Abstract
Background:
The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position.
Method:
Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas.
Objectives and ethical considerations:
First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research.
Discussion and conclusion:
Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop.
Keywords
Introduction
The introduction of the World Medical Association’s Declaration of Helsinki in 1964 stressed the importance of establishing Research Ethics Committees or institutional review boards. By establishing research ethical guidelines, it was stipulated that researchers should not take ethical responsibilities entirely on themselves. 1 –4 The national committees and/or institutional review boards should give advice, guidance, and even permission to do research based on generally accepted principles and guidelines of research ethics regulated by international bodies such as the Declaration of Helsinki. The Declaration of Helsinki (1964/2013) is based on the Nuremberg Trials and includes obligations of openness and other ethical principles to provide guidance to researchers in medical research involving human subjects. 5 Medical research ethics are anchored in the Hippocratic Oath; doing no harm, and has tended to take the protection of the individual as its main objective. 1,6 According to the Declaration of Helsinki, studies should be designed in the safest manner and every medical research study involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits for the ones involved in the research or for others. Furthermore, informants in research should be recruited on a voluntary basis and should be informed of the research study in order to freely give informed consent, preferably by filling in a written consent form. Accordingly, the informants must provide entirely voluntary agreement to participate—that is, without physical or psychological coercion. 7,8 Also, the Declaration of Helsinki 5 paragraphs 19 and 20 especially consider protection of vulnerable groups and individuals. Vulnerable informants can be incapable of giving informed consent, and therefore, the researcher must seek informed consent from a legally authorized representative (paragraph 28). Nursing research often involves “vulnerable people”: people in advanced age, with chronic illness, mental illnesses, co-morbidity, and/or frailty, which could be reasons for dependencies, limited self-determination, and even autonomy. Ethical dilemmas in both including and excluding “vulnerable people” in qualitative nursing research are discussed, 9 since the exclusion of “vulnerable people” from research projects would disadvantage these people by not covering their needs, which would also violate the ethical principles of justice and beneficence. 10 All in all, guidelines are constructed in order to protect people from misuse of register data and other personal sensitive data, and to ensure ethical practice in all research including qualitative research.
Despite the willingness of most qualitative researchers to follow the Declaration of Helsinki 5 and national or institutional ethical guidelines in research, there is a debate in the qualitative research milieu about the mismatch between such guidelines and the nature and essence of qualitative research. 2 –4,11 . First, the mismatch is related to the principle of doing no harm by protection of vulnerable patient groups or individuals, 5 while qualitative researchers do not necessarily understand patients’ vulnerability based on predefined traits, but rather as situational. 9,10 Schrems 10 argues for combining vulnerability as a context-related and situational concept with existing approaches of informed consent, so that the different ethical principles can be balanced and preserved at every step of the research process. Second, an often claimed mismatch is the mismatch between the ethical guideline of informed consent which is based on individual rights and justice related to the principle of voluntariness, 3 and qualitative research which often takes place in collectivistic settings. 9,10,12 Ethical knowledge in qualitative research develops from relationship in a certain situation between at least two persons, and a research relation is a responsive relationship in an ongoing decision-making process. Third, a common claimed mismatch is between guidelines which are standardized and the fact that qualitative empirical research is performed at a certain place and time. 2 Therefore, qualitative researchers would uphold that research ethics are always at play in relationships and are also always present in qualitative empirical research, and particularly at play in the phase of constructing empirical material. 6,13 –15,16 Therefore, a standardization of research ethics rubs uneasily against qualitative empirical research, since qualitative methods are intrinsically unpredictable in nature as well as the data collection process is often invisible due to this unpredictability. 6,9,17,18
Based on the debate in the qualitative research milieu related to the mismatches between research ethical guidelines and qualitative research, the aim of this article is to describe, analyze, and discuss selected ethical challenges and dilemmas qualitative researchers are confronted with especially related to different research ethical principles, such as “informed consent” and “doing no harm.” At the end of the article, we will discuss the usefulness of research ethical guidelines in order to support qualitative research in its ethical challenges. The discussion will be based on three selected cases from the authors’ previous research. All authors have carried out qualitative empirical research during years.
Case 1: when others, in addition to the researcher team, are needed in the recruitment process
The study aimed to understand the significance of work in the labor market when people get cancer. The study comprised narrative interviews with 16 cancer patients (primary informants) and their closest relatives, work leaders, and co-workers, a total of 58 informants. The study took place in an oncological outpatient clinic in Denmark. The primary informants had all kinds of cancer diagnosis, except brain cancer as that make the interviews impossible, and the informants were allocated to the about ½–1½ years after the end of their treatment. They were between 30 and 60 years old, men and women, and active in the labor market at the time of diagnosis. The selection of the cancer patient was stratified by education and job, so that different types of education and job positions in society were represented, and, consequently, also different living conditions. 19 –22 The first plan was that this selection strategy was possible through screening the booking system, the patient records, and the nurse documentation, but unfortunately these were not updated on education and job, or the detail was insufficient in order to screen the patients for the study. Therefore, a personal contact with the patient was needed to identify whether the patient could be included within the defined job categories. In this process, the nurses at the outpatient clinic provided assistance to the study, because they often had more updated knowledge about the patients’ job and working conditions than was noted in the patient records and nurse documentation. In many cases, the nurses could identify relevant patients for the study based on their nondocumented knowledge about the patients, which was actively used in the recruitment process. In other cases, the nurses could close the gate on the patients. An example is that the researcher assistant, who recruited patients into the study, found that a patient met the criteria of inclusion, but the nurse in the outpatient clinic did not find him suitable for interview. The nurse deemed his physical condition to be good considering that he had been treated with radiotherapy, but they found he was always mute, unable to maintain a dialogue, and regarded him as an alcohol abuser and a bit of a loner. But when asked directly the nurse responded that she had not talked to him and did not know anything about him and his life. The researcher assistant insisted that the interview by this patient was just as important as the other potential informants and invited him into the study. He accepted immediately by telephone; we just had to meet after lunch because he slept late in the mornings and had trouble waking up.
Case 2: the other informants and professionals disagree on inclusion of informants
The case is based on a 9-month fieldwork in a psychiatric hospital in two different wards, where staff and patients were followed in their daily life and routines. 23 Both participant observations and formal and informal interviews were used. Patients as well as staff were included, and the inclusion criteria were that the staff had worked more than half a year at the ward and had a half position or more. Patients should have stayed at the hospital for more than a week and have some knowledge of daily life matters and routines. We followed research ethical guidelines by not interviewing patients who were incapable of giving an informed consent due to a long-lasting mental confusion. To do participant observation and interviews, the patients must have agreed and given their informed consent to be interviewed and observed in the hospital milieu. Most patients agreed to be observed and interviewed, but a few patients in each ward could not give their consent due to a long-lasting mental illness and a prolonged state of confusion. Other patients were staying for only a short time, did not trust the researchers’ confidentiality, or the informants asked for elements of their narrative to be treated in confidence. For instance, one informant told the researcher that what he was about to tell the researcher was strictly confidential and should not be written down. The professionals regarded others as unsuitable to follow either due to their prolonged mental illness, or for other reasons such as lack of interest for the research study. One patient at the psychiatric hospital wanted to be interviewed, but the professionals said that he was not an interesting person to include. When asked why the person was regarded as not interesting by the researcher, the professionals said that he was not a very communicative person and in general did not have any opinions on daily life matters. He followed the researcher and asked questions about the research study, and the researcher noted that he wanted to be interviewed. A co-patient told the researcher that her friend at the hospital should be interviewed since he had long experience as a patient and had some interesting stories he wanted to speak about. The researcher said that she had to inform him about the study herself and collect an informed consent form. The co-patient responded: “I have asked him and he thinks it is cool that you are here to do research.” The researcher told a healthcare professional in charge of the ward about her plan to ask this patient for an interview, but this enquiry was challenged by the healthcare professional who recommended that he should not be interviewed or followed. The researcher decided to follow the recommendation of the healthcare professional and did not ask him for an interview. Despite his interest in the study, he was never asked to fill in an informed consent form, and therefore, the interesting empirical material based on informal talks with him could not be used in the material. In this case, the researchers, the co-patient, and the professionals had different views on whom to follow and interview. A research ethical challenge in this case is either to go along with the professionals’ recommendations based on protection of the patient or the researchers’ wish for the patient to decide by himself.
Case 3: the researcher excludes a research informant after having collected informed consent
This case is based on fieldwork in a closed psychiatric ward. The research aim was to gain knowledge about everyday life with mental illness in different settings. 24 Over a fortnight, patients were followed in daily life situations and some were interviewed about their everyday social experiences. Before the fieldwork started, the researcher sent written information about the study with an informed consent form regarding participating in interviews. The inclusion criteria were patients able to understand the information given and capable of giving an informed consent. Patients who were not able to understand the criteria for participation due to a long-lasting mental confusion were excluded.
At the beginning of the fieldwork, potential informants were asked to participate in the study, and among these potential informant was a man who signed the informed consent form and an interview was arranged. During the interview, the informant spoke in a disjointed manner in which it was clear to the researcher that the informant did not know the difference between his father and his grandfather. He also had difficulties in remembering, but despite this he told the researcher a number of small details of a noncoherent life story. He told the researcher about his position as a city commander, who controlled everything. After half an hour, his voice was hard to hear and suddenly he fell asleep in the chair. The next day he wanted to continue the interview, in which he kept telling sad stories about his life. After the conversation, the researcher looked at the informed consent form, where the informant had added something to the form. It said: “This is a war announcement between the US and Russia, signed: The Emperor of Russia.” The researcher decided to end the interview and excluded the informant from the empirical material based on ethical consideration. The selection of informants in this study was based on mutual trust between the researcher and the participant without any interference from healthcare professionals. In the above case, the healthcare professionals did not have any recommendations of whom to be interviewed or not.
Analyzing discussion
Research ethical dilemmas—interference and negotiations with gatekeepers
In the three cases, the patients’ decisions to participate in research were influenced either by healthcare professionals, co-patients, researchers, or as in Case 3 by voices of a fictive city commander. One main principle of research ethics is the notion of voluntariness, 3 which is intended to secure patients’ recruitment, based on the principle of voluntariness. Accordingly, patients should decide by themselves with as little influence as possible by others whether to participate in research or not by filling in an informed consent form. 8,12 However, in qualitative empirical research, researchers engage in different forms of social relations in collectivistic settings where influence on informant’s choice is possible just by their own presence. 9 When doing fieldwork in healthcare institutions, the researcher is visible and available by participating in the healthcare milieu and being on the spot. Potential informant’s choice is not only influenced by researcher’s presence, but as we have seen in Case 2, there may be an attempt to influence the informant’s choice by other members of the healthcare environment such as a co-patient. In interviews, healthcare professionals may also influence the informants’ choice of participation by giving patients information about the study or by not giving the patients information about the study as described in Case 1. In both cases, either when researchers themselves, healthcare professionals, or co-patients gave or did not give information about the study, a selection process was going on where these different actors functioned as gatekeepers. Such gatekeepers can open or close the gate to informants in the recruitment process. Therefore, the dominating research ethical ideal of a noninfluential milieu based on the ideal of free choice seems rather naive when doing qualitative research.
In all three cases, the participants’ decisions to take part in research, or not, were influenced by other persons or voices. In Case 1, the professionals engaged themselves in the selection and access process of picking out informants, despite well-known criteria for inclusion and exclusion. It is a well-known phenomenon that there often is difference between what a person ought to do and actually does. 25 Usually professionals do not have full insight into research conditions, and therefore, they may not be able to fully consider the consequences of who to select or not to select as informants in a qualitative research study. The role of gatekeeper is well known in qualitative research as that of persons that function as intermediaries between researchers and informants. 26 Accordingly, gatekeepers can control the pathways between potential informants and researchers. For instance, gatekeepers can give access to interesting informants who might not have been selected as informants without the help of such gatekeepers. However, gatekeepers might also blur the picture of the real inclusion and exclusion process in research as seen in the example of Case 1. The clinical nurse functioned as a gate-closer which meant that the selection of the patient into the research program led to a latent risk that other parameters than the predefined inclusion criteria were followed, namely the nurse’s personal or professional preferences. The selection process carried out by the nurse became unknown to the researcher. An important principle in all research is transparency in all parts of the research process. The consequence of going along with the gatekeepers is that researchers cannot see who has been omitted from the research. The researcher, then, will not have the full picture of the inclusion and exclusion process, and such a “secret selection process” will therefore give the results of the research an unknown aspect. Therefore, a challenge in qualitative research working with gatekeepers calls for a close, honest, and sincere continuous contact and dialogue between researchers and gatekeepers who select informants for the specific study, in order that researchers may follow the principle of openness and transparency in all parts of the research process. 17
Furthermore, differently positioned actors who function as gatekeepers may have different interests in whose voices and experiences are to be illuminated. For instance in Cases 1 and 2, the professionals might have had a latent professional interest in proposing patients with “uncritical voices” with the aim of presenting their practice in a “nice” way. In contradiction, patients might also have an interest in presenting their experiences and worldviews to improve their condition when institutionalized, as shown in Case 2. The researchers are then intertwined in a set of differently positioned actors with different interests caught in a web of power relations. 4 Accordingly, the researcher must consider whom to include while balancing within a web of power relations consisting of actors in different positions with different interests, and the implications of such choices for the results of the research study.
In Cases 1 and 2, gatekeepers “locked” the gate to valuable patient voices and knowledge. In both cases, patients who were identified as not suitable for inclusion in the studies were already excluded and stigmatized persons in the institutional milieu and in society in general. As we have seen, even though gatekeepers are important collaborators in qualitative research because they give access to informants’ voices and experiences, 26 gatekeepers can both open and lock the gate for interesting informants and their voices and experiences. Closing the gate to interesting patient voices might depreciate an important principle in qualitative research: giving a broad picture of informants’ “worlds” and experiences. If researchers follow the choices made by healthcare professionals, they run the risk that vulnerable and/or silent voices are excluded and hidden in qualitative research. 9,20,22 This might lead to a further stigmatizing of already stigmatized patients. Thereby, researchers can be part of a double stigmatization process, leading to further exclusion of already excluded and stigmatized patients. If researchers are not aware of this, they can do harm to patients by taking part in an ongoing stigmatization process. Furthermore, doing qualitative empirical research means also giving voices to silent, vulnerable, and/or neglected people in order to throw light on the research area. 10,27 –29 And so to speak, by solely following professionals’ choice of informants, the researcher might be in danger of representing the professional’s point of view at the expense of the patient’s point of view. 30 Accordingly, the research results might therefore be presented with a bias at the expense of a richness and complexity valued in qualitative research.
It is not only professionals, but also patients who can function as “their own gatekeepers.” The informants themselves can function as gatekeepers based on the process of informed consent. In principle and in reality, they have the opportunity to stop the study since all potential informants can decide not to take part in the study. However, giving an informed consent is seldom a straight-forward process in qualitative research. 2,6,9 For example, having Case 2 in mind, the informants could ask for confidence in elements of their narratives, despite their voluntary entry into the research by the principle of free choice and informed consent. This means that determination of the ethically correct and acceptable response is coming into existence and under negotiation in the actual situation, on the spot, between researcher and informant. 31 It has been shown that participant observation, which includes both observations and interviews, is primarily an advanced exercise in forming and maintaining intimate relationships for professional purposes, 6,32 and per se it calls on a situational ethical approach from the researcher driven by the judgment of the person caught up in the situation. A situational dilemma in qualitative research is shown in Case 3, where the informant insisted continuously that he wanted to tell his story and the researcher followed his demand. He was informed about the project, had given his signature, and the ethical guidelines had been followed so far. The ethical dilemma arose in the research situation in connection with balancing and assessing different considerations between respecting an “informed consent” versus “doing no harm.” In this case, the informant was experienced as psychotic by the researcher during the interview, and therefore, the researcher regarded him as unable to decide by himself, for the time being. The researcher had to take over the responsibility and put aside his informed consent given at an earlier stage in the research process. This case shows that ethical considerations and decisions are distinctly situational in qualitative research; they are conditional on the situation. The researcher had to balance her interest in and knowledge of the research area with her intuition, morality, and personal conviction on the spot in the situation.
Research ethical dilemmas—balancing between different research ethical principles
The researchers had to balance between different ethical considerations: between wanting the patient to decide by himself and protecting the potential vulnerable patient from harm. Such balancing creates certain dilemmas for the researcher, as for example in Case 3 where the researcher on one hand wanted the psychiatric patient to decide by himself, but on the other hand the researcher also had to consider the patient’s well-being. In this case, the researcher balanced considerations in utilitarian ethics and patient autonomy with the patients’ mental illness and therefore need for protection in line with the Hippocratic Oath. Both traditions imply that research informants are by nature either fundamentally autonomous or innately vulnerable and therefore in need of protection. 9,33 A mixture of different epistemological traditions in medical research ethics implies guidelines that might appear paradoxical when applied to qualitative empirical research. Nevertheless, the ethical guidelines reflect possible ethical dilemmas experienced in qualitative research when it comes to balancing ethical considerations in a certain research setting. As shown in Case 3, there are inherent problems in using and obtaining informed consent as a one-time inclusion criterion for participating in qualitative research for at least two reasons. First, primarily qualitative research is carried out in a contemporary situated context, in a particular period of people’s life, where the person’s situation can suddenly change. Second, informants may find it difficult to understand and overlook the consequences of participation in research beforehand. Therefore, ethical issues in qualitative research cannot be predicted or managed solely in advance. In these situations, it is not sufficient to obtain informed content at the beginning of the research process, but to be ethical requires an open and continuous information process during the time the research goes on. 4,10 In that sense, it requires an ethical alliance to be continuously established in each particular research setting. Conversely, one can say that ethical dilemmas are rooted in a qualitative research epistemological basic condition of involvement and closeness. This is why an ethical judgment is always demanded in a concrete situation by the researcher, on the spot.
Another dilemma often experienced by qualitative researchers is the dilemma between taking into consideration the individual perspective versus collecting empirical material in a collectivistic setting where there are many different considerations to be undertaken. In Case 2, the researcher was caught between considering the individual patient’s will to participate and considering the judgment of the staff on whom to include and exclude in the research. Research ethics, as it is formulated in the Declaration of Helsinki, 5 is primarily individualistic based on the free will of the individualistic patient or the protection of the individualistic patient, while qualitative research is primarily collectivistic when it is practiced in a healthcare milieu. As we have shown, patients in all three cases were influenced by a number of differently positioned actors. In qualitative research, it is not uncommon that researchers have to balance between differently positioned actors with different interests and views. 34 Accordingly, research ethics formulated solely on individualistic considerations is not in line with the “reality” in much relational based qualitative empirical research.
Implications for research ethical guidelines committees
As argued above, there might be a mismatch between research ethics as predefined by research ethics committees and qualitative research which constructs data on the spot. Obviously, a stated challenge for qualitative researchers is the implicit understanding that ethics can be “fixed” on the desktop before the research starts and away from the situational setting in which the research takes place. Therefore, institutional review boards that advise and give permissions to research studies should rewrite and practice the medical ethical guidelines in a more flexible way so that they are more in line with the ethical dilemmas experienced in qualitative empirical research. However, it is not easy to rewrite research ethical guidelines in line with ethical dilemmas experienced in qualitative empirical research since, as we have shown, ethical dilemmas experienced are usually unpredictable. 6,9 Nevertheless, both researchers and ethical review boards can be better prepared for ethical dilemmas experienced in qualitative research. For instance, the researchers through their research design should ensure proper selection criteria in the protocol in order to minimize gatekeepers’ opinions and preferences. However, formulation of selection criteria approved by ethical committees is always a matter of interpretation of different positioned gatekeepers; therefore, a selection process will always be a matter of subjective judgment. Also, research ethical guidelines could be rewritten related to informed consent as individualistic and pre-given. As we have shown, self-determination when giving an informed consent is not absolute, but informants’ self-determination is rather influenced by different positioned actors in the health milieu. Therefore, the ethical committees should be open to consider a process-based informed consent if this is done in close cooperation with the health institutions where the research takes place. The main issue for researchers and ethical committees is to ensure that researchers are able to handle ethical dilemmas on the spot in a way that protects the informants’ health, dignity, and integrity, also of most importance in the Declaration of Helsinki. 5 Since research ethics in qualitative research must be understood and practiced as relational, situational, and emerging, 3,6,17,18,35 qualitative researchers in the research ethical review boards should be open to discuss research ethical dilemmas with researchers during the whole research process. In addition to modifying research ethical guidelines and practice, healthcare lecturers in all stages of research education and training should be introduced to different examples in qualitative research and discuss different ethical dilemmas as they emerge and appear.
Conclusion
In all three cases, we have focused on how ethical considerations are always a question in situations on the spot when carrying out qualitative research in healthcare settings. It is difficult for researchers in qualitative research to foresee ethical dilemmas since such dilemmas appear in the relational situations on the spot, and not beforehand at the desktop. Being aware of that all research, also quantitative research, can face ethical dilemmas, qualitative research is often an unpredictable and “messy” occupation, and consequently is not possible to predict before entering the field of research. The article has discussed ethical dilemmas related to interference by and negotiations with gatekeepers. The researcher and informants are often intertwined in a set of relationships and are influenced by different actors with different views and positions. It has also been discussed how the possible mismatch between research ethical guidelines and dilemmas are experienced by qualitative researchers. First of all, ethical guidelines are influenced by different ethical traditions, which might create concerns for the researcher when considering which guidelines to follow, either utilitarian ethics or paternalistic ethics. Both ethical traditions are based on individual rights either to be autonomous or to be protected from harm. However, qualitative empirical research is often relational and collectivistic which means that no possible informant is free of influence. To sum up, research ethical guidelines are important, but ethical considerations have to take place continuously both for the sake of doing no harm to the patients and for the trustworthiness of the study. In qualitative research, the role of the researcher is inter-relational and constructed. Because the researcher and the informants negotiate continuously, the role and position of the researcher are created and recreated on the spot. This complexity makes it necessary to keep the consideration of ethical issues and dilemmas in qualitative research open during the whole period when interviews and fieldwork are carried out. Therefore, in qualitative empirical research, it is not sufficient to follow ethical guidelines formulated and prepared at the desktop. Qualitative research is fundamentally relational, situational, and collectivistic, and therefore, research ethical guidelines must be formulated and practiced as relational, situational, and emerging.
Footnotes
Conflict of interest
The authors declare that there is no conflict of interest.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.