SOCIAL MEDICINE AS A SCIENCE

◼ Development
◼ Nature, structure, subject and functions
◼ Methodology
History

◼ Johann Peter Frank (1745-182) "Medical Police

System"
◼ 1848 - J. Guerin formulates the concept of
"Social Medicine"
◼ 19th century - R. Virhov - “Medicine is a
social science. Politics is nothing but
medicine on a grand scale. "
HISTORY

◼ 19th century - Petenkofer formulates the multifactorial

conditionality of diseases.
◼ 1912 - Rene Sand founds the Belgian Association of
Social Medicine
◼ Alfred Grotian - 1903 - “Social pathology
◼ 1920 - A. Grotian establishes the first department of
social medicine in Germany.
◼ 1922 - N. Semashko establishes the Department of
Social Hygiene in Moscow.
◼ 1942 - John Ryle establishes a chair in Oxford
University in England
IN BULGARIA

◼ After the Liberation in Bulgaria D. Mollov -

"Temporary rules for the structure of medical
management in Bulgaria"
◼ The biggest contributors are Dr. P. Orahovac,

◼ Dr. M. Rusev, Dr. K. Kusitasev.

Teaching social medicine. introduces

◼ Prof. Toshko Petrov

◼ 1947 - Prof. Asen Panev - first independent department

of social medicine
◼ 1948-prof. T. Zahariev established a department of
social medicine in Plovdiv
Nature, structure and subject of social
medicine
1. Names
◼ social hygiene

◼ healthcare organization

◼ social medicine

◼ public medicine

◼ Public Health
Social medicine examines the health of:

◼ supra-individual level
◼ population
◼ public level

Social medicine is an integrative science - it

stands between clinical medicine and the
social sciences
 SOCIAL MEDICINE ESSENCE

CLINICAL SOCIAL SOCIAL

MEDICINE MEDICINE SCIENCE

INTEGRATIVE MEDICINE
 SOCIAL MEDICINE STRUCTURE
(V.BORISOV )

Applied sociomedical disciplines -

health management, health informatics, health promotion

Border socio- Social Profile

Medical Medical disciplines-

disciplines - СМ
Medic. Sociology Social Pediatric
Medic. Statistics Social Cardiology, etc.
Medic. ethics, etc. -

Social medicine theory

 In order for a discipline to exist
independently, it must have:

◼ Own subject
◼ Own methodology
◼ Object for application of research results
SUBJECT:

◼ Until 1980, it was defined as follows:

The subject of social medicine is the influence of
social factors on health and disease.
◼ After 1980:

The subject of social medicine is the public

health as a complex systemic object.
Methodology - based on the understanding
that health is determined by the complex
influence of social and biological factors as a
determining role is the social one.
 OBJECT:

The object of application of the results of social

- medical research is:
◼ medical and social assistance

◼ the organization of health care

◼ The object - the health care system is
a social phenomenon that uses for its
development the achievements of social
medicine.

◼ The tree that studies social medicine is

inherently a biological phenomenon .
 DEFINITIONS:

◼ Social medicine is a non-traditional integrative

science with the subject of studying public health
as a systemic phenomenon with its specific
patterns.
◼ Social medicine is the science of social factors
and problems of public health, as well as
measures to improve it.
◼ Social medicine studies public health and its
determinants.
The focus of science is public health , the
various aspects of which it deals with:

◼ with the influence of social factors on health

◼ with the influence of health on social factors

◼ with the social object of the healthcare activities

(the individual, the microgroup, the society)

◼ with the social subject of the healthcare activities

(the healthcare system)
FUNCTIONS:

1. Integrative - methodological - creating an

appropriate methodology that will achieve the
goals of social medicine
◼ improving public health
◼ the creation of a more perfect healthcare
system.
2. Social - ethical

These include:
◼ equitable allocation of resources in
healthcare,
◼ creation of a system for quality service to
the population ,
◼ respect for the dignity of the individual
and the rights of the patient in the
healthcare system, etc.
3. Management function

◼ is realized through the health

management at each level of the health
service
The mission of social medicine is to create a
scientific foundation for health management."
V. Borisov
МETHODS

1. Classical methods
◼ Historical - studying the phenomena and
processes related to public health in
the past , analyzes of its current state and
forecasts for future development are made.
◼ Statistical method - with its help
the frequency and tendency of disease
spreadare estimated.
◼ Economic - serves to prepare economic
analyzes and financial estimates in the health
care system

◼ Sociological method - used to study the

opinion and behavior of both the individual
and the group and society in the occurrence
and spread of disease.
2. New modern methods
◼ Epidemiological method - serves to study and
assess the risk factors for the occurrence and
spread of various, most often socially significant
diseases.

◼ Mathematical - uses mainly the methods of

mathematical modeling in planning one or
another activity related to public health
◼ Psychological - applies the psychological approach

◼ Expert assessment - the Delphi method

The Delphi method is a technique for evaluating and selecting a specific project.
◼ It was developed by RAND Corporation in the 1960s. Its name comes from the
mythical Delphic oracle. It selects a certain circle of experts who must express their
opinion and make a forecast for a particular project.
◼ Each expert acts independently and separately from his colleagues and does not
communicate with them. After sharing his opinion, he learned the average result of
the group, and also got acquainted with anonymous forecasts of other experts. Once
he knows this information, he adjusts his own forecast, and for the final result again
considers the average, which is again told to the experts and this process is repeated
2-3 times.
◼ The advantage of the Delphi method is that the mutual psychological influence
between the experts in giving the answers is avoided.

◼ All methods help to perform a logical analysis of

phenomena related to public health.
LITERATURE

◼ Borisov V. Lectures on social medicine. PHC, MU - Plovdiv 2009

◼ Borisov V. Methodology of social hygiene. With honey. and physical
education 1990.
◼ Balabanov P, Zapryanov N. Social medicine (textbook for students of
dentistry). With honey. and physical education 1992.
◼ Gargov K, Apostolov E, Trendafilov T et al. Social hygiene (textbook for
medical students). With honey. and physical education 1984.
◼ Grancharova G, Alexandrova S. Social medicine. Issue. center of MU -
Pleven, Pleven, 2015.
◼ Stefanov R. Training approaches and models. meduniversity-plovdiv.bg -
01.2010
 Communication in dental practice.
Behavioral medicine-appearances,
physiognomic, suppression of negative
emotions
 Communication Channels
• face-to-face conversations
• telephone calls
• text messages
• email
• the Internet (including social media such as Facebook and Twitter)
written letters, brochures.
The three main goals of doctor-patient communication include
• creating a good interpersonal relationship
• facilitating the exchange of information
• including patients in decision-making.
Types of communication

• Non-verbal communication includes facial expressions, the tone and

pitch of the voice, gestures displayed through body language (kinesics)
and the physical distance between the communicators
• Verbal communication - The sharing of information between individuals
by using speech
• Written Communication: letters, e-mails, books, magazines, the Internet
or via other media
• Visualizations: graphs and charts, maps, logos and other visualizations
can communicate messages
Types of non verbal communication

• Kinesics- The word kinesics comes from the root word kinesis,
which means “movement,” and refers to the study of hand, arm,
body, and face movements. Specifically, this section will outline
the use of gestures, head movements and posture, eye contact,
and facial expressions as nonverbal communication.
• Gestures -There are three main types of gestures: adaptors,
emblems, and illustrators (Andersen, 1999). Adaptors are touching
behaviors and movements that indicate internal states typically
related to arousal or anxiety. Emblems are gestures that have a
specific agreed-on meaning.
Types of non verbal communication
Illustrators are the most common type of gesture and are used to illustrate the
verbal message they accompany. For example, you might use hand gestures to
indicate the size or shape of an object
• Head Movements and Posture
In terms of head movements, a head nod is a universal sign of acknowledgement
in cultures. There are four general human postures: standing, sitting, squatting,
and lying down. Within each of these postures there are many variations, and
when combined with particular gestures or other nonverbal cues they can express
many different meanings.
Eye Contact We also communicate through eye behaviors, primarily eye contact.
While eye behaviors are often studied under the category of kinesics, they have
their own branch of nonverbal studies called oculesics, which comes from the
Latin word oculus, meaning “eye.” The face and eyes are the main point of focus
during communication, and along with our ears our eyes take in most of the
communicative information around us. The saying “The eyes are the window to
the soul” is actually accurate in terms of where people typically think others are
“located,” which is right behind the eyes (Andersen, 1999). Certain eye behaviors
have become tied to personality
Types of non verbal communication
• Pupil dilation refers to the expansion and contraction of the black part of the
center of our eyes and is considered a biometric form of measurement; it is
involuntary and therefore seen as a valid and reliable form of data collection as
opposed to self-reports on surveys or interviews that can be biased or
misleading. Pain, sexual attraction, general arousal, anxiety/stress, and
information processing (thinking) also affect pupil dilation.
• Facial Expressions Our faces are the most expressive part of our bodies.
Although facial expressions are typically viewed as innate and several are
universally recognizable, they are not always connected to an emotional or
internal biological stimulus; they can actually serve a more social purpose. For
example, most of the smiles we produce are primarily made for others and are
not just an involuntary reflection of an internal emotional state (Andersen,
1999). These social smiles, however, are slightly but perceptibly different from
more genuine smiles.
Types of non verbal communication

• Haptics
There are several types of touch, including functional-professional,
social-polite, friendship-warmth, love-intimacy, and sexual-arousal
touch (Heslin & Apler, 1983). At the functional-professional level,
touch is related to a goal or part of a routine professional
interaction, which makes it less threatening and more expected.
For example, we let barbers, hairstylists, doctors, nurses, tattoo
artists, and security screeners touch us in ways that would
otherwise be seen as intimate or inappropriate if not in a
professional context.
Types of non verbal communication

• Vocalics
A louder voice is usually thought of as more intense, although a soft voice combined
with a certain tone and facial expression can be just as intense. We typically adjust
our volume based on our setting, the distance between people, and the
relationship. A voice at a low volume or a whisper can be very appropriate when
sending a covert message or flirting with a romantic partner, but it wouldn’t enhance
a person’s credibility if used during a professional presentation. Speaking rate refers
to how fast or slow a person speaks and can lead others to form impressions about our
emotional state, credibility, and intelligence. As with volume, variations in speaking
rate can interfere with the ability of others to receive and understand verbal
messages. A slow speaker could bore others and lead their attention to wander. A fast
speaker may be difficult to follow, and the fast delivery can actually distract from the
message. Speaking a little faster than the normal 120–150 words a minute, however,
can be beneficial, as people tend to find speakers whose rate is above average more
credible and intelligent (Buller & Burgoon, 1986).
Types of non verbal communication

Appearance
Our choice of color, clothing, hairstyles, and other factors affecting
appearance are also considered a means of nonverbal
communication. Research on color psychology has demonstrated
that different colors can evoke different moods. Appearance can
also alter physiological reactions, judgments, and interpretations.
Types of non verbal communication

• Proxemics
Proxemics refers to the study of how space and distance influence
communication. We all have varying definitions of what our
“personal space” is, and these definitions are contextual and
depend on the situation and the relationship. Although our bubbles
are invisible, people are socialized into the norms of personal space
within their cultural group. Scholars have identified four zones for
US Americans, which are public, social, personal, and intimate
distance (Hall, 1968). The zones are more elliptical than circular,
taking up more space in our front, where our line of sight is, than at
our side or back where we can’t monitor what people are doing.
Types of non verbal communication
• Public and social zones refer to the space 120 sm. away from our body, and the
communication that typically occurs in these zones is formal and not intimate.
Public space starts about 360 sm. from a person and extends out from there.
Communication that occurs in the social zone, which is 120 sm. to 360 sm. away
from our body, is typically in the context of a professional or casual interaction,
but not intimate or public. This distance is preferred in many professional
settings because it reduces the suspicion of any impropriety.
• Personal and intimate zones refer to the space that starts at our physical body
and extends 120 sm. These zones are reserved for friends, close acquaintances,
and significant others. As we breach the invisible line that is 60 sm. from our
body, we enter the intimate zone, which is reserved for only the closest friends,
family, and romantic/intimate partners.
Why good patient communication is
important?
• The goal of effective communication is simple: To empower your
patients with the knowledge required to make an informed
decision about their oral health. It is up to you to communicate
your goals and expert opinions about your patients’ oral health so
that you and your patient can determine the best treatment plan
• If you include your patients as fully informed partners in their
care, they’ll return the gesture by being loyal and continuing care
with you. As an added bonus, you’ll discover more satisfaction in
your work, renewed motivation and increased productivity
How to improve communication with patients

• Increased patient satisfaction: Medical evidence has demonstrated

a positive association between a patient’s satisfaction with the
care they receive and their provider’s ability and willingness to
communicate and empathize with them.
• Reduced complaints: Open dialogue with patients results in better
patient retention and a reduction in complaints.
• Improved efficiency: Improved communication with your patients
will make your practice more efficient. For example, giving
patients time to express their concerns doesn’t take any longer
but can significantly reduce the likelihood of late-arising concerns
Communicating with care

• The first law of patient care is: Patient Satisfaction = Perception –

Expectations If your patient perceives care at a certain level but
expected something more or different, then they will be
dissatisfied. Both perception and expectation are states of mind
and you need to consider these if you want to keep your patient
happy
• In its most basic form, good patient care consists of listening to,
understanding and responding to your patients’ needs. While your
oral health knowledge and clinical skills may be exceptional, few
of us are taught the ‘soft skills’ of patient communication
While there are a multitude of patient needs-six basic
needs stand out

1. Friendliness: Basic courtesy and politeness; being warm and caring.

2. Empathy: The patient needs to know that the dentist appreciates
their wants and circumstances and provides personal attention.
3. Efficiency and punctuality: The patient wants to feel they are
respected.
4. Control : The patient wants to feel that they are an important part of
their own treatment plan.
5. Options and alternatives: The patient wants to know what treatment
options are available; explaining options thoroughly
6. Information: The patient wants to know about fees and services but
in a pertinent and time-sensitive manner
The fundamentals of patient relations

• Patients want to be treated as individuals, not numbers. Here are a few rules of thumb for patient
relations, which you and your staff should be mindful of:
1. The patient is never an interruption to your work – the patient is your work. Everything else can wait.
2. Even if you are delegating a task to a member of your staff, a casual “How are you feeling” gesture while
your colleague does the work will comfort your patient.
3. Never argue with a patient. The patient is always right (in their own eyes). Be a good listener, agree with
your patient where you can, and do what you can to make them happy.
4. Never make the first point of contact with your patient about finances. Too often the first question asked is
“Do you have insurance?” Discuss money matters at the appropriate time – only after
Portrait of the ideal dentist from the patients
perspective
• Confident: The dentist’s confidence gives me confidence.
• Empathetic: The dentist tries to understand what I am feeling and
experiencing, and communicates that understanding to me.
• Humane: The dentist is caring, compassionate and kind.
• Personal: The dentist is interested in me, interacts with me, and
remembers me as an individual.
• Frank: The dentist tells me what I need to know in plain language and in
a forthright manner.
• Respectful: The dentist takes my input seriously and works with me.
• Thorough: The dentist is conscientious and persistent
Touchpoints of patient communication
• There are five key moments of interaction with your patients during their visit to your clinic.
Each component can influence your patients’ overall experience and their level of satisfaction
• The initial contact Get the patient encounter off to a good start. As we know, first
impressions matter. Try to spend a few moments to slow down and focus your attention on
meeting your patient’s needs.
• Be the first to greet your patient in the operatory – even if they are having hygiene work done
first.
• Explain what will happen during their visit and introduce them to staff members who will be
providing care.
• Greet every patient with a friendly smile.
• Call patients by name.
• Introduce any colleagues who may accompany you.
• Sit at eye level.
• Listen attentively to their concerns.
• Don’t use technical jargon or terms that convey value judgments.
• Ask permission to examine the patient.
• Take the leadership role and guide the patient through the appointment.
Key moments of interaction with your
patients during their visit to your clinic
• The dental examination and discussing the treatment options
The dental examination is one of the most important, under-appreciated or even mis-understood components of the
dental visit. For most this is a routine procedure, but for many patients it is perhaps the highlight of their visit and the
only point at which they will have to interact directly with you. It is an opportunity to educate your patients as to what is
involved in the examination process.
INFORMED CONSENT In the context of a dental office, informed consent is “permission obtained as a result of the
process of information sharing in ongoing dialogue between the dentist and patient”. No treatment should be performed
without the express or implied consent of the patient. The onus is on you, the health care provider, to ensure that
whatever decision a patient makes, to accept or decline treatment, it must be informed. Consent must be obtained in
advance of treatment – not in the middle and not after the fact. Remember to document consent decisions in the
patient chart.
Discussing treatment options: In order for your patients to feel like true partners in their oral health care, they must
be fully informed of the treatment options available to them. Be thorough in your explanation of treatment options so the
patient understands the pros and cons of each. This is an opportunity to demonstrate your clinical expertise and to build
trust in your abilities and motivations.
Key moments of interaction with your
patients during their visit to your clinic
• Discussing fees and insurance
• Concluding the visit The last few minutes of the patient consultation are just as
important as the first. Ask your patient if they understand the treatment options discussed
or have any questions. Watch for those last minute questions people have as they leave
the operatory.
• Look at your patient when speaking to them and avoid turning your back while anyone is
speaking to you.
• Confirm your patient’s treatment plan or follow-up.
• End the consultation with a reinforcing-type of physical contact. When appropriate,
personally escort your patient to the reception area.
• • At a minimum, use your patient’s name at the beginning and at the end of the interaction.
See a sign of hesitations as your opportunity to ask “Do you have any other questions or
concerns?”
Dealing with difficult patient situations
• Learn to see each problem as an opportunity for improvement. Here are some steps in dealing with patients.
By following these simple steps, a disgruntled patient can become your most valuable patient. Experience
shows that a dissatisfied patient will share their story with more people than will a satisfied patient. Avoid
downplaying the seriousness of the patient’s complaint.
• Let the patient tell you their side of the story without interruption. Sometimes all they need is to be heard.
• Express empathy. Let patients know that you understand the problem and are concerned about their
feelings. Patients need to hear that you are on their side and are willing to do whatever it takes to solve their
problem.
• Do not go on the defensive. You are certain to lose the patient if you become confrontational.
• Take control of the situation. Once you have heard the patient’s side of the story, take the appropriate action
to resolve the problem.
• Ask the patient what they want. You may be surprised to find that the patient’s solution to the problem is both
fair and simple.
Dealing with difficult patient situations

Once you have established a plan of action, sell it. Explain to your
patient how the plan will solve the problem.
Ensure that the plan has been carried out and the results are
acceptable to your patient – follow-up to ensure your patient is
happy with the way you have handled the problem
Fear and dentophobia

• The fear of dentists results from direct or indirect negative

experiences. Dental work often involves painful root canal
treatments, cavity filling, extractions etc.
• Phobia is persistent, unrealistic, and intense fear of a specific
stimulus, leading to complete avoidance of the perceived danger.
Fear and dentophobia

Dentophobia leads to a variety of physical and mental symptoms:

• Feeling like crying, screaming, shaking, sweating.
• The phobic experiences a full blown panic attack.
• Avoidance is the most common symptom: one might put off seeing the dentist for so
long that it could lead to various complications. Gum disease, cavities, or worse, heart
problems can also occur in such individuals.
• Often, the fear of dentists leads to greater expenses: worsening oral health could lead
to more expensive treatments including root canal therapy, costly bridges, implants,
crowns etc. This becomes a vicious cycle as the phobic, due to this knowledge,
refuses to get treated, leading to greater health problems.
• Poor teeth can impact other areas of the individual’s life: getting a job where one is
expected to have clean, shiny teeth or even dating and relationships can be impacted
negatively. The person often becomes socially withdrawn, depressed, isolated or
turns into an Agoraphobic.
Fear and dentophobia

• Milgrom et al identified four different groups of anxious patients

based on their origin or source of fear (the “Seattle system”,
developed at the University of Washington). They were
1) anxious of specific dental stimuli,
2) distrust of the dental personnel,
3) generalized dental anxiety, and
4) anxious of catastrophe.
Fear and dentophobia

Identifying dentally anxious or phobic patients

• Semistructured interview and subjective assessment using questionnaires
• Anxiety questionnaires
Multiple- and single-item self-reporting questionnaires are available for assessing
anxious and phobic patients. A few such popularly used multi-item scales are Corah’s
Dental Anxiety Scale (CDAS), Modified Dental Anxiety Scale (MDAS), Spielberger State–
Trait Anxiety Inventory, Kleinknecht et al’s Dental Fear Survey (DFS), Stouthard et al’s
Dental Anxiety scale
• Objective measures
Objective measures involve assessment of blood pressure, pulse rate, pulse oximetry,
finger temperature, and galvanic skin response. An extremely accurate objective
method used in various
Management of dental anxiety

• The dental office environment

• Communication skills, rapport, and trust building
• Psychotherapeutic management -Behavior-management techniques, Relaxation
techniques
• Hypnotherapy
• Pharmacological management
Pharmacological control of pain and anxiety can be achieved by the use of sedation and general
anesthesia, and should be sought only in situations where the patient is not able to respond and
cooperate well with psychotherapeutic interventions. Patients with special needs (mental
retardation, autism, mental illness, traumatic brain injury) and clinical situations can also
necessitate pharmacological management.

•
Ethics in medical research
Assoc. Prof. Musurlieva
Ethical Codes on Human Biomedical Experimentations:

• NUREMBERG CODE (1947) The first internationally accepted set of ethical

guidelines in this context is known as Nuremberg Code and it was a direct result
of the war-crimes trials: basic principles must be observed in order to satisfy
moral, ethical, legal concepts:
The voluntary consent of human subject is absolutely essential. This means that the
person involved should have legal capacity to give consent. Many national
authorities have attempted to explain and expand upon the basic principles
established in the ten clauses of Nuremberg Code (1947).
• In Europe, the Council of Europe has set out a recommendation which has been
adopted by the Council of Ministers. Medical profession publicly endorsed these
principles.
NUREMBERG CODE

• The experiment should be so designed and based on the results of

animal experimentation
• The experiment should be so conducted as to avoid all physical and
mental suffering and injury
• The degree of risk to be taken should never exceed determined by the
humanitarian importance of the problem to be solved by the
experiment
• The experiment should be conducted only by scientifically qualified
persons
DECLARATION OF HELSINKI

• It is the mission of the medical doctor to safeguard the health of the

people. His or her knowledge and conscience are dedicated to the
fulfillment of this mission.
• The Declaration of Geneva (1968) binds the doctor with the words,
“The health of my patient will be my first consideration‘...
• The purpose of biomedical research involving human subjects must
be to improve diagnostic, therapeutic and prophylactic procedures
and the understanding of the etiology and pathogenesis of disease.
Basic Principles
• Biomedical research involving human subjects must conform to generally
accepted scientific principles and should be based on adequately performed
laboratory and animal experimentation and on a thorough knowledge of the
scientific tradition.
• The design and performance of each experimental procedure involving
human subjects should be clearly formulated in an experimental protocol...
• Biomedical research involving human subjects should be conducted only by
scientifically qualified persons and under the supervision of a clinically
competent medical person. Biomedical research involving human subjects
cannot legitimately be carried out unless the importance of the objective is
in proportion to the inherent risk to the subject.
• The right of the research subject to safeguard his or her integrity must
always be respected
What is Research ?
• In modern society where science activates as a power forming the world, scientific
production is necessarily based on research. Scientific method and production are
also the major forces of biomedical research. The progress of medicine, like the
rest of the scientific development, depends on research. Ideas are developed,
theories are explored, but in the end each new drug or treatment has to be tested.
The first stage of testing often takes place in the laboratory; sometimes animals are
used for tests, but before a new drug or technique can be released for general use,
it has to be tried on human beings. Sometimes research needs information along
the way which can only be obtained from human beings. If progress is going to be
made, human beings will have to be used as test subjects in clinical research in
some way or other. Research subjects may be an individual patient, a group of
patients who are suffering from a specific illness; other patients who accept to take
part in researches; or healthy volunteers. Researchers may be doctors in
attendance, other physicians / investigators, nonphysician investigators.
Research and Experiment
• Research implies a predetermined protocol with a clearly defined
endpoint. Experimentation, by contrast, involves a more speculative
approach to an individual subject. Research activities can be broadly
categorized as clinical research, which is aimed at the improved
treatment of a patient or a group of patients. On the other hand, non-
therapeutic research, in which the essential object is the
development of pure scientific knowledge, has a wider application
than patient care.
Controlled Trials
• A biomedical experiment almost inevitably involves a controlled trial.
The principle is simple –in order to decide whether a new drug or
other treatment is better than the existing one, the treatment is given
to a group of patients or healthy volunteers, not given to a similar
group.
Therapeutic and Non-therapeutic Research

• Therapeutic researches are where patient suffers from the condition

and the research aims to establish a new or modified treatment which
is expected to be better than the existing treatment. That means there is
a direct benefit to the patient if he agrees to become a test subject.
• Non-therapeutic researches are those where research results are the
only purpose – the test subject is not expected to benefit medically
from the trial himself. In both types of researches it is always assumed
that the risk to the subject has been reduced as much as possible by
testing the treatment in a laboratory and on animals to establish the
possible effects and side-effects, and to ensure the safety of the
subject.
Therapeutic and Non-therapeutic Research

• Therapeutic researches fall into two classes. The first is where no

treatment for the condition exists. For eliminating other factors,
placebos – ineffective drugs or tablets– are used. Placebos are
administered randomly to some among the group, while the rest are
given the new treatment. In order not to give any hint on which is
getting the active treatment which is placebo, a double-blind method
can be used, where neither patient nor the researcher knows who is
getting what. The second type research is for answering whether the
new treatment is an improvement on the existing one. The use of
placebos in such cases is unethical, since it would mean not to treat the
patient.
Therapeutic and Non-therapeutic Research

• Non-randomized trials-a treatment is tried on a group of patients

without the use of a control group.
• Randomized studies-patients are divided into two groups. One group
has the standard procedure, and the other the new procedure.
• Randomized double-blind studies- the doctor assessing and treating
the patient does not know which treatment is being used.
• Cross-overall studies
Ethical Principles and Rules for a Biomedical Researcher:

• A subject must not be harmed or injured during researches. The injury may
differ even from compulsion of patient to give personal information to
various disorders in organic systems, up to organ loss.
• Subject‘s right of autonomy should be respected by taking her/his free
informed consent.
• The researcher should respect the rule of confidentiality and secrecy on
behalf of the subject; and be always honest to him.
• Research involving human subjects is ethically justified on the principles of
beneficence and justice, as well. To the beneficiary approach, every
individual may contribute to the good of the society as a whole.
• The justice argument gives reference to the experiments in the past. People
make use of earlier volunteers‘ involvement in researches such as the
experiments on radiography, antibiotics, vaccination, radiotherapy etc
Experiments with animals

• To include as few animals as possible

• animals to be used only for specific purposes
• to avoid causing pain
• humane treatment of animals
• to look for ways to study the same results without using animals
INFORMED CONSENT
MORAL PRINCIPLES IN
MEDICAL ETHICS
Assoc. Prof. Nina Musurlieva, DD,PhD
 Principle for autonomy – this principle is described in the Lisbon
Declaration and includes the following patient rights :
1. Every patient has the right to choose his own doctor
2. Every patient has the right to accept or refuse treatment after
having received information
3. Every patient has the right to accept or refuse participation in
the study
4. Every patient has the right to die with dignity

BASIC MORAL PRINCIPLES IN MEDICAL

ETHICS
5. Every patient has the right to receive further information from the
doctor about the disease
6. The physician must respect the patients right to choose a doctor
and treatment
 Autonomy is capacity for self-determination, independent
decisions, actions, evaluations
 Respect for autonomy means to acknowledge personʼs right to hold
views, make choices and to take actions based on personal values
and beliefs
 Autonomy may be compromised or lost (partially or completely) on
personʼs life and it develops over time (in case of children)
 Tell the true
 Respect the privacy of the others
 Protect confidential information
 Obtain consent for intervention
 Physician performes the intervention after obtaining the patientʼs
consent, this means that the patient is involved in the choice of
treatment
 The patient has the right to receive information about the disease,
examination, diagnostic methods, treatment, prognosis, potential risks
of treatment and cost of treatment

SPECIFIC MORAL RULES DERIVED FROM THE

PRINCIPLE RESPECT FOR AUTONOMY
 Informed consent is based on the principle of respect for autonomy. The
law relating to consent is founded upon the patientʼs autonomy and
there are clear legal consequences if the physician acts in its absence
 Informed consent is the process by which a fully informed patient can
participate in choices about his health care
 The complete informed consent includes a discussion of :
-The diagnosis and nature of the treatment, reasonable alternatives, the
expected outcome and the prognosis
- The description of goals and nature of the treatment
-The relevant risks
-the likelihood of a favorable impact, and the risks in the application of
other methods of treatment or in the refusal of treatment

INFORMED CONSENT
 The medical information shall be provided in a timely manner
and in an appropriate amount and format to ensure the freedom
of choice of a treatment
 The doctor shall have the duty to communicate the information
in a way that it can be understood and assessed by the patient
 The doctor shall assess the intellect, age, social environment,
profession of the patient
 The patient can only give adequate consent, if can understand
the essence of the information and the information is provided in
an adequate amount

INFORMED CONSENT
 Functions of informed consent
1. Protects patients from harm
2. Protects and facilitates the patient's autonomous choice
3. Еncourages medical professionals to act responsibly
4. Рeduces risk and injustice in medical practice

FUNCTIONS OF INFORMED CONSENT

 Stages of informed consent
1. Perception of the necessary information
2. Understanding the necessary information
3. Awareness of the necessary information
4. Acquisition of competence
5. Giving consent

STAGES OF INFORMED CONSENT

• Most often the informed consent is in a written form (but can be in oral
form) that has to be signed by the patient
• Informed consent is valid for usually of 30 days. In case of treatment
planned in advance, consent may be valid for 6 monts.
 What sorts of interventions require informed consent?
All health care interventions require some kind of consent by the patient,
following a discussion of the procedure with a health care provider.
Patients fill out a general consent form when they are admitted or receive
treatment from a health care institution. Most health care institutions have
policies that state which health interventions require a signed consent
form. For example, surgery, anesthesia, and other invasive procedures
are usually in this category. These signed forms are the culmination of a
dialogue required to foster the patient's informed participation in the
clinical decision.
 Is it ever acceptable to not have a full informed consent?
 Exceptions to full informed consent are:
 If the patient does not have decision-making capacity, such as a
person with dementia, in which case a proxy, or surrogate
decision-maker, must be found
 A lack of decision-making capacity with inadequate time to find
an appropriate proxy without harming the patient, such as a life-
threatening emergency where the patient is not conscious
 When the patient has waived consent
 When a competent patient designates a trusted loved-one to
make treatment decisions for him or her. In some cultures, family
members make treatment decisions on behalf of their loved-
ones.
 In most cases, it is clear whether patients have capacity to make
their own decisions. Occasionally, it is not so clear. Patients are
under an unusual amount of stress during illness and can
experience anxiety, fear, and depression.
 There are several different standards of decision-making
capacity. Generally, you should assess the patient's ability to:
 Understand his or her situation,
 Understand the risks associated with the decision at hand
 Communicate a decision based on that understanding.

WHEN IS IT APPROPRIATE TO QUESTION A PATIENT'S ABILITY TO

PARTICIPATE IN DECISION MAKING?
 If the patient is determined to be incapacitated/incompetent to
make health care decisions, a surrogate decision maker must
speak for her.
 If no appropriate surrogate decision maker is available, the
physicians are expected to act in the best interest of the patient
until a surrogate is found or appointed.

WHAT SHOULD OCCUR IF THE PATIENT CANNOT GIVE

INFORMED CONSENT?
 Children do not have the decision-making capacity to provide
informed consent
 Parents have the responsibility and authority to make medical
decisions on behalf of their children. This includes the right to
refuse or discontinue treatments, even those that may be life-
sustaining. However, parental decision-making should be guided
by the best interests of the child. Decisions that are clearly not in
a child's best interest can and should be challenged.
 The primary responsibility of the physician is the well-being of the
child. Therefore, if the parental decision places the child at risk of
harm then further action may be indicated.

HOW DOES INFORMED CONSENT APPLY TO

CHILDREN?
 After receiving information, the patient may refuse treatment. It is
called an ”informed refusal”. The refusal is certified by the
signature of the patient.
Reasons for patient refusal:
 When no trust is established in the patient's doctor relationship
 Influenced by different religious and cultural beliefs

REASONS FOR PATIENT REFUSAL

 The obligation to do good, to make efforts to secure the patients well-
being

 Applying this principle in medical practice often poses difficult problems

for the physician. The mayor problem in applying the principle of
beneficence is whether the respect for autonomy must take priority over
professional obligation to provide benefit

THE PRINCIPLE OF BENEFICENCE

 The obligation to protect the patients from harm, to avoid doing harm,
reduce risk of harm
 Risk can be imposed by careless or unreasonable action of
professionals. Medical competence is a must for professional practice
 Some ethicists claim that the duty to avoid harm is actually a stronger
obligation in health care relationships than the obligation to benefit
 “Primum non nocere” is the Hippocratic tradition in medical
practice

THE PRINCIPLE OF NON-MALEFICIENCE

 The patient should receive optimal treatment according to his own
needs. Social status, factors such as race, gender, ethnicity should not
affect the quality of treatment

 This principle involves fairness, equity and equality

 The principle of formal justice states the equals should be treated

equally and that those who are unequal should be treated differently
according to their needs

THE PRINCIPLE OF JUSTICE

INTRODUCTION TO BIOETHICS
Ethicals aspects of physician-patient relationship
Assoc. Pof. Musurlieva, DD, PhD
PHYLOSOPHY AND SOCIOLOGY OF MORALITY.
DEFINITIONS AND CONCEPTS

 Values – to consider something to be very important.

Moral values are generally shared values held by
individuals and held collectivelly by socially cohesive
groups of individuals. Morality depends by several
cultural factors, traditions, education, religion
 Morality – is the term to define the differentiation of
intentions, decisions and actions between those that
are good (or right) and those that are bad (or wrong).
Morality is related to relationship with other people –
family, friends, patients, students…….
 Ethics – the branch of philosophy that deals with
distinctions between right and wrong and with the
moral consequences of human actions.
DEFINITIONS AND CONCEPTS
 Deontology – the science of moral duty, a set of
practical rules of professional duty
 Medical ethics – is a set of rules and principles
governing the relationship of health professional
staff with their patients and society. Section –
ethics in medical education, ethics in medical
science and research, ethics in medical research
MORAL DECISION-MAKING PROCESS
 Ethics is both a theoretical and a practical
discipline. The language of ethics refers to duties
and values. One goal of ethics is to determine
right decision.
 Good moral decision making involves

1. Knowing the facts of the situation (analyzing

the facts step by step)
2. Careful consideration of the moral values that
are relevant to a given situation
3. Sensitivity to the moral dimensions of everyday
situations
FEATURES OF MEDICAL PROFESSION
 The first feature is the direct contact between doctor
and patient and the specific relationships between
them. Empathy is the ability of a man to experience
emotions, feelings of the others. This concept includes
the ability of the physician to understand the patient
and to show him this understanding, so empathy is a
feeling of sympathy and trust.
 The second feature is the emotional stress in the
doctorʼs practice because of his constant responsibility
for the health and life of the patient.
 The third feature is the specific mental activity
(clinical thinking) – this is the combination of
theoretical knowledge and clinical experience
FEATURES OF MEDICAL PROFESSION
 The forth feature - is the diversity of medical
practice. In the daily practice the physician meets
hundreds and thousands of patient, each of whom is
an individual with his personal qualities.One and the
same disease has different course in different
patients.
 The fifth feature - is its activity- often requires the
doctor to make immediate, life-saving decisions, to act
in emergency situations and accidents.
 The sixth feature - is that the working hours of the
physicians are not limited
 The last feature – is that the doctorʼs work not has
always equal to the quality and quantity of work
result. Sometime the result is not immediate.
REGULATION OF PROFESSIONAL CONDUCT OF THE
DOCTOR

Two groups of rules are responsible for this

regulation
Legal norms – that is health legislation, written
regulations, these norms force the conduct of the
physician through government coercion
Moral norms – are unwritten laws of medical
profession
Accordance's between legal and moral norms :
Their primary objective is to provide high quality of
medical care.
Difference: moral norms acts on physician conduct
through internal motivation and legal norms-
through government coercion
BASIC MORAL PRINCIPLES IN MEDICAL ETHICS
 Principle of autonomy – this principle is
described in the Lisbon Declaration and includes
the following patient rights:
1. Every patient has the right to choose his own
doctor
2. Every patient has the right to accept or refuse
treatment after having received information
3. Every patient has the right to accept or refuse
participation in the study
4. Every patient has the right to die with dignity
5. Every patient has the right to receive further
information from the doctor about the disease
6. The physician must respect the patients right to
choose a doctor and treatment
SPECIFIC MORAL RULES DERIVED FROM THE
PRINCIPLE RESPECT FOR AUTONOMY

 Tell the true

 Respect the privacy of the others

 Protect confidential information

 Obtain consent for intervention

 Physician performs the intervention after

obtaining the patients consent, this means that
the patient is involved in the choice of treatment.
 The patient has the right to receive information
about the disease, examination, diagnostic
methods, treatment, prognosis, potential risks of
treatment and cost of treatment
INFORMED CONSENT
 The principle of consent aims to achieve the
following objectives:
1. To assert patientʼs autonomy
2. To protect the patient and prevent any coercion
3. To support the process of rational decision
making
4. To increase the public health literacy
THE PRINCIPLE OF NON-MALEFICENCE
 The obligation to protect the patients from harm,
to avoid doing harm, reduce risk of harm.
“Primum non nocere”

THE PRINCIPLE OF BENEFICENCE

The obligation to do good, to make efforts to secure
the patients well-being.

THE PRINCIPLE OF JUSTICE

The patient should receive optimal treatment
according to his own needs. Social status, factors
such as race, gender, ethnicity should not affect
the quality of treatment.
INFORMED CONSENT
 Informed consent is the process by which a fully
informed patient can participate in choices about
his health care. Elements :
1. The nature of the decision/procedure
2. Reasonable alternatives to the proposed
intervention
3. The relevant risks, benefits and uncertainties
related to each alternative
4. Assessment of patient understanding
5. The acceptance of the intervention by the
patient
In order for the patientʼs consent to be valid, he
must be considered competent to make the
decision at hand and his consent must be
voluntary.
INFORMED CONSENT

 Criteria for capacity to consent

1. The ability to understand given information
2. The ability to appreciate the nature of the
situation
3. The ability to assess the relevant facts
4. The ability to exercise choice
5. The ability to use understood information for
realistic and reasonable decisions
6. The ability to appreciate the consequences of
giving or refusing consent
GROUPS OF PEOPLE WITHOUT THE
CAPACITY TO CONSENT

 The patients with learning difficulties

 The mentally ill patients

 The children

 Confused elderly

 Unconscious people
PARENTAL DECISION MAKING
When can a child make medical decisions?
The child have the ethical and legal authority to
make medical decisions when they have reached
the legal age of majority.
PARENTAL DECISION MAKING
 Who has the authority to make decisions for
children? Parents have the responsibility and
authority to make medical decisions on behalf of
their children. This includes the right to refuse or
discontinue treatments, even those that may be
life-sustaining.
 Parental decision making should be guided by
the best interests of the child.
 Decisions that are clearly not in a childʼs best
interest can and should be challenged.
 When parents are not avaible to make decisions
about a childʼs treatment, the doctor may provide
treatment necessary to prevent harm the childʼs
health.
 Physicians have many different roles in the provision of
healthcare, including individual patient care, public
health delivery, healthservices management and policy
development. The relationship with individual patient
forms the professional and ethical core of their work.
Three key concepts define this relationship – consent,
confidentiality and truth telling.

What is a fiduciary relationship?

 Most of the medical encounter is spent in discussion
between practitioner and patient

 The medical interview is the major medium of health

care

 The interview has three functions and 14 structural

elements
 There are three aspects of the psychodynamic
model:
 Real relationship – this relationship is an equal
and unique relationship between two adults.
The physician will have been chosen by the
patient because of his clinical attributes and
skills
 Treatment alliance – is an equal relationship
between two adults but this relationship can be
affected by the patients anxieties and concerns
 Transference – this is not an interaction
between two adults. In this interaction the
patient is the child and the physician is the
father. Represents the past.
Other aspects important to the relationship
include
 eliciting patient's own explanations of their
illness
 giving patients information

 involving patients in developing a treatment

plan
 obtaining patient′s informed consent

 applying the basic moral principles

  The four principles that form the core of modern
bioethics discussion include autonomy, beneficence,
nonmaleficence and justice ( Beuchamp and Childress
1983)
 Principle for autonomy – this principle is described in
the Lisbon Declaration and includes the following
patient rights :
1. Every patient has the right to choose his own doctor
2. Every patient has the right to accept or refuse treatment
after having received information
3. Every patient has the right to accept or refuse
participation in the study
4. Every patient has the right to die with dignity
5. Every patient has the right to receive further
information from the doctor about the disease
6. The physician must respect the patients right to
choose a doctor and treatment
 Autonomy is capacity for self-determination,
independent decisions, actions, evaluations
 Respect for autonomy means to acknowledge
personʼs right to hold views, make choices and to
take actions based on personal values and beliefs
 Autonomy may be compromised or lost (partially or
completely) on personʼs life and it develops over
time (in case of children)
 Tell the true
 Respect the privacy of the others
 Protect confidential information
 Obtain consent for intervention
 Physician performes the intervention after obtaining the
patientʼs consent, this means that the patient is
involved in the choice of treatment
 The patient has the right to receive information about
the disease, examination, diagnostic methods,
treatment, prognosis, potential risks of treatment and
cost of treatment
 Informed consent is based on the principle of respect
for autonomy. The law relating to consent is founded
upon the patientʼs autonomy and there are clear legal
consequences if the physician acts in its absence
 Informed consent is the process by which a fully
informed patient can participate in choices about his
health care
 The complete informed consent includes a discussion
of :
- The nature of the procedure
- Reasonable alternatives to the proposed intervention
- The relevant risks
- Assessment of patient understanding
-The acceptance of the intervention by the patient
 The obligation to do good, to make efforts to secure the
patients well-being

 Applaying this principle in medical practice often poses

difficult problems for the physician. The mayor problem
in applaying the principle of beneficence is whether the
respect for autonomy has to take priority over
professional obligation to provide benefit
 The obligation to protect the patients from harm, to
avoid doing harm, reduce risk of harm
 Risk can be imposed by careless or unreasonable
action of professionals. Medical competence is a must
for professional practice
 Some ethicists claim that the duty to avoid harm is
actually a stronger obligation in health care
relationships than the obligation to benefit
 “Primum non nocere” is the Hippocratic tradition in
medical practice
 The patient should receive optimal treatment according
to his own needs. Social status, factors such as race,
gender, ethnicity should not affect the quality of
treatment

 This principle involves fairness, equity and equality

 The principle of formal justice states the equals should

be treated equally and that those who are unequal
should be treated differently according to their needs
 Ethics is a philosophical science and ethical principles
have much in common with the systematized
principles of philosophical theorists.
Principle of utility (J. Mil 1806-1873)-the moral value of an
action determines its benefit; those actions that have the
best consequences are correct.
Principle of formalism ( Immanuel Kant) -it is related to
the deontological theories that proceed from due behavior
and duty.
Principle of justice (Rauls)-is based on the cooperation
between people
Figure 1. A time line indicating the evolution of the doctor-patient relationship.
The PATERNALISTIC MODEL – the physician-patient interaction ensures that
patients receive the interventions that best promote their health and well-being.

Strong paternalism – the patient is competent to give his consent, but

the doctor does not provide him with sufficient information. Accepted
only in few cases :
- obligatory treatment of infectious diseases
- obligatory tests in specific professions
Weak paternalism - the patient can not give his informed consent due to
age, incompetence. Accepted in:
- emergency situations
- small children, very old patients
- mentally ill patients in emergency situations with no time for surrogate
decision-making
- when the patient can not make decision because of temporal
Active paternalism – the patient himself prefers the
doctor to make decisions for him
Passive paternalism – the doctor refuses to cooperate
with the execution of the patients choices because these
are not compatible with medicos standards or are against
the doctors conscience
 The patient takes the decision and the responsibility for
its consequences
 Doctor is responsible for the execution of the medical
part of the decision
 Based on the principle of respect for autonomy-
informed consent
 Disadvantages : the autonomy of the physician is not
respected; the patient can choose even medically
irrational course of action
 Patient and the doctor decide together what is
the best in the context of patient′s life and
interests
 The doctor brings his knowledge and the patient
share his values
 Based on the balance of beneficence and respect for
autonomy
 Best applied to cases of chronic diseases
 Acute diseases – paternalistic model might be
appropriate
 Chronic diseases – partnership model might be
appropriate
 Always try the partnership model and if this
model is not applicable, try with autonomous
model
 The model of activity-passivity is entirely
paternalistic in nature; this is analogous to the
parent-infant relationship described
previously. They argued that this model is not
an interaction, as the person being acted upon
is unable to actively contribute. The treatment
session – an example of the model
The model of guidance-co-operation is employed in
situations which are less acute. They argued that despite
the fact that the patient is ill, they are conscious and thus
have feelings and aspirations of their own. During this
time the patient may suffer from anxiety and pain and in
light of this he may seek help. The patient is, therefore,
ready and willing to “cooperate” and in doing so he places
the doctor in a position of power. Therefore the doctor will
speak of guidance and thus expect the patient to
cooperate and obey without question. They described this
model as a prototype in the relationship between a parent
and a child (adolescent). The dental chek-up visit – an
example of the model
The model of mutual participation is based on the belief that
equality amongst human beings is mutually advantageous. In
this model the doctor does not confess to know exactly what is
best for the patient. The management of chronic disease
provides a good example (caries, periodontal diseases). This
model therefore provides the patient with a greater degree of
responsibility and is characterised by a high degree of empathy
and has elements often associated with friendship and
partnership, as well as the imparting of expert medical advice.
Three basic models of the doctor-patient relationship (adapted from Szasz and Hollender
1956).5 Reprinted from Arch. Intern. Med. 1956, 97; 585–92. Copyright © 2006 American
Medical Association. All rights reserved.

Clinical
Physician's Prototype
Model Patient's role application of
role model
model
Recipient Anaesthesia,
Does
Activity- (unable to acute trauma,
something to Parent-infant
passivity respond to coma,
the patient
inert) delirium, etc.
Acute
Guidance-co- Tells patient Co-operator Parent-child
infectious
operation what to do (obeys) (adolescent)
processes, etc.
Participant in Most chronic
Helps patient
Mutual “partnership” illness,
to help Adult-adult
participation (uses expert psychoanalysi
himself
help) s
 Emanuel's models of physician patient
relationship
The INFORMATIVE MODEL
The objective of the physician-patient interaction is for the
physician to provide the patient with all relevant
information about:
❑ the disease state

❑ the nature of possible diagnostic and therapeutic

interventoins
❑ the probability of risks and benefits of interventions

and the cost

The INFORMATIVE MODEL

At the end patients could come to know all the medical

information and select the intervention, that best realizes
their values. Than the patients can give the informed
concent.
 The aim of the physician-patient interaction is to
elucidate the patient’s values and what he actually
wants and to help the patient select the available
medical interventions that realize these values.
 The DELIBERATIVE MODEL

❑ The physician’s objectives include suggesting why

certain health-related values are more worthy and
should be aspired

❑ The patient is empowered to consider through

dialoguee, alternative health related values, their
worthiness, and their implications on the treatment
 Creating trust between a doctor and a patient plays a
major role in the success of a therapy
 To build this trust, before starting treatment, the doctor
should inform his patient about: diagnosis and
prognosis of the disease; upcoming tests; potential
risks of those and the subsequent therapy; treatment
options
 The quality of the health service depends on how well it
meets the individual needs of the patient. In the
complex system of modern health insurance the best
way to achieve high-quality care is to use a patient-
centered approach. This includes respect for the dignity
of the individual, based on the ethical and moral
standards
 A major role in understanding the presented
information by the patient is the way in which
communication is carried out. According to some
authors, 65% of information is transmitted nonverbally
and only 35% verbally
 This two methods of communication complement each
other, the information given can be accepted as a
complete message
 To be successful, the physician should be familiar with
the various methods and techniques of communication,
because it is a part of good medical practice
 Physicians should:

❑ sit down

❑ attend to patient comfort

❑ establish eye contact

❑ listen without interrupting

❑ show attention with nonverbal cues, such as nodding

❑ allow silences while patients search for words

❑ acknowledge and legitimize feelings

❑ explain and reassure during examinations

❑ ask explicitly if there are other areas of concern