Ethical Conduct of Research Policy – Appendix 2: Explanation of Terms and Notes Relating to Ethical Conduct of Research

Aboriginal and Islander People – research involving

The Committee will consider any research involving Aboriginal people in the light of the existing NHMRC Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research. Researchers are advised to contact Jumbunna for advice prior to completion of their ethics application, as all such protocols are referred to the Director of Jumbunna for comment, which is taken into consideration by the Committee.

Accessing patient records/materials/medical images

Where a researcher is accessing patient records/medical images, additional UTS ethics approval will not be required as long as:

• the data is non-identifiable, and anonymous
• the hospital/institution has approved the research (see below on External approval)
• there is no patient contact.

However, should the researcher need to be in contact with the patient for any reason (including obtaining of consent) then she/he will require formal ethics approval.

AHEC

AHEC refers to the Australian Health Ethics Committee. AHEC is a principal subcommittee of the National Health and Medical Research Council (NHMRC). It is responsible for the development of guidelines for the conduct of medical research involving humans, and for overseeing all AHEC registered institutional ethics committees. Ethics committees registered with AHEC must comply with its guidelines and make an annual compliance report. The UTS HREC is a registered AHEC committee.

Amendments to approved research

If the proposed amendment is minor, then it will not be necessary to seek formal approval. The researcher should discuss the proposed amendment with the Research Ethics Officer, who will decide whether it will be sufficient to write to the HREC detailing the proposed changes rather than formally applying for approval. The letter will be tabled at the next meeting and the Committee's response noted in the minutes of that meeting.

Anonymous

Literally, 'nameless'. In this context, it refers to research where information/data is collected in such a way that the identity of participants is not known. It is important to distinguish between 'anonymity' and 'confidentiality'. Anonymity means that identity is unknown and therefore cannot be revealed, whereas confidentiality means that identity is known but will not be revealed. Anonymity cannot therefore be promised when the researcher knows the identity, but confidentiality can be assured. Taping research allows the possibility of identification of participants, and therefore the research is not anonymous. Similarly, the use of consent forms means that identity is recorded (see section below on consent) and therefore the use of a consent form is not appropriate in anonymous research. Instead, if the researcher wishes to provide a written record for the information of participants, he or she would use an explanatory letter or information sheet.

Applying for formal ethics approval

The UTS Human Research Ethics Committee usually meets on the second Tuesday of each month (excepting January). Researchers should allow at least three to six weeks to enable full consideration of their applications. Application forms are available from the Research Ethics Officer (telephone (02) 9514 1279, email Research.Ethics@uts.edu.au). Researchers who wish their application to be considered at a particular meeting need to allow at least 12 working days before that meeting to ensure that the Committee has had sufficient time to consider their proposal.

Compensation/coercion

It may be reasonable or desirable in certain circumstances to recompense participants for their time. This may be culturally appropriate, and may not necessarily involve financial compensation. For example, it might involve providing a service to participants in return for their time, such as taking people to the doctor or shopping. Compensation may be seen as just recognition of the value of participant's time and their contribution to research.

Such compensation should never be constituted so as to form an improper inducement, either by the size of the payment, or any conditions imposed for payment. Payments should not be linked to research outcomes.

Complaints

Any complaints relating to a breach of these guidelines or concerns relating to their interpretation should be referred to the Research Ethics Officer (telephone (02) 9514 1279, email Research.Ethics@uts.edu.au) or the Chair of the UTS Human Research Ethics Committee. The Chair and Secretary will investigate any complaints in accordance with section 7 of the Joint NHMRC/AVCC Statement and Guidelines on Research Practice and where necessary, will refer the matter to the Vice-Chancellor for further action.

Complaints paragraph

The standard paragraph below should be at the bottom of all UTS consent forms. The purpose is to provide an independent reference in case any subjects/participants have any ethical problems or concerns about the research. The paragraph should be in smaller font than the body of the consent form. This is to discourage research participants from contacting the Research Ethics Officer rather than the researcher if they have any queries which might be best answered by the researcher (e.g. questions about how to complete a questionnaire, etc., rather than a complaint relating to the ethics of the research).

If the research is being carried out at another institution, it may be more appropriate to have a person from that institution given as a contact point. For example, the Patient Advocate, or the Secretary of a hospital's ethics committee would probably be more appropriate for hospital-based research. The UTS HREC is happy to have that person listed as a contact either instead of or with the UTS Research Ethics Officer.

The complaints paragraph is as follows:

Note: This study has been approved by the University of Technology, Sydney Human Research Ethics Committee. If you have any complaints or reservations about any aspect of your participation in this research which you cannot resolve with the researcher, you may contact the Ethics Committee through the Research Ethics Officer (telephone (02) 9514 1279). Any complaint you make will be treated in confidence and investigated fully and you will be informed of the outcome.

Confidentiality

Confidentiality refers to keeping information in confidence, i.e. not revealing information gathered, or disguising such information, so as to protect the identity of research participants. (See Anonymity for differences to confidentiality.)

Anyone providing information for the purpose of research is reasonably entitled to expect that the researcher will keep that information confidential unless the participant authorises the researcher to do otherwise. Such information should be regarded as belonging to the individual, not to the researcher, no matter how worthwhile the use of the information might be in terms of the research being conducted and the public interest.

Confidentiality is provided as a matter of fairness to persons particularly where the information, including personal views expressed by the participant, is sensitive and its disclosure might affect the participant's employment, personal relationships or academic results.

Researchers need to be aware of the possibility of an action at law being taken for breach of confidentiality, i.e. unauthorised use of confidential information. They should therefore ensure that any staff they employ with access to that information, such as research assistants, translators, transcribers, etc., are also aware of the need for confidentiality.

Researchers should also be aware of the possibility of a defamation action arising from the publication of allegedly defamatory material. Care should be taken to avoid publishing information, with or without consent, which could involve the participant, the researcher or the University in defamation proceedings. If researchers are in any doubt they should seek legal opinion before seeking to publish such material.

Researchers should also be aware that by law they cannot promise total confidentiality of their research material, as such material, including raw data and notes, can be subpoenaed. This is particularly important to bear in mind when dealing with information which may relate to illegalities and criminal behaviour.

Consent (informed)

Consent, or agreement to participate in research, must be voluntary, free from any possibility of coercion, and informed. Researchers must ensure that the participant has the capacity to give informed consent. This capacity may be affected for a number of reasons, such as mental incapacity, illness, power imbalance in relationships, etc. In some cases, such as with minors, there may be a legal incapacity to consent. If there is any doubt as to a participant's capacity to consent, the Research Ethics Officer should be consulted.

One of the most important aspects about consent is that it can also be withdrawn at any time and without a reason. Consent is a process rather than a fixed event or piece of paper, such as a consent form.

Consent may not be possible in some forms of research (e.g. observational research – see below for a fuller discussion). In such cases the researcher is nonetheless obliged to protect the privacy of participants.

Consent form

A consent form is employed in research primarily to provide a reference for the subject/participants, and should be seen as a vital part of the consent process. Ideally it will be an adjunct to the process of verbal consent, and provide a written record of relevant information to subjects/participants of research. Therefore a consent form should never be used solely for the purpose of protecting the interests of the researcher and the institution.

Consent forms should be worded appropriately for their target group. For example, groups with little literacy will require more attention in the consent process. Overly technical terms should be avoided. All relevant information should be provided as long as this does not make the form too long. A consent form should never be longer than one page. If necessary, an additional information sheet may be provided.

Consent forms should contain the standard complaints paragraph (see Complaints paragraph above).

A sample consent form is attached to the ethics application form and is available from the Research Ethics Officer.

Consent – verbal

In some cases, verbal consent may be preferable. Reasons include the possibility of a signed consent form creating difficulties for the subject/participant, because it would record their identity. Alternatively, in primarily oral cultures verbal consent may be more culturally acceptable. In such cases, an information sheet containing the same information that would normally be in a consent form should be provided. A witness may or may not be appropriate, depending upon the reason for verbal consent.

Data – storage, retention of data

The Joint NHMRC/AVCC Statement & Guidelines on Research Practice recommend that data be recorded in a durable and appropriately-referenced form, and that original data be safely held for periods of at least five years, and should comply with relevant privacy protocols, such as the Australian Standard on personal privacy protection.

The Statement and Guidelines also state that the 'department or research unit must establish procedures for the retention of data and for the keeping of records of data held', and that researchers 'must be responsible for ensuring appropriate security for any confidential material, including that held in computing systems. Where computing systems are accessible through networks, particular attention to security of confidential data is required. Security and confidentiality must be assured in a way that copes with multiple researchers and the departure of individual researchers.'

Dependents – use of in research

See below under Students.

Disclosure of information

Information collected for the purpose of research may only be disclosed:

• with the consent of the person who provided the information
• to prevent a serious threat to a person's life or health
• as required or authorised by law.

The recipient of the information can only use it for the purpose for which it is disclosed. (See the Privacy principles below for more details.)

External approval

External researchers using UTS staff/students as subjects

External researchers wishing to use UTS staff and or students as subjects of their research are required to seek formal approval from the UTS ethics committee. They may either submit a full UTS proposal or submit approval from another AHEC accredited ethics committee, together with copies of any and all correspondence (including initial application form).

• UTS staff:
  The Committee will not necessarily require a full application for ethics approval where such approval has already been obtained from an AHEC accredited ethics committee. Instead the Committee requires that the applicant submit a letter requesting that the external approval be accepted, together with four copies of the original application and all correspondence (i.e. letter of approval, etc.), and a completed copy of the UTS HREC Checklist for Ethics Approval. The Checklist includes a summary of the proposal and indicates any additional documentation that may be required to meet UTS requirements.

  The Research Ethics Officer will then forward this to a subcommittee who will recommend to the next full committee meeting whether or not to accept the approval, or to require a new application.

• UTS students:
  In the case of students of UTS who have external approval from an AHEC accredited ethics committee, the UTS HREC still requires a full application for ethics approval rather than external approval. This is because it is the responsibility of the University to ensure that the research of its students is ethical. The HREC cannot abrogate this responsibility.

Harm

Damage or hurt to the wellbeing, interests or welfare of an individual, institution or group. Harm could range from physical hurt or damage such as illness or injury, to psychological or emotional hurt or damage, such as embarrassment or distress.

Information privacy principles

See Privacy principles below.

Interim approval

Where there is a degree of urgency attached to an application, and the Chair is satisfied that no ethical problems exist with the proposed research, he or she may arrange for a subcommittee to consider the proposal and to decide whether or not to grant interim or preliminary approval. Such interim approval must be ratified by the full HREC at the next formal Committee meeting.

Justice

See Natural justice below.

Minors and consent

Minors cannot enter into a legally binding contract before the age of 18. However, the purpose of the consent form is to ensure that participants are informed of the nature of the research beforehand and that they understand and consent to it, rather than being a legally binding contract. In the absence of a parent or guardian, participants should sign the consent form regardless of their age. Care should be taken to phrase the consent form in a way which the minor will understand, taking age and level of education into account.

Moral rights

At present, moral rights are not embodied in Australian legislation. Universities, however, have long-standing codes of good academic practice which include recognising moral rights in academic works. Fair attribution of authorship and the recognition that a work should not be altered so as to harm the reputation of the author, are part of established academic culture.

Natural justice

Natural justice is also known as procedural fairness. The rules of natural justice are principles developed to ensure that fair decision-making procedures are followed by any person or body who adjudicates upon disputes between people or the rights of others. For example, a decision-maker who reaches a decision without hearing all sides of the argument may have reached a just decision but has not been just in doing so.

Principles of natural justice include:

• acting fairly, in good faith and without bias
• giving each party an opportunity to adequately state his/her case
• ensuring that a decision-maker declares any interest which he or she may have in the subject matter of the dispute before them.

Observational research

Observational research is subject to the same considerations as other types of research. Formal approval should not be necessary where the research is unobtrusive and non-threatening, and the behaviour under observation does not pose a risk to participants. Wherever possible, the researcher should identify himself or herself, and the purpose of the research. This will avoid misunderstandings from arising. For example, in one case a researcher was observing consumer behaviour in a chemist shop, and was interested only in the amount of time people spent in the shop before making a purchase. Some customers became concerned, however, because they felt their privacy was invaded, especially where they wanted to buy personal items, such as tampons or condoms. In this case, the researcher's intentions were misunderstood. Had the researcher been able to communicate his or her intention, this would have been avoided and the negative outcome avoided.

Some researchers argue against identifying themselves for fear of affecting the results. However, as in the case above, results may be affected anyway. Anecdotal evidence suggests that people become accustomed to observers, and any impact will hopefully be minimised. Such identification also eliminates the problem of people feeling anger or resentment at perceived deception. In some cases, the researcher might wish to obtain consent after the research has been conducted, which gives those observed an opportunity not to participate in the research.

The most desired points for observational research are the same as for all research, including:

• identification of researcher and purpose of research
• obtaining consent
• minimising any possible harm.

Power

Power in this context is defined as the ability to influence, shape, coerce, manipulate or control others in society.

Researchers need to be aware of the substantial degree of power that they wield in relation to the people they use as subjects or participants in their research. This is due to a number of factors, including the position that researchers hold, their association with a tertiary institution, and the public perception of researchers, scientists and academics.

The nature of the relationship between researchers and the researched is one of unequal power, similar to that between doctor/patient, teacher/student, parent/child, therapist/client, etc., and as such is open to both intentional and unintentional abuse. This inequality is exacerbated when there is an additional pre-existing relationship, such as those just mentioned. In such cases it is important that the researcher not only avoid such abuse, but be aware of and avoid even the possible appearance of abuse.

Privacy principles

The eleven Privacy principles are taken from the Privacy Act 1988 (Cwlth) and are summarised as follows:

1. restricting collection of information to lawful purposes and by fair means
2. informing people why information is collected
3. ensuring personal information collected is of good quality and not too intrusive
4. ensuring proper security of personal information
5. allowing people to know what personal information is collected and why
6. allowing people access to their own records
7. ensuring that personal information stored is of good quality, including allowing people to obtain corrections where it is not
8. ensuring that personal information is of good quality before using it
9. ensuring that personal information is relevant before using it
10. limiting the use of personal information to the purposes for which it was collected
11. preventing the disclosure of personal information outside the agency (which gathered the information).

Public record/register

Information which is freely available to members of the public does not involve issues of privacy. For example, telephone books, electoral roles, published information, etc., are all matters of public record.

Some information which is a matter of public record or register may still be confidential, such as the Register of Adoptions, Register of Births, criminal records, etc.

The changes in information technology have meant that some information which has been collected as public record may be used for intentions other than that for which it was originally gathered. For example, electoral roles, re-keying of telephone directories to create reverse telephone directories, etc., have allowed that information to be used for other purposes.

Queries

Queries should be addressed to the University's Research Ethics Officer (telephone (02) 9514 1279 or email Research.Ethics@uts.edu.au), or to the Chair of the HREC, care of the Research Office, Level 7, Broadway Campus, UTS.

Questionnaires not requiring ethics approval

Questionnaires will not require formal ethics approval providing that they are anonymous (i.e. ask no identifying information) or will remain confidential and will not be used to elicit further interviews of participants, and

• are non-intrusive
• do not involve any ethical dilemmas (e.g. carried out through particular types of institutions, such as hospitals, or involve a particular target group that might be problematical, such as people with a mental disability)
• do not involve any degree of risk of harm (which could include embarrassment, etc.).

Risk

Likelihood or possibility of damage or hurt to the wellbeing, interests or welfare of an individual or a group.

Student assessment material – access to student records for research purposes

The University's Policy on the Privacy of Student Records follows:

The University treats information on students as confidential and will only reveal such information with the permission of the student or where access is limited to staff required to fulfil the legitimate and authorised purposes of the University … (4.2) Neither academic supervisors nor any other persons have a right to access any information which is irrelevant to the job needs of the person seeking the information.

Section 5.1 states:

Requests … for access to student records are generally denied. In particular, personal addresses and telephone numbers will not be provided to other employees, students or external organisations except:

5.1.1 to persons authorised in writing by the student, in which case all means possible should be taken by the receiver to ensure that the student's written permission is bona fide;

5.1.2 to persons permitted by law for example, to police with warrants and to parties as directed by subpoenas.

Academics wishing to use student assessment material for research and publications therefore cannot assume that they have a right to do so. If the research is not extensive or intrusive, with little possibility of harm or distress to students, it may be sufficient for the researcher to write a letter to the Committee seeking approval to access student material, and attaching a copy of the proposed information/consent letter to students, and a letter of approval from the appropriate responsible academic officer.

In such circumstances as these, a full ethics application may not be required. However, the Committee reserves the right to request further information, including a full application, if it should consider this necessary.

The information/consent letter should contain the following assurances:

• that students have full anonymity wherever possible (in which case an information letter would be used instead of a consent letter),
• that academics must ask students' permission to access their assessment papers and or results for research purposes,
• that students are under no compulsion to agree, and
• that students not be identified in any subsequent publications (unless they give permission for this).

Students/dependants – use of in research

Where researchers wish to make use of their students or anyone over whom they exercise power as research subjects (such as their child, employee, patient, client, etc.), they must apply to the Faculty or to the HREC for approval, even if the research is an innocuous anonymous survey. (Note: this does not apply to teaching evaluations.) To ensure that a local overview is kept of research involving students, all such applications must include written approval from the appropriate responsible academic officer, such as Head of School/Department or Dean.

Research must be constructed in such a way as to remove any possibility of students feeling coerced to participate. This may done through some or all of the following steps:

• ensure wherever possible that the research is anonymous
• ensure benefits will accrue to the students/dependents and that they are aware of those benefits. Benefits can be short term, such as where the research can contribute to the immediate learning experience of the student, or long term, where beneficial research outcomes are shared with participants.
• ensure any disadvantages, such as loss of lesson time, are minimised
• wherever possible, have a colleague not involved in a prior relationship with the participants (such as assessing students) distribute and collect the questionnaires, surveys, etc., or arrange a collection box or provide addressed, reply-paid envelopes so that all participants can return the questionnaire/survey without revealing whether or not they have completed it
• reassure participants both verbally and in writing that they are under no compulsion to take part in the research, and that if they decline to participate or withdraw at any stage they may do so without giving a reason and that this will in no way affect their marks, academic progress, employment, treatment or whatever is at issue

• should the research be part of the participant's normal learning program, treatment, or employment, allow them to not include their data in the research pool and offer an alternative to those not wishing to participate in the research.

Telephone surveys

Telephone surveys have a number of advantages for researchers. They can be cheaper and quicker than face-to-face interviews, and less intrusive. Additionally, it is easier for respondents to decline or withdraw participation, as they can hang up at any time.

The same points apply for telephone surveys as for all research, including:

• immediate identification of researcher and purpose of research,
• description of the research and what is involved, including length of time
• a contact name and telephone number at UTS
• obtaining free and informed consent
• minimising any possible harm or intrusion.

Last administrative update: February 2000