Project specific guidelines

The following guidelines apply to specific research activities. They contain conditions and advice which should be taken into account when making an application to the Department of Health Department of Families, Fairness and Housing HREC.

Dual relationships

In the context of research with humans, a dual relationship can exist when the researcher has another (or several) significant relationship(s) with the research participant other than that which is the subject of the research protocol. An example of a dual relationship is when, for example, the researcher is also responsible for project, program or administrative oversight within the organisation where it is proposed to implement an approved research protocol when participants in such a research program are also under the administrative care of the researcher. Such secondary relationships can create inappropriate power relationships between researchers and participants, with consequent ethical difficulties, when for instance the research participant may reasonably perceive:

1. actual or potential conflicts of interest for the researcher 'as researcher' and 'as administrator or manager in the secondary relationship' in addressing for example such issues as security of information and the handling of complaints;
2. the likelihood of potential compromises concerning the confidentiality and anonymity being assured to research participants in the research protocol.

The securing of genuine voluntary informed consent from research participants may also be compromised when it may be perceived by potential participants at the recruitment stage that it may be prejudicial to their interests should they decline participation in the research.

In submitting research protocols for consideration by the department HREC, researchers should:

1. Disclose in the protocol any actual or potential dual relationships with the research participants and notify the Committee should such a situation arise during the implementation of an approved research protocol.
2. Advise how the dual relationship can be managed so that the interests of the research participant are fully protected on the one hand, and the integrity of the research program is not compromised on the other.
3. Address any possible perceptions by research participants that confidentiality and anonymity may be compromised.
4. Establish appropriate processes within the protocol for complaints procedures that involve notification to other persons or authorities in addition to, or instead of, the researcher in the first instance.
5. Ensure that, as much as is practically possible, an appropriate power distance is maintained by the researcher (or actively and effectively monitored by a person independent of the researcher) during the implementation of any approved research protocol.
6. Ensure that procedures are followed that prevent the information collected for the purposes of an approved research program is not used for any other purpose with which the researcher may be associated in the secondary or dual relationship.

Research into illegal behaviours

In considering applications for ethical review of research into illegal behaviour, the Human Research Ethics Committee (HREC) takes into account the following factors:

• The importance of the participant not being misled as to the possible legal consequences of responding to questions about his or her illegal behaviour, particularly the risk of self-incrimination;
• Whether any legal proceedings, such as summary hearings, trials, fitness to stand trial, or proceedings for breach of a sentencing order are still pending;
• Whether the participants of the research are juveniles;
• Any existing obligations the researchers may have under mandatory reporting legislation in relation to their knowledge of illegal activity;
• The discretionary nature of the legal powers to prosecute those who are alleged to be involved in criminal activity;
• The fact that the law cannot be relied upon to protect the confidentiality of information if the researchers are subject to a subpoena to produce documents to a court, or to appear in person to give evidence.

In dealing with research into illegal behaviour, the Committee will not accept wording in Participant Information and Consent Forms that “absolute” confidentiality can be guaranteed. This is because researchers may be obliged under mandatory reporting legislation to supply information to authorities, or under subpoena to testify in court or to produce documents in relation to information supplied to them in the course of their research. However, it is not necessary to spell out in precise detail the nature of the circumstances in which a legal obligation may arise to reveal information to police, prosecuting authorities, or to a court. The Committee will accept statements in the Participant Information and Consent Form to the effect:

“You are not obliged to disclose information about illegal behaviours. The researchers cannot guarantee absolute confidentiality with respect to illegal behaviour of which they are made aware.”

A warning to this effect should be followed by a brief description of the steps proposed by the researchers to maintain the confidentiality of the information supplied to them by participants, as far as is legally possible.

Where it is known that the researchers are subject to the requirements of mandatory reporting legislation if the research participants disclose certain matters, e.g. sexual abuse, the Committee will require an explanation in the research protocol of how these situations will be handled if they arise. A similar (briefer) explanation should also appear in the Participant Information and Consent Form.

In all questionnaires, focus group schedules or similar instruments used in research, it must be made clear that the research participants are not obliged to answer questions. Where only part of the questionnaire deals with illegal behaviour, that warning should normally be repeated prior to that group of questions.

Where the researchers intend to question a research participant about criminal matters that are still before the courts (whether the participant is involved as offender or victim), researchers must exercise extreme caution. The consent of the participant may not be sufficiently informed if the person has not obtained legal advice regarding the possible consequences for his or her defence (in the case of an offender), or for the success of the prosecution case (where the participant is a victim of crime).

Storage and disposal of data

Data collected in the course of research approved by the department HREC must be retained for a period of at least 7 years in accordance with the Public Records Act 1973. However, the data retention period may be longer for certain types of research. For example, clinical trial data should be retained for a period of at least 15 years (Guidelines for Good Clinical Practice in Australia (1991)), while health data collected in relation to minors must be retained until the individual attains the age of 25 (Health Records Act 2001 (Vic)).

It is the responsibility of the Principal Researcher to ensure that all data collected during the project are stored and disposed of securely following the seven-year data retention period.

Researchers are required to inform the Committee about the location where data will be stored and who will have access to the data. They must also provide a detailed account of the security arrangements in place to protect individuals' privacy and confidentiality. In addition, a clear statement of the method of destruction must be provided.

Researchers must bear in mind that data cannot be retained indefinitely for use in future research unless participants have been advised of this and have consented to the use of their data in additional research. It is important to consider the need to use data collected in future research and make the necessary arrangements with the Ethics Committee when initially submitting the application, as well as with participants when recruiting them.