF, 413.65 KB) for more information regarding the ethical and scientific review process regarding:

• Negligible Risk
• Low Risk
• More than Low Risk (Standard Risk)

Requirements for the ethical review of negligible risk and low risk research are explained in the National Statement paragraphs 5.1.18- 5.1.21.

Why is this important?

Understanding the allocated level of risk for your research project is important because it will determine which documents and forms that you need to complete and collate as part of the ethical clearance and research governance authorisation process. It also determines the length of time that will be required to receive both ethical clearance and research governance authorisation. The below diagram describes the type of HREC and research governance review required in reference to the allocated level of risk.

It is recommended that researchers contact the Metro South Health HREC Office to seek assistance in determining the correct level of risk for the research project at initiation. This is vitally important because it will assist you in determining your research project design and planning requirements. If you have any questions about a research question, project or activity, including if you are unsure if your work requires ethical review and clearance, please contact the Metro South Health HREC Office and/or Metro South Health Research Governance Office.

Read more about the ethical clearance process for Negligible Risk, Low Risk and More than Low Risk (Standard Risk) applications.

Conflicts of Interest (COI)

During the initiation and planning phase any (perceived or actual) Conflicts of Interest (COI) including unresolved personal, professional, or financial matters, must be identified and managed. In research COI may include a convergence between the individual interests of a person and their professional or other (such as personal, commercial or other professional) responsibilities, such that an independent observer might reasonably conclude that the professional actions of that person are unduly influenced by their own interests.

A COI may compromise the research process itself and/or the institutional processes governing research, and may lead researchers or institutions to base decisions about the research on factors outside research requirements. Such compromises could undermine community trust in research. Information for managing perceived and actual COI involving Metro South Health, researchers and the Metro South Health Human Research Ethics Committee (HREC) members or advisors are included in the following procedures:

• Management of Conflict of Interest - Policy (staff intranet link)
• Management of Conflict of Interest - Procedure (staff intranet link)
• Research Complaints and Misconduct Procedure (PDF, 481.46 KB)
• Research Integrity Procedure (PDF, 268.87 KB)

Research Protocol

The preparation of a Research Protocol is mandatory for Low Risk and More than Low Risk (Standard Risk) research projects. The Metro South Health ECF1 Research Protocol Template attached to  Ethical and Scientific Review of Human Research Procedure (PDF, 413.65 KB) may be utilised however it is important to note that not all fields are required.

Clinicians and researchers are encouraged to contact the Metro South Health HREC Office to determine the most appropriate template to use when preparing a research protocol.  Please note if your research project is considered Negligible Risk you do not require a research protocol. Read more about Negligible Risk research projects.

Recruitment and Participant Information and Consent Form (PICF)

There are firm guidelines around the way potential participants may be approached, as well as the format and content of participant information. The informed consent process places the onus on the researcher to ensure participation is entirely voluntary and participants are well informed of their rights and responsibilities. Please see the Ethical and Scientific Review of Human Research Procedure (PDF, 413.65 KB) for more information regarding recruitment and informed consent requirements.

An appropriate Participant Information and Consent Form (PICF) and other associated supporting documents relevant to the recruitment of participants for the research project must also be developed (if required).

The Metro South Health HREC Office recommends the use of the National Health and Medical Research Council (NHMRC) endorsed standardised PICFs templates and who also provides extensive information about informed consent on their National PICF ABC website.

**Please note the NHMRC standardised standardised PICFs templates templates are mandatory in some states in Australia. If your research project is multi-centre please consider using these templates**

Researchers may also refer to the  Biospecimen Ethics and Participant Information and Consent Form Procedure (PDF, 344.61 KB) for more information if utilising biospecimens as part of their research.

Data requirements

If the research question requires access to data consider planning the following:

• plan the type of research data
• plan the methodology
• plan the sampling: sample size and population
• plan data analysis techniques
• identify data required for analyse to meet outcomes

Data is available from the following sources:

• AUSLAB access - email Laboratory Information Systems
• Forensic AUSLAB data - email the Forensics and Scientific Services (FSS) Human Research Ethics Committee (HREC)
• Database of Research Activity (DORA) – search for Queensland Health human research studies

Data is also available directly from Queensland Health departments and Hospital and Health Services. It is important to note that when researchers require access to data, approval is required from the data custodian delegate. Requests for data must be approved by the data custodian prior to release (a fee for provision may be applicable).

View a list of Queensland Health and Hospital and Health Services data custodians. If the data custodian list is not up to date please contact us for assistance.

Depending on the research project, Public Health Act 2005 (Qld) approval is required where confidential patient medical information is to be obtained without consent. Please contact the relevant data custodian (as listed above) and complete and submit the Public Health Act 2005 – Application and Information for Researchers Form.

Researchers must ensure when Public Health Act 2005 (Qld) approval is received it is immediately forwarded to the Metro South Health Research Governance Office in accordance with the research governance authorisation process.

Metro South Health data

Researchers who require data from Metro South Health data custodians—Directors of Health Information Management Services (HIMS)—are required to seek approval to access relevant data.

HIMS contacts

Metro South Health researchers also have access to the Metro South Health Data Hub.

Additional ethical and scientific review requirements

The ethical review of research, as defined by the NHMRC, provides guidelines on ethical considerations that must be addressed when preparing research materials and documents for the ethical and scientific review of research.  Please see  Specific Human and Animal Ethical and Scientific Review Requirements Procedure (PDF, 219.59 KB) for more information. This includes research pertaining to:

• gene technologies and related therapies
• ionising radiation
• use of approved and unapproved medicines and medical devices
• access to coronial material for research purposes
• research involving adults with impaired capacity to consent
• research that may affect the health and wellbeing of Aboriginal people and communities
• research Involving persons in custody and/or employees of Department of Justice and Attorney-General
• research requiring access to state-wide data collections
• clinical trials with persons unable to provide consent
• use of animals **see note below**

Please note:

• Aboriginal and Torres Strait Islander Research requires additional consideration around cultural implications and engagement of community juries - for instance Inala Indigenous Services has a Research Jury and a letter of support must be provided.
• Metro South Health does not administer an Animal Ethics Committee (AEC) or provide information on the use of animals in research

Researchers are encouraged to contact the Metro South Health HREC Office and Metro South Health Research Governance Office when determining relevant ethical and scientific review requirements for the ethical clearance and research governance authorisation of research.

Other supporting documents and forms

As part ethical clearance and research governance authorisation of research processes other supporting documents may be required. Some these include:

• ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form
• RGF1Research Contracts Approval and Study Execution Form (Application and Submission Form)
• Therapeutic Goods Administration (TGA) Clinical Trial Exemption Form (CTX) or Clinical Trial Notification Form (CTN)
• Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Radiation Risk Assessment
• Risk Versus Benefit Letter
• Quotes and Approvals
• Invoicing Details
• Health Support Queensland (HSQ) Pathology or Coronial Material Approval
• Public Health Act 2005 – Application and Information for Researchers Form
• Indemnity arrangements (for industry sponsored studies, Medicines Australia form of indemnity may be required if the HREC is not located at a participating site)
• Curriculum Vitae (CV) of researchers who have not submitted a CV within the past two (2) years
• Any advertising or marketing material that is to be given to participants
• Data collection tool(s)—(eg case report form)
• Questionnaires or other instruments
• Letter of invitation/letter to GP etc
• Participant diaries
• Participant wallet card
• Other correspondence—(eg Food and Drug Administration (FDA) reviews, correspondence from other Human Research Ethics Committees (HRECs), expert independent reviews, peer reviews, etc)
• Aboriginal and Torres Strait Islander Research Jury Support Letter

View our Quick links, tools, forms and templates page to access information relevant to the above supporting documents.

Researchers are encouraged to contact the Metro South HREC Office and Metro South Health Research Governance Office when identifying and determining relevant requirements for supporting documents and forms.

Master file

It is also recommended that a master file is created to assist you in maintaining and monitoring all of your essential research project documentation. If you would like guidance in creating a master file please contact the Metro South Health Research Monitoring Office for more information.

Please note that PowerTrials has a document management component within the Protocol Office Manager application.

Version control

Metro South Health recommends that you have a discussion with your research team early on and agree to a consistent format for version control. This small preparation can save you many hours of searching through emails and having multiple phone conversations to ensure everyone is reviewing the most recent version of documents and that the correct versions of each document is being submitted for ethical clearance. It can also assist if/when your research project goes through the on-site monitoring process.

If you have no experience with this or no preferred system of version numbering, the system below may work for you, however, if you already have a system in place that works, you are welcome to keep using it—the most important thing is that the version numbers are included and match to version which has been given ethical clearance.

It may also assist to document a Standard Operating Procedure (SOP) which details the version control and numbering system to be used by the research project team. For example:

• When a document is updated following comments from the research team (see Step 2) the version number increases by decimal point (eg 0.0 to 0.1).
• When a document is updated following feedback from the Metro South Health HREC Office and/or Metro South Health Research Governance Office (see Step 4) the version number increases by a whole number (eg 1.0 to 2.0)

Step 1: Generate the first version of your document and assign the date and version number to the footer (for the sake of example we will use a PICF.

PICF – Research Project    Version 0.1    Date 01/01/2018

Step 2: Circulate this version to reviewers for changes and comments.

PICF – Research Project    Version 0.2    Date 02/01/2018

Circulate this document back to the people who need to review it and they will make further tracked changes if needed. Every time you implement the changes from your team, the document is saved as a new version number (in the decimal point) and distributed again for comment until no more changes are required.

Step 3: Once you have made the changes suggested by the team it is time to save the document with a new version number and the date in the footer.

PICF – Research Project    Version 1.0    Date 03/01/2018

In this type of version control, only versions 1.0 or 2.0 are considered ‘final versions’, with 1.1, and 2.2 for example considered as revisions. This final document is saved in the master file and is submitted to the Metro South Health HREC Office and Metro South Health Research Governance Office.

Step 4: Submit the final version of your document with your cover letter for review. If the Metro South Health HREC Office and Metro South Health Research Governance Office sends you feedback resulting in changes to the document, when you update the document also change the version number (eg the draft 1.3 will become a final 2.0). A new date will also be added.

PICF – Research Project    Version 2.0    Date 04/01/2018

Step 5: Circulate the changed document to your team and save in your master file. Only use the document as part of your research project once ethical clearance and research governance authorisation is received.

Step 6: If an amendment is required, begin the tracked changes process again. From this point on any changes made to the document based on the new round of tracked changes will now be reflected in the version number decimal points again.

PICF – Research Project    Version 2.1    Date 05/01/2018

Amendments which are sent to Metro South Health HREC Office and Metro South Health Research Governance Office should be a final version (eg Version 3.0).