Pre-approval
All ethics applications
In order to conduct research within the RBWH, it is a requirement that researchers first obtain the following:
- Ethics approval from the Human Research Ethics Committee (HREC)
- Site authorization at each facility where the research will be undertaken
- The Human Rights of research participants should be considered.
Parallel submission
RBWH encourages parallel submission for research ethics and governance applications. It has been shown that the parallel assessment of applications for ethics approval and site authorization leads to an earlier study commencement by as much as 100 days for clinical trials.
The Human Research Ethics Committee and Research Governance Office are the first contact point for obtaining relevant research approvals. Research Ethics and Research Governance application forms are prepared and submitted through ERM.
Non-clinical trial Ethics Approval process
There are three types of non-clinical trial applications submitted to an HREC, which are based on the level of risk to the participants of the research:
- Greater than low risk research studies: reviewed by the HREC
- Low risk research studies: reviewed by an HREC Sub-Committee
- Research which is Exempt from HREC review: reviewed by the HREC Chairperson (out-of-session) – Request for Exemption from Ethics Review Guideline
Prior to Submission
Come and visit us at an Information Clinic
Ethics & Governance have initiated an engaging Information Clinic which is held on a Monday & Tuesday morning each week. This clinic provides researchers with the opportunity to seek advice on their new projects, as well as obtaining advice on ethical and governance submission requirements. It is highly recommended that researchers attend one of these Clinics prior to the submission to the HREC or Research Governance Office. For more information and to book an appointment, please contact Research Services on 3647 1002 / 3647 1001 or email MNHHS-RGO@health.qld.gov.au.
Develop a Protocol
A project protocol is an essential element of all applications and should be developed early-on in the research process. The protocol guideline is provided to assist researchers with writing a research protocol.
Obtain an expert review for your project
Peer review of a project should be undertaken after the Protocol has been developed and must always occur before the application is submitted for HREC review. Investigators must allow sufficient time to find a reviewer, allow the reviewer time to conduct the peer review and allow time for the reviewer’s comments to be adequately addressed prior to submission to the HREC.
Develop a Participant Information Sheet & Consent Form (PICF)
The NHMRC provides researchers with standardized PICF templates. It is not compulsory to use these templates, however they are useful tools and accepted by the RBWH HREC. Please refer to the MNHHS Checklist for preparing PICFs.
Application process
- Complete the Ethics Checklist. The Coordinating Principal Investigator should complete the Ethics Checklist when preparing the ethics application.
- Complete a Human Research Ethics Application (HREA). Applicants must complete the HREA for all research projects via Ethics Review Manager (ERM).
– For further information and step-by-step guides on submitting via ERM, please refer to the ERM Researcher User Guide (available from a Queensland Health computer only) or ERM Quick Guides
– Help and Support can be obtained from: helpdesk@infonetica.net or HIIRO_Reg@health.qld.gov.au - Upload all supporting study documentation (with versions, dates & page numbers in the footers) into ERM, i.e. Covering Letter, Protocol, PICF, Letters of Invitation, Transcripts for telephone contact, Invoicing and Fee Form, Questionnaires, Patient Diaries, Assessment Tools, Advertising Materials, Data Collection Sheets, CVs etc. Please note, CVs for all investigators listed in the application must be submitted if one has not been submitted to the HREC within the last 2 years.
- Once the application has been completed, all the supporting documentation uploaded into the form and the application has been signed by the Coordinating Principal Investigator (and their supervisor/s if they are a student), press ‘Submit’ in ERM. Once submitted via ERM, please then send an email with all attached documents for review to RBWH-Ethics@health.qld.gov.au. This is a safeguard to ensure that the HREC has received the application via ERM. No hard copies are required for submission to the RBWH HREC.
- The HREA (for submission of greater than low risk studies) must be received via ERM by 12.00 noon on the closing date.
- It is recommended that the Site Specific Assessment (SSA) be submitted to the RBWH Research Governance Office in parallel submission.
Prior to Submission
Come and visit us at an Information Clinic
Ethics & Governance have initiated an engaging Information Clinic which is held on a Monday & Tuesday morning each week. This clinic provides researchers with the opportunity to seek advice on their new projects, as well as obtaining advice on ethical and governance submission requirements. It is highly recommended that researchers attend one of these Clinics prior to the submission to the HREC or Research Governance Office. For more information and to book an appointment, please contact Research Services on 3647 1002 / 3647 1001 or email MNHHS-RGO@health.qld.gov.au.
Develop a Protocol
A project protocol is an essential element of all applications and should be developed early-on in the research process. The protocol guideline is provided to assist researchers with writing a research protocol.
Obtain an expert review for your project
Peer review of a project should be undertaken after the Protocol has been developed and must always occur before the application is submitted for HREC review. Investigators must allow sufficient time to find a reviewer, allow the reviewer time to conduct the peer review and allow time for the reviewer’s comments to be adequately addressed prior to submission to the HREC.
Develop a Participant Information Sheet & Consent Form (PICF)
The NHMRC provides researchers with standardized PICF templates. It is not compulsory to use these templates, however they are useful tools and accepted by the RBWH HREC. Please refer to the MNHHS Checklist for preparing PICFs.
Application process
- If the low risk application will be accessing confidential health information for a research purpose without seeking participant consent, the application should justify a waiver of consent in accordance with the National Statement section 2.3.10.
- Complete the Ethics Checklist. The Coordinating Principal Investigator should complete the Ethics Checklist when preparing the ethics application.
- Complete a Human Research Ethics Application (HREA) via Ethics Review Manager (ERM).
– For further information and step-by-step guides on submitting via ERM, please refer to the ERM Researcher User Guide (available from a Queensland Health computer only) or ERM Quick Guides
– Help and Support can be obtained from: helpdesk@infonetica.net or HIIRO_Reg@health.qld.gov.au - Upload all supporting study documentation (with versions, dates & page numbers in the footers) into ERM, i.e. Covering Letter, Protocol, PICF, Data Collection Sheet, CVs, etc. Please note, CVs for all investigators listed in the application must be submitted if one has not been submitted within the last 2 years.
- Once the application has been completed, all the supporting documentation uploaded into the form and the application has been signed by the Coordinating Principal Investigator (and their supervisor/s if they are a student), press ‘Submit’ in ERM. Once submitted via ERM, please then send an email with all attached documents for review to RBWH-Ethics@health.qld.gov.au. This is a safeguard to ensure that the HREC has received the application via ERM. No hard copies are required for submission to the RBWH HREC.
- The HREA (for submission of low risk studies) can be submitted at any time, as the RBWH HREC provides an expedited review process for low risk research applications. This approval is then noted or ratified by the Committee at the next available meeting.
- It is recommended that the Site-Specific Assessment (SSA) form be submitted to the RBWH Research Governance Office in at the same time as the ethics application. See parallel submission.
The National Statement on Ethical Conduct in Human Research (paragraphs 5.1.22 and 5.1.23) defines research that can be exempted from ethics review as negligible risk research that involves the use of existing collections of data or records that contain only non-identifiable data about human beings.
Following are examples of types of research exempt from ethics review:
- Systematic reviews and meta-analysis of published and non-identifiable data
- Studies that involve data available in the public domain
- Experimental or laboratory studies that do not involve data collected from or about humans or animals
Non-research activities exempt from ethics review include quality assurance activities and the publication of case reports. Quality Assurance activities, where there is intent to publish the findings, may be submitted to the HREC Chairperson for a request of exemption from HREC review. Individual patient consent should be obtained for the publication of a Case Report, however, ethics review is not required (HREC Chairperson advice can be sought, if required). Case reports involving more than 2 individuals are classified as a case series and require ethics review.
Is my project research or quality assurance?
This is a common question for locally developed projects aimed at measuring patient outcomes and the impact of models of care. Quality assurance and research exist on a continuum of activity and sometimes expert advice is required to determine the appropriate approval pathway to follow. Key questions to ask are: ‘What is the primary aim of my project?’ and ‘How will the results be used?’
If the aim of your project is to evaluate and monitor local practice and your results will be used by local staff to inform and improve health care or service delivery, then (in most cases) you are undertaking a quality assurance activity rather than research. Ethical principles apply to both quality assurance and research, however, quality assurance requires institutional oversight (e.g. by a Departmental Director, Executive Director or the Safety and Quality Unit), while most research requires ethical review and site authorization.
Research is defined in the Australian Code for the Responsible Conduct of Research as an original investigation undertaken to gain knowledge, understanding and insight. In contrast, quality assurance is an organized process that evaluates, assesses and seeks to improve health service delivery, including improvement of patient and population outcomes and health service efficiency.
For specific guidance, you should contact the HREC Coordinator/Chairperson or site Research Governance Officer. See also the National Health and Medical Research Council publication on Ethical Considerations in Quality Assurance and Evaluation Activities.
Exemption application process
The requirements for submitting a request for an exemption from HREC review (for quality assurance/audit activities) are provided in the guideline Requesting an exemption from HREC review guideline
Complete the Exemption Form on Ethics Review Manager (ERM). Upload all supporting documentation into the Exemption Form, sign the application and then press ‘Submit’.
Outcomes (Exemptions)
You will receive correspondence from the Chairperson with one of the following outcomes:
- A letter of exemption from full HREC review; or
- A request for further information; or
- • If considered not a Quality Improvement / Audit activity, a request to submit via the research pathway (i.e. completion of an Human Research Ethics Application [HREA]).
Clinical Trials
Clinical Trials can be distinguished as commercially sponsored, where funding is provided by a commercial sponsor and the trial is managed by the sponsor or a Clinical Research Organisation (CRO), or as investigator initiated clinical trials. In the latter case, funding may come from a variety of sources by the sponsor would be the RBWH and the trial would be run by a clinician investigator with the assistance of study co-ordinators or collaborative research groups.
The following information separates the clinical trials into the identified types.
Studies where the Royal Brisbane & Women’s Hospital will formally act as sponsor for a research project, including:
- RBWH sponsored clinical trials (CTN/CTX clinical trials within the scope of the Therapeutic Goods Act); and
- All RBWH-led multi-centre studies
Ethics application process
Prior to submission
- Attend a Ethics & Governance Clinic
- Ethics and Governance have initiated an engaging Information Clinic which is held on a Monday & Tuesday morning each week. For new researchers who are submitting a project for the first time, it is compulsory to attend an Information Clinic prior to an application being submitted for ethics review. These clinics are beneficial in identifying any issues upfront and provide researchers with correct advice, therefore, it is highly recommended that researchers attend one of these Clinics (hyperlink to Clinic Flyer) prior to submission to the HREC or Research Governance Office. For more information and to book an appointment, please contact Research Services on 3647 1002 / 3647 1001 or email MNHHS-RGO@health.qld.gov.au.
- Develop a Protocol
A project protocol is an essential element of all applications and should be developed early-on in the research The protocol guideline is provided to assist researchers with writing a research protocol. - Develop a Participant Information Sheet & Consent Form (PICF)
The NHMRC provides researchers with standardized PICF templates. It is not compulsory to use these templates, however they are useful tools and accepted by the RBWH HREC . Please refer to the MNHHS Checklist for preparing PICFs. - Have the project peer reviewed
Peer review of a project should be undertaken after the Protocol has been developed and must always occur before the application is submitted for HREC approval. The investigators must allow sufficient time to find a reviewer, allow the reviewer time to conduct the peer review and allow time to address the reviewer’s comments adequately. - Obtain a statistical review for the project
Investigators must allow sufficient time to find a reviewer, allow time for the reviewer/review body time to conduct the statistical pre-review and allow time to address any comments adequately.
Complete the steps below to apply for HREC ethical review
- Complete the Ethics Checklist. The Coordinating Principal Investigator should complete the Ethics Checklist when preparing the ethics application.
- Complete an Human Research Ethics Application (HREA). Applicants must complete the HREA for all research projects (both low risk and greater than low risk) via Ethics Review Manager (ERM) .
– For further information and step-by-step guides on submitting via ERM, please refer to the ERM Researcher User Guide
– Help and Support can be obtained from: helpdesk@infonetica.net or HIIRO_Reg@health.qld.gov.au - Upload all supporting study documentation (with versions, dates & page numbers in the footers) into ERM, i.e. Covering Letter, Protocol, PICF, Letters of Invitation, Transcripts for telephone contact, Invoicing and Fee Form, Questionnaires, Patient Diaries, Assessment Tools, Advertising Materials, Data Collection Sheets, CVs etc. Please note, CVs for all investigators listed in the application must be submitted if one has not been submitted within the last 2 years.
- If conducting a clinical trial of a drug or device, please submit the Investigator’s Brochure (IB).
- Once the application has been completed, all the supporting documentation uploaded into the form and the application has been signed by the Coordinating Principal Investigator (and their supervisor/s if they are a student), press ‘Submit’ in ERM. Once submitted via ERM, please then send an email with all attached documents for review to MetroNorthResearch-Ethics@health.qld.gov.au. This is a safeguard to ensure that the HREC has received the application via ERM. No hard copies are required for submission to the HREC.
- It is recommended that the Site Specific Assessment (SSA) be submitted to the RBWH Research Governance Office in parallel submission.
Prior to submission
- Attend a RBWH Ethics & Governance Clinic
Ethics and Governance have initiated an engaging Information Clinic which is held on a Monday & Tuesday morning each week. For new researchers who are submitting a project for the first time, it is compulsory to attend an Information Clinic prior to an application being submitted for ethics review. These clinics are beneficial in identifying any issues upfront and provide researchers with correct advice, therefore, it is highly recommended that researchers attend one of these Clinics prior to submission to the HREC or Research Governance Office. For more information and to book an appointment, please contact Research Services on 3647 1002 / 3647 1001 or email MNHHS-RGO@health.qld.gov.au. - Develop a Protocol
A project protocol is an essential element of all applications and should be developed early-on in the research The protocol guideline is provided to assist researchers with writing a research protocol. - Develop a Participant Information Sheet & Consent Form (PICF)
The NHMRC provides researchers with standardized PICF templates. It is not compulsory to use these templates, however they are useful tools and accepted by the RBWH HREC. Please refer to the MNHHS Checklist for preparing PICFs. - Have the project peer reviewed
Peer review of a project should be undertaken after the Protocol has been developed and must always occur before the application is submitted for HREC approval. The investigators must allow sufficient time to find a reviewer, allow the reviewer time to conduct the peer review and allow time to address the reviewer’s comments adequately. - Obtain a statistical review for the project
Investigators must allow sufficient time to find a reviewer, allow time for the reviewer/review body time to conduct the statistical pre-review and allow time to address any comments adequately.
Complete the steps below to apply for HREC ethical review
- Complete the Ethics Checklist. The Coordinating Principal Investigator should complete the Ethics Checklist when preparing the ethics application.
- Complete a Human Research Ethics Application (HREA). Applicants must complete the HREA for all research projects (both low risk and greater than low risk) via Ethics Review Manager (ERM) .
– For further information and step-by-step guides on submitting via ERM, please refer to the ERM Researcher User Guide (available from a Queensland Health computer only) or ERM Quick Guides
– Help and Support can be obtained from: helpdesk@infonetica.net or HIIRO_Reg@health.qld.gov.au - Upload all supporting study documentation (with versions, dates & page numbers in the footers) into ERM, i.e. Covering Letter, Protocol, PICF, Letters of Invitation, Transcripts for telephone contact, Invoicing and Fee Form, Questionnaires, Patient Diaries, Assessment Tools, Advertising Materials, Data Collection Sheets, CVs etc. Please note, CVs for all investigators listed in the application must be submitted if one has not been submitted within the last 2 years.
- The RBWH HREC charges fees for the ethical review for commercially sponsored research projects. Please provide the HREC with the sponsor’s contact details for invoicing purposes.
- If conducting a clinical trial of a drug or device, please submit the Investigator’s Brochure (IB).
- A copy of the CTN Registration of the drug or device must be presented with the application.
- Once the application has been completed, all the supporting documentation uploaded into the form and the application has been signed by the Coordinating Principal Investigator (and their supervisor/s if they are a student), press ‘Submit’ in ERM. Once submitted via ERM, please then send an email with all attached documents for review to MetroNorthResearch-Ethics@health.qld.gov.au. This is a safeguard to ensure that the HREC has received the application via ERM. No hard copies are required for submission to the HREC.
- It is recommended that the Site Specific Assessment (SSA) be submitted to the RBWH Research Governance Office in parallel submission.