Research, ethics and governance

Directive number: QH-HSD-035

Effective date: 14 March 2023

Review date: 30 September 2025

Supersedes: version 3

On this page:

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 directive applies to all Hospital and Health Services (HHS).

Principles

  • 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.

Outcomes

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.

Mandatory requirements

Research applications

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.

Supporting documents

Business area contact

Office of Research and Innovation, Clinical Planning and Service Strategy

Review

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

Date of last review:  26 September 2022

Supersedes: Version 3

Approval and implementation

Directive Custodian

Executive Director, Office of Research and Innovation, Queensland Health.

Approval by Chief Executive

Director-General,  Queensland Health

Approval date: 14 March 2023

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

Definitions of terms used in this directive

Term Definition / explanation / detailsSource
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.

National Statement on Ethical Conduct in Human Research 2023

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. National Statement on Ethical Conduct in Human Research 2023
multi-centre research means a research project undertaken by a group of institutions (or individuals) at more than one site.

NHMRC: National Certification Scheme for the ethics review of multi-centre research

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

Queensland Health: Teletrials

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

Version control

VersionDate Prepared byComments
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
4.0 14/03/2023 Office of Precision Medicine and Research

Supersedes version 3

Administrative change to directive custodian from Director-General to Executive Director, Office of Research and Innovation

5.0

05/06/2024

Office of  Research and Innovation

Supersedes version 4

Administrative changes including updated National Statement and ISO14155

Last updated: 22 July 2024