Many aspects of the sections below would apply to all types of research, but for practical reasons they are integrated with issues particularly concerning qualitative research.

Introduction

Van den Hoonaard (2008) states that ethical guidelines for bio-medical research have – problematically in his opinion – shaped the ethical guidelines for social research, an area which encompasses qualitative health research. He suggests that the traditional medical view of the human ‘subject’ is inadequate in social research when compared to the holistic understanding of the World Health Organization (WHO). For qualitative researchers a holistic view of ‘participant’ as an active and interactive human being is of major importance, and researchers need to be aware of the social and cultural context. These issues must be considered especially in qualitative research, as it is context bound and usually interactive. The following section is a discussion of research with patients which includes the particular concerns of qualitative researchers.

Ethics in research with patients

Patients are in a particularly endangered position for two main reasons: the perceived imbalance of power in their relationship with health professionals and the special vulnerability of being ill. Participants are in a situation in which they have limited power, and they feel a lack of control. They are not always aware of their rights to refuse participation in the research, particularly if it lasts over a long period of time, and when unexpected issues arise. The researcher must understand the feeling of obligation that participants might have. Often they feel powerless to deny the researchers access to their world. While official documents focus on the rights of patients, research in healthcare often deals with people who have little real power in their situation. The power balance is perhaps more equal in the client’s own setting than in the hospital situation.

Timing is an important issue in qualitative research (Cowles, 1988). Bad timing can inhibit informants, especially when they have recently had a traumatic experience. They might feel threatened at this particular time and too emotionally involved to make rational decisions about taking part or continuing the research. This leads to the problems of interviewing patients.

Interviews and observations

Interviews, in particular, may deeply affect participants who do not just reveal their experiences and deep thoughts to the researcher but also might become aware of hidden feelings for the first time. Interviews might provoke distressing memories and strong emotions (Butler, 2003), and the researcher should be prepared to allow the participant to work through these. Interviewers also might find these conversations distressing and stressful, and they too might need peer support or even counselling.

Towards the end of the research project another problem may arise: the continuous, intimate nature of the interviewer–informant relationship generates trust and sometimes friendship; therefore, it is difficult for both researcher and participants to extricate from it. A sensitive researcher does not leave the patient anxious or worried. The ‘debriefing’ of informants and the provision of emotional support, if needed, is important. If health researchers find strong distress in patients, there is need for debriefing and a mechanism for following up the participants.

Mander (1988) claims that patients are particularly vulnerable because they are ‘a captive population’. Patients are vulnerable especially when they are very young or very old. Interviews must take into account the difficulty they might have in sustaining long in-depth interviews; the researcher might consider several short interviews instead. Children, people with learning difficulties and those who have a mental or terminal illness need particular protection. For the children and some people with learning difficulties, researchers are obliged not only to gain permission from the participants but also from parents or legal guardians as ethical issues are particularly complex in this case. Even experienced health professionals should undertake research with these groups only after careful consideration. (NRES has specific guidance documents for research with those who cannot give consent for themselves.)

There are particular issues to be considered when carrying out research with frail older people (Harris and Dyson, 2001) as much qualitative research now focuses on this group. It is difficult for some, though by no means all, members of this group to give fully informed consent as they might be prevented from doing so by ill health, chronic disease or fatigue. Even factors such as size of writing in the information sheet or consent form or the clarity of the researcher’s voice are important, as is the potential participant’s ability to understand the information and to concentrate on it. Older people are sometimes loath to commit themselves to being interviewed for research purposes and must therefore be recruited with care and diplomacy.

Harris and Dyson (2001) add among other suggestions:

• Researchers should not underestimate difficulties in recruiting vulnerable older people.
  
• Researchers need to develop skills in recruiting members of this group while also protecting their rights to refuse to take part.
  
• Researchers should attempt to obtain genuine consent in a study (See Further reading).

Very similar issues are taken into account in research with children. Researchers also need special consideration of ‘giving voice’ to minority groups as there is often a tension between using people as sources of data and respecting the rights of individuals to be heard. Researchers must give reasons for focusing on or excluding minority groups.

Ethical questions arise in observation, too. Covert observation is problematic and its ethics debatable. Researchers in the field of healthcare usually disclose their presence as observers and reveal the purpose of the observation. This may generate the observer effect – the change that observers may bring about in the setting through their presence. Patton (2002) suggests that the effect can be overestimated, as participants are immersed in the setting and get used to their presence. In any case, clients and colleagues generally trust the health professional to behave ethically.

Permission for observation must always be obtained. Rogers (2008) gives the example of midwifery research where a researcher might wish to observe the empathising skills of midwives during the labour process. This means that clients and others in the setting have to be asked for permission and not only midwives.

Informed consent and voluntary participation

Informed, voluntary consent means that research participants are fully informed about the research and give their voluntary agreement to take part in it. There should be neither implicit or explicit pressure from researchers nor any inducement. The Royal College of Nursing (2005) gives guidance about informed consent in health and social care research and states: ‘Informed consent is an ongoing agreement by a person to receive treatment, undergo procedures or participate in research, after risks, benefits and alternatives have been adequately explained to them’ (RCN, 2005: 3).

The nature of qualitative research is its flexibility, the use of unexpected ideas arising during data collection (serendipity) and the prompts that are allowed during interviews. Qualitative research focuses on the meanings and interpretation of the participants. The developing concepts are grounded in the data rather than in a previously established framework; hence qualitative researchers have inherent problems with informed consent. When the research begins, they have no specific objectives for the research, though they have a general aim and focus. Shaw (2008) discusses this problem: the participants cannot always have full and detailed information about the project as the ideas of the researcher might change during its process. This is a dilemma of which participants must be informed. Researchers must often make difficult decisions after balancing advantages and disadvantages of giving full information from the beginning of the research. The initial lack of complete information is only justifiable because it produces data without harming the participants. By the end of the research participants need full disclosure of details, so they can make an informed decision on the use of their data; consent given before the interview cannot be taken for granted and must be confirmed throughout without putting pressure on the participants.

Consent in qualitative research is an ongoing process. Whilst consent may be implied in one phase of the research, it cannot be assumed at another stage when the researcher’s ideas change on the basis of the information provided, or indeed, when participants change their minds. Thus consent is not a once and forever agreement by participants but requires ongoing consent.

The process of informed consent is located within the principle of respect for autonomy. This principle demands that participation is voluntary and that informants are aware not only of the potential benefits of the research for the population but also of the personal and individual risks they take. First-time researchers, in particular, should take care that there is no major risk involved, though all research involves some risks. Participants then must be informed throughout about the voluntary nature of participation in research and about the possibility of withdrawing at any stage. This should be shown in the written consent form required in most health research. Van den Hoonaard (2002), however, thinks that written consent is inappropriate in qualitative research, and Green and Thorogood (2004) even believe that the research relationship might be damaged through this. They argue that, although individuals are usually willing to participate, they often reconsider when asked to sign forms. However, these writers are sociologists and not health professionals, and the latter would have to ask for consent forms; otherwise they would not generally gain permission from ethics committees, however ethical their behaviour. Ethics committees generally request a consent form (see later in this chapter).

It is useful to anticipate potential problems in the course of the research and consider their solutions. The researcher must be aware that the research might threaten participants, superiors or institutions, even if it is intended to have a positive effect. Sim (1991) identifies a major dilemma of researchers: they experience conflict between the recognition of the rights of human beings and the wish to advance professional knowledge. Electronic mail and internet inquiry also pose particular problems as it is difficult to ascertain that the consent is truly given by the participants (Kralik et al., 2005). Special measures need to be taken to safeguard people when the internet is used for research (see Further reading).

Anonymity and confidentiality

Qualitative healthcare research might be more intrusive than quantitative research; therefore, the researcher needs sensitivity and communication skills. Usually, anonymity is guaranteed, and a promise is given that identities will not be revealed. Qualitative researchers work with small samples and use thick description (see Glossary); it is not always easy to protect identities. Even a detailed job description or an unusual occupational title of an informant may destroy anonymity.

Researchers sometimes change minor details about the participants so that they cannot be identified. For instance, researchers may change the age of all participants by two or three years when age is not an important factor in the research (Archbold, 1986). This of course must be reported in the research account without giving exact particulars. Only the researcher should be able to match the real names and identities with the tapes, report or description; participants are given numbers or pseudonyms. Tapes, notes and transcriptions – important tools for the qualitative researcher – must be kept secure and names not located near the tapes. If other people, superiors, supervisors or typists have access to the information – however limited this might be – names should not be disclosed, participants’ identities must be disguised and they should be asked for permission. It is also worth noting that, although undertakings of confidentiality are given, participants need to know that others might have access to the tapes for peer reviews for verification of the analysis.