Key Ethical Concerns for the HREC

Before applying researchers should familiarise themselves with the National Statement on Ethical Conduct in Resarch Involving Humans (2007). See below for guidance on the following issues.

• Informed Consent & Web-based Surveys
• Confidentiality
• Privacy & the Internet
• Recruitment
• Use of Lotteries or Raffles
• Research in Schools

 

Informed Consent

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 Form

The National Statement on Ethical Conduct in Research Involving Humans (2007) - Chapter 2.2 outlines information that should be communicated to participants of research.

The following should be communicated to participants:

(a) participation is voluntary;

(b) any alternatives to participation;

(c) how the research will be monitored;

(d) provision of services to participants adversely affected by the research;

(e) contact details of a person to receive complaints;

(f) contact details of the researchers/supervisor/HREC details and if overseas research, a local contact;

(g) how privacy and confidentiality will be protected;

(h) the participant's right to withdraw from further participation at any stage, along with any implications of withdrawal, and whether it will be possible to withdraw data;

(i) the amounts and sources of funding for the resarcher;

(j) financial or other relevant declarations of interests of researchers, sponsors or institutions;

(k) any payments to participants;

(l) the likelihood and form of dissemination of the researchers results, including publication;

(m) any expected benefits to the wider community;

(n) any other relevant information including research-specific information required under other chapters of this National Statement.

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. 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.

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.

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 persons 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.

Consent and Web-based Surveys

Provided that a privacy statement (i.e. warning) is prominently displayed, completion of the survey can be deemed to constitute consent. See Privacy and the Internet.

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Confidentiality

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”.

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Privacy

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:

• What information is being collected about individuals when they visit the website or use email.
• Why this information is being collected.
• How it will be used.
• If it will be disclosed.

A warning that there are risks associated with using the Internet as a transmission medium. (This applies also to emails, if this medium is to be used.) An offer to provide other options if possible for providing information, e.g. telephone or paper response.
If any security measures, such as encryption, are provided, then information about this should be given. This could include a hyperlink to a brief statement on web security.

At a minimum, the following should be included in the privacy statement. Additional information may be needed depending on each case:

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 mail out. 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.

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Recruitment

Details on how participants will be recruited should be included with the application. In particular researchers should be aware that initial contact might 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:

• consent was sought at the outset from the researcher's clients by the researcher’s business partner;
• their signed consent form was placed by the clients in envelopes that they themselves sealed;
• these sealed envelopes were held by the researcher's business partner (or by the researcher where they were clients of the business partner);

this methodology was clearly explained in the information provided to potential participants, so that it would be clear that their decision whether or not to participate could not affect the outcome of the counselling process by the researcher.

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Use of Lottories or Raffles

Generally, the HREC does not approve of lotteries or raffles in research projects, but will consider on a case-by-case basis. Lotteries and raffles are viewed as being inherently unfair, as only the winner is rewarded. Additionally, for some people with gambling addictions, participating in a study with a lottery or raffle may set off their gambling problems.

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Research in Schools (using students and/or staff as participants in Schools)

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.

ACT

The 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:

1. Approval from ANU HREC;
2. ‘In-principle approval’ from the  Measurement, Monitoring and Reporting Directorate in the Department; and
3. ‘Permission to proceed’ from individual school principals.

Contact details for the The ACT Education and Training Department research approval and enquiries:

T: + 61 02 6205 9375
F: + 61 02 6205 8353

NSW

The 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/Territories

Please contact the relevant Department of Education to verify its policies and practice.

For further information regarding Human Ethics please contact Human Ethics :

Ms Kim Tiffen on T: + 61 2 6125 3427, or Ms Leanne Micklethwait on T: + 61 2 6125 3931, or email Human Ethics Officer.

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