TEXTBOOK PEDIATRIC GYNECOLOGY - 2013

Chapter 1. INTERNATIONAL, STATE, AND BIOETHICAL FOUNDATIONS OF A PEDIATRIC GYNECOLOGIST'S PRACTICE

BIOETHICAL FOUNDATIONS OF A PEDIATRIC GYNECOLOGIST'S PRACTICE

The clear fact of the successful establishment and dynamic development of bioethics in Ukraine is undoubtedly a landmark event that vividly reflects our society's commitment to the principles of democratic development, international integration, and the protection of individual rights. The fundamentals of bioethics and biosafety have been taught in all faculties of higher medical educational institutions since the 2011/2012 academic year. Bioethical knowledge holds both applied and general theoretical, worldview significance. For a pediatric gynecologist, applied information relates to the bioethical evaluation of modern assisted reproductive technologies, Medical and Genetic Counseling and population screening, artificial termination of Pregnancy, and the conflict between mother and fetus, etc.

From the perspective of shaping the worldview of a modern medical specialist, it should be noted that bioethics is a logical response to the numerous ethical Questions and Problems that have emerged in recent decades during clinical practice, as well as in biomedical research and experimentation. It is designed not only to identify and analyze conflict situations arising at the intersection of medicine, biology, philosophy, and law, but also to determine specific ways to resolve them.

The Subject Matter of bioethics primarily concerns the latest achievements in biology and medicine, determining the degree of their hazard to humans and society today and in the future. Bioethics aims to develop moral and, subsequently, legislative measures capable of protecting the individual, society, and humanity as a whole from the undesirable and sometimes disastrous consequences of implementing new biomedical technologies.

The establishment and rapid progress of bioethics are associated with revolutionary changes and achievements in the field of biomedical disciplines. These include the deciphering of The Human Genome, animal cloning, the potential for human cloning, artificial sex reassignment, In vitro Fertilization, The Use of Transgenic Plants for food, the successes of Gene Therapy, embryonic tissue Treatment, new family planning Methods, progress in transplantology, the improvement of vaccine Prevention, and the Introduction of advanced technologies for the Diagnosis, treatment, and prevention of various human diseases. Issues of medical confidentiality, euthanasia, family planning concepts, and biomedical research methodology require modern bioethical evaluation.

The Emergence of bioethics was a direct consequence of the Structure/182.html">Practical Application of scientific and technological revolution achievements amid a deep ideological crisis and the accumulation of global environmental problems. Significant successes in The Development of biomedical sciences have raised a multitude of moral questions. Matters have reached a point where humans are attempting to extend control over their own evolution, claiming not merely to sustain life, but to improve and alter their own nature based on their own understanding. In such a situation, justified discussions arise regarding the ethical basis and moral legitimacy of these actions.

Bioethics represents a modern stage in the development of medical ethics and deontological science, serving as the basis for establishing a scientifically grounded balance between cutting-edge biomedical technologies on the one hand, and human rights, the principles of humanism, and social progress on the other. Bioethics is rooted in respect for the life and dignity of the healthy and sick child, whose interests must always be prioritized over the interests of science or society. A leading postulate of bioethics is THE PRINCIPLE OF autonomy, entailing the inviolability of the child's mental and physical status, which is implemented through the rule of informed consent from the patient and society for therapeutic and prophylactic Procedures.

Bioethics encompasses a wide range of socio-economic, moral-ethical, and legal problems addressed not only by the medical community, but also by public authorities, the public, and the mass media. Bioethical issues are widely discussed in authoritative international organizations—the UN, UNICEF, UNESCO, the Council of Europe, and WHO. The respective declarations, conventions, agreements, recommendations, and resolutions of these organizations ensure the Development of National legal and ethical regulation for practical healthcare and biomedical research.

Recently, much has been accomplished in Ukraine toward implementing ethical principles in medical practice and biomedical science. Specifically, Bioethics Commissions have been established under the Cabinet of Ministers of Ukraine, as well as the Bioethics Committees of the National Academy of Sciences, the National Academy of Medical Sciences, and the Ministry of Health of Ukraine. Medical ethics committees operate within treatment and diagnostic facilities where clinical drug trials and biomedical research are conducted.

Our state can and must make a significant contribution to the development of bioethics. Ukraine's geographical position, situated between West and East, undoubtedly influences The formation of our philosophical views on science in general and medicine and biology in particular. Historically, our country has absorbed elements of Western technocracy and Eastern spirituality. Such a harmonious unity promotes the humanization of medicine and the understanding of the human being as a unity of biological, psychological, and social components. The mutual penetration and enrichment of Western and Eastern cultures are facilitated by cooperation between Ukrainian higher medical educational institutions and medical universities in other countries across administrative, scientific, and educational fields.

A retrospective evaluation of The history of bioethics indicates that in the 1970s, it focused on the protection of human rights; in the 1980s, it addressed the issue of improving the quality of life; and in the 1990s, it acquired the character of global bioethics. Additional socio-political challenges in medical biology and cutting-edge technologies served as an impetus for the further development of technological and ethical thought.

Thus, the development of ethical science can be represented by a logical shift of paradigms. Classical ethics was directed toward investigating ethical relations within the "human-to-human" system. Albert Schweitzer's ethics of "reverence for life" expanded its scope to include all living things in general. V. Potter's bioethics began to examine ethical problems from the perspective of the existence of humans, living organisms, and nature within the biosphere. Nooethics, in our view, represents the ethics of the noospheric stage of civilization's development.

The transition from bioethics to nooethics is primarily driven by the unprecedented intensification of the global ecological and ideological crisis. Nooethics, as the ethics of humanity's intellectual activity within the noospheric environment, has at least two important practical aspects. One of them is associated with the Development of the human individual, their interaction with the environment, the development of psychological resources and creative potential, and the activation of vitality. The questions of good and evil, as well as the Protection of the child from psychological manipulation, acquire special significance. The other aspect concerns the ecology of the information environment and the restoration of planetary self-regulation. Since the noosphere lacks its own self-regulatory mechanisms, nooethics is intended to serve as one of them (though not the only one) in resisting phenomena of chaos and growing Entropy. This includes the formation of a nooethical information environment and the harmonization of television, the Internet, and other mass media. As an element of the "sustainable development concept," nooethics is designed to integrate its three main components: economic, ecological, and social.

Nooethics is an ethical trend focused on the sustainable development of society. The core idea of nooethics is an ethical veto on any "progress" or social project if the latter is implemented through violence against the individual or nature. Nooethics, as an ethics of noospheric orientation and human intellectual activity, must serve as a regulatory mechanism for the noosphere amid a global ecological and spiritual crisis.

Several principles can be distinguished within the bioethical foundations of a physician's professional practice: "do no harm," "do good," the principle of respect for patient autonomy, and the principle of justice. Derived from these principles are the principles of confidentiality, veracity, and informed consent.

The principles of modern bioethics emerged long before the period of its establishment; some of them are associated with the Hippocratic school (4th century BC) and are contained in the famous Hippocratic Oath, which consists of two parts: the dedication and the code of conduct.

The second part of the Hippocratic Oath contains the ethical code proper, regulating the professional activity of the physician in the fields of dietetics, pharmacotherapy, and surgery. The Oath includes A number of prohibitions, notably regarding abortion and euthanasia. In the Hippocratic tradition, emphasis was placed on the special knowledge, training, and experience of the medical practitioner, which were to be applied directly in the course of treatment. According to this approach, the physician issues instructions, and the dutiful patient follows these guidelines, knowing that a specialist with profound knowledge and experience is acting in their best interest.

For a long time, physicians used the text of the Hippocratic Oath as generalized moral wisdom. Some modern professional ethical codes adhere to the Hippocratic tradition, at least in the sense of emphasizing that a physician's duty is to provide care, assist the patient, and do no harm.

The Hippocratic traditions, which espouse the principles of assistance, support, and non-maleficence, were dominant during the formative period of bioethics and retain their influence today.

From an ethical and legal standpoint, harm caused by the following is unacceptable:

— inaction, failure to render assistance to someone in need;

— unscrupulousness, malicious or mercenary intent;

— improper, uncalculated, or unqualified actions.

It is difficult to imagine an individual physician, let alone an entire healthcare system, whose sole objective is simply to do no harm to patients. If that were the case, society would have no reason to support such a system. Therefore, the goal of the entire healthcare system is not merely to avoid causing harm, but to ensure the well-being of patients, and consequently, of all people and society as a whole. The mission of healthcare is to prevent the loss of health whenever possible, and to restore a patient's lost health when There is a reasonable hope for recovery. In some cases, one has to settle for less—halting the Progressive development of a disease or (in the realm of palliative medicine) easing the pain and suffering of the dying.

In the Hippocratic tradition, the principles of beneficence and non-maleficence are implemented through medical paternalism. For a long time, this approach was justified; however, starting from the 1960s, it came under multifaceted criticism due to changing dynamics in the doctor-patient relationship. First, personal interaction was disrupted by the Increasing complexity of medicine, the deepening of medical knowledge, and the advancement of medical technologies. Second, the rise in iatrogenic illnesses resulting from medical interventions cast doubt on the infallibility of a physician's knowledge and actions. Third, society grew suspicious that many doctors were engaging in practices that prioritized the interests of medical professionals, pharmaceutical companies, insurance firms, and state healthcare programs over those of the patients.

Shifts in attitudes toward physicians in post-industrial society sparked debates directed against the excessive paternalism of traditional medical ethics codes. Many authors joined the moral opposition to professional codes that upheld paternalistic judgments in clinical practice. For instance, the ethics of deception for the patient's own good was called into question as a practice that violates a patient's right to autonomy. Not only patients, but also healthcare workers, authorities, philosophers, and medical sociologists began to question the right of doctors to make medical decisions on behalf of patients.

As a result, new oaths and medical ethics codes emerged—ones that broke away from Hippocratic traditions and occasionally drew upon non-professional ethical systems. The most significant of these documents is the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Council of Europe, 1997).

The Implementation of these new ethical approaches unfolded against the backdrop of the late 1960s, when cutting-edge advancements in biomedical science and practice gave rise to fundamentally unprecedented clinical scenarios.

During the 1960s and 1970s, the practice of obtaining informed consent for medical interventions and human subject research became a frequent subject of litigation. Despite some physicians' opinions that full disclosure of medical information and obtaining informed consent are incompatible with qualified clinical practice, the legal consensus firmly shifted toward the requirement that patients must be provided with information on any fact that could form the basis for making an informed decision.

Another objection to the principle of social justice is the assertion that its associated ethical criteria—used for allocating healthcare resources—are difficult to apply in actual clinical practice. Primarily, the "standard of need" in resource allocation assumes that the meaning of "need" remains relatively constant. However, the term "need" is inherently ambiguous, and the actual needs of a real patient are shaped by specific circumstances.

Consequently, the principles of beneficence and assistance, non-maleficence, patient autonomy, and social justice are recognized as foundational in modern biomedical ethics. While the resolution of ethical issues in modern healthcare for girls and adolescents relies on these core bioethical principles, methodological approaches and models may vary.

Any characterization of the relationship between a physician and a female patient would be incomplete without addressing the various conflicts of interest inherent to medical practice. For a long time, medical tradition recognized the promotion and support of patient health as the ultimate goal of medicine. The modern formulation of this goal is often supplemented by the phrase "within the framework of respecting patient autonomy." Traditionally, more specific goals of medicine are also acknowledged, including preserving life, relieving pain and suffering, restoring physical and mental function, and caring for the sick person, among others. Aside from disagreements over which specific objectives should be integrated into the strategy of promoting and supporting patient health, there are other motivations and incentives that compete with a physician's exclusive focus on the patient's well-being. Such competing motivations generate conflicts of interest for the physician, manifesting in numerous ways.

The relationship between a physician and a female patient may possess unique characteristics stemming from differing cultural backgrounds. The doctor and the patient may be citizens of different countries, speak different languages, or belong to different cultures (or subcultures within the same country). Because of these factors, the physician and the patient may hold divergent cultural understandings of acceptable ethical practices, as well as vastly different worldviews. A doctor and a patient with disparate cultural Perspectives may encounter serious clashes over ethical issues—for instance, disagreeing on legitimate decision-making authority, The Role of truthfulness in medical practice, the family's role in determining treatment methods, or what constitutes acceptable care for a child.

Racial, ethnic, or national prejudices can also pose significant barriers in the doctor-patient relationship. Overcoming them is not merely a matter of biomedical ethics, but a universal human imperative.

The interactions among various medical professionals (doctors, nurses, administrators, pharmacists, etc.) and patients form a complex social network through which individual, group, and state interests related to healthcare are realized. Certain norms play a vital role in the ethical regulation of interactions between medical staff and patients. The principles of truthfulness and informed consent are formally enshrined in the Declaration on the Promotion of Patients' Rights in Europe (Amsterdam, 1994).

The Principle of Informed Consent. Discussions surrounding truth and deception in medical ethics frequently arise during debates over the requirement of informed consent. Today, it is widely accepted that a competent adult patient possesses the moral and legal right to refuse medical intervention in the absence of their informed and voluntary consent. Clearly, deception or even the withholding of information severely undermines the possibility of a meaningful Discussion and the provision of informed consent. To grant such consent and exercise the right to self-determination, a patient must have access to necessary information, which physicians are generally obligated to provide.

Medical interventions involving health risks are permitted only as an exception in cases of urgent necessity, provided that the potential harm from diagnostic, preventive, or therapeutic methods is less than the expected harm of refusing the intervention, and that neutralizing the threat to the patient's health by other means is impossible.

Risky diagnostic, preventive, or therapeutic methods are deemed acceptable if they comply with modern, scientifically grounded standards, aim to avert an immediate threat to the patient's life and health, and are applied with the consent of a patient who is fully aware of their potential negative consequences, while the physician commits to taking all appropriate measures to safeguard the patient's life and health.

If refusing medical intervention could lead to severe consequences, the physician is obligated to explain this to the patient. Should the patient persist in their decision, the doctor has the right to demand written confirmation or, if that is impossible, to document the refusal in an official act in the presence of witnesses. If the refusal is issued by a patient's legal representative and threatens severe consequences for the patient, the physician must notify the guardianship authorities.

Competence and voluntariness are mandatory "threshold" elements or preconditions of the principle of informed consent. The competence of a patient or research subject is a necessary prerequisite for obtaining informed consent. The law establishes a fairly straightforward binary rule—distinguishing between patient or subject competence and incompetence. Minors are considered incompetent, as are adults who have been legally declared incapacitated. The right to provide informed consent on behalf of an incapacitated patient is transferred to their legal representatives. In this sense, the law establishes only a minimal, universally accepted baseline of moral regulation, leaving aside a number of ethically controversial and ambiguous situations. In particular, it often inadequately addresses a child's right to receive information about their physical and mental state and to control what happens to their body during treatment. Naturally, a child lacks the maturity to make responsible treatment decisions without adult guidance. However, this does not mean an adult can completely replace them in the decision-making process. Can a minor patient's individuality be outright ignored? A more justified approach is likely a differentiated one, which grants the child a greater or lesser degree of decision-making autonomy regarding their treatment, tailored to their individual level of development.

From a moral standpoint, forcing children into surgical interventions through coercion or deception is fundamentally wrong. The difficulties in obtaining genuine consent in certain cases simply highlight the urgent need for clinical and psychological education for physicians and the active involvement of professional psychologists in resolving communication barriers between young patients and medical staff. One must also account for the possibility that legal representatives might make decisions contrary to the patient's own best interests. In such cases, the physician's duty is to advocate for the child's interests and pursue legal measures to restrict the rights of the legal representatives on this matter. There have been instances where parents, out of ignorance or religious prejudice, refused life-saving surgeries for their children. In such scenarios, the interests of incapacitated patients must override the rights of their legal representatives.

A patient's competence refers to their capacity for independent decision-making. A critically ill girl is not always competent, nor is someone under immense emotional stress and pain. Therefore, it is critically important to determine whether a patient is competent. Assessing incompetence by a medical board is based on the patient's loss of ability to make decisions that serve her well-being, taking into account her previously expressed values and preferences. Bioethical practice continues to develop standards of competence that are highly specific to various branches of clinical practice.

The Scope of information that a young female patient must receive and comprehend in order for her consent to be considered genuinely informed is a question of paramount importance.

Voluntariness in giving informed consent is no less crucial than competence. A decision is considered voluntary if it is made free from external pressure by physicians, guardians, relatives, or friends. Various Forms of influence can severely compromise voluntariness, including direct coercion through threats, authoritarian imposition of decisions, and the manipulation of information—which may seem objective at first glance, yet is framed in a way that steers the patient toward a predetermined choice. Consequently, when obtaining informed consent, it is essential to explicitly reassure the patient that a refusal will not diminish her rights or restrict access to alternative medical interventions.

Any illness, particularly a severe one, impacts a girl's psychological state, frequently limiting her capacity for independent decision-making. A state of helplessness makes her especially vulnerable to direct, authoritarian pressure from her attending physician. In such cases, even if there is no reason to doubt the young patient's competence, she must be given the opportunity to discuss her situation with loved ones. It is also important to remember the patient's statutory right to seek independent consultations. The highest level of guarantees is provided by bioethical practices where research protocols must undergo independent review by an ethics committee.

The Procedure of obtaining informed consent is designed to operationalize the moral principle of recognizing the patient as a person who has the right to collaborate with medical professionals in making decisions regarding her treatment. The core tenets of the informed consent rule are articulated as specific ethical norms within codes and declarations adopted by international and national medical associations and bodies.

Procedural aspects are regulated by national legislation, healthcare regulations and guidelines, and the internal rules of healthcare and research institutions. The tradition of oral briefing has the advantage of being less formal and more trust-based. However, it virtually eliminates the possibility of independently verifying what was actually communicated to the patient, thereby reducing the accountability of medical personnel.

Obtaining informed consent is vital for the socio-psychological adaptation of girls to new life circumstances that may arise as a result of medical intervention. Discussing the treatment process, goals, and potential outcomes of an intervention with the physician fosters psychological readiness for necessary lifestyle adjustments and, consequently, promotes more effective adaptation. The rule of informed consent not only regulates a specific procedure preceding major medical intervention but also fosters meaningful interpersonal communication between physicians and young patients throughout the entire treatment process.

The principle of informed consent should not be viewed merely as a measure triggered by the threat of harm to a patient caused by physicians. While preventing such danger is important, it is neither the sole nor the primary objective. Rather, the principle of informed consent should be understood as a norm governing the relationship between a physician and a female patient for the purpose of jointly substantiating and agreeing upon the optimal medical intervention. This principle must be seen not as an end in itself, but as a means to ensure a collaborative dialogue between the interested parties, namely the physician and the patient.