Research Office
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Research Office
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Frequently Asked Questions
Human Ethics at the Australian National UniversityQ: Does the new National Statement on Ethical Conduct in Human Research require many changes at ANU?A: Whilst the framework for ethical consideration remains essentially unchanged in the new National Statement, there are many changes in relation to particular issues and emphases. The new National Statement also allows a more flexible approach to ethical review. The ANU Human Research Ethics Committee (HREC) will oversee the introduction of a new approach to ethical review of human research at ANU in the light of the new National Statement.
Q: Why is ethical review needed for research involving humans?A: Awareness of the need for ethical codes in research stems in large part from the evidence of the horrendous medical experiments conducted by the Nazis during the Second World War and the findings of the Nuremberg military tribunal on war crimes. In Australia the National Health and Medical Research Council has taken responsibility for developing a code of ethics in research. In 1999, following a wide-ranging process of consultation including the learned Academies, the NHMRC, in conjunction with the Australian Vice-Chancellors’ Committee, issued a set of national guidelines on ethics in human research. These guidelines, the National Statement on Ethical Conduct in Research Involving Humans, were tabled in federal Parliament in July 1999 and are intended to cover all disciplines. The primary purpose of the National Statement is the protection of the welfare and rights of participants in research. The National Statement mandates the establishment of human research ethics committees to review all research projects involving human participation. The Australian National University established its Human Research Ethics Committee (HREC) in 1986 (then known as the Ethics in Human Experimentation Committee, reflecting the medical and health focus of the NHMRC guidelines at the time). The HREC considers the ethical implications of proposals for human research in all disciplines. Protocols (as ethics applications are known) are considered in disciplines as diverse as anthropology, history, epidemiology, psychology and sociology.
Q: What should be reviewed by the HREC?A: The National Statement attempts a definition of research (pp.6-8). It makes clear that quality assurance or audit activities do not fall within the definition of research and do not need to be reviewed by the HREC. A useful way of clarifying what constitutes quality assurance as opposed to research is to ask what the outcome is likely to be. If publication (in a thesis or other form) is envisaged, then the project is almost certainly research. If the project is in-house, for the purposes of refining procedures, then it is quality assurance or audit activity. If in doubt, please contact the Ethics Office.
Q: Who should apply for human ethics clearance?A: Research projects being undertaken by staff, visiting fellows, postgraduate and graduate student and Honours level undergraduate students are reviewed by the HREC. Undergraduate projects below Honours level are deemed to be training, and are not reviewed by the HREC. Only the thesis component of Honours level work is reviewed by the HREC.
Q: When should I start thinking about ethics clearance?A: Obtaining ethics clearance is a time consuming process and allowance for this needs to be built into research plans. It can take months, for example, if your proposal has to go to the main ethics committee and the committee asks for some amendments. If you think your proposed research will need ethics clearance, you should start the process by reading The National Statement on Ethical Conduct in Research (2007) and consider the implications for your research. PhD students should submit their ethics protocol after they have completed their proposal seminar and been given permission to commence fieldwork.
Q: How do I apply for human ethics clearance?A: The Human Research Ethics Committee (HREC) works on a monthly cycle. Applications (protocols, as they are known) need to reach the Secretary by close of business on the first working day of the month in order to be considered at the committee meeting later that month. To start the application process, register for the next ARIES training session.
Q: What do I need to do if I need to make a change to the protocol application that was approved?A: As Research Projects evolve variations to the original protocol can occur. Please notify the Committee of any changes to your protocol in the course of your research, this can be done by submitting a variation request from the Variation tab of your protocol in ARIES.
Q: Why do I have to fill out a monitoring report?A: Under the NHMRC ethical guidelines,the National Statement on Ethical Conduct in Human Research (2007), research projects that have received ethical clearance from the ANU HREC will need to provide a brief report on any ethical issues which may have arisen during your research and whether it proceeded according to the plan outlined in the above protocol. To minimise disruption to your ongoing research activities, the Ethics Office will send a reminder email at regular intervals to submit your report using the monitoring tab in ARIES.
Q: How long is my protocol valid for?A: The validity of approval for a protocol is five years' maximum from the date of approval. For longer projects you are required to seek renewed approval from the Committee.
Q: How do I know when my protocol is Complete?A: Human Ethics protocols are Complete when the data collection phase of the research project is completed. You can advise the Ethics Office of the completion of your protocol by submitting a final Monitoring report in ARIES. It is possible to re-open a completed protocol if further data collection is needed - please contact the Ethics Office in this instance.
ARIES Human EthicsQ: What is changing about the ANU’s Human Ethics Review?A: A new three-level classification of ethical risk will be used to simplify the preparation and ethical review of protocols, and to streamline the ethical review of low-risk protocols. To assist in the introduction of the new system, and also to improve the efficiency of administration, the ANU is introducing a new on-line application form in the ANU Research Enterprise System ARIES. The new system draws from an approach to ethical review that has been used successfully at Griffith University for a number of years.
Q: What are the three levels?
Q: How will I know which level applies to my research?A: The on-line application form is self-classifying in respect of the level of ethical risk, using desiderata derived from the National Statement. The form itself determines the amount of information required to assess and review the ethical risk of a project. Low-risk research involves a very simple form.
Q: How will ethical review occur in the new system?
Q: How will the on-line application form work?A: The new on-line form is part of the “Human Research Ethics Module” in the ARIES system. Researchers view the form using a browser, and complete the form on-line by entering answers to check boxes and/or text as requested. Partial entries may be saved for later addition, edit and review. When satisfied the researcher submits the completed proposal for administrative proceeding and ethical review.
Q: This sounds complicated. How can I get help?A: The ANU’s Animal Research Ethics Committee has been using a similar form for approximately a year, and the new Human Research Ethics form has benefited from this experience. Help is available through the Ethics Help Desk, the Ethics Office, Research Integrity Advisers, and local Ethics Experts.
Q: Why are there so many questions in the form?A: The form is designed to follow closely the patterns of ethical considerations set out in the National Statement. It mimics the National Ethics Application Form (NEAF). The form is “smart” and often you are asked questions only when your answers to previous questions have indicated that a particular ethical consideration applies to your research. If you encounter a lot of questions, it is likely that your research involves a variety of ethical considerations.
Q: How can I get a paper copy of my Protocol?A: After you have submitted your application on the ARIES system you will be able to print a copy of your protocol on your local printer. A hard copy will be used to obtain the necessary signatures and will be sent to Research Office for processing.
Q: How will I know when my protocol has been reviewed? How will I get feedback? How will I respond to feedback? How will I know when my Protocol has been cleared?A: You will receive an email at each important step, similarly to the present processes: when you submit your protocol, if your protocol requires revision or comment, and when your protocol is approved. Where required, you will respond by email to the sender and your responses will be saved within the ARIES system. You can view a field in the system that indicates the status of your protocol.
Q: How do I request a variation to a protocol? What if the protocol was approved under the old system?There is a Variation Tab in the new system, into which you enter your request. Protocols approved under the old system will have their title, relevant dates and status migrated to the new system. If you wish to vary an old protocol, enter the system, find your record using a title search, and use the Variation Tab to enter your request for variation.
Q: I have collaborators at ANU. Can they help me to fill in the form? What about colleagues at other universities – can they see the form and help me fill it out?A: Any person named on a protocol can edit it within the system. This means that data entry may be collaborative as soon as the names of the researchers are entered. While it is technically possible to allow researchers from other universities to enter data into the ANU ARIES system, it requires that they be registered as affiliate researchers within the ANU IT registration system. This is slightly fiddly, but if required the Research Office staff will do this for you.
Q: How do I file a monitoring report? What if the original protocol was submitted using the paper form?A: Monitoring reports will be submitted on-line. Protocols approved under the old system will have summary data relating to title, relevant dates and status migrated to the new system. You will complete your monitoring report by searching on title or protocol id, and entering data into the Monitoring tab.
Q: Can I still use the paper form?A; From 1 September 2007, all data entry will be done online. The ARIES system is accessible from the Internet so an application may be entered by an ANU staff member or student from anywhere in the world. If data entry poses difficulties staff from your local areas or from the Research Office will help you. 
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Page last updated: 17 June 2009 Please direct all enquiries to: Research Office Page authorised by: Director, Research Office |
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