BIOETHICS: THE SUBJECT, PURPOSE AND OBJECTIVES AT

HEALTH CARE SYSTEM. HISTORY OF MEDICAL ETHICS AND

BIOETHICS AT INTERNATIONAL HEALTH CARE SYSTEM.

International Association of Bioethics experts, established in 1991, gives the following

definition: "Bioethics - the doctrine of social, legal and ethical implications associated with the
use of new biomedical technologies."
Medical ethics is a system of moral principles that apply values and judgments to the
practice of medicine. As a scholarly discipline, medical ethics encompasses its practical
application in clinical settings as well as work on its history, philosophy, and sociology.
GENERAL QUESTIONS OF BIOETHICS
While bioethics as a field may be understood in different ways and be
enriched by different perspectives, at its heart lie some basic human questions.
Three of them are paramount. What kind of a person ought I to be in order to live a
moral life and to make good ethical decisions? What are my duties and obligations
to other individuals whose life and wellbeing may be affected by my actions? What
do I owe to the common good, or the public interest, in my life as a member of
society? The first question bears on what is often called an ethic of virtue, whose
focus is that of personal character and the shaping of those values and goals
necessary to be a good and decent person. The second question recognizes that
what we do can affect, for good or ill, the lives of others, and tries to understand
how we should see our individual human relationships—what we ought to do for
others and what we have a right to expect from them. The third question takes our
social relationships a step further, recognizing that we are citizens of a nation and
members of larger social and political communities. We are citizens and neighbors,
sometimes acquaintances, and often people who will and must live together in
relatively impersonal, but mutually interdependent, ways.
These are general questions of ethics that can be posed independently of the
making of biomedical decisions. They can be asked of people in almost any moral
situation or context. Here we encounter an important debate within bioethics. If
one asks the general question ―What kind of person ought I to be in order to make
good moral decisions?‖ is this different from asking the same question with one
change—that of making ―good moral decisions in medicine‖? One common view
holds that a moral decision in medicine ought to be understood as the application
of good moral thinking in general to the specific domain of medicine (Clouser).
The fact that the decision has a medical component, it is argued, does not make it a
different kind of moral problem altogether, but an application of more general
moral values or principles. A dutiful doctor is simply a dutiful person who has
refined his or her personal character to respond to and care for the sick.
HISTORICAL BACKGROUND FOR BIOETHICAL APPROACH
Historically, Western medical ethics may be traced to guidelines on the duty
of physicians in antiquity, such as the Hippocratic Oath, and early Christian
teachings. The first code of medical ethics, Formula Comitis Archiatrorum, was
published in the 5th century, during the reign of the Ostrogothic king Theodoric
the Great. In the medieval and early modern period, the field is indebted to Islamic
scholarship such as Ishaq ibn Ali al-Ruhawi (who wrote the Conduct of a
Physician, the first book dedicated to medical ethics), Avicenna's Canon of
Medicine and Muhammad ibn Zakariya ar-Razi (known as Rhazes in the West),
Jewish thinkers such as Maimonides, Roman Catholic scholastic thinkers such as
Thomas Aquinas, and the case-oriented analysis (casuistry) of Catholic moral
theology. These intellectual traditions continue in Catholic, Islamic and Jewish
medical ethics.
By the 18th and 19th centuries, medical ethics emerged as a more self-
conscious discourse. In England, Thomas Percival, a physician and author, crafted
the first modern code of medical ethics. He drew up a pamphlet with the code in
1794 and wrote an expanded version in 1803, in which he coined the expressions
"medical ethics" and "medical jurisprudence".[1] However, there are some who see
Percival's guidelines that relate to physician consultations as being excessively
protective of the home physician's reputation. Jeffrey Berlant is one such critic
who considers Percival's codes of physician consultations as being an early
example of the anti-competitive, "guild"-like nature of the physician community.
 In 1815, the Apothecaries Act was passed by the Parliament of the United
Kingdom. It introduced compulsory apprenticeship and formal qualifications for
the apothecaries of the day under the license of the Society of Apothecaries. This
was the beginning of regulation of the medical profession in the UK.
In 1847, the American Medical Association adopted its first code of ethics,
with this being based in large part upon Percival's work.[4] While the secularized
field borrowed largely from Catholic medical ethics, in the 20th century a
distinctively liberal Protestant approach was articulated by thinkers such as Joseph
Fletcher. In the 1960s and 1970s, building upon liberal theory and procedural
justice, much of the discourse of medical ethics went through a dramatic shift and
largely reconfigured itself into bioethics.
Well-known medical ethics cases include:
Albert Kligman's dermatology experiments
Deep sleep therapy
Doctors' Trial
Greenberg v. Miami Children's Hospital Research Institute
Henrietta Lacks
Human radiation experiments
Jesse Gelsinger
Moore v. Regents of the University of California
Surgical removal of body parts to try to improve mental health
Medical Experimentation on Black Americans
Milgram experiment
Radioactive iodine experiments
The Monster Study
Plutonium injections
The David Reimer case
The Stanford Prison Experiment
Tuskegee syphilis experiment
Willowbrook State School
 Yanomami blood sample collection
Darkness in El Dorado
Since the 1970s, the growing influence of ethics in contemporary medicine
can be seen in the increasing use of Institutional Review Boards to evaluate
experiments on human subjects, the establishment of hospital ethics committees,
the expansion of the role of clinician ethicists, and the integration of ethics into
many medical school curricula
For the first time the idea that man is responsible not only to others, but before
all other creatures, was made a great humanist, a German doctor, missionary,
theologian and musicologist Albert Schweitzer.
Albert Schweitzer (14 January 1875 – 4 September 1965) was a German
and then French theologian, organist, philosopher, physician, and medical
missionary. He was born in Kaysersberg in the province of Alsace-Lorraine, at that
time part of the German Empire. Schweitzer, a Lutheran, challenged both the
secular view of Jesus as depicted by historical-critical methodology current at his
time in certain academic circles, as well as the traditional Christian view. He
depicted Jesus as one who literally believed the end of the world was coming in his
own lifetime and believed himself to be a world savior. He received the 1952
Nobel Peace Prize for his philosophy of "Reverence for Life", expressed in many
ways, but most famously in founding and sustaining the Albert Schweitzer
Hospital in Lambaréné, now in Gabon, west central Africa (then French Equatorial
Africa). As a music scholar and organist, he studied the music of German
composer Johann Sebastian Bach and influenced the Organ reform movement
(Orgelbewegung).
Since the beginning, the founder fathers - Van Rensselaer Potter and Fritz
Jahr proposed Bioethics as this. Even Aldo Leopold, that uses Land Ethics concept
instead of Bioethics, used this approach. Interdisciplinarity is a core characteristic
of Bioethics.
Potter, in 1971, justifying Bioethics, in the same way, enhanced this point of
view by saying: We must plead not for a moratorium on new knowledge, but a
coupling of biological knowledge and human values. Potter, when proposed Deep
Bioethics, instead of a shallow Ethics approach to health and science issues says:
Bioethics as a new ethics science that combine humbleness, responsibility and an
interdisciplinary competence, intercultural, that potential our sense of humanity.
Modern medicine is the difficult social-cultural system which deals with
transhistoic and transculutural phenomena of human life (health, life, birth and
death, illness, survival and maintainance of man). All, without an exception,
people are the participants of process of recreation of these phenomena (as the
special sort of values) and thus enter into permanent, but each time specific
relationships with medicine. Exactly it and allows to talk, that a hodegetics, as
form of estimation of human relations, can not be only by the report of professional
rules and prohibitions. It regulates and estimates the relations of people in the
world - religious, class, ethnonational, political and other the contexts - therefore
limitation of ethics of medicine by specific clinical relations or relations "doctor-
patient illegally.
Scientists (T. Bosham and J.Vitch. Chayldress, A.J. Ivanyushkin, B.G.
Yudin and other) are marked much, that a hodegetics, based on traditions of ethics
of Hippocrates, does not answer spiritually-intellectual, political and economic
features and queries of development of modern society today. English scientist-
biotic R. Vitch sees reasons of such disparity in that:
• a traditional hodegetics is corporate ethics the action of which is limited
to mainly the scopes of the proper professional society;
• ethics of Hippocrates is built on the idea of paternalism (from Lat. pater is
a father), which orders and allows a doctor to come forward as a "father", tutor,
irrefutable authority in relation to a patient (or to the medical corporation in
relation to society);
• not "harm" principle is not sufficient for adjusting of relations of doctor
and patient (medical concord and society on the whole), as does not answer the
necessities of the ethics setting of norms in connection with development and
application of global biomedical technologies;
 • ethics of Hippocrates does not contain sufficient grounds in order to ratify
principle of respect of autonomy of patient, interests of doctor prevail over
interests of patient.
There may not be a definitive resolution to the puzzle of whether bioethics
should find its animating moral foundations within or outside medicine and
biology. In any case, with time these two sources become mixed, and it seems clear
that both can make valuable contributions (Brody, 1987). Perhaps more important
is the problem of which moral theories or perspectives offer the most help in
responding to moral issues and dilemmas.
BIOETHICAL APPROACHES.
Broadly defined, paternalism is an action performed with the intent of
promoting another's good but occurring against the other's will or without the
other's consent. In medicine, it refers to acts of authority by the physician in
directing care and distribution of resources to patients. Medical paternalism is
a philosophy that certain health decisions (e.g., whether to undergo heroic surgery,
appropriateness of care in terminally ill patients) are best left in the hands of those
providing healthcar. Paternalism has a long history in medicine. Medicine, as art or
science, whether in historical or contemporary contexts, depends on the
fundamental assumption that a physician has access to information to which the
patient does not, and that it is the physician’s job to utilize this information to
achieve benefit (or at the very least, to cause no harm) to the patient’s health and
well-being. This paternalistic philosophy largely pervaded the medical
establishment from the time of Hippocrates well into the 20th century until the mid-
1960s, when tremendous changes to this established status quo occurred. The
assumption that a doctor’s relationship with his patient was a ―sacred trust‖ that did
not require any sort of external regulation came to be questioned. Similarly, the
assumption that doctors alone know what is best for patients was also questioned.
Many rights seem to stem from our capacities as autonomous agents. These
are rights of self-governance — the right to make core decisions about one’s body
and life. But might doctors, with their extensive training, knowledge, and
experience, be able to justify infringing on those rights in order to benefit the
patient? Defenders of medical paternalism think so.

The personalist approach to biomedical ethics presents itself as a typical

European reaction to the rapid changes in medicine and health care. Some call it,
however, a kind of renewal of the old Thomistic approach, whereby the concept of
`nature' has been replaced by the more dynamic concept of `person'. In that way
personalism has been situated by many observers as a `person' centred natural law
tradition which focuses on the rational nature of the human person as the moral
norm of nature.
Does an ethic of virtue or an ethic of duty offer the best point of departure?
In approaching moral decisions, is it more important to have a certain kind of
character, disposed to act in certain virtuous ways, or to have at hand moral
principles that facilitate making wise or correct choices? The traditions of
medicine, emphasizing the complexity and individuality of particular moral
decisions at the bedside, have been prone to emphasize those virtues thought to be
most important in physicians. They include dedication to the welfare of the patient
and empathy for those in pain.
Some philosophical traditions, by contrast, have placed the emphasis on
principalism—the value of particular moral principles that help in the actual
making of decisions (Childress; Beauchamp and Childress). These include the
principle of respect for persons, and most notably respect for the autonomy of
patients; the principle of beneficence, which emphasizes the pursuit of the good
and the welfare of the patient; the principle of nonmaleficence, which looks to the
avoidance of harm to the patient; and the principle of justice, which stresses
treating persons fairly and equitably.
The advantage of principles of this kind is that, in varying ways and to
different degrees, they can be used to protect patients against being harmed by
medical practitioners and to identify the good of patients that decent medical and
healthcare should serve. Yet how are such principles to be grounded, and how are
we to determine which of the principles is more or less important when they
conflict?
Moral principles have typically been grounded in broad theories of ethics—
utilitarianism, for example, which justifies acts as moral on the basis of the
consequences of those acts (sometimes called consequentialism). Utilitarian
approaches ask which consequences of a choice or an action or a policy would
promote the best possible outcome. That outcome might be understood as
maximizing the widest range of individual preferences, or promoting the greatest
predominance of good over evil, or the greatest good of the greatest number. Just
what one should judge as a ―good‖ outcome is a source of debate within utilitarian
theory, and a source of criticism of that theory. Such an approach to healthcare
rationing, for instance, would look for the collective social benefit rather than
advantages to individuals. A competing theory, deontology, focuses on
determining which choices most respect the worth and value of the individual, and
particularly the fundamental rights of individuals. The question of our basic
obligations to other individuals is central. From a deontological perspective, good
consequences may on occasion have to be set aside to respect inalienable human
rights. It would be wrong, for instance, to subject a human being to dangerous
medical research without the person’s consent even if the consequences of doing
so might be to save the lives of many others. Our transcendent obligation is toward
the potential research subject.
Not all debates about moral theory come down to struggles between
utilitarianism and deontology, though that struggle has been central to much of the
moral philosophy that influenced bioethics in its first decades. Another classical
struggle turns on the dilemma that arises when respect for individual freedom of
choice poses a threat to justice, particularly when an equitable distribution of
resources requires limiting individual choice. Autonomy and justice are brought
into direct conflict. Recent debates on healthcare rationing, or setting priorities,
have made that tension prominent.
 Even if principles—like autonomy and justice—are themselves helpful, their
value declines sharply when they are pitted against each other. What are we
supposed to do when one important moral principle conflicts with another? The
approach to ethics through moral principles—often called applied ethics—has
emphasized drawing those principles from still broader ethical theory, whose role
it is to ground the principles. Moral analysis, then, works from the top down, from
theory to principles to case application. An alternative way to understand the
relationship between principles and their application, far more dialectical in its
approach, is the method of wide reflective equilibrium. It espouses a constant
movement back and forth between principles and human experience, letting each
correct and tutor the other (Daniels).
Such a contract would be threefold. It comprises basic ethical principles for
society as a whole, a contract between society and the medical profession about the
latter’s social role, and a contract between professionals and laypersons that spells
out the rights and prerogatives of each. This strategy is designed both to place the
ethics of medicine squarely within the ethical values of the larger society and to
make sure that laypeople have sufficient choice and power to determine the kind of
care they, and not paternalistic physicians, choose. Still another approach, more
skeptical about finding any strong consensus on ethical foundations, stresses an
ethic of secular pluralism and social peace, devising a minimal ethic for the
community as a whole but allowing great play to the values and choices of
different religious and value subcommunities.
A common framework used in the analysis of medical ethics is the "four
principles" approach postulated by Tom Beauchamp and James Childress in their
textbook Principles of biomedical ethics. It recognizes four basic moral principles,
which are to be judged and weighed against each other, with attention given to the
scope of their application. The four principles are:[7]
Respect for autonomy – the patient has the right to refuse or choose their
treatment. (Voluntas aegroti suprema lex.)
 Beneficence – a practitioner should act in the best interest of the patient.
(Salus aegroti suprema lex.)
Non-maleficence – "first, do no harm" (primum non nocere).
Justice – concerns the distribution of scarce health resources, and the
decision of who gets what treatment (fairness and equality). (Iustitia.)
Other values that are sometimes discussed include:
Respect for persons – the patient (and the person treating the patient)
have the right to be treated with dignity.
Truthfulness and honesty – the concept of informed consent has
increased in importance since the historical events of the Doctors' Trial of the
Nuremberg trials and Tuskegee syphilis experiment.
Values such as these do not give answers as to how to handle a particular
situation, but provide a useful framework for understanding conflicts.
When moral values are in conflict, the result may be an ethical dilemma or
crisis. Sometimes, no good solution to a dilemma in medical ethics exists, and, on
occasion, the values of the medical community (i.e., the hospital and its staff)
conflict with the values of the individual patient, family, or larger non-medical
community. Conflicts can also arise between health care providers, or among
family members. Some argue for example, that the principles of autonomy and
beneficence clash when patients refuse blood transfusions, considering them life-
saving; and truth-telling was not emphasized to a large extent before the HIV era.
Autonomy
The principle of autonomy views the rights of an individual to self-
determination. This is rooted in society's respect for individuals' ability to make
informed decisions about personal matters. Autonomy has become more important
as social values have shifted to define medical quality in terms of outcomes that
are important to the patient rather than medical professionals. The increasing
importance of autonomy can be seen as a social reaction to a "paternalistic"
tradition within healthcare.[citation needed] Some have questioned whether the
backlash against historically excessive paternalism in favor of patient autonomy
has inhibited the proper use of soft paternalism to the detriment of outcomes for
some patients.[8] Respect for autonomy is the basis for informed consent and
advance directives.
Autonomy is a general indicator of health. Many diseases are characterised
by loss of autonomy, in various manners. This makes autonomy an indicator for
both personal well-being, and for the well-being of the profession. This has
implications for the consideration of medical ethics: "is the aim of health care to do
good, and benefit from it?"; or "is the aim of health care to do good to others, and
have them, and society, benefit from this?". (Ethics – by definition – tries to find a
beneficial balance between the activities of the individual and its effects on a
collective.)
By considering autonomy as a gauge parameter for (self) health care, the
medical and ethical perspective both benefit from the implied reference to health.
Psychiatrists and clinical psychologists are often asked to evaluate a patient's
capacity for making life-and-death decisions at the end of life. Persons with a
psychiatric condition such as delirium or clinical depression may not have the
capacity to make end-of-life decisions. Therefore, for these persons, a request to
refuse treatment may be taken in consideration of their condition and not followed.
Unless there is a clear advance directive to the contrary, in general persons lacking
mental capacity are treated according to their best interests. On the other hand,
persons with the mental capacity to make end-of-life decisions have the right to
refuse treatment and choose an early death if that is what they truly want. In such
cases, psychiatrists and psychologists are typically part of protecting that right.[9]
Beneficence
The term beneficence refers to actions that promote the well being of others.
In the medical context, this means taking actions that serve the best interests of
patients. However, uncertainty surrounds the precise definition of which practices
do in fact help patients.
James Childress and Tom Beauchamp in Principle of Biomedical Ethics
(1978) identify beneficence as one of the core values of healthcare ethics. Some
scholars, such as Edmund Pellegrino, argue that beneficence is the only
fundamental principle of medical ethics. They argue that healing should be the sole
purpose of medicine, and that endeavors like cosmetic surgery and euthanasia fall
beyond its purview.
Non-maleficence
Main article: Primum non nocere
The concept of non-maleficence is embodied by the phrase, "first, do no
harm," or the Latin, primum non nocere. Many consider that should be the main or
primary consideration (hence primum): that it is more important not to harm your
patient, than to do them good. This is partly because enthusiastic practitioners are
prone to using treatments that they believe will do good, without first having
evaluated them adequately to ensure they do no (or only acceptable levels of)
harm. Much harm has been done to patients as a result, as in the saying, "The
treatment was a success, but the patient died." It is not only more important to do
no harm than to do good; it is also important to know how likely it is that your
treatment will harm a patient. So a physician should go further than not prescribing
medications they know to be harmful — he or she should not prescribe
medications (or otherwise treat the patient) unless s/he knows that the treatment is
unlikely to be harmful; or at the very least, that patient understands the risks and
benefits, and that the likely benefits outweigh the likely risks.
In practice, however, many treatments carry some risk of harm. In some
circumstances, e.g. in desperate situations where the outcome without treatment
will be grave, risky treatments that stand a high chance of harming the patient will
be justified, as the risk of not treating is also very likely to do harm. So the
principle of non-maleficence is not absolute, and balances against the principle of
beneficence (doing good), as the effects of the two principles together often give
rise to a double effect (further described in next section).
Depending on the cultural consensus conditioning (expressed by its
religious, political and legal social system) the legal definition of non-maleficence
differs. Violation of non-maleficence is the subject of medical malpractice
litigation. Regulations therefore differ over time, per nation.
Double effect
Main article: Principle of double effect
Double effect refers to two types of consequences that may be produced by a
single action,[10] and in medical ethics it is usually regarded as the combined
effect of beneficence and non-maleficence.[11]
A commonly cited example of this phenomenon is the use of morphine or
other analgesic in the dying patient. Such use of morphine can have the beneficial
effect of easing the pain and suffering of the patient while simultaneously having
the maleficent effect of shortening the life of the patient through suppression of the
respiratory system.[12]
Respect for human rights
The human rights era started with the formation of the United Nations in
1945, which was charged with the promotion of human rights. The Universal
Declaration of Human Rights (1948) was the first major document to define human
rights. Medical doctors have an ethical duty to protect the human rights and human
dignity of the patient so the advent of a document that defines human rights has
had its effect on medical ethics.[13] Most codes of medical ethics now require
respect for the human rights of the patient.
The Council of Europe promotes the rule of law and observance of human
rights in Europe. The Council of Europe adopted the European Convention on
Human Rights and Biomedicine (1997) to create a uniform code of medical ethics
for its 47 member-states. The Convention applies international human rights law to
medical ethics. It provides special protection of physical integrity for those who are
unable to consent, which includes children.
No organ or tissue removal may be carried out on a person who does not
have the capacity to consent under Article 5.[14]
As of December 2013, the Convention had been ratified or acceded to by
twenty-nine member-states of the Council of Europe.[15]
 The United Nations Educational, Scientific and Cultural Organization
(UNESCO) also promotes the protection of human rights and human dignity.
According to UNESCO, "Declarations are another means of defining norms, which
are not subject to ratification. Like recommendations, they set forth universal
principles to which the community of States wished to attribute the greatest
possible authority and to afford the broadest possible support." UNESCO adopted
the Universal Declaration on Human Rights and Biomedicine to advance the
application of international human rights law in medical ethics. The Declaration
provides special protection of human rights for incompetent persons.
In applying and advancing scientific knowledge, medical practice and
associated technologies, human vulnerability should be taken into account.
Individuals and groups of special vulnerability should be protected and the
personal integrity of such individuals respected.[

INFORMED CONSENT: CONDITIONS AND EXCEPTIONS

Obtaining valid informed consent before intervening on a patient is a crucial
part of protecting that patient’s autonomy. And valid informed consent is much
more than just a signed document.
To give informed consent:
• The patient needs to understand the risks and benefits involved.
Given how complicated those can be, health care providers have an obligation not
just to disclose them, but to help the patient understand them.
• The patient also needs to be free from the controlling influence of
others. If the patient signs a document because she has been manipulated, it is not
valid consent.
According to the Nuremberg Code, to consent to participate in research one
must: 1. be ―so situated as to be able to exercise free power of choice‖; 2. have the
―legal capacity‖ to give consent; 3. have ―sufficient … comprehension‖ to make an
―enlightened‖ decision; and 4. have ―sufficient knowledge‖ on which to decide
(Germany [Territory under Allied Occupation], p. 181).
 More recent discussion emphasizes the knowledge or information
component of consent—hence the term ―informed consent‖ (Katz). The
Nuremberg Code’s focus on freedom of choice rather than on the quantity or
quality of information transmitted is represented by its use of the term voluntary
consent, instead of informed consent. It is worth recalling that a demand for
informed consent at the expense of other styles of self-determination such as
Freedman’s responsible choice is not necessarily respectful of persons. Most
commentators agree that compromise on any one of the four conditions specified
by the Nuremberg Code jeopardizes the ethical acceptability of the consent.
―Free power of choice.” The Nuremberg Code proscribes ―any element of
force, fraud, deceit, duress, overreaching, or other ulterior forms of constraint or
coercion‖ in obtaining consent. Any flagrant coercion—for instance, when
competent, comprehending persons are forced to submit to research against their
expressed will—clearly renders consent invalid. There may be more subtle or
indirect ―constraints‖ or ―coercions‖ when prospective subjects are highly
dependent, impoverished, ignorant, or ―junior or subordinate members of a
hierarchical group‖. Some argue that consent obtained from such persons violates
the intent of the Nuremberg Code. This argument has been posed most sharply
with respect to prisoners and other institutionalized populations, because
institutionalization often involves both dependency and impoverishment.
Some argue that consent to participate in research is not valid when it is
given (1) to procure financial reward in situations offering few alternatives for
remuneration; (2) to seek release from an institution either by evidencing ―good
behavior‖ or by ameliorating the condition for which one was confined; or (3) to
please physicians or authorities on whom one’s continued welfare depends. But in
his contribution to a 1976 U.S. National Commission report, Cornel R. West
argued that such indirect forms of constraint do not constitute coercion in a strict
sense and thus do not render consent involuntary.
―Coercion,‖ says West, consists in a threat to render one’s circumstances
worse if one does not do something. Hence, a threat to withdraw basic necessities
of existence, or in some other way to render a prison inmate’s situation worse if he
declines to participate in research, would constitute coercion and render consent
invalid. Similarly, to condition release from prison upon participation would
constitute coercion, because it would make the inmate’s situation worse by
removing normal alternatives for seeking release. But the provision of better living
conditions in exchange for participation in research does not constitute a threat to
make conditions worse; rather, it is an enticement to make conditions better. While
enticement and bribery can invalidate consent by undermining the rational grounds
for choice, they do not undermine the voluntariness of the choice. Similarly, a
desire to get well or to favorably influence institutional authorities is not an
ulterior constraint in the strict sense of the Nuremberg Code, though it may be a
very real psychological constraint.
Competence and comprehension.
The Nuremberg Code requires both ―legal capacity‖ to consent (often called
competence) and ―sufficient understanding‖ to reach an ―enlightened‖ decision.
Definitions of competence often include elements of comprehension, for example,
to evaluate relevant information, to understand the consequences of action, and to
reach a decision for rational reasons.
Assessments of incompetence.
The various standards employed for assessing competence are variations of
four basic themes (Appelbaum, Lidz, Meisel):
1. Reasonable outcome of choice. This is a highly paternalistic standard in
that the individual’s right to self-determination is respected only if she makes the
―right‖ choice—that is, one that accords with what the competency reviewer either
considers reasonable or presumes a reasonable person might make.
2. Factual comprehension. The individual is required to understand, or at
least be able to undestand, the information divulged during the consent negotiation.
3. Choice based on rational reasons. Individuals must demonstrate a capacity
for rational manipulation of information. They may, for example, be required to
show that they not only understand the risks and benefits but also have weighed
them in relation to their personal situations.
4. Appreciation of the nature of the situation. Individuals must demonstrate
not only comprehension of the consent information but also the ability to use the
information in a rational manner. Furthermore, they must appreciate that they are
being invited to become research subjects and what that implies.
While there is disagreement as to the grounds for assessing incompetence,
most commentators agree that such assessments are limited in several ways. First,
a judgment of incompetence may apply to only certain areas of decision making,
for example, to one’s legal but not to one’s personal affairs. Second, confinement
to a mental institution is not in itself equivalent to a determination of
incompetence. Third, some people are legally competent but functionally
incompetent, whereas others are legally incompetent but functionally competent.
Disclosure of information.
The Nuremberg Code have been modified by subsequent codes and
regulations. U.S. federal regulations require: 1. a statement of the purpose of the
research and a description of its procedures; 2. a description of foreseeable risks
and discomforts; 3. a description of benefits; 4. disclosure of appropriate
alternatives, if any; 5. a statement of the extent of confidentiality; 6. an explanation
of the availability of medical treatment for injury and compensation for disability;
7. an explanation of whom to contact for answers to questions; and 8. a statement
that participation is voluntary and that neither refusal to participate nor withdrawal
at any time will result in a loss of benefits to which the subject is otherwise entitled
(―General Requirements‖ 1993).
The regulations further specify six additional elements of information to be
provided when appropriate: 1. additional risks to the subject or to the fetus if the
subject becomes pregnant; 2. circumstances in which a subject’s participation may
be terminated without his consent; 3. additional costs to the subject that may result
from participation; 4. the consequences of a subject’s decision to withdraw and
procedures for orderly termination of participation; 5. a commitment to divulge
significant new findings developed during the research that may relate to the
subject’s continued willingness to participate; and 6. the approximate number of
subjects in the study.
Finally, the regulations forbid use of any exculpatory language through
which the subject or her representative is made to waive any of their legal rights or
that releases of the investigator, sponsor, or institution from liability for
negligence. While these requirements have the force of law, they are by no means
exhaustive of possible standards for disclosure. To them one might add the
following: a clear invitation to participate in research, distinguishing maneuvers
required for research purposes from those necessary for therapy; an explanation of
why the particular person is invited (selected); a suggestion that the prospective
subject might wish to discuss the research with another person; and an
identification of the source of funding for the research. Robert M. Veatch (1978)
would add the names of members of any review boards that had approved the
research and an explanation of the right, if any, to continue receiving treatments
found useful. In short, there is no universal agreement on standards for disclosure
of information or on what it takes for a person to have sufficient knowledge to
give informed consent.
In the context of medical practice, two exceptions to the requirement for
informed consent are recognized—emergency exception and therapeutic privilege.
The former, which permits the doctor to proceed without delay to administer
urgently required therapy in emergencies, is reflected in a limited form in two
provisions of the regulations of the U.S. Food and Drug Administration: (1) In
some ―lifethreatening‖ emergencies in which informed consent is ―infeasible,‖
physician-investigators are authorized to employ investigational drugs and devices
for therapeutic purposes (Levine). (2) In carefully defined circumstances, research
designed to evaluate the safety and efficacy of investigational drugs or devices in
emergency conditions may be carried out without the consent of the patientsubjects
or the permission of their representatives. In such protocols either consent or
permission must be obtained within a reasonable period of time after the initiation
of the research; this entails authorization of the research participation already
completed as well as the continuing participation of the subject in the research
(Biros et al.).
The success of some research activities is contingent upon withholding from
the subjects information about the purposes or procedures of the activities or, in
some cases, upon deliberate deception (providing false information). U.S. federal
regulations permit waivers and alterations of consent requirements if there is no
more than minimal risk; if the waiver or alteration will not adversely affect
subjects’ rights or welfare; if without the waiver or alteration the research ―could
not practicably be carried out‖; and if the subjects will be debriefed (given a full
and accurate explanation afterward) when appropriate (―General Requirements,‖
pt. 46.116d).
There are some categories of research which, until recently, have been
customarily carried out without individual informed consent; waiver of the
requirement for informed consent in these categories was generally considered
justified according to the waivers and alterations provisions of the regulations.
Such activities included most research involving medical records and ―leftover‖
specimens of tissues and body fluids obtained for either clinical or research
purposes. Institutional patient information brochures generally contained notices of
such routine research activities (Levine). Such routine uses of medical records
without consent have had to be reconsidered in the light of the requirements of the
Health Insurance Portability and Accountability Act of 1996 (DHHS). Similarly,
routine use by researchers of specimens of tissue, without informed consent, have
had to be reevaluated in the light of rapidly evolving standards (Clayton et al.);
there is general agreement that such research is permissible without informed
consent if the specimens are anonymous.
A new ethics theory must be based on four concepts: first is independence,
second is rationality, third is responsibility, fourth is realism.
1. Sokrat declared yet, that ethics which is based on a mind must be independent.
He is apt at self-regulation without interference of external factors. But what these
external factors? Foremost, religion. Yet Sokrat, in order to avoid this form of
interference, spread a moral on those gods. It was confirmed during ages, that
ethics after the nature was not religious, therefore it submits exceptionally to the
mind. Such ethics rationalism was taken to the extreme forms by Kant, which
repeated over and over again that a «practical mind», if to interpret him as basis of
ethics, did not depend on any knowledge, religious or speculative. Except for
religion, ethics must be independent similarly and from a policy, from a right and
from science. If ethics depends on the last, scientism and positivism appear, and
within the limits of term «bioethics» of value, that is given «ethos», would be the
value of ethics not independent, but dependency upon biology and medicine. Why
must ethics be autonomous? For this question will find an answer during a further
analysis.
2. Basis of Socrate ethics is rational. A mind exists and develops as selfmeasured
principle. However described development of ethics idea was inefficient ethics
theories which was founded at liberty, passions and senses. Therefore there is
possibility to ground new ethics on a base not mind, but will. What to do a choice?
In my opinion, it is necessary to do a choice in behalf of mind, at least on one
important reason: through a mind it is possible to attain универсалий. Universal
ethics is able to enter in human society in all of the globalness and so to send
problems, descendant technological application of biomedical sciences, that to give
humanity, to confused and disturbed, necessary rest and possibility confidently to
look forward.
3. Responsibility originates from an autonomy and rationality. Not clear in
Sokrata, but afterwards well certain Plato, responsibility is meant by ability in
everything responsible for the actions. Plato writes «Republics» in Book:
«Everybody is responsible for an own choice! God is not guilty, and we are the
unique creators sew on fates through the choice of way of life». A concept
«responsibility», which manages classic ethics, again appears in modern ethics
opinion substantially changed. Unlike an old concept which responsibility was
based in on eternity and transcendentness, presently it touches time — not only
contemporaneity and the nearest future but also (foremost) distant future. Our
responsibility must spread on the distant future in an order to protect humanity
from the danger of sciences which study the body of man: a survival of humanity
in the future is the result of this responsibility. It new interpretation of
responsibility is a merit of G.Yonase. That responsibility could serve all presently
and always, it must lean against a mind and on универсалии and begun with a
realistic look.
4. Realism is meant by ability to accept that indeed exists, see the terms of life and
existence such, what they are, in their tragic and full of sufferings of essence. The
real can show up through gladness, but it not that other, as the back of suffering. In
history of ethics thought realism is a theory which is divided by a little bit of
philosophers. In particular, he was supported by Shopengauer and Nicshe. In our
time realism regenerates again and characterizes an alarm, descendant
technological application of biomedical sciences.
We will summ four concepts, which new ethics must lean against.
- Independence protects ethics from external interferences — such, as religion,
policy, right, science.
- Rationality, that mind, enables it to attain universals — necessary condition for
adjusting of problems, broken biomedical sciences.
- Responsibility does a man the judge of the choice and obligates it to protect the
future of humanity.
- Realism opens it eyes on such reality which it is, that on sufferings and tragedies.
In modern medicine it is heavy to expose such areas which scientific and
technological progress would not touch. Exactly under his action the traditional
problems of hodegetics are transformed in the problems of bioethics.
Bioethics tries to comprehend ethics problems from the different points of
view, positions and world view grounds. Its syncretism and multilevel character is
given by possibility of "manoeuvre" in a look to ethics positions and acceptance of
moral decisions not only in the not simple situations of application of biomedical
technologies but also in a certain - philosophical, social-cultural, medical context.
References:
A. Main:
1. The Cambridge Textbook of Bioethics / Edited by Peter A. Singer and A. M.
Viens. - Cambridge University Press, The Edinburgh Building, Cambridge CB2
8RU, UK, 2008. – 526p.
2. Encyclopedia of Bioethics, Third Edition in 5 vols / Stephen G. Post, Editor in
Chief. - Macmillan Reference USA, 2004. – 3300p.

B - Additional:
1. Bioethics and Biosafety/ M K Sateesh. - I K International Pvt Ltd, 2008. - 820 p
2. Bioethics and public health law / David Orentlicher, Mary Anne Bobinski, Mark
A. Hall. -Aspen Publishers, 15 февр. 2008 – 687p.
3. Professionalism in Health Care: A Primer for Career Success / Sherry Makely,
Vanessa J. Austin, Quay Kester. - Pearson, 2012 – 238p.