Health Science Journal

Keywords

Research ethics, moral dilemmas in research, nature of nursing, nursing research, nursing advocacy

Introduction

Ethics is rooted in the ancient Greek philosophical inquiry of moral life. It refers to a system of principles which can critically change previous considerations about choices and actions. [1] It is said that ethics is the branch of philosophy which deals with the dynamics of decision making concerning what is right and wrong. Scientific research work, as all human activities, is governed by individual, community and social values. Research ethics involve requirements on daily work, the protection of dignity of subjects and the publication of the information in the research.

However, when nurses participate in research they have to cope with three value systems; society; nursing and science. The societal values about human rights, the nursing culture based on the ethic of caring and the researcher's values about scientific inquiry. According to Clarke these values may conflict with the values of subjects, communities, and societies and create tensions and dilemmas in nursing. [3]

In this paper, the most important ethical issues will be addressed. After a short description of the nature of nursing, and the advocacy role of nurses, the writer will attempt to highlight the possible conflicts that nurses have to deal with, when undertaking or participating in research.

Historical overview- Ethical codes

Human experimentation has been conducted even before 18th century. However, the ethical attitudes of researchers drawn the interest of society only after 1940's because of human exploitation in several cases. Professional codes and laws were introduced since then in order to prevent scientific abuses of human lives. [4] The Nazi experiments led to the Nuremberg Code (1947) which was the leading code for all subsequent codes made to protect human rights in research. This code focuses on voluntary informed consent, liberty of withdrawal from research, protection from physical and mental harm, or suffering and death. It also emphasises the risk- benefit balance. [5] The only weak point of this code was the self regulation of researchers which can be abused in some research studies. [4] All declarations followed, forbade nontherapeutic research. It was only in 1964 with the declaration of Helsinki that the need for non therapeutic research was initiated. [6] The declaration emphasised the protection of subjects in this kind of research and strongly proclaimed that the well being of individuals is more important than scientific and social interests. [4]

In terms of Nursing the first inquiry was the "Nightingale Pledge" (1983). Since then there has been a significant development of professional codes in conduct and research. The American Nurses' Association (ANA) Guidelines for Research, the Human Rights Guidelines for nurses in clinical and other research (1985) and the Royal College of Nursing Code for nurses in research (1977) provide a strong assistance to professional nurses as well as reassurance to patients, the public and society, of professionals’ intentions. [7-9]

Major ethical issues in conducting research

Informed consent

Informed consent is the major ethical issue in conducting research. According to Armiger: "it means that a person knowingly, voluntarily and intelligently, and in a clear and manifest way, gives his consent" . [10]

Informed consent is one of the means by which a patient's right to autonomy is protected. Beauchamp and Childress define autonomy as the ability for self determination in action according to a personal plan. [11] Informed consent seeks to incorporate the rights of autonomous individuals through self- determination. It also seeks to prevent assaults on the integrity of the patient and protect personal liberty and veracity. [3] Of course individuals can make informed decisions in order to participate in research voluntarily only if they have information on the possible risks and benefits of the research. [12] Free and informed consent needs to incorporate an introduction to the study and its purpose as well as an explanation about the selection of the research subjects and the procedures that will be followed. [8] It is essential to describe any physical harm or discomfort, any invasion of privacy and any threat to dignity as well as how the subjects will be compensated in that case. [5] In addition the subjects need to know any expected benefits either to the subject or to science by gaining new knowledge.8 A disclosure of alternatives is also required as for example in the Tuskegee study about syphilis. In this study, rural black men were chosen as subjects in a study of syphilis. Although a cure for syphilis was found after the start of the study, it was decided not to treat them and they had not been told that penicillin was effective to their disease. [13] The researcher must inform the subjects about the methods which will be used to protect anonymity and confidentiality and indicate a person with whom they can discuss the study. He must also provide a "Noncoersive Disclaimer" which states that participation is voluntary and no penalties are involved in refusal to participate. [14] Moreover, the subject must be told that some information has been deliberately withheld in order to avoid altered behaviours. The researcher must also take into account that persons with physical, cultural and emotional barriers may require a very simple language in order to understand him. [15] Finally, the freedom to withdraw must be explained. [5] This is very important but raises the issue of how difficult the subjects can withdraw after developing a personal and sometimes friendly relationship with the researcher. [12] With regard to withdrawal a researcher may be in a dilemma in case many subjects choose to withdraw at an advanced stage of the study, because this can affect the validity of the results. The Declaration of Helsinki provide some help as it declares that the interest of the subject must always prevail over the interests of society and science. [3] According to this, the will of the subject must be respected at any cost for the research.

Another major ethical issue is obtaining an informed consent from groups with diminished autonomy which will be further discussed later. From what has been discussed, it becomes clear that disclosure, comprehension, competency and voluntariness are the four essential parts of a consent. [5]

Beneficence- Do not harm

The ethical principle of beneficence refers to the Hippocratic "be of benefit, do not harm". Beauchamp and Childress, suggest that

"the principle of beneficence includes the professional mandate to do effective and significant research so as to better serve and promote the welfare of our constituents". [11]

Beneficence is sometimes difficult to predict when creating a hypothesis especially in qualitative research. Carr says that if the research findings prove that it was not beneficial as it s expected, this can raise immense ethical considerations especially for nurses. [16] Ford and Reutter say that "beneficence relates to the benefits of the research, while non-malificence relates to the potential risks of participation". [12] Nonmalificence requires a high level of sensitivity from the researcher about what constitutes "harm". According to Burns and Grove "discomfort and harm can be physiological, emotional, social and economic in nature". [5]

When a researcher tries to learn intimate details of the participants lives he has to deal with opening old wounds. [12] Nonmalificence dictates both preventing intentional harm and minimising potential harm. A researcher must consider all possible consequences of the research and balance the risks with proportionate benefit. The type, degree, and number of potential risks must be assessed as well as the patients value system which ranks various harms. [17] The risk benefit ratio can only be achieved by identifying these factors. If the risks outweigh the benefits, the study should be revised. [5]

Last, debriefing at the end of a study, should be mentioned. Treece and Treece say that debriefing refers to explaining the exact aim of the study and why the disclosure was not full. [18] Treece and Treece suggest that subjects should feel as much at ease as possible and express their feelings. [18] In addition, Burns and Grove suggest that if the subjects experienced a high level of discomfort, they should be debriefed or referred to appropriate professional intervention as necessary. [5]

Respect for anonymity and confidentiality

The issue of confidentiality and anonymity is closely connected with the rights of beneficence, respect for the dignity and fidelity. [3] ANA suggests anonymity is protected when the subject's identity can not be linked with personal responses. If the researcher is not able to promise anonymity he has to address confidentiality, which is the management of private information by the researcher in order to protect the subject's identity. [19] Levine advocates that confidentiality means that individuals are free to give and withhold as much information as they wish to the person they choose. [20] The researcher is responsible to "maintain confidentiality that goes beyond ordinary loyalty". Clarke addresses the ethical dilemma of the researcher when confidentiality must be broken because of the moral duty to protect society. [3]

According to the utilitarian theory, which focuses on the best interest of all involved, the happiness of society is of greater importance. On the other hand, the deontological theory which ignores the result implies that the moral duty is what really matters. If a researcher, though, acts deontologically he may feel that he has not protected society. Another issue is that the researcher may have to report confidential information to courts which can also cause

moral dilemmas. In that cases it can be argued that the moral duty and personal ethos can be stronger than legal requirements. [3] Even if there are no duty conflicts, the researcher faces several problems with respect to maintaining confidentiality especially in qualitative research where conduct is personal, the sample is smaller and the reports display quotations of interviews. Ford and Reutter suggest using pseudonyms and distorting identifying details of interviews when transcribing the tapes used. [12]

In situations that are particularly complex, sensitive, and in which the participants are extremely vulnerable, a Certificate of Confidentiality issued by the U.S. Department of Health and Human Services (DHHS) may be useful to help ensure the privacy of research participants especially in studies in which participants and researchers may be exposed to compelled legal disclosure of research data.

The researchers must always bear in mind all psychological and social implications that a breach of confidentiality may have on subjects. In order to protect participants, they have to inform them on their rights, and use all possible coding systems that they regard appropriate in each case.

Respect for privacy

The fifth principle of the entitled "A Patient's Bill of rights" document published in 1975 by the American Hospital Association (AHA), affirm the patient's right of privacy. [21] According to Levine : "privacy is the freedom an individual has to determine the time, extent, and general circumstances under which private information will be shared with or withheld from others ". [20]

Kelman believes that an invasion of privacy happens when private information such as beliefs, attitudes, opinions and records, is shared with others, without the patients knowledge or consent. [22] However, the American Nurses Association says that different persons may held different opinions about when privacy is invaded. A researcher cannot decide on behalf of other persons on those delicate issues. All aims, instruments and methodology must be discussed with the prospective subject and the research workers prior to the investigation.

Treece and Treece suggest that whenever subjects refuse to report personal information as they regard it an invasion of privacy, the researcher ought to respect their views. [18] This may even apply to report of age, income, marital status, and other details that the subject may regard intimate. They also imply that privacy can be invaded when researchers study certain groups without their knowledge and without identifying themselves. An example of such a study that the researcher hid his identity, was Humphrie's study "Impersonal Sex in public places" in which, he observed homosexuals during sexual activities in public men's rooms. [18] Health care practitioners need to be aware that "an invasion of privacy may cause loss of dignity, friendship or employment, or create feelings of anxiety, guilt, embarrassment or shame". [5] In conclusion, all possible measures have to be taken in order to protect subjects from potential physical, psychological or social damage during the research or after circulation of the results. [8]

Vulnerable groups of people

Nowadays, there is an increased concern about vulnerable groups and whether it is ethical or not for them to be used as research subjects." Fisher classifies vulnerability as one characteristic of people unable to protect their own rights and welfare". [23] So, vulnerable groups include captive populations (prisoners, institutionalised, students etc), mentally ill persons, aged people, children, critically ill or dying, poor, with learning disabilities, sedated or unconscious.

The different opinions about their participation in research can be attributed to their inability to give an informed consent and also to their need for further protection and sensitivity from the researcher as they are in a greater risk of being deceived, threatened or forced to participate. Many are in favour of the use of such subjects in research whilst others would argue strongly against it. Most condition their responses according to the seriousness of the research, the level of potential risk and the availability of alternatives. [6] According to Burns and Grove vulnerability increases the need for justification for the use of such subjects.5 An intense analysis of potential risks and benefits should be the first step of starting such a research and careful approach should exist both in acquiring consent and during the research procedure itself. Persons with diminished autonomy are also more vulnerable to invasion of privacy, since their right to privacy is limited in contrast to other's right to know. In the case of mentally ill, family as well as employers and colleagues have the right to know while patients may not be able to see the testimony of others in their own record. In the case of mentally ill patients, it is important to measure comprehension and develop valid tools for it, before obtaining informed consent to participate in a research study. In a descriptive study of Beebe and Smith the Evaluation to Sign Consent (ESC) form was used in order to document comprehension in 29 schizophrenia outpatients. [24] Participants living in supervised housing were significantly more likely to require prompts than those living alone. Participants prescribed two antipsychotic medications were significantly more likely to require a prompt than those prescribed only one antipsychotic.

According to Lasagna there are strong feelings among professionals who disagree with experimentation on vulnerable groups. [25] However, the potential improvement of their nursing care raises the issue of careful consideration before rejecting or accepting this kind of research.

Skills of the researcher

Jameton declares that in research the three more important elements are the competency of the researcher, the careful design, and worthwhile expected outcomes. [13] The Royal College of Nurses declares that nurse researchers should have the necessary skills and knowledge for the specific investigation to be carried out and be aware of the limits of personal competence in research. Any lack of knowledge in the area under research must be clearly stated. Inexperienced researchers should work under qualified supervision which has to be reviewed by an ethics committee. [26]

What is more, careful choice of method for data collection, to ensure validity and reliability, are two main requirements that must be met in all kinds of research. The choice depends on the object of the study. When human beings are involved, all the ethical issues, discussed above, must be taken into account. [2]

The nature of Nursing

The nature and essence of nursing reflects on human beings and their relationship with health. [27] Mckenna states that the primary scope of nursing is to help persons to adapt in different stages of illness which is a rather task-orientated and behaviouralistic approach. [28] On the other hand, Swanson notes that nursing views persons as a whole and health as a subjective and meaningful experience of integrating with the environment. [29] Mckenna views nursing's main elements as interpersonal interactions which involve practical actions but Chinn and Jacobs make hints on holism as well. [28,30] Literature contains diversed nursing definitions which indicates the complicate and uncertain nature of it. [28] However, most authors reflect on caring as the most important part of nursing. Raya focuses on the unique element of caring in nursing while Swanson views Nursing in the same scope as "informed caring for the wellbeing of others". [29,31] The ANA policy statement declares that "Nurses diagnose and treat human responses to actual or potential health problems". [8] This is quite indicative of the nurses' role, but it does not reflect the values, experience and passion of nursing. Swanson suggests that nursing has to do with "science, concern for humanity and caring. [29]

What exactly does it mean to care? Mayeroff describes caring as an interaction which offers space for personal growth for both the carer and the cared. [32] Roach says that caring describes precious moments when participants realise their common base of humanity". [33] Burnard and Chapman suggest that the most important elements of caring are: "knowledge, alternating rhythms in relationships and continuous changes in reactions to others, patience, honesty, trust, humility, hope and courage". [9]

In Nursing however, the element of caring is undervalued because the profession was viewed as "women’s work" in which, care is governed by sentiment and not by logic. [34] Nursing was perceived by society as an extension of medicine while curing is regarded more important than "enhancing life quality" and preserving human dignity". [29] On the other hand, Roach says that the curecare dichotomy used to distinguish nursing from medicine is an artificial one. [33]

As McNeil et al say, "care is the basis and precondition of all cure". [34] Swanson proposes a structure for caring which includes maintaining belief in persons, knowing the other person, being with, doing for, and enabling. [29] The last two are the most important parts related to research. Doing for, means predicting individual needs, encouraging, performing tasks with adequate skills and competence, protecting the patient from harm and preserving the dignity. On the other hand, enabling, means enhancing self-care by training, informing and explaining to the patient as well as assisting with finding alternatives. [29] Leininger supports the thesis that:"there is no discipline that is so directly and intimately involved with caring needs and behaviours than the discipline of Nursing". [35]

However, caring is not unique in nursing. Other professions can also claim that caring is an important part of their practice. It can not be stated either that all nursing procedures include caring. [29] What is more, can nursing today be a synonym of caring? The vulnerability of the sick and the lack of patient participation in health care, creates a danger of patient exploitation by nurses. [13] . The rapid change and development of nursing emerged the need for a code of professional conduct to guide nurses in their practice.

Advocacy in nursing

Advocacy primarily used in legal contexts, refers to the protection of human rights of people who cannot defend them for themselves. [17] The role of nurses as advocates is closely related to the purpose of nursing, the nurses views about humans and the needs of persons in health care. [36] In literature advocacy is described in three different models: The rights protection model implies that nurses helps persons to understand and exercise their rights. They also aim to protect and enhance personal autonomy. [37] The value based decision model suggests that nurses should not impose decisions but assist persons to decide which choices are most consistent with their values. They should also support the patients' confidence in their own decisions and prevent limitations of their freedom. [17] This model is considered by Gadow in the "existential advocacy" which focuses on the clarification and reconsideration of the values of the patients by self examination. [38] According to Fowler and Arrif this thesis is distinct from both "paternalistic and consumer rights protection" and declares the fundamental rights of self determination. [17] However according to Johnstone, Gadow does not provide adequate reasoning why self-determination is the most important value or why the human rights claim to selfdetermination are quite different from a patients rights claim to self-determination. Last, the respect for persons model focuses on human dignity, privacy and selfdetermined choices that the nurse has to protect if the person is not autonomous or self-determining. [1] Murphy argues that this model which she calls the advocate model of the nurse-patient relationship, reflects the basic value of nursing which is the best possible care for patients. [39] However, nurses should not be considered as being in a solely position to act as patients advocates.

According to Johnstone all professions with a morally significant relationship with a patient ought to fulfil the role of the advocate. [1] The ANA Code for nurses though, refers to the nursing role of advocate in safeguarding the well being of the client and the society. [8] However, both the nature of nursing which focuses on caring, preventing harm and protecting dignity and the advocates role of nurses which calls for defending the rights of subjects, are sometimes incongruent with the ethics in research.

Conflicts in nurses

Beneficence-Non malificence

A common feature in professional conduct codes and those specific to research is the principle of non-malificence. The ANA Code of conduct declares that the nurse protects the clients and the public from unethical, incompetent or illegal practice of any person. [8] This statement raises the issue of advocacy when nurses have to protect patients from the researchers’ incompetence or unethical behaviour. Even if nurses are certain about the incompetence of the investigator, which is usually very difficult, they have to deal with serious dilemmas. First they have to consider the fact that if patient learn that they are exposed to professional misconduct, they may lose faith in health care. Jameton though, believes that patient should be informed as they will appreciate the trust shown to him by frankness. [13] If the researcher does not inform or compensate patient then nurses have to decide between the duty to safeguard the well-being of patient and be loyal to them, and the loyalty to colleagues.

However, even if nurses decide that their duty of caring and being loyal to the patient is more important, they may have to deal with the hierarchical and bureaucratic systems of institutions which demand loyalty to subordinates to the institution. In case the incompetent researcher is a higher status professional, nurses may be obliged to show loyalty, but this can conflict with loyalty to patients. Consequently, nurses may feel that their patients are vulnerable and exposed and that they can not prevent it because they do not have a voice or power to resist. This is merely why many authors believe that it may not be possible for nurses to act as advocates of subjects in research. Many support the idea that the prohibition from the advocacy role comes from the origins and development of nursing as a women’s occupation dominated by medicine in a bureaucratic system. [40]

Another possible issue of conflict is that the caring nature of nursing with regard to the right of patients to the best treatment/care is sometimes conflicting with the aim of research in non therapeutic studies. According to the Belmond commission the general aim of practice is to enhance the well being of individuals while the purpose of research is to contribute to general knowledge. This distinction highlights the differences in the aims of a nurse practitioner and a researcher. It is therefore very difficult for nurses to be engaged in studies whose aim is not directly beneficial to the subject. They must though, consider that these studies may generate and refine nursing knowledge.

Another problem that nurses may have to face is taking part in randomised control trials. According to Brink and Wood dedicated nurses are finding themselves under pressure when they are asked to exclude some patients from an obvious beneficial treatment such as relaxation techniques for relief of post operative pain. [41] So, they suggest that whenever it is possible to predict such problems for nurses, the control data should be collected before introducing the beneficial variable. Skodol Wilson implies that there should be some provisions for alternative effective care. [42] Finally, Brink and Wood recommend that withholding benefits can be rectified at the end of an experiment. [41] This compensation must be planned in advance so that enough money and time will be available.

In order to prevent human exploitation, ethics committees were introduced. [3] The criteria on which the proposals are to be judged are the physical and mental discomfort or harm of subject, the qualifications and experience of the supervisor, the scientific value, the adequate consent procedures and the adequate information given to subjects. [43] Clark warns that there is a danger that the members may have vested interests in a research. [3] The success of any ethics committee will always depend on the commitment and moral competency of its members. If instead of the patient and his needs, the central aims of the committee are personal interests, profits and academic prestige, then nurses will have none to share their concerns with, and deal with their dilemmas in research. [1] Nurses, need a greater accessibility to committees and demand a multidisciplinary synthesis in order to deal with very difficult cases. [26] Moreover, the committees should be less strict so as not to prevent knowledge development in nursing.

Confidentiality

The issue of confidentiality which is stated as very important in the Hippocratic oath, is another possible issue of conflict for nurses either as practitioners or researchers. Clause 10 of the ICN Code for nurses emphasises that all information obtained during nursing practice should be kept secret apart from cases that it should be reported in a court, or in cases that the interests of society are important. [9] On the other hand the ICN Code for nurses in research states that: "Nurses acting as data collectors must recognise that they are now committed to two separate roles " . [26]

According to the professional code they can not reveal confidential information not even to the members of the research team. It is important therefore, to seek advice in ethics committees to get approval for disseminating the results of the data collection including an account of what happened. [26] In addition, they have to deal with the issue of anonymity when some features of the research make the subjects easy to identify. [15] It is very important that nurses always bear in mind that they should protect the privacy of the patient. The trust showed to them must not be jeopardised. Patients reveal information concerning their body and mind and expect them to be used only in a therapeutic manner. When dilemmas according to confidentiality arise, trust as a basic element of a therapeutic relationship should be considered and maintained. [9]

Informed consent

Nurses involved in research, have to consider many ethical problems relating to the issue of informed consent. The ICN code for nurses in research, states that nurses as practitioners may be called upon to witness that informed and voluntary consent has been obtained from the subjects of research. It suggests that they should make sure that patients have fully understood what has been proposed, which means that they are aware of potential risks or discomforts. Nurses who spend more time with patients are in a good position to judge it. In addition, they must ascertain that patients have understood their right to withdraw at any time. In order to maintain the self-determination of patients, nurses must be fully informed themselves about the study and its purpose. [44] The patient's consent should be obtained freely, with full awareness of implications. If nurses find out that it was not obtained in an appropriate manner, they should inform patient and refuse co-operation. Webb suggests that the informed consent is an obligation of the researcher and no nurse should obtain it on behalf of another professional, nor agree to give the explanation as a substitute. [40] If a nurse tries to get a consent, then the persons will feel obliged to participate, either because information is coming from their carer that they trust and depend on, or, because they feel grateful for the care they are receiving. [15]

Another conflicting issue is that giving information to patients is accepted as a major role of the nurse; but if for the sake of a research, nurses have to withhold information, this may create conflicts when they have to decide whether to participate or not. [40] Hurst suggests that if nurses cannot tell patients about the true research objectives, they should provide a full explanation at the end of data collection. [45] Provided, of course, that a supervisor body has decided that disclosure should not be full in order not to invalidate the research outcome.

Consent, can however, be a major ethical issue for nurses when it involves persons with diminished autonomy, such as children, aged, mentally ill etc. Nurses should ascertain that consent has been obtained either from the individual, when possible, or, by relatives or guardians. They must also protect the dignity and privacy of such groups who are more vulnerable to loss of dignity and privacy. Nurses taking part in research on children should be alert, in order to notice any verbal or non verbal dissent which warrants exclusion of the child from the study (even if this creates conflicts with the researcher. [46] In the same prospect, nurses must act as advocates when vulnerable groups are used in research, and not prevent it. According to Levine, restricting these groups from research could end in disadvantaging those populations, even further, especially when research involves no risk and a high potential for benefit. [20]

Researcher role conflict

With regard to nurse researchers, the International Council of Nurses declares that they are not responsible for the care of patients. They should only intervene in case that "a harmful situation appears imminent". This statement is not congruent with the culture of nursing which is "intertwined with the ethic of caring". [3] The commitment of nurses to caring, may create dilemmas according to the conflict between the researcher's and clinician's role.

If a researcher nurse provides physical or psychological care during an interview, the results will be biased and generalisation will be difficult. [5] Another issue raised from the ICN statement, is to determine when a "harmful situation appears imminent" and the intervention of the researcher is required. [26] The declaration of Helsinki says that the interest of the individual should prevail over the interests of society of science. [3] This can solve some of the ethical dilemmas of the nurse, but in case the situation is not lifethreatening, the conflict remains. Burns and Grove suggest that in case that support from the researcher is required, then, it should be given, but the subjects should be excluded from the research. [5] They also recommend that another alternative, is to seek help in other professionals to proceed with the data collection. Nevertheless, most health professionals, no matter how skilled they are in supportive techniques will provide some care if they feel that it is needed in a certain case.

Conclusion

Ethical issues, conflicting values, and ambiguity in decision making, are recurrently emerging from literature review on nursing research. Because of lack of clarity in ethical standards, nurses must develop an awareness of these issues and an effective framework to deal with problems involving human rights. This is necessary in order to come into terms with the issue of the researcher's values relative to the individual's rights versus the interests of society. Professional codes, laws, regulations, and ethics committees can provide some guidance but the final determinant of how research is performed, rests with the researcher's value system and moral code. To prepare future nurses, ethics in research, must receive special attention in nursing curricula. The criticism and uncertainties that arise, should be rather encouraged than suppressed in nursing education. Hunt suggests that in order to liberate nursing from its "technocratic impasse" ethics should be broadly interpreted as an arena of new ideas which can change professional hierarchies, to open cross-disciplinary discussions, and question the concepts "abnormality", "patient" and " illness". He also declares that nursing, not as a biomedical branch, but as a science and art of caring, is able to start the redefinition of research in health care which was in the recent history dominated by the biomedical "paradigm".

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