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Ethical Considerations

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Principles of research ethics

Ethical Issues
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Ethics in Clinical Research

Qualitative research aims at an in-depth understanding of an issue, including an exploration of the reasons and context for participants' beliefs and actions, so is often designed to be probing in nature. Interviews, the commonest qualitative method in health services research, are particularly well suited to the collection of data on sensitive topics.

These characteristics of the method may provoke anxiety or distress in participants. The questions which lead to anxiety and distress depend on the personal biography and experience of individual participants and cannot always be predicted accurately.

Even when prediction is possible, the open-ended nature of qualitative research means that these topics cannot be avoided reliably. For example, in a study of chest pain carried out by HR, the focus of the interviews led some respondents to express anxieties that episodes of chest pain which they had previously considered to be insignificant might signify serious disease.

The importance of power relationships and the potential for research to exploit as well as exclude women have been debated extensively by feminist theorists. When a researcher is also a health professional, this power imbalance is exaggerated in two ways.

If the interview becomes confused with a therapeutic encounter, a researcher may be tempted inappropriately to ask sensitive questions and participants may divulge more information than they had anticipated when consenting to the study. These problems are more likely to arise when one person fulfils the dual roles of researcher and health professional, especially if they are directly involved in the care of the participant.

The analysis of qualitative data inevitably is influenced by the theoretical framework, epistemological commitments, personal characteristics and preconceptions of the researcher. Although all research is, to some extent, socially constructed, it is in qualitative studies that participants are more likely to feel that their views have been misrepresented or taken out of context.

Personal narrative comprises a person's sense of individual identity, and when participants lose control over how their narratives are interpreted and generalized upon, they also risk losing control over self-identity.

These issues are particularly relevant to health services research. First, most health services research projects are designed to answer specific questions about the patients' perceptions and behaviour and as such are strongly directed by preconceived theories. Secondly, sampling strategies are often determined by these theories, and participant characteristics which are considered significant, such as gender and socio-economic status, are built into the study design.

Thirdly, there is some evidence that the dynamics of the qualitative interview 25 and the nature of data collected 26 can be affected by the professional background of the researcher.

Qualitative health services research studies collect large amounts of information about participants' health and illness, lifestyles and views about health care, as well as information about members of their families and social groups. If identification occurs, it potentially may lead to serious harm such as prejudice and reprisal to the participant or their wider social group.

Interview transcripts contain multiple clues to the person's identity, such as their name, employment details, place of residence and events which have occurred in their communities. It is therefore impossible to anonymize interview data at the stage of analysis, and the identity of participants often will be known to the person carrying out the transcription.

Even after protocols of anonymization are applied, quotations, speech mannerisms and context may provide enough information for participants to be identified by themselves or others, and it is not always easy to predict which data will lead to identification.

As well as the serious potential risks outlined above, the inconvenience and opportunity costs involved in participating in qualitative research are often underestimated. Most qualitative studies in the health services involve in-depth interviews with participants. Such interviews normally last for at least an hour and necessitate the participant travelling to a research centre or allowing the interviewer into their home.

In some studies, participants will be asked to take part in a second interview. A fundamental ethical requirement of all research is that it is scientifically sound. It should be properly designed and carried out by researchers with adequate levels of expertise and supervision.

To ensure that agreed standards are met, it may be necessary for ethics committees to include or refer to experienced qualitative researchers when assessing qualitative research proposals. Research into health and health care may raise participants' expectations that help will be forthcoming, especially when they know that the interviewer is a health practitioner.

In addition, researchers who are also health practitioners are arguably more likely to recognize that participants are in need of further care. Explicit ethical guidelines define the duty of follow-up care for participants in quantitative research involving therapeutic interventions, 27 but to date there has been no ethical guidance recognizing the special issues which arise when the researcher is also a health practitioner.

Informed consent is a prerequisite for all research involving identifiable subjects, except in cases where an ethics committee judges that such consent is not possible and where it is felt that the benefits of the research outweigh the potential harm.

A minimum requirement for an interview study should be that written consent be obtained from the participant after they have been informed, verbally and in writing, about the following issues: Participants should also be given time to both consider their participation and to ask questions of the researcher.

It is in the nature of qualitative research that unexpected themes can arise during the analysis; therefore, at the time of the interviews, the potential uses of the data are not always clear to the research team. In addition, researchers may wish to archive interviews which could then be accessed for future research. If so, participants should be informed and given the opportunity to withdraw consent for the use of their data.

There are two approaches to ensuring that adequate consent is obtained in qualitative studies: The principle of involving participants in the planning, implementation and dissemination of research is long established in sociology, 28 and is increasingly recognized by the academic medical community 29, 30 and funding bodies.

There are practical and ethical drawbacks to treat-ing consent as a process. Despite the small sample sizes of most qualitative studies, researchers may consider re-contacting participants to be costly and, with participants and researchers who are geographically mobile, impractical. More importantly, repeat contacting of participants may, in some circumstances, be regarded as unnecessary harassment. In spite of these drawbacks, and given the unpredictable nature of qualitative research, we advocate treating informed consent as a process.

Some special issues of consent arise in relation to qualitative health services research. First, in order to minimize the risk of exploitation and coercion, the professional background of the researcher should be made clear to the participant, particularly whether or not he or she is a health professional. Secondly, participants should be informed that the research is not intended to be therapeutic or to be an adjunct to their medical care.

Thirdly, participants should be reassured that refusal to participate will in no way jeopardize their health care. Several measures can be employed to minimize the risk of misinterpretation. However, that practice has limitations. Like treating consent as a process, it involves repeated contact with participants which may be impractical and considered to be harassment. A more fundamental objection is that data obtained through respondent validation are subject to the same process of interpretation as the primary data.

Misinterpretation of data is most likely to occur when a researcher is working in isolation. A less direct approach to minimizing the risk of misinterpretation is for researchers to be aware of and explicit about their possible biases. In practice, this requires researchers to state their theoretical approach to the topic, and, for health professional researchers, to consider the ways in which their personal and professional characteristics may affect their interpretation of data.

Qualitative studies collect large amounts of detailed personal information. Not only are there practical barriers to concealing this information, but such contextual data are often an essential component of the analysis. In some circumstances, participants may not wish to remain anonymous: Willingness to be identified with their narratives was observed in a project designed to disseminate patients' views and experience of illnesses, in which many participants agreed to the publication of video-clips of their interviews on the Internet www.

In most cases, qualitative health services research aims for anonymity and confidentiality, and should use foolproof strategies for the secure storage of tapes and transcripts.

Pseudonyms or initials should be used in transcripts and, where possible, other identifying details should be altered. The failure to address these issues can lead to the identification of participants and may make it easier, through a process of elimination, to identify others. For health care practitioners, confidentiality means that no personal information is passed on except in exceptional circumstances.

The detailed guidelines which exist for carrying out medical research have been designed largely for use in relation to quantitative research. Although the ethical principles governing qualitative and quantitative research are essentially the same, we have outlined a number of special ethical issues which arise in relation to qualitative health services research.

In addition, in order to guarantee ethical practice in qualitative health services research, researchers, funding bodies and reviewers should fully understand the scientific basis and methodology of qualitative research.

We have summarized the possible drawbacks of guidelines for qualitative research: However, we maintain, for the following reasons, that such guidelines are required for health services research.

Unlike social scientists, many health services researchers are not trained in philosophical and political aspects of research, so may require more guidance on the ethical issues. In addition, there is growing anecdotal evidence, both locally and internationally, that researchers and ethics committees have difficulty judging the ethical soundness of qualitative projects in health services research.

Research is needed in order to ascertain the risk to participants in qualitative studies. In addition, further debate is required involving health professionals, social scientists and ethicists in order to establish ethical guidelines for qualitative research so that agreement can be reached about what constitutes good practice.

The detailed literature on the ethics of qualitative research in sociology and anthropology has not pervaded the medical literature, and there is evidence that medical research ethics committees have difficulty assessing qualitative projects. Risks which are particularly relevant to participants in qualitative health services research include anxiety and distress; confusion of the research process with a therapeutic encounter; coercion; and the identification of need for further help and misrepresentation.

These risks may be minimized by researchers being clear about the boundaries of their research; by treating informed consent as a process; by being explicit about and reflexive toward their professional backgrounds; and by ensuring that they are adequately trained and supervised.

Whilst recognizing the potential drawbacks of codes of ethical practice for qualitative research, we argue that they are required to inform and guide health services researchers. In order that such guidelines can be formulated, research is required into the actual risks to participants as well as further debate and examination of the basic ethical principles. We would like to thank Dr Rosaline Barbour, Dr Margaret Reid and the anonymous reviewer for their helpful and perceptive comments.

Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Close mobile search navigation Article navigation. Risk to participants in qualitative health services research. Reducing the risk of harm. What follows is not a comprehensive list, but merely a guide to some key considerations in thinking about the ethical implications of particular research strategies:.

Researchers should be alert to signs of distress or reluctance to respond, even if people have agreed to participate in the first place. Assessing risk and harm Building ethics into the research design Sampling Consent Confidentiality Research methods Receiving funding Protocols and conflicts of interest Anticipating issues Ethics and project staffing Permission and approval Legal requirements Institutional requirements Funder requirements Permission and approval: Research methods There are a wide variety of different research methods available to social researchers, and they each raise their own ethics questions.

What follows is not a comprehensive list, but merely a guide to some key considerations in thinking about the ethical implications of particular research strategies: How well do your chosen methods fit the aims of your research?

In other words, do the methods offer the most reasonably efficient way of answering the research questions? What are the strengths and limits of the methods?

Have they been used before effectively in a similar context? Some methods will work better with some groups than with others.

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According to Bryman and Bell () the following ten points represent the most important principles related to ethical considerations in dissertations: Research participants should not be subjected to harm in any ways whatsoever. Respect for the dignity of research participants should be prioritised.

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Ethics in Research We are going through a time of profound change in our understanding of the ethics of applied social research. From the time immediately after World War II until the early s, there was a gradually developing consensus about the key ethical principles that should underlie the .

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Research methodology ethical issues in research an assignment 1. IDENTIFY AND EXPLAIN ANY 6 ETHICAL CONSIDERATIONS IN RESEARCH. Keywords: NASW Code of Ethics, IRB, human subjects protection, quantitative research, qualitative research, mixed-methods research, research design, experimental design, quasi-experimental design Oxford Scholarship Online requires a subscription or purchase to access the .

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Ethics should be applied on all stages of research, such as planning, conducting and evaluating a research project.. The first thing to do before designing a study is to consider the potential cost and benefits of the research. Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas.