(1) The University of Queensland (UQ or the University) is committed to promoting a culture of responsible and ethical research. Where research involves or is about humans, their tissue or data, researchers have specific obligations to ensure that all ethics approvals are obtained prior to the work commencing. This Procedure describes the processes for obtaining UQ ethics approval for human research. (2) This Procedure should be read in conjunction with: (3) Staff and students at the University are required to conduct themselves in a manner consistent with the Australian Code for the Responsible Conduct of Research 2018, the National Statement, and the standards set out in the relevant UQ code or charter: (4) This Procedure applies to all staff, students and title holders who conduct, or assist with the conduct of, human research at, or on behalf of, UQ. (5) Researchers external to the University who wish to conduct research at UQ must contact Research Ethics and Integrity for direction and assistance in obtaining gatekeeper approval. (6) To be ethically acceptable, human research must comply with the National Statement and demonstrate the values of research merit and integrity, justice, beneficence and respect. (7) Research involving Aboriginal and Torres Strait Islander Peoples must also be conducted in accordance with: (8) All research involving or about humans, their tissue or data must be subject to ethics review or qualify for an exemption from review. Applications must be made through MyResearch. (9) All human research must: (10) Complaints will be handled through the appropriate University process as outlined in clauses 26-29 of this Procedure. (11) The University has established different pathways for human ethics review. The level of review required is primarily determined by the risks involved in the research. The greater the risks to participants the more certain those approving the research must be that the risks will be minimised and managed appropriately and that the participants clearly understand the risks they are assuming. In accordance with the National Statement, risk is defined as the potential for harm, discomfort or inconvenience and its evaluation involves an assessment of the likelihood and severity of the risk: (12) In accordance with the National Statement, certain types of research may require review by a Human Research Ethics Committee (HREC) regardless of the level of risk involved (unless conditions for exemption exist, see clauses 13-14 and clauses 23-25). This includes research involving: (13) Negligible risk research may be exempt from ethics review if it meets all the following criteria: (14) An application for exemption must be registered through MyResearch. (15) Research in which the only foreseeable risk is one of discomfort or inconvenience may be reviewed by a Low and Negligible Risk Panel (LNR Panel). At UQ, applications will be directed to the researcher’s relevant LNR Panel and must be submitted through MyResearch. (16) All research that involves more than low risk requires review by an HREC. The University has established two NHMRC-registered HRECs, which operate in accordance with the National Statement. Applications for review must be submitted through MyResearch. (17) The University seeks to minimise the duplication of ethics review. In most instances a UQ researcher who has obtained approval from an external ethics committee is required only to register the approval, or seek ratification of it, at UQ. The University will typically recognise approvals from NHMRC-registered HRECs, delegated review bodies or equivalent international bodies. The external body provides the review, approval and monitoring of the research. It should be noted that research conducted overseas by researchers from Australian institutions must comply with the National Statement. (18) Projects involving any of the following require ratification of the external ethics approval: (19) All modifications to the original approval, incident reports and annual reports must also be submitted to UQ for review. (20) Applications for ratification must be made through MyResearch. The lead UQ investigator is responsible for ensuring the project is submitted for ratification. (21) All projects with external ethics approval that do not meet the conditions for ratification must be registered with UQ. The lead UQ investigator is responsible for ensuring the project is registered through MyResearch. (22) Ratifications and registrations may be referred to other areas of the University for governance purposes. (23) An activity of quality assurance is one where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation. An evaluation activity includes the systematic collection and analysis of information to judge the effectiveness, efficiency and/or appropriateness of an activity. Quality assurance and evaluation activities must be conducted in a way that is ethical, but in many situations, human research ethics review is not required. In accordance with the NHMRC guideline Ethical Considerations in Quality Assurance and Evaluation Activities, triggers for human research ethics review include: (24) Where one or more of the above triggers apply, the activity may require review by an HREC or LNR Panel. Research Ethics and Integrity may be contacted for assistance with determining the appropriate review pathway. (25) In some circumstances an individual undertaking a quality assurance or evaluation activity may require a notice that attests to the activity being exempt from research ethics review. An application may be registered through MyResearch. (26) Complaints relating to the following activities must be reported immediately to the project lead or Research Ethics and Integrity, these include: (27) Complaints that raise the possibility of a breach of the University’s Responsible Research Management Framework Policy will be handled as follows: (28) Projects that involve more than one institution and/or HREC will be handled in accordance with the agreement with that institution or, if no agreement exists, in negotiation with the external party. (29) Complaints concerning the HREC process should be progressed to the Director, Research Ethics and Integrity. The ultimate decision regarding the ethical acceptability of human research lies with the HREC or LNR Panel. (30) The Deputy Vice-Chancellor (Research and Innovation) or delegated officer is responsible for establishing and maintaining the operations, governance and resourcing of HRECs and LNR Panels. (31) The primary responsibility of the University’s HREC is to ensure that all human research is conducted in compliance with the National Statement. The University’s research ethics committees review and approve new applications and applications for amendments to existing approvals and provide advice to applicants on the ethical acceptability of the design and conduct of their research. The committees may also review concerns about activities related to an approved project and provide advice and recommendations to the University on issues related to human research ethics. (32) UQ review bodies must operate in accordance with their terms of reference and meet reporting requirements per section 6 of this Procedure and the National Statement. (33) In accordance with the National Statement, HREC and LNR Panel members must: (34) The Director, Research Ethics and Integrity is responsible for receiving complaints concerning the processes of an HREC that are not able to be resolved informally between the HREC and the researcher. The Director will aim to resolve the complaint, resolution may require consultation with other relevant parties. (35) Research Ethics and Integrity is responsible for: (36) In accordance with the National Statement, researchers must: (37) The Deputy Vice-Chancellor (Research and Innovation) is responsible for the development, compliance monitoring and review of this Procedure. (38) The University will conduct reviews of the operation of its review bodies to ensure they are effective and consistent with the National Statement and University policies. (39) All meetings of review bodies are minuted, and records of all decisions maintained. (40) UQ review bodies will: (41) All researchers associated with the University must fulfil all reporting requirements, including submission of documents to MyResearch, Research Ethics and Integrity or HREC as required. (42) Research Ethics and Integrity, Human Ethics website. (43) Research Ethics and Integrity, Human Ethics – forms and resources web page.Human Research Ethics Procedure
Section 1 - Purpose and Scope
Section 2 - Process and Key Controls
Section 3 - Key Requirements
Part A - Human Research Ethics Review Pathways
Exemption from Review for Negligible Risk Research using Existing Collections of Data
Research Involving No More than Low Risk
Research Involving Greater than Low Risk
Ratification of Research Approved by an External Ethics Committee
Ratification
Registration
Part B - Exemption for Quality Assurance and Evaluation Activities
Part C - Complaints
Complaints About the Conduct of Research
Complaints About the Merit of an HREC or LNR Process
Section 4 - Roles, Responsibilities and Accountabilities
Deputy Vice-Chancellor (Research and Innovation)
Review Bodies (HRECs and LNR Panels)
Review Body Members
Director of Research Ethics and Integrity
Research Ethics and Integrity
Researchers
Top of PageSection 5 - Monitoring, Review and Assurance
Section 6 - Recording and Reporting
Section 7 - Appendix
Resources
Definitions
Term
Definition
MyResearch
The enterprise platform for the management and administration of research projects.
Participants
Any person who is the subject of the research.
Research
The concept of research is broad and includes the creation of new knowledge and/or the use of existing knowledge in a new and creative way so as to generate new concepts, methodologies, inventions and understandings. This could include synthesis and analysis of previous research to the extent that it is new and creative.
Researcher
Any University staff member, student or title holder who conducts, or assists with the conduct of, research at, or on behalf of the University.
Review Body
UQ Human Research Ethics Committee (HREC) or Low and Negligible Risk Panel (LNR Panel).
Staff
Continuing, fixed-term, research (contingent funded) and casual staff members.
Student
a person enrolled as a student at the University or undertaking courses or programs at the University.
Title Holders
Visiting academics, academic title holders, industry fellows, emeritus professors, adjunct honorary title holders, and conjoint appointments.
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