Ethical Review of Research
All research which involves human interaction, access to human tissue and/or identified personal information that is not already on the public record must routinely undergo ethical review by the Adventist HealthCare Limited Human Research Ethics Committee prior to commencement.
Research activities that require ethical review include, but are not limited to the following:
Testing or treatment
The ethical review process incorporates all aspects of research governance to ensure that human research within Adventist HealthCare Limited meets appropriate standards of quality, safety, privacy, risk management, financial management and ethical acceptability. Retrospective ethical approval will not be granted. Our Guide to Submitting Research for Review outlines the procedure for applying ethical review to research.
Why It Is Important To Submit A Research Proposal For Ethical Review
Ethical review of research is important for a number of reasons. Firstly, Adventist HealthCare Limited is committed to the highest ethical standards in research and upholds the rights and interests of patients and participants in research. A breach of the Hospital’s Research Policy may be considered research misconduct with potential for serious disciplinary action.
Secondly, the ethical review process provides a mechanism for risk management. Ethical approval of research is a requirement for Adventist HealthCare Limited to be eligible for funding grants, to be indemnified by sponsors of research and for the research team to be indemnified.
Thirdly, ethical review is required by many academic journals before publication of an article.
Fourthly, submitting a research proposal for ethical review provides a source of advice on a range of ethical and regulatory issues that should assist with the design and conduct of individual research projects.
Student Research & Research Ethics
All research conducted under the auspices of Adventist HealthCare Limited must be submitted for prior ethical review. For example, a student who conducts research as partial fulfilment of an academic degree must submit the research for ethical review. Similarly, a student who will conduct their research overseas, as part of their research program, must submit the research for ethical review, even though the research will occur outside of Australia.
In the case of student research the primary supervisor is considered the Principal Investigator. The student is named as a member of the research team and has shared responsibility for the ethical conduct of the research, but it is the primary supervisor who has primary responsibility for the ethical conduct of the research.
In practice, the student may be listed as the Contact Person on an Application for Ethical Review which means they will be the main correspondent about the application. The primary supervisor must ensure that the application is of an appropriate standard, that any matters relating to ethical review are resolved in a timely manner and the research is conducted as approved, that the Human Research Ethics Committee (HREC) is notified of any changes to the project and reporting requirements are complied with.
Ongoing Ethical Conduct Of Research
Receiving ethical approval for the conduct of research is only the beginning of the ethical review process. It is the researcher’s responsibility to maintain a reflective approach to ethical issues throughout every stage of the research to ensure ongoing ethical acceptability of the research through to its conclusion. The researcher is required to notify the HREC of any changes to the project and must comply with the terms and conditions of approval imposed by the HREC. The HREC monitors the conduct of the research through to its conclusion. Researchers are required to submit progress reports, requests for amendments to approved protocols, immediate reporting of sudden adverse events and suspected, unexpected, serious adverse reactions and may be subject to audits of the research site.
Fees are payable for submitting an Application for Ethical Review. Where an application requires submission of a Site Specific Assessment Form, a fee for Governance Review may be payable in addition to the fee for Ethical Review. The fees are outlined in our Fee Schedule.
A Tax Invoice will be issued upon receipt of the application. Fees are non-refundable, even if an application is unsuccessful or is withdrawn prior to consideration or determination by the Committee.
When granting ethical approval for a research project, the Committee identifies the required terms of approval which include regular reporting and monitoring. It is a condition of approval that an Annual Report is submitted every twelve months from the date of approval; that a Final Report is submitted at the conclusion of the project; and access is available to the Committee upon request.