Research, ethics and governance
Directive number: QH-HSD-035:2013
Effective date: 27 July 2022
Review date: 27 July 2025
Supersedes: version 2
On this page:
- Mandatory requirements
- Related or governing legislation, policy and agreements
- Supporting documents
- Business area contact
- Approval and implementation
- Definitions of terms in this directive
The purpose of this Health Service Directive (HSD) is to ensure consistency across Hospital and Health Services (HHSs) in research ethics and governance processes.
This directive applies to all Hospital and Health Services (HHS).
- Queensland Health will provide advice, training and education to enable HHSs to comply with this HSD.
- All research, where a HHS is a collaborator or where the research is carried out at a Queensland Health or HHS facility, that involves humans and/or their data and/or tissue, will be conducted in a manner consistent with nationally recognised human research ethics and governance guidelines and legislation.
- All reasonable efforts should be made to minimise duplication of Human Research Ethics Committee (HREC) review of proposals for multi-centre research.
- Where appropriate, research has a plan of translation to the local community.
Hospital and Health Services included in the scope of this directive shall achieve the following outcomes:
- Consistent research ethics and governance processes that facilitate research activity relevant to the HHSs’ functions under the Hospital and Health Boards Act 2011 (Qld) (HHB) and provide valid and accurate research activity reporting.
- All proposed research must comply with the current version of:
- the National Health and Medical Research Council (NHMRC), National Statement on Ethical Conduct in Human Research, (2007) (updated 2018), as amended from time to time, and
- the NHMRC, Australian Research Council and Universities Australia, Australian Code for the Responsible Conduct of Research, (2007) (updated 2018).
- All clinical trials must be conducted in accordance with the requirements of:
- The Therapeutic Goods Administration Act 1989 (Cth)
- INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) Current Step 4 version dated 9 November 2016 – Annotated with TGA comments ICH Guideline for Good Clinical Practice, Therapeutic Goods Administration (TGA)
- ISO 14155 Clinical investigation of medical devices for human subjects—Good Clinical Practice (for devices)
- All clinical trials conducted using a teletrial model must comply with The National Teletrials Compendium
- Research governance review fees will not apply to satellite sites
- Each research application must include:
- Translation of research into practice: Researchers are required to outline their plan to translate research into practice in the outcomes section of the site-specific assessment (SSA) form.
- Approved research budget: The budget (actual and in-kind support) for a research application must have been approved by the relevant expenditure delegate prior to being submitted.
Processing of research applications
- Researchers must submit the research application through Ethics Research Manager (ERM) or its replacement.
- All research applications will be administered through ERM (in accordance with the standard operating procedures specified by the Office of Precision Medicine and Research (OPMR) formerly known as the Health Innovation, Investment and Research Office (HIIRO)).
Decisions on research applications
- The research application will be acknowledged by the HREC administrator and the relevant research governance officer (RGO) by changing the status in ERM, and where ERM does not automatically notify the applicant, by sending an acknowledgement email to the applicant registered in ERM (status update process).
- Following acknowledgment of receipt, the HREC administrator and the RGO will separately determine if the application is valid by reviewing whether the research application is in the required form and if further information is required to be submitted by the applicant before being referred for consideration.
- If no further information is required and the application is complete, the HREC administrator and RGO will separately use the status update process to advise the applicant that they are referring the research application for a decision (i.e., that the application is considered “valid”).
- The RGO will review research applications prior to or while it is being considered by the relevant HREC, if requested.
- The HREC will review the research application and make a decision:
- for an application not requiring review by a full HREC, within 60 clock days from the date of HREC administrator referral for a decision; or
- for an application requiring review by a full HREC, within 60 clock days from the meeting closing date for submission (notice of which is publicly available) of valid applications eligible for review by the next meeting of the relevant full HREC.
- The relevant health service chief executive (HSCE) (or their delegate) will review the application and make a decision whether to authorise the carrying out of the research activity proposed in the research application within 25 clock days from the date of acknowledgement by the RGO of a valid SSA (i.e., referral for a decision).
Review of eligible multi-centre research
- Ethics review is only required to be carried out once by a certified HREC under the following:
- National Mutual Acceptance Scheme
- the Memoranda of Understanding between Queensland Health and the HREC approving body which has agreed to mutual acceptance/recognition of approvals for multi-centre research studies to the extent each is applicable in the circumstances.
- A decision in relation to ethics approval by a HREC for:
- multi-centre research applications, the review may be referred to any HHS where the research is proposed to be conducted. The decision will then apply to all HHS facilities at which the research is proposed to be conducted.
- A decision in relation to governance authorisation for:
- low risk multi-centre research which includes low risk multi-centre research applications which include less than $10,000 of monetary or in-kind support per participating HHS may be referred to a single participating HHS research governance office by agreement of the participating HHSs. Subsequent research governance reviews for the project at other participating HHSs will require approval in accordance with the relevant delegations of the other HHS.
Carrying out approved research
- An appropriate binding contractual arrangement must be in place between all research partners for an approved research application to mitigate risks to the Queensland public sector health system and clarify the roles and responsibilities of, and allocate risks between, the parties prior to the commencement of the research project. While there is no mandatory form of contractual arrangement, standard terms and conditions developed through consultation between Queensland Health and the HHSs that the collaborating parties may consider for use, are available on request to OPMR.
Related or governing legislation, policy and agreements
- Australian Code for the Responsible Conduct of Research, (2007) (Updated 2018)
- AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020)
- Code for Radiation Protection in Planned Exposure Situations (2020)
- Code of Practice Exposure of Humans to Ionizing Radiation for Research Purposes 2005 (Cth)
- Coroners Act 2003 (Qld)
- Defence Trade Controls Act 2012 (Cth)
- Ethical Conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018)
- Fundamentals for Protection Against Ionising Radiation (2014)
- Framework for Monitoring: Guidance for the national approach to single ethics review for multi-centre research, 2012.
- Gene Technology Act 2000 (Cth)
- Gene Technology Regulations 2001 (Cth)
- Guardianship and Administration Act 2000 (Qld)
- Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (2018)
- Guide for Radiation Protection in Existing Exposure Situations (2017)
- Guidelines to Promote the Wellbeing of Animals Used for Scientific Purposes, 2008
- Guidelines for Good Pharmacoepidemiology Practices, 2015
- Health Sector (Clinical Records) Retention and Disposal Schedule
- Health Sector (Corporate Records) Retention and Disposal Schedule
- Hospital and Health Boards Act 2011 (Qld)
- Information Privacy Act 2009 (Qld)
- Keeping research on track II
- National Standard Operating Procedures for Clinical Trials
- National Principles for Teletrials in Australia
- National Certification Handbook, 2012
- National Statement on Ethical Conduct in Human Research, (2007) (Updated 2018), as amended from time to time
- Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, 2000
- Powers of Attorney Act 1998 (Qld)
- Privacy Act 1988 (Cth)
- Prohibition of Human Cloning for Reproduction Act 2002 (Cth)
- Public Health Act 2005 (Qld)
- Radiofrequency Electromagnetic Energy and Health: Research Needs
- Research involving patients who are unable to give consent Policy Statement (April 2018) (PDF 446 kB)
- Research Involving Human Embryos Act 2002 (Cth)
- Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Act 2003 (Qld)
- Research Involving Human Embryos and Prohibition of Human Cloning for Reproduction Regulation 2015 (Qld)
- Therapeutic Goods Act 1989 (Cth)
- Therapeutic Goods Administration ICH Guideline for Good Clinical Practice
- Therapeutic Goods Regulations 1990 (Cth)
- Transplantation and Anatomy Act 1979 (Qld)
- Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
- Australasian Tele-Trial Model Access to Clinical trials closer to home using tele-health
- Guideline for researchers—disclosure of confidential information
- Medicines Australia Clinical Trial Research Agreements
- Medicines Australia Forms of Indemnity
- Medical Technology Association of Australia, Clinical Investigation Research Agreements:
- Clinical investigation research agreement (CIRA)
- Standard indemnity form for a clinical investigation
- Compensation guidelines
- NHMRC ethical issues and resources:
- Standardised participant information and consent forms
- Standard Operating Procedures for Queensland Health HREC Administrators (PDF 1111 kB)
- Standard Operating Procedures for Queensland Health RGOs (PDF 737 kB)
- Therapeutic Good Administration:
Business area contact
Office of Precision Medicine and Research, Prevention Division
This Health Service Directive will be reviewed at least every three years.
Date of last review: 14/07/2022
Supersedes: Version 2
Approval and implementation
Director-General, Queensland Health.
Approval by Chief Executive
Approval date: 27/07/2022
Issued under section 47 of the Hospital and Health Boards Act 2011 (Qld).
Definitions of terms used in this directive
|Term||Definition / explanation / details||Source|
|calendar day||means a day of the calendar year, including weekends and public holidays.||Queensland Health Standard Operating Procedure for HREC Administrators and RGOs|
|certified HREC||means a HREC which has had its processes assessed and certified under the NHMRC National Certification Scheme. For more information about requirements for HRECs regarding multi-centre research: National Certification Scheme for the ethics review of multi-centre research.||Queensland Health: The National Approach|
|clinical research||has the meaning defined in section 13(1) of schedule 2 of the Guardianship and Administration Act 2000 (Qld).||Guardianship and Administration Act 2000 (Qld)|
|clock day||means each calendar day after a valid application has been received and is being processed excluding time taken for the applicant to respond to queries with further information that enables processing to recommence. That is, clock days are not a measure of total time elapsed since a valid application is received but, instead, are a measure of processing time.||‘Clock day’ is a term recognised in the Australian research community in relation to processing of research applications.|
|confidential information||means information designated as ‘confidential information’ under health portfolio legislation.||As defined in section 139, Part 7 (Confidentiality) of the HHB Act or section 76, Division 3, Part 2, Chapter 3 (Notifiable Conditions) of the PH Act.|
|coronial investigation document||coronial investigation document has the same meaning as ‘investigation document’ as defined in the Coroners Act 2003 (Qld).||Coroners Act 2003 (Qld)|
|Department of Health||means the department of the Queensland Government named ‘Queensland Health’ or its successor.|
|Ethics Review Manager||means a secure web-based Research Ethics Database where researchers upload research application forms and HREC administrators and RGOs review those applications and report outcomes of HREC and research governance reviews.||Ethics Review Manager website|
|HHB Act||means the Hospital and Health Boards Act 2011 (Qld).||Hospital and Health Boards Act 2011 (Qld)|
|HHS||means a Hospital and Health Service established under section 17 of the HHB Act.||Hospital and Health Boards Act 2011 (Qld)|
|Human Research Ethics Committee (HREC)||means a committee registered by the NHMRC and constituted under the guidance of the NHMRC National Statement on the Ethical Conduct in Human Research (2007) (Updated 2018), as amended from time to time, to conduct the ethical and scientific review of a human research project whose members have been appointed by a HSCE.||NHMRC National Statement on the Ethical Conduct in Human Research (updated 2018)|
|HSCE||means a Health Service Chief Executive or delegate.|
|in-kind support||means support in the form of goods, services, resources, or other support but not money.|
|low risk||means research in which the only foreseeable risk is no more than discomfort.||NHMRC National Statement on the Ethical Conduct in Human Research (updated 2018)|
|multi-centre research||means a research project undertaken by a group of institutions (or individuals) at more than one site.|
|National Mutual Acceptance Scheme||means the national approach to single ethical review of multi-centre research in which participating states of Australia have agreed to accept the scientific and ethical review of an HREC from a public health facility located outside of the institution’s state.||Queensland Health: The National Approach|
|NHMRC||means the National Health and Medical Research Council.||NHMRC|
|PH Act||means the Public Health Act 2005 (Qld).||Public Health Act 2005 (Qld)|
|Principal Investigator (PI)||means the individual who is responsible for the overall conduct, management, monitoring and reporting of research conducted at a participating site and submits the research project for site authorisation for that site. There will be one Principal Investigator per site.|
|QCAT||means the Queensland Civil and Administrative Tribunal.|
|Queensland Health||means the public sector health system which is comprised of the HHSs and the Department of Health pursuant to section 8 of the HHB Act.||Hospital and Health Boards Act 2011 (Qld)|
|Research Application||means the research ethics and governance application form (as approved by Queensland Health from time to time) and all required supporting documentation.|
|RGO||Research Governance Officer.|
|satellite site||means a satellite site that is located in a geographically separate health facility from the primary site and responsibility is delegated by the primary site (clinical trial site) to perform activities associated with the conduct of a clinical trial and to support trial accessibility of remote participants to a clinical trial.||Clinical Oncology Society of Australia: Australasian tele-trial model: access to clinical trials closer to home using tele-health|
|teletrial||means a clinical trial conducted from a primary clinical study site utilising telehealth communication to engage access to satellite sites, forming a clinical trials cluster in designated regions to enhance patient reach, recruitment, and management.||Clinical Oncology Society of Australia: Australasian tele-trial model: access to clinical trials closer to home using tele-health|
|valid||means an application that is in a state so it can be referred for a decision. A valid governance application is one which is deemed complete by the RGO (that is, it contains all relevant signatures and supporting documentation uploaded into ERM), and all RGO queries have been addressed||Queensland Health Standard Operating Procedure for HREC Administrators and RGOs|
|1.0||01/07/2013||Health and Medical Research||New Health Service Directive|
|2.0||15/11/2016||Health and Medical Research||Supersedes: version 1|
|3.0||14/07/2022||Office of Precision Medicine and Research||Supersedes: version 2|