Research, ethics and governance

Directive number: QH-HSD-035

Effective date: 10 July 2026

Review date: 10 July 2029

Supersedes: version 5

On this page:

• Purpose
• Scope
• Principles
• Outcomes
• Mandatory requirements
• Compliance
• Human Rights
• Aboriginal and Torres Strait Islander considerations
• Related or governing legislation, policy and agreements
• Supporting documents
• Business area contact
• Approval and implementation
• Review
• Definitions of terms in this directive

Purpose

The purpose of this Health Service Directive (HSD) is to ensure consistency across Hospital and Health Services (HHSs) in research ethics and governance processes.

Scope

This HSD applies to all HHSs.

Principles

• All research, where a HHS is a collaborator or where the research is carried out at a Department of 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.
• For research involving data from more than one HHS, all reasonable efforts should be made to source data from as few repositories as possible to minimise the number of requests for data.
• Where appropriate, research has a plan of translation to the local community.

Outcomes

Each HHS included in the scope of this HSD will achieve consistent research ethics and governance processes that facilitate research activity relevant to the HHS’s functions under the Hospital and Health Boards Act 2011 (Qld) (HHB Act) and provide valid and accurate research activity reporting.

Mandatory requirements

Research applications

• 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 (2025) or its replacement
  • the NHMRC, Australian Research Council and Universities Australia, Australian Code for the Responsible Conduct of Research, (2007) (updated 2018).
• All proposed clinical trials must be conducted in accordance with the requirements of:
  • the Therapeutic Goods Administration Act 1989 (Cth)
  • the 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) or its anticipated replacement
  • the ISO 14155 Clinical investigation of medical devices for human subjects—Good Clinical Practice (for devices)
• All proposed clinical trials to be conducted using a teletrial model must comply with the National Standard Operating Procedures for Clinical Trials in Australia
• Research governance review fees will not apply to satellite sites
• Applications for research requesting access to coronial documents or physical evidence subject to sections 53 or 62A respectively of the Coroners Act 2003 (Qld) must be directed by the applicant to the Queensland Health Coronial and Public Health Sciences Human Ethics Committee for scientific and ethical review.
• Each research application must include:
  • a plan to translate the research into practice in the outcomes section of the site-specific assessment (SSA) form.
  • a budget (actual and in-kind support) for the research that has been approved by the relevant expenditure delegate prior to the research application being submitted.
• With respect to the principle applicable to research involving data from more than one HHS that all reasonable efforts should be made to source data from as few repositories as possible to minimise the number of requests for data, the following is provided as an example: A researcher should submit a single request for data from a centralised statewide repository for relevant HHSs rather than numerous requests to source data from each relevant HHS. Individual HHS data custodian involvement is only required when:
  • a researcher seeks data from a dataset that is held only by that HHS rather than a centralised statewide repository; or
  • an act is required to be performed by the HHS for the researcher to access or receive the data (e.g. the individual HHS is required to specifically provision or extract the data).

Processing of research applications

• Researchers must submit a research application for a research project 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 Governance, Ethics and Trials Unit (GETU) in the Department of Health.

Decisions on research applications

• Receipt of a 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 a research 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 research 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 a research application prior to or while it is being considered by the relevant HREC (i.e. parallel governance and ethic review) if requested by the applicant.
• A HREC is required to undertake the scientific and ethical review of an application and give a decision within 60 clock days. Information regarding the calculation of elapsed clock days is located in the Standard Operating Procedures for Queensland Health HREC Administrators.
• Where the role of an HHS or the Department of Health in multi-centre research is limited solely to the provision of data, and they are not collaborating in the conception, design, conduct, analysis, interpretation, or reporting of the multi-centre research, the HHS or the Department of Health may rely on a human research ethics approval decision issued by any NHMRC-registered Human Research Ethics Committee rather than a decision made by a certified Human Research Ethics Committee.
• The relevant health service chief executive (HSCE) (or their delegate) will review a research application and make a decision as to 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.
• The following requirement is relevant to a quality improvement, quality assurance or service evaluation that constitutes ‘research’ as defined in section 280 of the Public Health Act 2005 (Qld) and has been granted an exemption from full HREC review by an HREC constituted in accordance with the National Statement on Ethical Conduct in Human Research. A document (e.g. a letter) issued by the HREC, including contact details for the HREC, specifying that the HREC has validly granted the exemption from full HREC review is taken to be evidence satisfying the requirement in section 282(2)(i) of the Public Health Act 2005 (Qld).

Review of eligible multi-centre research

• Ethics review of eligible multi-centre research is only required to be performed once by a certified HREC under one of the following mechanisms:
• National Mutual Acceptance Scheme
• the Memoranda of Understanding between Queensland Health and the HREC approving body which has agreed to mutual acceptance of approvals for multi-centre research studies.
• Once the decision has been made by the certified HREC under one of the above mechanisms, that decision applies to all HHS facilities at which the research is proposed to be conducted.
• For multi-centre research projects with less than $10,000 in monetary or in-kind support contributed by each participating HHS, a decision whether to grant governance authorisation may be made by a single participating HHS and relied upon by the other participating HHSs. However, each participating HHS must still obtain expenditure approval from its relevant expenditure delegate for the HHS’s contribution before the project can commence at their site regardless of the HHS’s reliance on the grant of governance authorisation made by another participating HHS.

Carrying out approved research

• An appropriate binding contractual arrangement must be in place between all research partners for approved research to mitigate risks to Queensland Health 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 the Department of Health and the HHSs that the collaborating parties may consider for use, are available on request to GETU.

Compliance

• HHSs are responsible for ensuring compliance with this HSD.
• GETU may check compliance by confirming that HHSs have implemented local polices and processes that comply with the minimum requirements specified in this HSD.
• GETU may request that HHSs submit evidence of compliance with the requirements of this HSD. In such cases, GETU will work with HHSs to agree on the information and timeframes within which this is provided.

Human Rights

• Human rights are not engaged by this HSD.

Aboriginal and Torres Strait Islander considerations

• The requirements of, and outcomes applicable to, this HSD align with existing expectations in the conduct of research involving Aboriginal and Torres Strait Islander stakeholders  and each HHS is required to consider implications for research involving Aboriginal and Torres Strait Islander stakeholders in the application of this HSD.

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 (the AIATSIS Code)
• 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)
• Gene Technology (Queensland) Act 2016 - Queensland Legislation - Queensland Government
• 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 in Australia
• National Principles for Teletrials in Australia
• National Certification Handbook, 2012
• National Statement on Ethical Conduct in Human Research 2023 | NHMRC[1]
• National Statement on Ethical Conduct in Human Research 2025 | NHMRC
• 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)
• Code of Practice Exposure of Humans to Ionizing Radiation for Research Purposes
• 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

Supporting documents

• Guideline – Disclosure of confidential information (Identifying Data) for researchers
• 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 1026 kB)
• Standard Operating Procedures for Queensland Health RGOs (PDF 832 kB)
• Teletrial Cluster Approval Process
• Therapeutic Good Administration:
  • Accessing unapproved products
  • Clinical trials
  • Australian clinical trial handbook

Business area contact

• Governance, Ethics and Trials Unit, Clinical Excellence Queensland, Department of Health

Approval and implementation

Directive Custodian

Executive Director, Office of Research and Innovation, Queensland Health

Approval by Chief Executive

Director-General, Queensland Health

Approval date: 10 July 2026

Issued under section 47 of the Hospital and Health Boards Act 2011 (Qld).

Review

This Health Service Directive will be reviewed at least every 3 years.

Date of next review:  10 July 2029

Supersedes: Version 5

Definitions of terms used in this directive

Version control

Change table

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