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Please note:
The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.
Qualitative Research
While there is a range of views on qualitative methodologies and the application of specific methods. The following is a more detailed discussion of the issues raised elsewhere in this Collection about ethics and qualitative methodologies in the statement of research questions. It should also be noted that most social science disciplines, through their professional associations and bodies, have published relevant ethical guidelines. HRECs should refer to these where appropriate.
Qualitative methods are used in many different disciplines. While there is a clear distinction between qualitative and quantitative approaches, many research protocols combine features of both and it is important to recognise that the two approaches share much in common. However, while quantitative approaches are best suited to answering certain kinds of questions, qualitative approaches are best suited to answering others. As noted in the NHMRC document referred to above, qualitative methods are especially appropriate for investigations in the following areas.
- the influence of economic, political, social and cultural processes on health, illness and disease;
- understanding the experiences of individuals and communities in relation to health, illness and disease;
- understanding interactions between individuals, and within social settings, in relation to health care and health care decision making;
- eliciting contextual data in explaining the results of quantitative studies;
- eliciting contextual data in order to improve the methodological validity of survey instruments; and
- elaborating on causal hypotheses emerging from clinical and epidemiological studies.
Types of methodological approaches, and specific methods, include in-depth, open-ended interviews with groups or individuals, where participants are encouraged to tell their own stories; direct observation of behaviours and interactions; written and documentary information; and participatory methods, including photo novellas, diaries, art and drawing, and other creative ways of relating experience and knowledge.
- Qualitative approaches are designed to best reflect an individual's experiences in the context of their everyday life. Therefore, most qualitative research is much less formally structured than quantitative approaches, though no less rigorous. What is important to note is that qualitative approaches have a different logic to quantitative approaches to research.
- Qualitative designs do not always begin with specific, testable hypotheses precisely because these methods are particularly suited to exploring health issues at the initial stages where problems are not well understood.
- All qualitative designs should have an initial set of research questions that can be better defined as the research progresses.
- Sampling procedures are designed to yield a rich set of data on smaller samples than in most quantitative studies. The logic of qualitative sampling rests not so much on generalisability, nor on representativeness, but on notions of 'saturation', that is, the point at which no new insights are likely to be obtained. Therefore, sample size is not so much a criterion for judging the rigor of a sampling strategy, but, rather, for judging the extent to which issues of saturation have been explicitly thought through.
- There are many different approaches to the analysis of qualitative
data and these are often based on different epistemological (theory of
knowledge) assumptions. A research proposal should be judged on the
extent to which the techniques of analysis have been made explicit and
the extent to which the data might be exposed to different, or
alternative, interpretations.
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Ethical issues in qualitative research
All research proposals, both qualitative and quantitative, should make provision for obtaining informed consent from potential research participants as required by the NHMRC (NS 1.7 - 1.12). However, in some qualitative studies it may be more appropriate to gain consent verbally rather than in writing. This is relevant where the participant may feel particularly vulnerable, as in research related to sexual issues or illegal or stigmatised activities. Here, written consent is likely to result in significant harm to the participant in that they are potentially identifiable. In addition, in participant observation studies it is virtually impossible to obtain consent from all observed individuals. Examples of such studies are ethnographic studies of particular settings; observing 'sun-smart' behaviours at a school or on a beach; 'social mapping' of the use of urban spaces; observations of eating and smoking patterns amongst social groups; and participant observation of self-help groups or national conventions such as Alcoholics Anonymous or Narcotics Anonymous. Indeed, obtaining consent would interfere with the strength of the 'naturalist' approach of ethnography. Seeking consent from participants in these situations may lead to behavioural changes that would invalidate the research, while public observation that neither identifies a person nor intrudes into their daily activities may well be ethically justifiable. Nevertheless, it is essential that the research proposal provide a clear account of exactly how verbal consent will be obtained and recorded, as well as provide adequate ethical justification for such a decision. A research proposal should also provide adequate justification for a decision not to seek consent at all from project participants.
In considering a request to waive consent in relation to the above types of studies, HRECs should refer to the NHMRC requirements:
It is ethically acceptable to conduct certain types of research without obtaining consent from participants in some circumstances, for example, the use of de-identified data in epidemiological research, observational research in public places, or the use of anonymous surveys (NS 1.11)
This is reinforced by the Council for International Organizations of Medical Sciences http://www.cioms.ch in International Ethical Guidelines for Biomedical Research Involving Human Subjects:
When the research design involves no more than minimal risk and it is not practicable to obtain informed consent from each subject the ethical review committees may waive some or all of the elements of informed consent. [Footnote 123]
In summary, an HREC should expect any research protocol to clearly state the logic for obtaining consent. If consent is to be verbal rather than written, or if there is a request to waive consent, this needs to be clearly argued for and justified in the research proposal.
As noted above, small sample size does not constitute adequate justification for rejection of a qualitative research proposal. Principles for establishing sample sizes in qualitative research should be clearly stated in the research proposal, which should set out the logic and methods for sampling in language that is easily understood. It is also common for qualitative studies not to specify an exact sample size at the commencement of the research project. This is because the principle of 'saturation' guides sampling. Also, in general, sampling strategies are not random but purposive.
Many qualitative researchers argue that one of the strengths of this approach, compared to the more intrusive quantitative approaches employed in much health and biomedical research, is that the relationship between the researcher and the research participant is more equitable. While this may be true in many situations, status and power differentials can still exist.
For example, good qualitative research requires the establishment of rapport between the researcher and the participant, and this can mean that the participant takes the researcher into their confidence, thereby establishing a social relationship. This can be particularly problematic when the researcher leaves the 'field'. This can also be problematic in small communities where the researcher is part of the community, or setting, being researched. Here, the researcher has access to private information about 'actors' in this social setting, and this can have a complex effect on the former's social relations when the 'research cap' is off. In particular, problems can occur when 'peers' take the role of researchers, thereby obtaining access to information about their friends that they would not normally be aware of.
Therefore, power relationships between researcher and participant in qualitative research, although often more equitable than in quantitative studies, are not always free of complications that may result in increased vulnerability for participants. It is therefore important that the ways in which these power issues will be dealt with are fully described in the research proposal.
In some respects qualitative research, perhaps more than surveys, poses the risk of generating unanticipated consequences precisely because of the 'reflexive' process. Here, research participants explore their feelings and experiences, and this can raise painful issues and open old emotional wounds. Interviews can also trigger feelings for the researcher. It is not uncommon for interviews to become confessionals for the participant. And while participants are often thankful for the opportunity to discuss these experiences, psychological harm such as embarrassment, worry and loss of self-esteem can occur.
Adequate support for both researchers and participants should be available as needed. This might include debriefing for the interviewer and counselling for the participant, particularly in studies investigating sensitive areas such as physical or psychological trauma or abuse, death, dying and grief. These support strategies should also be available to both parties at the point of disengagement and termination of the research relationship.
Maintaining confidentiality can, at times, be difficult when carrying out qualitative research precisely because of the nature of the way in which data are collected. Whereas a questionnaire filled out anonymously is an assurance of confidentiality, a face-to-face, in-depth interview is explicitly based on building a relationship between researcher and participant, if only for the duration of that interview. Even when identifying information is not collected, the interview is not anonymous. Researchers must also be aware that they cannot promise participants absolute confidentiality. For example, if legally required to testify in court researchers must do so and mandatory reporting of information that has been revealed by a participant may be required. In addition, the law does not necessarily protect 'field notes' and researchers need to be particularly careful about what they record and how this information is stored. While these issues have been widely discussed in the relevant literature and at professional gatherings, confidentiality in qualitative research remains problematic.
Because qualitative studies typically consider smaller samples and focus on local communities or groups, publishing results can be especially problematic if the findings are negative, or the results might further stigmatise or marginalise participant groups. In these situations, consideration should be given to the way research results will be reported and to what extent the participant group should influence decisions about the dissemination of results.
Points to consider
- Are HREC members familiar with the general principles of qualitative research and how these may differ from the principles on which quantitative studies are based?
- Even though qualitative research proposals commonly do not include sets of specific hypotheses to be tested, they should include a set of clearly set out research questions or research objectives. Have these been included in the research proposal under review
- In general, informed consent should be obtained in writing. However, there are legitimate instances when consent is not possible, or when it may need to be verbal rather than written. Research proposals should state clearly how consent will be obtained and, where a wavier is requested or verbal consent only is to be obtained, a clear rationale and reasons justifying such a course of action should be provided. Have these criteria regarding consent been met?
- HREC members should recognise that while, in general, qualitative research is non-threatening and non-intrusive, it can still result in harm for the research participant. Power relationships between researcher and research participant should be acknowledged, along with the possibility of unanticipated consequences. Does the research proposal provide a clear account of how these unanticipated consequences will be dealt with if they do eventuate? Does the research proposal provide a clear account of appropriate strategies for supporting both the participant and the researcher when the research relationship ends?
- Ethics committees should be aware that ethical guidelines for qualitative research have been developed and published by a number of social science professional bodies. Do HREC members refer to these when conducting assessments of multidisciplinary research proposals, for example, sociological, anthropological and public health proposals?
- Are HREC members aware of the areas of difficulty in relation to ethical assessment of qualitative research proposals?
- Given the diversity and complexity of the range of qualitative
methods, it is unlikely that any one member of an HREC will have the
expertise to assess the range of methodological approaches likely to
arise. Are ethics committee members aware that it is appropriate to
consult experts on qualitative aspects of research proposals as needed?
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Suggested reading
Council for International Organizations of Medical Sciences in collaboration with the World Health Organization, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, CIOMS in collaboration with the WHO, 1993, http://www.cioms.ch/frame_1993_texts_of_guidelines.htm .
S. Dodds, R. Albury & C. Thomson, Ethical Research and Ethics Committee Review of Social and Behavioural Proposals, Canberra, Commonwealth of Australia, 1995.
T.A. Glass, 'Ethical Issues in Group Therapy' in R.M. Anderson, T.L. Needels and H.V. Hall (eds.), Avoiding Ethical Misconduct in Psychology Specialty Areas, Springfield, USA, Charles C. Thomas, 1998. ch. 5.
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Handbook TOC
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Abbreviations
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Commentary on the National Statement
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A Research Ethics Collection
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A Research Law Collection
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Bibliography
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Appendices
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