1. Purpose of policy
The University of the Sunshine Coast is committed to assisting its researchers to undertake their research in an ethical manner, and the purpose of this policy is to promote the highest ethical standards in the University’s human research. In particular the policy aims to assist researchers to consider their ethical responsibilities with regards to the design and conduct of their research, and to clearly articulate the responsibilities of those involved in the ethical review and related protocols. The policy provides the basis and authority on which the University of the Sunshine Coast Human Research Ethics Guidelines and Human Research Ethics Procedures are produced and maintained.
This policy is an important element of the University's implementation of, and compliance with, the National Statement on Ethical Conduct in Human Research (2007), which is the national policy reference for human research ethics in Australia. This policy also contributes to the support of best practice in the conduct of research as described in the Australian Code of Conduct for the Responsible Conduct of Research.
A key principle and purpose of this policy is the facilitation of the design and conduct of excellent research which adheres to the national research ethics principles. The University believes that the best way to achieve this is, by resourcing the reflective practice of the University's researchers, and through the use of proportional arrangements that are relevant and appropriate to the specific research project and the risk.
2. Application of policy
This policy applies to all University staff (academic or professional) and all students, who conduct human research under the auspices of the University. It also applies to the University of Sunshine Coast Human Research Ethics Committee (USCHREC) and all staff and officers involved in the ethical review of proposed research and related protocols.
In this policy the following definitions apply:
Ethical principles means the four principles which the National Statement (see below) indicates need to be addressed in the design, ethical review (see below) and conduct of human research. These are: research merit and integrity; respect; beneficence; and justice.
Ethical review means the prior review of proposed research, with regards to its adherence to the National Statement (see below) and University guidance, as articulated by the booklets of the Human Research Ethics Guidelines (see below).
Human research means any research activity involving human participants (or their data or tissue), covering everything from anonymous surveys, observation of public behaviour, interviews, focus groups, behavioural tests, action research, through to exercise testing, exploration of sensitive personal behaviour and attitudes, clinical research and clinical trials.
National Statement means the National Statement on Ethical Conduct in Human Research (2007) released by the Australian Research Council (ARC) and the National Health and Medical Research Council (NHMRC), and endorsed by Universities Australia. Institutional compliance with the National Statement is a condition of eligibility for ARC and NHMRC funding, as well as many other funding bodies. Adherence with the National Statement is an expectation of membership of Universities Australia, is increasingly a condition of publication in academic journals, and is often a condition of access to populations (e.g. students in Education Queensland schools).
Human Research Ethics Guidelines means the University of the Sunshine Coast Human Research Ethics Guidelines. This booklet-based manual is a resource for the University's researchers, outlines the University's interpretation and implementation of the National Statement, and provides a transparent policy basis for the conduct of ethical review. Additions or changes to the Guidelines, or to any of the associated information sheets, are coordinated by the Office of Research and approved by the USCHREC. Draft Guidelines and information sheets can be approved by the USCHREC Chair and then used for ethical review purposes, but must then be ratified by the HREC. Approved Guidelines are to be available in PDF format from the University’s portal.
Human Research Ethics Procedures means the University of the Sunshine Coast Human Research Ethics Procedures. This outlines procedures and forms to be used by ethics review bodies at the University when considering an application for ethics review and all other issues relating to the design and conduct of research involving humans, including the monitoring of this research. Additions or changes to the Procedures are approved by the Manager of the Office of Research, with consultation as appropriate with the HREC Chair.
USCHREC means the University of the Sunshine Coast Human Research Ethics Committee. The composition, Terms of Reference and Operating Guidelines of the USCHREC are in accordance with the National Statement. The USCHREC has a very important role in the University's human research ethics arrangements, but is not solely responsible for the efficient, timely and quality operation of those arrangements, as this is also a key function of the Office of Research.
4. Policy statement
4.1 Ethical principles in the design of research
All University research must be designed with an awareness of the ethical principles outlined by the National Statement and the guidance material contained in the University's Human Research Ethics Guidelines and associated information sheets. These principles and guidance material must be used in a thoughtful and project-specific manner, which is relevant for the research topic, potential participant pool, risks and ethical sensitivities. In many cases this requires a reflective balancing of imperatives, but the University expects that all researchers must: strive to safeguard the welfare, safety and interests of participants; only conduct human research when they have the requisite skills, experience, resources and facilities; and base research designs on a thorough review of the literature (where it exists) and sound methodology. Rather than simply 'following the rules' University researchers must regard these expectations as a key factor in establishing the quality of their work.
4.2 Ethical review
All University human research must be submitted to the USCHREC Secretary for prior ethical review via one of five pathways. These five ethical review pathways are:
Prior Ethical Review PR - Research already approved by another research ethics committee, where ethical clearance is sought through the completion and submission of a short covering form, along with the application considered by the other committee and the review decision of that committee. This paperwork is reviewed administratively within the Office of Research.
Expedited Ethical Review Level 1 (Negligible Risk) E1(NR) - Research involving no more than negligible risk, where ethical clearance is sought through the completion and submission of a Proportional Review Checklist (see below), and is reviewed administratively within the Office of Research.
Expedited Ethical Review Level 1 E1 - Research involving no more than low risk, and there are no significant ethical issues to explore. Ethical clearance is sought through the completion and submission of a Proportional Review Checklist, and is reviewed executively by the Chair of the USCHREC (see below).
Expedited Ethical Review Level 2 E2 - Research involving no more than low risk, and there are some significant ethical issues to explore, but these are adequately addressed by the research design. Ethical clearance is sought through the completion and submission of a Proportional Review Checklist and is reviewed executively by a panel of the USCHREC.
Full Ethical Review FR - Research that does not qualify for review by PR, E1 (NR), E1 or E2, or where the National Statement specifies that the category of research must be reviewed by a human research ethics committee. In these instances, ethical clearance is sought through the completion and submission of a National Ethics Application Form and is reviewed by the USCHREC.
This ethical review is to be timely, efficient and transparent. The review must be based upon the content of the National Statement, using ethical principles outlined in the University Human Research Ethics Guidelines, and the qualifying criteria and processes outlined above and in detail in the University Human Research Ethics Procedures.
The conduct of the review should be collegiate, with the aim of facilitating research, not only policing compliance with rules. Where clarification / elaboration, modification, or a major change in approach is required, and it is considered useful and appropriate, this must be directly referenced to the National Statement and/or University Human Research Ethics Guidelines, and helpful guidance provided as to useful approaches to the feedback from the reviewers.
All University human research must then be approved in writing through an approved pathway prior to the commencement of the research.
4.3 Ethical conduct of research
The conduct of human research must comply with the protocol approved by the ethical review process, and adhere to the National Statement and the University Human Research Ethics Guidelines. The conduct of the research must follow any special conditions stipulated by the ethical review, as well as any standard conditions established by the University for all research. This is a key responsibility of the University's researchers.
All members of a research team have shared responsibility for the ethical conduct of research, and must be aware of, and satisfied with, the degree to which the conduct of the research meets the national requirements and University policy. This includes an expectation that research supervisors are fully aware of, and have shared responsibility for, the conduct of the research by the students they supervise.
With respect to the treatment of human participants, the Human Research Ethics Committee and the Office of Research have a role in monitoring that all research is conducted according to approved research protocols, and in accordance with relevant University and external policies.
4.4 Administrative procedures
The University Human Research Ethics Procedures codifies the University's approach to matters such as: the duration of clearances; renewals; ethical conduct reports; audits; complaints from participants, allegations of breaches of ethical standards, or researcher appeals; variations to approvals; and other related procedural matter.
The University's approach to such matters is proportional to the risks and sensitivities of the research. Where appropriate the University makes use of administrative, executive and other 'out of committee' procedures to handle these matters.
The USCHREC must provide the Academic Board, via the Research Committee, with a copy of its annual report in the format specified in the Committee’s Terms of Reference. The Chairperson of the HREC is invited to attend the Research Committee to present the annual report.