Human Research Ethics - Procedures

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Human Research Ethics - Procedures

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Approval authority
Deputy Vice-Chancellor (Research and Innovation)
Responsible officer
Deputy Vice-Chancellor (Research and Innovation)
Designated officer
Director, Office of Research
First approved
16 August 2017
Last amended
18 August 2017
Effective start date
18 August 2017
Review date
16 August 2022
Status
Active
Related documents
Conflict of Interest - Governing Policy
Enterprise Risk Management and Resilience - Governing Policy
Human Research Ethics - Governing Policy
Research - Academic Policy
Research Data and Materials - Procedures
Research Misconduct - Governing Policy
Research Misconduct Allegations and Investigation - Procedures
Staff Code of Conduct - Governing Policy
Student Conduct - Governing Policy
Related legislation / standards
Australian Code for the Responsible Conduct of Research (2007)
National Statement on Ethical Conduct in Human Research (2007)
Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Re

Definitions

Please refer to the University’s Glossary of terms for policies and procedures. Terms and definitions identified below are specific to these procedures and are critical to its effectiveness.

Australian Code means the Australian Code for the Responsible Conduct of Research, which was developed jointly by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia.

Ethical review means the prior review of proposed research, with regards to its adherence to the National Statement and Human Research Ethics Guidelines.

Ethical values and principles means the values and principles that the National Statement on Ethical Conduct in Human Research indicates need to be addressed in the design, ethical review and conduct of human research. These are: research merit and integrity; respect; beneficence; and justice.

Human research means any research activity with or about human participants, including their data or tissue. This covers, but is not limited to, anonymous surveys, observation of public behaviour, interviews, focus groups, behavioural tests, action research, exercise testing, exploration of sensitive personal behaviour and attitudes, clinical research, and clinical trials.

Human Research Ethics Guidelines is a USC resource for researchers that outlines the University's interpretation and implementation of the National Statement, and provides a transparent policy basis for the conduct of ethical review. The guidelines are available on MyUSC for staff, and on Blackboard for research students.

National Statement means the National Statement on Ethical Conduct in Human Research 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).

Low risk means the only foreseeable risk is one of discomfort.

Negligible risk means no foreseeable risk of harm or discomfort, and any foreseeable risk is of inconvenience only.

Research means the creation of new knowledge and/or the use of existing knowledge in a new and creative ways to generate new concepts, methodologies and understandings. This could include synthesis and analysis of previous research to the extent that it leads to new and creative outcomes.

1. Purpose of Procedures

This document outlines the processes associated with ethical review and is to be read in conjunction with the Human Research Ethics – Governing Policy and the Human Research Ethics Guidelines.

This procedure applies to all USC staff and students who conduct human research under the auspices of the University. It also applies to the USC Human Research Ethics Committee (USC HREC) and all staff involved in the ethical review of proposed research and related protocols.

2. Human Research Ethics Committee

2.1 The USC Human Research Ethics Committee (USC HREC) is the prime body within USC that has overall responsibility for implementing the stated purpose of the Human Research Ethics - Governing Policy.

2.2 The HREC terms of reference and operating guidelines have been developed in accordance with the National Statement.

2.3 The HREC plays an 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.

3. Outside of scope activities

3.1 Activities that are outside the scope of the University’s human research ethics arrangements do not need ethical review or approval. However, researchers may choose to request written confirmation that a specific activity is outside of scope. In such cases, researchers should complete an Outside of scope request form for review by the Office of Research. See guideline 17 (Determining whether your work needs ethics approval) of the Human Research Ethics Guidelines for more information.

4. Ethical review pathways

4.1 Human research activities must not commence until written approval has been granted. In addition to the need for ethics approval, a project may be subject to other internal or external approvals before human research can commence. For example, a safety specific risk assessment or gatekeeper approval. See guideline 19 (Research requiring approval/agreement of other bodies or organisations) of the Human Research Ethics Guideline for more information.

4.2 Ethics approval is required for the time that participant recruitment and data collection is occurring. Ethics approval is normally granted for up to three years, unless the project is subject to a longer grant. Researchers may request a longer approval timeframe, but should provide appropriate justification.

4.3 Generally, chief investigators must be USC staff members, not students or external researchers. In the case where a USC student or external researcher has been approved as the chief investigator by another review body, and approval by USC is sought via the prior ethical review pathway, the student or external researcher may remain listed as the chief investigator.

4.4 Generally, applications must be accompanied by other relevant documents, such as research project information sheets, consent forms, data collection tools, evidence of research merit, and letters of endorsement. Where relevant, the inclusion of these attachments will be prompted by the form or cover sheet.

4.5 Applications requiring full ethical review must be submitted at least three weeks prior to the HREC meeting. Applications eligible for review via another pathway can be reviewed and approved at any time, and will be ratified by the HREC at the next meeting.

4.6 Except for human research activities that are out of scope or exempt, all human research conducted under the auspices of the University must be submitted to the Office of Research for ethical review via one of the below six pathways.

Exemption – for negligible risk research that only involves access to existing collections of non-identifiable data or records about humans, an Exemption request cover sheet must be used to request an exemption from ethical review and approval, and will be reviewed administratively within the Office of Research. See guideline 16 (Negligible risk research involving use of existing collections of non-identifiable data about human beings) of the Human Research Ethics Guidelines for more information.

Prior ethical review (PR) - for research that has already been granted ethics approval by another ethical review body. For this option, review is via the Prior ethical review cover sheet, along with the application documentation considered by the other ethical review body and evidence of their ethics approval. Generally, this is reviewed administratively within the Office of Research and ratified by the USC HREC, except where an application involves a clinical trial, in which case it will be reviewed by the USC HREC Chairperson and ratified by the USC HREC.

Expedited ethical review level 1 (negligible risk) - E1(NR) - for research involving no more than negligible risk. For this option, review is via the Low risk ethics application form (and relevant attachments) and is reviewed administratively within the Office of Research and ratified by the USC HREC.

Expedited ethical review level 1 (E1) - for research involving no more than low risk and there are no significant ethical issues to explore. For this option, review is via the Low risk ethics application form (and relevant attachments) and is reviewed by the USC HREC Chairperson and ratified by the USC HREC.

Expedited ethical review level 2 (E2) - for research involving no more than low risk, where there are some significant ethical issues to explore, but these are adequately addressed by the research design. For this option, review is via the Low risk ethics application form (and relevant attachments) and is reviewed by a panel of USC HREC members and ratified by the USC HREC.

Full ethical review (FR) - for research that does not qualify for any of the above pathways, or where the National Statement specifies that the category of research must be reviewed by a HREC. For full review, applicants must submit a Human Research Ethics Application (HREA) form (and relevant attachments), which is reviewed by the USC HREC.

5. Research merit

5.1 Evidence of research merit needs to be provided before ethics approval can be granted for new projects.

5.2 Research merit can be established through peer review, the award of funding through a competitive funding process, confirmation of candidature by a higher degree by research student, or prior ethics approval from an appropriate body.

5.3 Evidence of peer review should be provided using the Peer review checklist.

6. Amendments to approved projects

6.1 Amendments to approved projects require written ethics approval. Amendments may be granted ethics approval via one of the six pathways outlined in section four of these procedures.

6.2 The appropriate pathway will be determined by the level of risk associated with the amendment rather than the original ethical review pathway for the project. See guideline 6 (Amending an ethics approved project) of the Human Research Ethics Guidelines for more information.

6.3 An amendment can be requested via the Amendment request cover sheet. Revised versions of all relevant application documentation will also be required. All changes should be clearly tracked (using track changes) or highlighted.

6.4 Amendments requiring full ethical review must be submitted at least three weeks prior to the HREC meeting. Amendments eligible for review via another pathway can be reviewed and approved at any time, and will be ratified by the HREC at the next meeting.

6.5 The amended protocol must not commence until written ethics approval has been granted.

7. Projects involving more than one institution or HREC

7.1 Where USC staff and/or students are formally involved in collaborative human research, ethics approval must be granted via one of the six ethical review pathways listed in section 4 of these procedures.

7.2 If the research project has been reviewed and approved by another ethical review body, USC ethics approval may be granted via the prior ethical review pathway, unless the ethical review was not in line with the requirements of the National Statement or the ethical review body that previously granted approval will no longer be involved in monitoring the project. In these cases, USC ethics approval will need to be granted via one of the other ethical review pathways outlined in section 4 of these procedures. See guideline 8 (Research approved by another HREC) of the Human Research Ethics Guidelines for more information.

8. Monitoring human research activities

8.1 Researchers must submit annual and final reports using the Annual/final report form.

8.2 Annual reports are due annually from the date of ethics approval, but the HREC may request these on a more frequent basis, if required.

8.3 A final report is due as soon as data collection is complete, ethics approval has expired, or the project has been discontinued.

8.4 Reports for projects originally approved via the full review pathway must be reviewed by the HREC.

8.5 Reports for projects originally approved via an expedited pathway may be reviewed by the Office of Research, unless departure from the approved protocol, an adverse participant experience resulting from the research, non-compliance with the conditions of approval, or unforeseen ethical issues are reported, in which case the HREC Chairperson must review the report. See guideline 3 (Ethics responsibilities of USC researchers) of the Human Research Ethics Guidelines for more information.

8.6 Compliance may also be monitored by any other means deemed necessary or appropriate, such as random audits. See guideline 5 (University monitoring procedures) of the Human Research Ethics Guidelines for more information.

9. Standard operating procedures

9.1 Standard operating procedures (SOP) for processes likely to be relevant to more than one ethics application may be documented and submitted to the HREC for approval. New SOPs and amendments to approved SOPs must be approved by the HREC before implementation.

9.2 Once approved, SOPs may be referenced in a Human Research Ethics Application. The use of a HREC approved SOP does not negate the need for human research ethics approval.

9.3 The HREC may grant a maximum three-year approval for a SOP to be used in human research activities. The HREC will only approve the use of a SOP in a research project when it is satisfied that each researcher or other person who implements all or part of a proposed SOP has the necessary expertise and competency to do so.

9.4 A register of approved SOPs will be maintained by the Office of Research and made available to researchers.

10. Adverse events

10.1 Researchers must report unexpected or serious adverse events to the USC HREC within one working day of the event occurring using the Adverse event report. See guideline 3 (Ethics responsibilities of USC researchers) of the Human Research Ethics Guidelines for more information.

10.2 In cases where a researcher is not able to complete the relevant form within one day of the adverse event occurring, they should report the event to the Office of Research by another means, such as email or phone, until such time they can submit the relevant form.

11. Complaints and non-compliance

Complaints and non-compliance are managed in accordance with the Australian Code, the National Statement and where appropriate the Research Misconduct – Governing Policy and related procedures.

11.1 Complaints about human research

Where complaints are made about projects that would normally require ethics approval, the USC HREC Chairperson is authorised to review the matter. The Chairperson may refer such complaints to the full HREC or to the Office of Research as appropriate. If complaints relate to activities that may have unexpected adverse effects, ethics approval may be withdrawn or suspended.

11.2 Non-compliance with ethical review decisions

Any non-compliance with ethical review or HREC decisions should be reported to the HREC Chairperson. The Chairperson then considers appropriate actions, and may refer the non-compliance to the HREC or to the Office of Research as appropriate.

11.3 Complaints about HREC review process

Where complaints concerning the HREC review of a human research application, amendment, or report cannot be resolved by communication between the complainant and the HREC, the Office of Research is authorised to receive complaints in writing. The Office of Research will consider the complaint, seeking further advice internally and/or externally as appropriate. The Office of Research will respect the privacy and confidentiality of the complainant and only engage other parties on a need to know basis. If justified, the Office of Research may request that the HREC review its process in reaching its decision on a project and consider re-evaluating its original decision.

11.4 Complaints about the merit of the HREC decision

The ultimate decision regarding the ethical acceptability of human research lies with the HREC and cannot be overridden. Researchers who disagree with a HREC decision are welcome to provide their reasons to the HREC Chairperson, and resubmit a revised application for further ethical review. Researchers should be assured that submitting complaints about the merit of a HREC decision can be done so confidentially and will not affect any future ethics applications.

END

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