Frequently Asked Questions

• Human Ethics at the Australian National University

• ARIES Human ethics

 

Human Ethics at the Australian National University

Q1: 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 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. Human Ethics applications are considered in disciplines as diverse as anthropology, history, epidemiology, psychology and sociology.

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Q2: 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.

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Q3: 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.

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Q4: 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 applications after they have completed their proposal seminar and been given permission to commence fieldwork.

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ARIES Human Ethics

Q5: How does the on-line review system work?

A: A three-level classification of ethical risk is used to simplify the preparation and ethical review of protocols, and to streamline the ethical review of low-risk protocols. To assist in the system, and also to improve the efficiency of administration, the ANU has an on-line application form in the ANU Research Enterprise System ARIES. The system draws from an approach to ethical review that has been used successfully at Griffith University for a number of years.

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Q6: What are the three levels?

a. Low-risk protocols E1 (Expedited Level 1 – E1) engage participants only in activities that they would encounter in normal everyday life.

b. Low-risk protocols E2 (Expedited Level 2 – E2) engage participants who are fully competent and not vulnerable in research settings that are relatively benign - not what the participants would encounter in everyday life.

c. High-risk protocols (Full review - F) engage participants who are in some way vulnerable, or research settings that are particularly unusual or uncomfortable.

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Q7: 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.

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Q8: How will ethical review occur in the new system?

a. Low-risk protocols (Level E1) will be reviewed and approved by the Chair or the deputy chair of the ANU Human Research Ethics Committee.Depending on the discipline your research falls under, a low-risk protocol will normally entail no requests for adjustment. If no adjustment is requested, a low-risk protocol normally will be approved within 5 working days of submission.

b. Low-risk protocols (Level E2) will be considered and approved by one of 2 Sub-Committee of the ANU Human Research Ethics Committee.

c. High-risk protocols (Full review) will be considered and approved by the ANU Human Research Ethics Committee.

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Q9: How does the on-line application form work?

A: The 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.

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Q10: This sounds complicated. How can I get help?

A: The office of Research Integrity has weekly training in the ARIES system which you can register for. you may also contact the Office of Research Integrity for assistance.

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Q11: 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.

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Q12: How can I get a paper copy of my application?

A: After you have submitted your application electronically on the ARIES system you will be able to print a copy of your application as a word document on your local printer.  You will then need to obtain the necessary signatures, and also provide the appropriate documents and extra copies if needed, then deliver these hard copies to the Research Office for processing.

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Q13: 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; 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.

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Q14: What do I need to do if I have to make a change to the protocol after it has been 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.

ARIES Variation Request Quick Guide

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Q:15 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.

ARIES Variation Request Quick Guide

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Q16: 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 ANU researcher named on a protocol can edit the application within the system.  This means that data entry may be collaborative as soon as the names of the researchers are entered. It is not 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.

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Q17: 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.

ARIES Monitoring Quick Guide

 

Q18: 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.

ARIES Monitoring Quick Guide

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Q19: Can I still use the paper form?

A; From 1 September 2007, all data entry will be done online only.  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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Q20: 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.

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Q21: What do I do when my data collection has been completed?

A: Human Ethics protocols are deemed to be complete when the data collection phase of the research project is completed. You can advise the Ethics Office of the completion of your data colection 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.

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