Pediatric Care Ethics Research Paper

Pediatrics ethics education should enhance medical students’ skills to deal with ethical problems that may arise in the different settings of care. This study aimed to analyze the ethical problems experienced by physicians who have medical education and pediatric care responsibilities, and if those problems are associated to their workplace, medical specialty and area of clinical practice.Pediatric Care Ethics Research Paper

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In recent decades, human rights for children have been firmly placed on political and academic agendas. The role of education for advancing children’s human rights has received increasing attention in policies and research, internationally and within nations. Aiming to bring current knowledge about the education of children in and about rights together, this paper examines how issues of teaching and learning of children’s human rights have been approached in educational research. Specifically the paper examines how earlier research discusses what is learned, how it is done and with what purposes (why).

Research with children
Many of the ethics questions that relate to adults apply equally to children, and you can find examples throughout this guidebook. This section is specifically about the differences between children and adults in research in relation to ethics questions. There is a burgeoning research literature on this – see the suggested additional reading.Pediatric Care Ethics Research Paper

The ethics of research with children is a balance. On the one hand, the focus is on ways of preventing and reducing harms in research and ensuring adequate protection of children and young people. On the other hand, there is concern about the risks and harms of silencing and excluding children from research about their views, experiences and participation.

There are, however, ongoing debates in the academic literature about the ethics of social research with children, related to different disciplinary perspectives (for example, developmental psychology and the sociology of childhood) and in relation to the differences between children and adults in research. The ethics principles that apply to research with adults – such as that of ensuring freely given fully informed consent, and the right to withdraw from research participation – apply equally to children, but there are four additional provisos specific to research involving children:

children’s competencies, perceptions and frameworks of reference, which may differ according to factors including – but not only – their age, may differ from those of adults;
children’s potential vulnerability to exploitation in interaction with adults, and adults’ specific responsibilities towards children;
the differential power relationships between adult researcher and child participant; and
the role of adult gatekeepers in mediating access to children, with concomitant ethical implications in relation to informed consent.
The key points are as follows:Pediatric Care Ethics Research Paper

As a researcher, you have to get initial consent from gatekeepers – parents and/or teachers or others with a duty of care for the child – and you need to consider who you have to get permission from. This permission does not mean the child has consented to participate, but it allows you to seek consent from the child.
You should get active consent from each individual child – not from children as a group (because individuals in the group could feel pressured to take part against their wishes). If you are not going to get consent from each individual child, your approach is very likely to be questioned by an ethics committee, and so you need really clear justification.
As a general rule, remember that the child is the participant, not the gatekeeper, and so ethics principles about consent should always apply to the child – whatever the child’s age. As with adults, start from a position of assuming competence, don’t assume children are incompetent, but recognise the need to adapt your methods for seeking consent to their level of understanding. See our section on defining and assessing competence to consent.
For more information about the permission and approval that may be required for research involving children, see our section does your research involve children?
Consent and gatekeeping in research with children

It is important to differentiate between consent for research and for consent to medical treatment (including clinical research trials). For example, The European Clinical Trials Directive (2001/20/EC) required parental consent for all clinical trials on minors. Although this Directive applies only to clinical trials, and not to other forms of research with children, it is usual for adult consent to be sought for research with children.Pediatric Care Ethics Research Paper

Gatekeepers to research with children and young people commonly include parents and professionals in mainstream services such as schools. Research with children in institutional settings such as schools can raise particular ethical issues in relation to individual consent, for example, if research participation is conducted as a whole-group (e.g. classroom) activity.

Additional layers of gatekeeping govern access to children and young people classed as ’vulnerable’ – such as children excluded from school, young offenders, young people with additional or complex needs, and looked after children. Issues such as vulnerability and potential imbalances in power relationships may be particularly acute in research with these groups of young people.

Equally, the role of gatekeepers in relation to informed consent highlights debate in the literature about children’s competency and autonomy to make decisions about whether to participate in research. Conceptual issues, for example relating to children’s human rights and to their agency as competent research participants, sit alongside legal requirements, including frameworks such as the Fraser Guidelines, based on the Gillick Ruling (Gillick [1985] 3 All ER 423), which are not intended for – but which may be applied to – research.Pediatric Care Ethics Research Paper

Alderson (2007, p2273) commented that legal debates about minors’ consent ’are less concerned with children’s rights than with adults’ freedoms’. Her comment highlights a question about the relative emphasis on adult and child consent, and seems particularly apposite in considering the role of gatekeepers in research with children. Is there a risk that regulatory requirements emphasise securing consent from adult gatekeepers, whilst agreement to participate from children may be elided, or based on passive assent rather than freely given and fully informed consent?

The difference between consent and assent

Guidance often mentions children’s assent, particularly the US literature. However, it is not a useful concept for several reasons:

Assent refers to agreement by minors who have no legal right to consent. However the Gillick Ruling does not specifically exclude any child as too young to be Gillick competent. Children, therefore, who can make informed ’wise’ Gillick competent decisions are giving consent, rather than assent.
Assent refers to agreement by children who understand some but not all the main points required for consent. But this begs the question of whether a partly informed decision can count as a decision at all.
Finally, assent can be taken to mean ’at least not refusing’. But that is very different from actually assenting – i.e. positively agreeing. Children may be too afraid, confused, or ignored to refuse. So the term assent may be misused to cover children’s refusal.Pediatric Care Ethics Research Paper

The general guidance is to ask parents’ consent to approach children and then ask for children’s consent. Ethical research involves informing and respecting everyone concerned. However, there are certain dilemmas, such as obtaining the consent of both parents.

Will the consent of one parent alone suffice, especially if they live apart? There is no law that both parents must be asked.

In one study about separated families, the researchers usually asked the residential parent. They asked both parents when a child was co-parented (living part-time in two households) or saw both parents often. Yet they found that gaining consent from both parents could often be both impossible and unethical because it was intrusive. They decided to work with the family dynamics, trying not to interfere with them or alter them for the sake of the research.

Some parents and children discussed consent to the research with the ’other’ parent as a matter of course. Some parents asked the researchers to contact the other parent; the researchers checked that the other parent did not mind being contacted or having their contact details being given to the researchers. But some parents did not want the other parent to know about the research at all.

The researchers respected their wishes, having checked the implications, and that the first parent would be responsible for any potential repercussions. The researchers decided that as long as the child wished to take part, and there were no obvious risks, they trusted the first parent they contacted to decide what was best for that family. They knew that children were adept at moving between separated households and different family contexts and rules. They believed that taking an individual flexible approach, as they went along, tailored to real lives and relationships, was the only way to conduct ethical research with these families.Pediatric Care Ethics Research Paper

Child maltreatment research requires a host of ethical and legal considerations in formulating a research agenda for this field. Although research in this field typically focuses on children who have been identified through case reports of child abuse or neglect, studies on prevention and intervention strategies as well as those on the etiology or consequences of child maltreatment may uncover previously undetected incidents of prior, current, or imminent abuse. The ethical and legal obligations of research investigators to their research subjects1 can be problematic, especially when research topics involve embarrassing, violent, and illegal actions (Myers, 1992; Sieber, 1992a,b).

The panel reviewed the state of knowledge about ethical issues in child maltreatment research, both to identify gaps in that knowledge base and to highlight areas in which studies are needed to examine basic assumptions and guidelines that influence research behavior and project outcomes. Such studies can help clarify the needs and values of the research community, research subjects, and other parts of society; strengthen the integrity of research on child maltreatment, especially in the development of large data sets; and offer guidance when conflicts develop among competing interests.

Education is established as a right in the UN Convention on the Rights of the Child (United Nations, 1989 United Nations. (1989, November 20). Convention on the Rights of the Child (General Assembly resolution 44/25. U.N. Doc. A/RES/44/25).
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; United Nations, 1966b United Nations. (1966b, December 16). International Covenant on Economic, Social and Cultural Rights. General Assembly resolution 2200A (XXI). U.N. Doc A/6316.
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). Access to and receiving education are central rights aspects of education. Equally important elements of the right to education are the aims and role of education to respect and develop children’s and young people’s abilities to enjoy and enact other rights. In short, education is not only itself a human right of the child, it is also an important vehicle for a wider and fuller achievement of all human rights (Grover, 2002 Grover, S. (2002). Why aren’t these youngsters at school? Meeting Canada’s charter obligations to disadvantaged adolescents. The International Journal of Children’s Rights, 19, 1–37.
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).

Educational children’s rights research is a small research field and the work that has been undertaken has contributed important knowledge about rights issues in educational contexts. To a large extent the research so far undertaken has focused on the responsibility of education to respect children as holders of rights, for example by listening to children and taking their views into account (I’Anson & Allan, 2006 I’Anson, J., & Allan, J. (2006). Children’s rights in practice: A study of change within a primary school. International Journal of Children’s Spirituality, 11, 265–279.10.1080/13644360600797263
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). The responsibility of education to educate children and young people as holders of human rights has not been given the same attention in research (Quennerstedt, 2015 Quennerstedt, A. (2015). Education and children’s rights. In W. Vandenhole, E. Desmet, D. Reynaert, & S. Lembrechts (Eds.), The Routledge international handbook of children’s rights studies, 201–215. Oxon/New York: Routledge.
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). This means that matters that lie at the heart of educational thinking–the content(s) of the teaching and learning and the processes with which this is undertaken–have not been much addressed in scholarly children’s right work within education. This paper seeks to make a contribution towards addressing these issues by collating and examining research that has so far been undertaken. The specific purpose is to identify the motives, content and processes of teaching and learning human rights that are expressed in research and to map and synthesise these.

The examination of the research field was undertaken within the European Didaktik tradition. This educational tradition focuses on the key elements of education: the educational content and the educational processes. The conceptual framework of the Didaktik tradition provided us with analytical tools to determine how the content and processes of teaching and learning of human rights is addressed in the analysed research.Pediatric Care Ethics Research Paper

When approaching research that addresses children as holders of rights, an important matter to take into account is the different understandings of how human rights relate to children. This matter suffers from a lack of clarity in both policy and academic work. Some children’s rights researchers argue that “children’s rights” have to be viewed as part of the broader human rights framework (Alderson, 1999 Alderson, P. (1999). Human rights and democracy in schools do they mean more than “picking up litter and not killing whales”? The International Journal of Children’s Rights, 7, 185–205.10.1163/15718189920494336
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). This reasoning is explicitly supported by some human rights theorist, for example Bobbio (1996 Bobbio, N. (1996). The age of rights. Cambridge: Polity Press.
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) who describes children’s rights as being a step in the expansion of human rights. Other authors within the field of children’s rights make no reference at all to human rights in their work, and instead discuss “rights for children” as being a separate entity than the general human rights.

There are also varying views as to whether the rights that children have differ from the general rights of humans, or whether they are the same. One expression of the idea that children’s rights is a separate set of rights can be found in the vocabulary often used to describe and discuss children’s rights. In children’s rights research, rights categories for children are frequently conceptualised as “provision”, “protection” and “participation” rights (Quennerstedt, 2010 Quennerstedt, A. (2010). Children, but not really humans? Critical reflections on the hampering effect of the “3 p’s”. The International Journal of Children’s Rights, 18, 619–635.10.1163/157181810X490384
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). In comparison, human rights are often categorised as “civil”, “political” and “economic, social and cultural rights” (UN, 1966a United Nations. (1966a, December 16). International Covenant on Civil and Political Rights. General Assembly resolution 2200A (XXI). U.N. Doc A/6316.
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). Depending on the vocabulary used in research that addresses rights for children, these are consequently either constructed as being separate from general human rights or as part of human rights.Pediatric Care Ethics Research Paper

In our examination of educational children’s rights research, awareness about the different approaches and vocabularies informing studies that address the teaching and learning of rights is essential. First, the differing ideas about children’s rights represented in the field need to be taken into account when searching and selecting publications for analysis. Second, important insights could be gained by reflecting the results of the research synthesis against the background of varying thinking about children’s rights.

The ethics of pediatric health care have changed radically in the past 50 years. “History,” they say, “is written by the victors.” So, if you are not careful, you will only get part of the story. Clinical ethicists learn to seek out, involve, and empower the voices of all stakeholders. To fully appreciate how much things have changed, you must learn more than one side of the story. Indeed, piecing together the history of medical ethics reminds me of the Indian story of five blind men describing an elephant, in which each can only describe a part of an ultimately much bigger animal.

If you ask philosophers about the history of medical ethics, they will point to events 50 years ago as the beginning of the modern era. In the 1960s, physicians tended to be paternalistic authoritarians. Some considered it best not to even tell a patient that he had cancer. There was minimal patient education provided. Medications were prescribed as orders for the patient to follow. Medical research had harmed volunteers, and new protections were needed.

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.Pediatric Care Ethics Research Paper

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]Pediatric Care Ethics Research Paper

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.Pediatric Care Ethics Research Paper

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]Pediatric Care Ethics Research Paper

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 Pediatric Care Ethics Research Paper

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.Pediatric Care Ethics Research Paper

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.Pediatric Care Ethics Research Paper

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]Pediatric Care Ethics Research Paper

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.Pediatric Care Ethics Research Paper

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.Pediatric Care Ethics Research Paper

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.Pediatric Care Ethics Research Paper

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]Pediatric Care Ethics Research Paper

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]Pediatric Care Ethics Research Paper

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]Pediatric Care Ethics Research Paper

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.Pediatric Care Ethics Research Paper

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”.

Ethical considerations in research are critical. Ethics are the norms or standards for conduct that distinguish between right and wrong. They help to determine the difference between acceptable and unacceptable behaviors. Why are ethical considerations so important in research? First, ethical standards prevent against the fabrication or falsifying of data and therefore, promote the pursuit of knowledge and truth which is the primary goal of research. Ethical behavior is also critical for collaborative work because it encourages an environment of trust, accountability, and mutual respect among researchers. This is especially important when considering issues related to data sharing, co-authorship, copyright guidelines, confidentiality, and many other issues. Researchers must also adhere to ethical standards in order for the public to support and believe in the research. The public wants to be assured that researchers followed the appropriate guidelines for issues such as human rights, animal welfare, compliance with the law, conflicts of interest, safety, health standards and so on. The handling of these ethical issues greatly impact the integrity of the research project and can affect whether or not the project receives funding.Pediatric Care Ethics Research Paper

Because ethical considerations are so important in research, many professional associations and agencies have adopted codes and policies that outline ethical behavior and guide researchers. These codes address issues such as honesty, objectivity, respect for intellectual property, social responsibility, confidentiality, non-discrimination and many others. These codes and policies provide basic guidelines, but researchers will still be faced with additional issues that are not specifically addressed and this will require decision-making on the part of the researcher in order to avoid misconduct. The resources on this page address many of those issues and the case studies used in these resources provide excellent examples of these types of issues.

One of the most important ethical considerations in research is the use of human subjects. To address these considerations, most institutions and organizations have developed an Institutional Review Board (IRB). An IRB is a panel of people who help to ensure the safety of human subjects in research and who assist in making sure that human rights are not violated. They review the research methodology in grant proposals to assure that ethical practices are being utilized. The use of an IRB also helps to protect the institution and the researchers against potential legal implications from any behavior that may be deemed unethical.

Examples of some of these issues include voluntary participation and informed consent. These principles are followed to guarantee that all human subjects are choosing to participate of their own free will and that they have been fully informed regarding the procedures of the research project and any potential risks. Ethical standards also protect the confidentiality and anonymity of the subjects Pediatric Care Ethics Research Paper

As research subjects, children have special needs because of their vulnerabilities and developmental peculiarities. Doctors involved in research on children must respect the autonomy and the individuality of children, be aware of children’s apprehension about medical procedures, and acknowledge the fundamental biological differences between adults and children. In this article, we will review some of the ways in which pediatric trials differ from adult trials and discuss some of the practical and ethical issues that remain to be solved.

Consider, for example, that in the year 2000, the European Union had about 75 million children and 45,000 pediatricians, but only 12 clinical pediatric pharmacologists. Pediatricians have been informed of the problem of unlicensed and off-license pharmaceutical use, but such use is commonplace. In the United States, the Food and Drug Administration (FDA) Modernization Act and its successor, the Best Pharmaceuticals for Children Act, provide companies a six-month patent extension in recognition of adequately conducted pediatric trials.

A European conference held in Brussels in January 2002, co-hosted by the European Forum for Good Clinical Practice (EFGCP) and the Confederation of European Specialists in Paediatrics (CESP), addressed the ethical, scientific, and regulatory issues in pediatric research. Both authors of this article participated.

The need for pediatric research In 1989, the United Nations General Assembly approved a Convention on the Rights of the Child.1 The following four principles articulated in this declaration are of fundamental importance in pharmaceutical studies:Pediatric Care Ethics Research Paper
All human rights apply to children without exception.
All interventions must have the child’s best interest as a primary consideration of the highest priority.
Children have the right to the highest attainable level of health.
Children have the right to obtain information and the right to respect of their opinion.
Optimal medical care is based on evidence-based intervention. There are, however, significant deficits in our current knowledge of the quality and efficacy of many therapeutic measures in children, 2 and much pediatric therapeutic data is derived from studies in adults. 3 In fact, children have been described as “therapeutic orphans” because of the deficit of appropriate studies in their age group. 4, 5 As a result of this deficit, about 50% of medications used in children’s hospitals are not properly licensed for use in children. 6

Many differences exist in physiology, pathology, pharmacokinetics, and pharmacodynamics between children and adults. 7 For example, in pharmacokinetics, there are differences in metabolic pathways, in organic functions, and in metabolic rates. In pharmacodynamics, differences exist in receptor functions, effector systems, and homeostatic mechanisms. Growth and development influence side effects, and the dose of medications is dependent on body weight or surface area. Finally, age influences severity of disease, pathological agents, and natural history. These differences imply that extrapolation of adult data on medicinal products for the child population is inappropriate.

Furthermore, childhood has several ages and stages. Studies must be performed on specific age groups such as premature newborns, full-term newborns, infants and toddlers, older children, and adolescents.

The FDA, EMEA, and other authorities state that research in children should be supported and encouraged. The Committee for Proprietary Medicinal Products (CPMP) recommends the following categorization of products to be studied in pediatric clinical trials: 7 Pediatric Care Ethics Research Paper

medicinal products for diseases affecting children exclusively, such as surfactant in neonates
medicinal products intended to treat diseases that mainly affect children, or are of particular gravity in children, or have a different natural history in children
medicinal products intended to treat diseases occurring in adults and children, for which there is currently no treatment
medicinal products to treat a disease occurring in adults and children for which treatments exist, but where there is insufficient knowledge of efficacy or toxicity in children.
When should pediatric trials begin? One ethical issue pediatric researchers face is the fact that clinical research involves some risk to the subjects. Research procedures range from techniques involving minimal risk, such as questioning, observation, and measurement carried out sensitively, to techniques involving higher risk, such as chemotherapy and surgery. Risk is greatest in the early phases of clinical research. At what point in a drug’s development should research in children begin? The International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for Human Use (ICH) makes several suggestions regarding the inclusion of children in the development program of medicinal products. 8 For medicinal products for diseases affecting children exclusively or predominantly, the entire development program can be conducted in the pediatric population beginning with phase 1 or 2 trials. For products for serious diseases affecting both adults and children for which a sufficient treatment does not currently exist, the development program should be conducted early in the pediatric population after safety and tolerability data have been obtained in adults (phase 2 or 3). For other products for serious diseases, the product usually should not be tested in the pediatric population until phase 2 or 3, after substantial experience in adults.

In all cases, efficacy, pharmacokinetic, and safety studies must be performed first in animals, as is required for adult studies. Placebo-controlled trials are inappropriate in pediatrics when risk would be increased by withholding a proven, effective treatment. 9

Good clinical practice issues No child should participate in a study unless a benefit to children in general will result. The ICH notes that the benefit to the individual and the benefit to the group must be balanced, as follows: The ethical imperative to obtain knowledge of the effects of medicinal products in paediatric patients has to be balanced against the ethical imperative to protect the individual child in clinical studies and respect his/her integrity and personal dignity. Good clinical practice (GCP) helps maintain that balance by ensuring that subjects are properly protected in research studies; studies are based on good science, well designed and properly analyzed; and study procedures are properly undertaken and documented. If GCP is not followed, children who take part may be at risk, the data may be unreliable or unusable, and the study should be rejected by the ethics committee.Pediatric Care Ethics Research Paper

Good clinical practice follows the general principles of medical ethics: 10

respect for life, human dignity, and personal autonomy
beneficence (do some good)
non-maleficence (do no harm)
justice.
From these ethical principles, general guidelines for good clinical practice in pediatric research can be derived. 8, 11, 12 Trials should focus on the knowledge, cure, relief, or prevention of diseases of children. Biomedical studies must be devoted to reducing suffering and improving the prognosis of diseases. Expected benefit must exceed recognizable risks. Serious predictable risks should be avoided. Only well-designed studies are ethically appropriate. Study protocols must be evaluated by ethics committees (institutional review boards) and reviewed by experts in pediatric issues. Informed consent or assent must be obtained from the child participant and informed consent from the legal representative, according to national law.

Detailed operational guidelines for clinical investigations of medicinal products in the pediatric childhood population are provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 8

It is imperative that pediatric studies be performed by medical and scientific personnel who are familiar with good GCP guidelines and are capable of a trusting relationship and communication with the child and parents. Studies should be performed in institutions that provide a child-friendly atmosphere with a pediatric infrastructure and personnel.

Ethics committees are an effective instrument to protect subjects from inadequate research. An ethics committee that is going to review pediatric research should have members experienced in working with children. A European study (1998) showed that local committees usually review pediatric studies, because there are only a few national committees examining research projects in children. CESP recommended in 1998 that all national pediatric specialties establish Ethics Committees and that the interests of children should be represented on these committees. 14, 15

Informed consent and assent Once the ethics committee has approved a properly designed study, the problem of obtaining consent or assent from children and their parents arises. The latest version of the Declaration of Helsinki13 suggests that for a legally incompetent minor, the investigator must obtain informed consent from the child’s legally authorized representative in accordance with applicable law. Even a legally incompetent minor may be able to give assent to decisions about participation in research, and in such cases the investigator must obtain that assent in addition to the consent of a legally authorized representative Pediatric Care Ethics Research Paper

The 1970s brought change, with the courts laying out new rules for informed consent in cases like Canterbury v Spence (1972). For over 5 years, a national commission studied the research scandals, as in the Tuskegee Syphilis Study. In 1978, it produced the landmark document known as the Belmont Report.1 That report formed the basis for the modern institutional review board (IRB). Another landmark publication was the first edition of Principles of Biomedical Ethics by Tom L. Beauchamp and James F. Childress in 1979, which provided the four principles of the Georgetown Mantra of Bioethics: autonomy, beneficence, nonmaleficence, and justice. With time, autonomy became the first among equals of those four principles.
In 1995, the American Academy of Pediatrics Section on Bioethics emphasized the importance of obtaining the child’s assent in addition to the parent’s consent.2 Most states have passed laws permitting minors to give consent for treatment for pregnancy, sexually transmitted diseases, drug addiction, and mental health care.
Technology alters ethics
At the same time, technology has been changing medicine. New life sustaining technologies in the 1960s – such as dialysis and ventilators – created new issues of extreme financial cost, allocation of scarce resources, and even the existential question of when life ends. In 1968, an ad hoc committee at Harvard created criteria for what is colloquially called “brain death.”3 Many landmark legal cases further developed the ethics of end-of-life care.Pediatric Care Ethics Research Paper

Over the past 6 decades, cancer care for children has become more collaborative, increasing survivorship.
©Xavier_S/Thinkstock
Over the past 6 decades, cancer care for children has become more collaborative, increasing survivorship.

Meanwhile, pediatric oncologists began a new way of caring for children with cancer. They collaborated on a national level. Each newly diagnosed child was entered into a registry and treated according to a national protocol that was updated every few years. This blurred the distinction between experimental and clinical care. But, it yielded results. Within a couple decades, acute leukemia went from few survivors at 1 year after diagnosis to 95% becoming long term survivors of more than 5 years. With that success and new research always promising hope, the pediatric oncologist’s ethical dilemma became when to palliate rather than seek a cure.
The boundaries were even less clear at the beginning of life. Technological advances in ventilators, improvements in nursing care by neonatal intensive care unit nurses, and the whole new subspecialty of neonatology progressively lowered the gestational age for survival. The distinction between clinical care and experimental care was again blurry as neonatologists sought to overcome previously unknown complications, like retinopathy of prematurity resulting from too much oxygen and bronchopulmonary dysplasia from the ventilator. Many babies survived with profound physical and neurological compromise. The ethical dilemmas were continuously present.

The boundaries are even less clear at the beginning of life, when more newborns are surviving with severe complications.
Herjua/Thinkstock
The boundaries are even less clear at the beginning of life, when more newborns are surviving with severe complications.

Some pediatricians will claim that medical ethics is driven primarily by advances in technology, not law. Perhaps the most telling point for this has been that, when clinical ethicists specializing in pediatric ethics get together at national meetings, about half are neonatologists and a quarter are pediatric ICU physicians. These physicians have acquired expertise in ethics as a survival mechanism for the daily challenges presented by new technology.Pediatric Care Ethics Research Paper
Change in the status of children
There is more to the story than philosophy, law, and technology. Pediatric ethics has been profoundly impacted by a change in the status of the children. One change from 50 years ago has been the social response to child abuse.4 Norms changed. Before, fathers pretty much could raise their children any way they saw fit, including corporal punishment. Neighbors didn’t intervene. The proverb was “spare the rod and spoil the child,” but abuse was not motivated by discipline. It was cruel, authoritarian, and demeaning. The landmark article describing the Battered Child Syndrome was published in 1962.5 By 1967, the local Society for the Prevention of Cruelty to Children had become nearly obsolete, but understaffed local government agencies were just beginning to respond. In 1974, federal action produced the Child Abuse Prevention and Treatment Act.6 Medical personnel became mandatory reporters, developed expertise, and, in 2009, child abuse became a boarded subspecialty in pediatrics.

Pediatric ethics are constantly changing, often riding the waves of public health measures and increased awareness.
NaiyanaDonraman/Thinkstock
Pediatric ethics are constantly changing, often riding the waves of public health measures and increased awareness.

There also has been a huge change in the status of children with mental and physical disabilities. Fifty years ago, it was the short bus and the County School for Retarded Children.
Then, in 1971, a documentary “Who Should Survive?” explored the ethical decision making for babies with birth defects.7 The harms of institutionalization became recognized. The benefits of early intervention and special education have been established. Support for an Individual Education Plan has progressed through successive laws beginning in 1975 until the Individuals with Disabilities Education Improvement Act of 2004.

This is just another example of how ethics develops from a philosophical ideal to a change in social status, followed by consciousness raising, civil rights legislation, enabling legislation, funding, and program development and implementation.

It takes a village of philosophers, activists, lawyers, legislators, physicians, and other experts to implement ethics. There are also countervailing forces. The mainstreaming of children with disabilities is one factor in the movement of children into private schools and the pressure for a voucher system, as advocated by the new Secretary of Education, Betty DeVos.

There also has been a change in the status of children as future providers. Historically, children were relied upon to provide for the parents in their old age. With decreases in infant mortality, the availability of birth control, and legalized abortions, smaller families became the social norm. Worldwide, there has been a marked drop in fertility rates in developed nations. Governmental programs such as Social Security, particularly with the introduction of Medicare in 1965, meant that the elderly were less dependent on their descendants. China found that acceptance of the One Child policy was heavily dependent on convincing parents that the State would provide for them in their old age. The modern political state has assumed duties previously performed by the family.Pediatric Care Ethics Research Paper
More recent changes
Pediatric health care is strongly impacted by public health measures. Infant mortality has been reduced by improved nutrition and public health, not medication and surgery. Mass immunization programs were viewed as an appropriate function of civic government.

The introduction of polio vaccine in the 1950s made a large impact. Families lined up at any opportunity to get the vaccine. Polio went from hundreds of thousands of cases of paralysis each summer down to zero cases of wild polio transmitted within the western hemisphere. Measles cases went from 450,000 cases a year in the early 1960s down to zero, until a fraudulent link to autism led to a significant number of parents not immunizing their children. Vaccine refusal, previously a rare ethical issue related to religious liberty, became corrupted by efforts at boutique medicine and alternative facts. In modern America, the ethics of individualism and personal rights have eclipsed civic responsibility. With herd immunity compromised, a blip up to 100 cases of measles per year was histrionically described as a huge epidemic. That spin shows ignorance of the historical record, but the risk was enough for the liberal state of California in 2015 to ban philosophical exemptions to vaccination with one of the strictest state laws in the nation.

Ethics is about values. So, as I look at the changes over 50 years, the areas that have failed to make progress are illuminating. Mental health care for children has not made the same progress achieved with vaccines and cancer therapy. My most recent clinical ethics case involved a teenager who had made a suicidal gesture by taking a handful of pills. The nurses were caught between caring for their patient and meeting the demands of an upset, authoritarian parent in a world where customer satisfaction is critical. I spent much of the night exploring hospital policy and state law. I solicited and listened to widely disparate interpretations of law, medical ethics, and hospital policy from the floor nurse, the nursing supervisor, the nursing staff on the adult inpatient psychiatric unit, three ED docs, a social worker, a government agency, and a judge’s representative. The physician of 1967 was captain of the ship and would not recognize the chaotic teamwork of modern medicine. The exercise showed me how little progress we have made in mental health care for adolescents during my 25 years of practice.

It also reminded me that I have the luxury to debate ethical minutia like vaccine hesitancy and adolescent consent in a world with Syrian refugee camps and starvation in South Sudan. Mahatma Gandhi said, “There are people in the world so hungry that God cannot appear to them except in the form of bread.” That, unfortunately, has not changed in 50 years.Pediatric Care Ethics Research Paper

Identify ethical difficulties in the role of parental decision-making. Discuss pediatric assent and the ability to consent for themselves. Recognize the diiculty with applying the “best interest” standard for some children. Tommy, 3, sustained a traumatic brain injury (TBI) from a motor vehicle accident. Two weeks into his ICU stay, physicians presented Tommy’s parents with the option to forgo life-sustaining treatments (FLST). After a few days of reflecting and discussing the issue, they agreed that stopping the ventilator was best, but by that time there was a new ICU physician who, after review of Tommy’s condition, did not think that FLST was warranted. With more intensive therapy, Tommy was able to breathe without the vent, and he was moved to the rehabilitation unit. Because of his TBI, however, he continued to be fed through a tube. Neurological scans indicated problems with the basal ganglia, and Tommy’s parents suggested that Tommy’s condition was not in his best interest and asked the palliative care physician about the possibility of stopping feeds. At the same time, the physical and occupational therapists working with Tommy, as well as nurses and social workers from the PICU who came to visit him in rehab, believed they saw slight but noticeable improvements in his cognitive status – possibly tracking, smiling, and reacting to some stimuli. The entire unit, as well as these PICU staff members, is concerned about the ethics of what the parents are suggesting.

Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. Although the historical roots of Western medical ethics may be traced to early writings on the duties of physicians from Hippocrates to rabbinic and Christian teachings, the world’s first official national code of medical ethics1 was adopted by the American Medical Association in 1847, which served as a body of rules and regulations for the medical profession.

Since the mid-twentieth century, concerns about human experimentation2, 3, 4 and the availability of new technologies have led to a larger role for ethical analysis in medicine, as witnessed by the increasing use of institutional review boards, hospital ethics committees, and the expansion of the role of clinical ethicists. At the same time that the complexity of medical decisions has been increasing, there has been growing respect for the autonomy of the patient and shared decision making. Medical ethics has therefore of necessity evolved from a theoretic, philosophic justification of moral principles into a pragmatic approach to resolving everyday dilemmas in clinical care.5
Such dilemmas are particularly common in critical care, because of the wealth of issues surrounding imbalances of supply and demand between the resources of the health care system and the needs of the public, conflicts between the health care team and the patient/surrogate decision maker over whether life-sustaining technologies should be used, and appropriate use of experimental therapies in heroic attempts to save a life. Technological advances have enabled us to prolong life, but values play into the decisions about what quality or length of life is worth preserving at what costs of suffering on the part of the patient or of resources on the part of society. In pediatric critical care, more and more children are surviving with chronic illnesses,6 and some of these children need ongoing or frequent intensive care and technological support. These questions are therefore likely to become even more common as time passes, and reaching shared goals among all parties involved is even more essential.  Pediatric Care Ethics Research Paper
Moral theory and midlevel principles
Theoretic biomedical ethics is grounded in philosophic traditions of moral theory, which underlie how individuals and society determine what is right. Deontology is a system of moral theory delineated by Immanuel Kant, in which certain actions are deemed intrinsically right or good based on whether they could logically and morally be universally applied8(pp350–1). As an example, truth telling is held to be an intrinsically good action because society could not function if it could not be assumed that others were usually telling the truth. Kant also famously held that “the end does not justify the means,” upholding the right of the individual to self-determination as more important than achieving a common good if doing so required sacrificing that individual. There are obvious implications in research ethics, in which it is inappropriate to knowingly harm 1 person even if the knowledge gained could benefit many others. An alternative moral theory is utilitarianism or consequentialism, which argues that an action is considered right that achieves the greatest good for the greatest number of people. Many policy and public health decisions by their nature rely on balancing such utilitarian concerns with the rights of individuals.

In their groundbreaking book Principles of Biomedical Ethics,8 Tom Beauchamp and James Childress outline 4 midlevel principles that can be derived from either underlying moral theory to help guide clinical and policy decisions relating to health care. Most decisions require balancing the directives of these principles against one another. The 4 principles described by Beauchamp and Childress are:

•Respect for autonomy: a competent patient has the right to refuse or choose their treatment.
•Beneficence: a clinician should act in the best interest of the patient.
•Nonmaleficence: “first, do no harm” or avoid harming the patient
•Justice: making sure that those in similar circumstances are treated the same, whether concerning the distribution of scarce health resources or who receives which treatment (fairness and equality).
Other values that are sometimes discussed include:

•Respect for persons: the patient (and the person treating the patient) has the right to be treated with dignity. Autonomy derives from this underlying Kantian directive.
•Truthfulness and honesty: related to the concept of informed consent, emphasized since the historical events of the Nuremberg trials and Tuskegee syphilis experiments

Methods
A self-applied semi-structured questionnaire was answered by 88 physicians with teaching and pediatric care responsibilities. Content analysis was performed to analyze the qualitative data. Poisson regression was used to explore the association of the categories of ethical problems reported with workplace and professional specialty and activity.Pediatric Care Ethics Research Paper

Results
210 ethical problems were reported, grouped into five areas: physician-patient relationship, end-of-life care, health professional conducts, socioeconomic issues and health policies, and pediatric teaching. Doctors who worked in hospitals as well as general and subspecialist pediatricians reported fewer ethical problems related to socioeconomic issues and health policies than those who worked in Basic Health Units and who were family doctors.

Conclusions
Some ethical problems are specific to certain settings: those related to end-of-life care are more frequent in the hospital settings and those associated with socioeconomic issues and public health policies are more frequent in Basic Health Units. Other problems are present in all the setting of pediatric care and learning and include ethical problems related to physician-patient relationship, health professional conducts and the pediatric education process. These findings should be taken into consideration when planning the teaching of ethics in pediatrics.

Trial registration
This research article didn’t reports the results of a controlled health care intervention. The study project was approved by the Institutional Ethical Review Committee (Report CEP-HIJG 032/2008). Pediatric Care Ethics Research Paper