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Ethics in research involving humans

Introduction

In the course of academic research a number of ethics-related issues may commonly arise. It is therefore essential for supervisors and students to have ongoing discussions about the ethical implications and responsibilities that accompany a research project especially where the research involves human subjects or participants.

The purpose of this guide is to:

Before any academic research project involving human participants can proceed in an Australian institution, students must be granted formal approval for their project by the University Human Research Ethics Committee or one of the Divisional sub-committees of the university. Even students who are not involved in the medical sciences (where ethics approval is most frequently required) must be made aware that they, too, need to apply for ethics approval if their research involves human participants. Similarly, in the case of a researcher and/or participants living in another country, if the research is being conducted under the auspices of an Australian university, the ethics guidelines and principles promoted by that university must be observed.

It is important to note that sensitivity to, and respect for the culture of Australia’s own Indigenous people has prompted the University of South Australia to devote a separate section to this and related issues in the University’s Human Research Ethics Guidelines.

Part of a supervisor’s role is to direct students to the policies and procedures for obtaining approval from the relevant ethics committee.

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UniSA Human Research Ethics policies and guidelines

In designing its internal ethics procedures, the University has adopted the guidelines provided in the National Statement on Ethical Conduct in Human Research 2007 which replaces the former National Statement on Ethical Conduct in research Involving Humans (1999). The National Statement has been co-issued by the NHMRC, the Australian Research Council and the Australian Vice-Chancellors’ Committee, now Universities Australia.

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Role of the supervisor

In the University of South Australia it is the student who applies for ethics approval as the Chief Investigator, so students need to be familiar with the University’s Human Research Ethics Guidelines and follow the procedures set out by the University of South Australia’s Ethics Committee (USAHREC).

However supervisors, who must countersign the application, need to ensure that the student understands what is required and why the approval of the Committee is important in the interests of successful and ethical research. The expertise and guidance of supervisors is also important to help students become familiar with the principles and standards set by various professional associations. In an increasing number of cases, students will find that their research is within the field of a profession that has drawn up its own code of ethics with which the student/researcher is expected to be familiar. Some institutions and associations have their own ethics approval processes in place and supervisors must ensure that their students gain approval from the external stakeholder as well as the University.

The University is firmly committed to ensuring that national ethical guidelines outlined in the National Statement on Ethical Conduct in Human Research are adhered to.

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Principles of human research ethics

In its promotion of ethical human research, the National Statement expresses four key values:

The role of a university’s ethics committee is to promote these values and ensure the interests of the participants are protected through initial and ongoing monitoring of the project. The following three directives which are set out in the University’s Human Research Ethics Guidelines are in response to these standards and guidelines.

1. Any research involving human subjects requires ethics approval

Approval for a research project involving humans must be gained from the University’s Human Research Ethics Committee (USAHREC) or Divisional Ethics Committee (DEC) before it can proceed. This includes research projects involving clinical research, action research projects, and research involving data collection by interviews, questionnaires, focus groups, as well as by observation.

2. The human rights and civil liberties of all participants must be protected

The University’s Human Research Ethics Guidelines direct that research involving human participants, whether the research involves staff and/or students, must be conducted in such a way that all who participate in the research project can be assured that they will be treated with respect and that every effort will be made to protect their human rights and civil liberties.

3. Professional and cultural standards are to be met

3.1 Professional standards:

The University alerts researchers to the need to meet appropriate professional standards. Professional bodies, such as AARE (Australian Association for Research in Education) and the Australian Psychological Society (APS), have developed and revised their own codes of ethical practice in research. These professional codes are essential resources for university researchers, students and supervisors, in their particular disciplines.

3.2 Respect for cultural traditions and beliefs:

The involvement of participants and researchers (including students) from other cultures introduces into the ethics process a number of complex issues. This calls for great sensitivity to other traditions and beliefs on the part of all involved. Sensitivity and respect are keywords used frequently by writers on human research (Bouma 2000; Evans & Jakupec 1996). USAHREC, before approving a project that involves other cultures, makes every effort to ensure that the researcher’s methodology and approach respects the beliefs, perceptions, customs and cultural heritage of those involved both at the individual and collective levels.

Researchers must respect equally the dignity of each one involved in the research, and each person is to be treated as a ‘free moral agent’ (Evans & Jacupek 1996, p.94). There must be a balance between the power and empowerment of the researcher and the researched. Bouma (2000) suggests that students conducting research could be encouraged to ask themselves: ‘How would I react if I were in the place of the person or group I am studying?’ (Bouma 2000, p.191).

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Transnational research in universities

Australia has played a leading role in developing ethics guidelines for research involving humans, and in doing so has set high standards for maintaining the integrity of its research (Evans & Jacupek 1996). However, the expansion of the University’s transnational interests has led to a substantial change in the profile of research projects being undertaken by the University’s community.

Research must not only respect culturally sensitive areas for participants, but where the researcher’s own academic and professional background is transnational, special effort needs to be made to inform and guide the student or researcher to observe the Australian policies and standards that guide research involving humans. Certain expectations and social norms may vary from one country to another, but high standards need to be maintained especially regarding an individual’s right to freedom of expression, freedom to participate, respect for personal privacy and other factors relating to the participant’s empowerment. This applies to any university research, whether it is being conducted within or outside Australia.

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University approval for a human research project

Process for obtaining ethics approval

The process of obtaining approval from the University’s Human Research Ethics Committee (USAHREC) to proceed with a human research project is often regarded by students as a hurdle to be negotiated, rather than a positive step in the research process. When supervisors use the process to point out to their students the advantages they can gain by carefully following through the procedures, the process itself can become a positive and educative experience and an important part of a student’s research education. The principles and many of the procedures that need to be followed in obtaining ethics approval are fundamental to any research project that involves human participants, and lessons learned from the post-graduate experience will remain valid throughout the student’s research life whether it be in an academic or professional context.

In the course of the ethics approval process, much can be gained by both student and supervisor from the expertise of the academics and researchers who form the ethics committees. There are also practical benefits to be had from obtaining formal approval for research of this nature. Providing that the process has been followed conscientiously and methodically, there can be benefits of insurance cover, or some protection from litigation should such issues arise.

The steps for gaining approval from the USAHREC are clearly laid out in the Human Research Ethics Guidelines. In the same document there are directives about the conditions under which the approval is granted. Examples are given of when the researcher is required to notify the ethics committee of unforeseen changes to the research, whether these changes are associated with the methodology or the research question itself.

Key elements in obtaining approval

It is not uncommon for applications for ethics approval to be returned to the student for amendment before the approval of the ethics committee is finally granted. Students seem to have difficulty with certain key elements in the research methodology and generally these amendments are linked to these. The following steps are those that commonly cause the ethics committee to return the original application for revision or amendment before the committee can give its approval:

The comments below expand on these categories and are supplementary to the notes given in the Human Research Ethics Guidelines .

Information sheet or letter of invitation/introduction

Students, when they are caught up in the excitement or novelty of the research, often lose sight of the fact that, in agreeing to be part of the research, participants are actually doing the student/researcher a favour. One of the challenges for the student/researcher is to describe his/her research project in simple terms using everyday language. This is an aspect of the ethics approval process that ethics committees look at carefully before approving a project.

The Information Sheet Guidelines provided by the ethics committee make it clear what should be covered in the letter. Unless the research is described in language simple enough for all participants to understand, it is questionable whether many (or any) of them can give their ‘informed consent’ to be part of the research. To make this point, some ethics committees refer to the letter of introduction as the ‘Plain Language Statement’.

Informed consent

Students need to be aware that before research can proceed they must obtain the informed consent of those participating. This is to safeguard the human rights and civil liberties of research participants. The University’s Ethics Committee provides a Model Consent Form which introduces the essential elements of the Consent Form.

This principle of informed consent is fundamental to sound ethical research and before the research can proceed, the subjects or participants are required to give their informed consent if they are willing to be part of the research.

There may be special problems when the research is cross-cultural. It is then the researcher’s duty to communicate the importance that Australian society places on such issues as:

More important, it is essential that these principles be understood when the researcher(s) – students and academics – are from another culture where research ethics may be based on a different set of principles or legal requirements, where principles of privacy or individual empowerment may not be the same concern as they are in Australia, or, in some cases, where a code of ethics is yet to be formulated. In all cases it is better for the student to ‘err on the side of caution’, and to take even more care than they might normally consider necessary in order to preserve the civil rights of their participants.

Data storage

Another key element in conducting human research is determining how and where the research data is to be stored. What happens to the data, once it is collected, must involve respecting the wishes of individual participants relating to their privacy, confidentiality and protection of their anonymity. Provision must be made to preserve the raw data so that the authenticity and credibility of the findings of the research can be verified. These are fundamental issues in ensuring that a research project meets Australian ethical standards. In 4.1 – 4.3 of its Guidelines for preparing Ethics Protocols the University provides guidelines for the retention of data in various forms.

Conducting research in the workplace

The University attaches such importance to the complex ethical issues surrounding the use of the workplace as a research site that it devotes a special section in the Human Research Ethics Guidelines to a discussion of the difficulties and challenges inherent in such a situation. The general advice is to keep a clear demarcation between professional and research roles.

At first sight using one’s own workplace, or that of a family member or close friend, as the context or location for academic research carries a number of attractive features: many of the costs might be absorbed into the business, ‘volunteers’ should be readily available, it can be a clever use of the researcher’s time and the company itself might benefit from the ‘free’ consultancy.

However, using your own workplace, or one with which you have close ties, can also create considerable difficulties: in fact the difficulties and disadvantages in many cases have been found to outweigh the advantages, particularly if the researcher is the boss or in a position of power.

It is easy to see how a power relationship that invariably exists to a greater or lesser extent between employer/employee, junior/senior staff associate and patient/health worker, affects the freedom to speak or offer an opinion within a group discussion or in an interview. Such a relationship brings into question the freedom of participants to participate or to withdraw from the research without their work or education or family life being (or being seen to be) affected. This type of situation can also affect the quality of the responses and the freedom of the participants to give honest answers. The blurring of professional and academic boundaries and the likelihood of unequal power distribution between various players in the research project can weaken the validity and credibility of the research findings.

Careful thought therefore needs to be given as to how participants will be selected, what risks are involved, and what positive and negative effects could possibly result. Ethics committees require evidence that the permission of the organisation(s) is sought before the participants are approached and the research proceeds. Other difficulties of research in the workplace relate to the security of corporate or industrial secrecy and the protection of commercial competitiveness which in turn can lead to restrictions on publishing or disseminating the findings of the research.

Workplace research is not the easy option it might appear to be. Experience has led the USAHREC to treat such applications for ethics approval with great caution.

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Conclusion

Embarking on a research project that involves human participants brings with it significant responsibilities for both students and supervisors. In addition, the complex cultural and social issues associated with research conducted in a transnational context calls for these responsibilities to be addressed with great care. Students need help in identifying these responsibilities early in the research process, and supervisors need to guide their students through the regulatory process of obtaining ethics approval. The University takes a serious view of its obligations in this regard, and provides clear policies and directives to guide the student through the process. The process itself should be looked upon as a valuable educative experience.

There are excellent statements and references available at the national and institutional levels. These are listed in an annotated Quick Guide to Resources on Human Research Ethics that accompanies this Guide for Supervisors. An online workshop ‘Introduction to Human Research Ethics'.

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References

 

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