Research Office
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Research Office
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Human Ethics
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 Nationall Statement was reviewed in 2007 and released as the National Statement on Ethical Conduct in Human Research (2007). 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.
The National Statement attempts a definition of research. 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, inquiries can be sent to the HREC as per the contact details below.
A researcher based at the Canberra Hospital who is also affiliated to the ANU will need to obtain ethics clearance both from the ACT Health HREC and from the ANU HREC.
If you are a researcher (from any college) conducting a clinical trial involving a drug or device, it will need to be assessed by the ACT Health HREC Clinical Trials Committee before being assessed by the ACT Health HREC and the ANU HREC. If you are conducting a clinical trial not involving a drug or device within the ACT Health system, it will need to be assessed by the ACT Health HREC. In both situations, once clearance is received by the ACT Health HREC for the clinical trial, please submit your application to the ANU HREC. If you are conducting a clinical trial that does not involve a drug or device or is conducted within the ACT Health system, please submit your application direct to the ANU HREC. http://health.act.gov.au/c/health?a=da&did=10051705&pid=1054022557
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.
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. Click here for Application Deadlines and Committee Meeting Dates.
Applications should be submitted as follows:
The National Statement mandates a minimum membership of an HREC as: a chairperson, at least two lay members, one man and one women, who have no affiliation with the university, at least one member with knowledge of and current experience in the areas of research regularly considered by the HREC, at least one member with knowledge of and current experience in the professional care, counselling or treatment of people, at least one member who is a minister of religion or Aboriginal elder or similar, and a lawyer. The current membership of the ANU’s Human Research Ethics Committee is listed below. All inquiries and correspondence with the committee should be directed to the Secretary, as follows:Mailing address:Secretary (Human Ethics Officer) Human Research Ethics Committee Research Office Chancelry 10B The Australian National University ACT 0200 Telephone: 02-6125-7945 Fax: 02-6125-4807 Email: Human Ethics Officer
Before applying researchers should familiarise themselves with the National Statement on Ethical Conduct in Research Involving Humans (2007). See below for guidance on particular issues.
Informed consent is a key ethical requirement. Participants must understand what the research involves and what will be done with their data before they consent to take part (see the National Statement). The usual way to obtain informed consent is in writing, by use of a consent form that is signed by the participant and retained by the research as a record of the agreement.Because the researcher retains the consent form there needs to be an information sheet for participants to keep, with the same details. Both the consent form and the information sheet should include the researcher’s name and contact details, the title and brief description of the project, details on how the identities of participants will be protected (both when storing the raw research data and in its published form), a statement that participation is voluntary and participants can withdraw at any time, and provision for signature and date. The Information Sheet and Consent FormThey should mirror each other – the Information Sheet is left with participants and the researcher takes the signed consent form. The following information should be included: The information sheet should include contact details for the Human Research Ethics Committee in case of any ethical concerns (see the National Statement). Any special provisions should also be included, e.g. agreement to the use of audio and/or videotapes, with details about how these will be stored and handled. Generally speaking the HREC prefers that written consent be obtained. However in some cases, e.g. with illiterate participants or in particular cultural settings, it may not be possible to seek written consent. If researchers do not propose to seek written consent, they need to explain to the HREC in their submission why oral consent will be sufficient and how they propose to obtain it. This should include a list of the points that will be made in order to obtain informed consent. If possible in such situations the HREC asks whether it might be possible to have a witness present during the oral consent process. Even where consent is obtained from people in positions of authority, e.g. village elders, community groups etc., individual consent from each participant should still be sought in principle. In the case of off-shore fieldwork, where it can be difficult for participants to contact the researcher or the HREC after the researcher’s departure, the HREC asks whether it is possible to have a local agency or individual who could serve as a first point of contact for inquiries or complaints after the researcher has left the area. Tear-off slips at the bottom of an information sheet are not adequate as consent forms. The consent form should provide the same details as the information sheet. They should be on separate pages. It may be possible to dispense with the need for a consent form in the case of questionnaires, where return of the questionnaire can be deemed to constitute consent. This can be done with low-risk anonymous questionnaires. However if the questionnaire is actually or potentially identifiable the HREC prefers a written consent form, which can be separated from the questionnaire immediately upon its return so that no link is possible between the consent form and the questionnaire in most cases. Participants should be told in the information sheet and consent form that this separation will take place. Consent to a child’s or young person’s participation in research must be obtained from: (a) the child or young person whenever he or she has sufficient competence to make this decision; and either (b) the parents/guardian in all but exceptional circumstances; or (c) any organisation or person required by law. Copies of the consent form and information sheet should be attached to the application. The application should provide full details on how consent will be obtained. Example Information Sheet and Consent Forms and Oral Consent Scipt
Provided that a privacy statement (i.e. warning) is prominently displayed, completion of the survey can be deemed to constitute consent. See below, under Privacy and the Internet.
The HREC needs to know how the researcher will address the issue of confidentiality, i.e. how the identities of participants will be protected in the raw research data and in any published material. Researchers must ensure that the privacy of their participants is adequately protected. The Australian National University is the only tertiary institution established under federal legislation and so is bound by the provisions of the Commonwealth Privacy Act 1988. Of specific relevance are its 11 Information Privacy Principles (IPPs) that form Appendix II of the National Statement. The IPPs detail the requirements for collection, storage, use and disclosure of personal information. The term “anonymous” is sometimes used incorrectly by researchers when they mean that identities will be suppressed in published material. If individuals are identified or potentially identifiable in the raw research data, then it is not accurate to refer to them as “anonymous”, even if they are not identified in any publications. In the consent form and information sheet researchers need to explain to participants how their privacy will be protected. Blanket guarantees of confidentiality (e.g. assurances of “strict confidentiality”) are not helpful. If the term “confidential” is used in information provided to participants, a full description of what precisely confidentiality means in the context of a given research project should be given. Researchers should be aware that, under Australian law, any data they collect can potentially be subpoenaed. Depending on the nature of the research, it may be helpful to qualify promises of confidentiality with terms such as “as far as possible” or “as far as the law allows”.
Increasingly the web is being used for surveys, but that raises particular privacy concerns. The Office of the Federal Privacy Commissioner has issued Guidelines for Federal and ACT Government Websites. These guidelines indicate the widespread concern among net users about a lack of transparency regarding the use and disclosure of personal information by websites, the tracking of individuals’ activities at websites and concerns about the security of their information in the Internet environment. The Privacy Act requires that a person be given details about what information is being collected, what purpose the information is being collected for, how the information will be used and if the information is to be disclosed, to whom it will be disclosed. It is important that a person be given sufficient information to enable them to make a decision about whether or not they wish to participate in the project. Apart from the ethical issues involved, the HREC requires that any email or web-based questionnaire must include a privacy statement in order to meet the requirements of federal, State and Territory privacy legislation. The following is needed: The privacy statement or warning for potential respondents must be prominently displayed with any web-based survey, usually on the same page as the questionnaire or prominently linked to it. Researchers using this methodology must familiarise themselves with the Office of the Federal Privacy Commissioner’s Guidelines for Federal ACT and Government World Wide Websites. If the survey is located on the ANU website, there should also be a hyperlink to the ANU’s own privacy statement and its information on security provided. At a minimum it should include the following information:
PRIVACY STATEMENT Security of the website Users should be aware that the World Wide Web is an insecure public network that gives rise to a potential risk that a user’s transactions are being viewed, intercepted or modified by third parties or that data which the user downloads may contain computer viruses or other defects. Purpose of data collection This information is being sought for a research project entitled (TITLE). The researcher is (NAME AND CONTACT DETAILS, including ANU location). The project aims to (BRIEF DESCRIPTION OF PROJECT AIMS). The information you provide will only be used for the purpose for which you have provided it. It will not be disclosed without your consent. Security of the data The data will be kept secure by (DESCRIBE METHODOLOGY IN BRIEF). At the completion of the research project the data will be (DESCRIBE HOW THE RAW DATA WILL BE KEPT, FOR HOW LONG, AND WHAT WILL HAPPEN WITH PUBLISHED DATA) [e.g. will names be used, or other identifying details?] As the web can be an insecure medium you may choose to complete this survey by [provide alternate methods, e.g. telephone or mailout. If any security measures are being used, then provide information about these.] Link to ANU website’s disclaimer and privacy statement [to be included if your survey is located on the ANU website] You can view the ANU’s privacy statement.
Details on how participants will be recruited should be included with the application. In particular researchers should be aware that initial contact may have to be at arm’s length if the personal contact details of potential participants are held by another person or agency. They could be in breach of privacy legislation if they release these details without the consent of the person whose information is held. In such cases the initial approach by the researcher should be made on their behalf by the holder of the data, e.g. by sending on a letter of invitation. Once the person responds to the researcher indicating their willingness to be contacted the researcher can contact them directly. A copy of that letter of invitation/flier etc. should be included with the application. The possibility of coercion must be avoided when seeking research participants (see the National Statement). This can be a particular concern where the researcher may be in a position of power relative to the potential participants, e.g. teacher/pupil relationship, or within a hierarchical organisation such as the military. The researcher should make clear to both the HREC and to participants that they will not be adversely affected in any way if they choose not to participate. When there can be a potential conflict of interest, e.g. where the researcher is also offering therapeutic or other services to potential participants and is consequently in a position of power vis-à-vis participants, the HREC has found a useful way of handling is by the “blind” method. In this case the consent and the data are gathered from the participants by using someone else, rather than the researcher. That way the researcher does not know who among their clients has chosen to take part and which clients have declined. This "blind" method ensures that there can be no imputation of coercion and redressed the client/researcher power imbalance. An example of this process in one particular protocol is as follows:
If research is to be conducted with students in government schools then permission must be sought first from both the relevant Department of Education and the individual schools through the principal. In the case of private schools the permission of the principal may suffice. ACTThe Department of Education and Training welcomes research in its schools but requires that all research activity must conform to the Department’s Research in Government Schools Information and must be approved in accordance with them. This document describes the approval procedures, the criteria for approving applications and the documentation that needs to be provided when seeking approval to undertake research in ACT Government Schools. The Department has an obligation to ensure that research is carried out in an ethical manner and therefore assesses all research projects intended for schools. Students’ and teachers’ privacy must be protected and the research must be appropriate to the school environment and students’ age. Parent/carer consent must be obtained for all research involving students under the age of eighteen years. Approval to conduct research in schools in the ACT by ANU researchers involves three stages:
Contact details for the The ACT Education and Training Department research approval and enquiries: T:+ 61 02 6205 9277 NSWThe NSW Department of Education and Training welcomes research in its schools but requires that all research activity must conform to the Department’s Research Guidelines and must be approved in accordance with them. The guidelines describe the approval procedures, the criteria for approving applications, and the documentation that needs to be provided when seeking approval to undertake research.The Department requires separate approval by the University’s Human Research Ethics Committee. Researchers can apply to the Department at the same time as they apply for ethics clearance from the HREC, but Departmental approval will be withheld until the Department is notified that HREC approval has been obtained. Other States/TerritoriesPlease contact the
relevant Department of Education to verify its policies and practice. For further information regarding Human Ethics please contact Human Ethics Officers: Ms Yolanda Shave on T: 6125 7945, or Ms Kim Tiffen on T: 6125 3427, or email Human Ethics Officer. National Statement on Ethical Conduct in Human Research (2007) (National Statement)This National Statement is intended for use by:
To view the National Statement: National Statement on Ethical Conduct in Human Research (2007). Internal ANU inquiries: Human Ethics Officer, Research Office (tel 57945) or email the Human Ethics Officer. |
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Page last updated: 04 June 2008 Please direct all enquiries to: Research Office Page authorised by: Director, Research office |
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