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GOOD MORNING
ETHICSIN
DENTISTRY
DR. JJ
CONTENTS
 INTRODUCTION
 HISTORY
 PHILOSOPHY OF ETHICS
 DUTIES AND OBLIGATION OF A DENTIST
 PRINCIPLES OF ETHICS
 ETHICS IN RESEARCH
 IRB
 ETHICAL RULES PRESCRIBED BY THE DCI
 LEGAL VULNERABILITY IN DENTAL PRACTICE
 COPRA
 DOCTOR PATIENT CONTRACT
 CONCLUSION
 REFERENCES
02-01-17 5
What is Ethics?
 It’s a branch of philosophy concerned with the study of those concepts
that are used to evaluate human activities, in particular the concepts of
goodness and obligation.
02-01-17 6
Definition of Ethics
 Is defined as "the science of the ideal human character and behaviour
in situations where distinction must be made between right and wrong,
duty must be followed and good interpersonal relations maintained".
Professional Ethics:
 It is the code by which it regulates actions and sets standards for its
members.
02-01-17 7
History of Ethics
 The "Hippocratic oath" has been regarded as a summing up of a
standard professional ethics.
 Over years various theories have been put forward regarding ethics.
 The theory of deontological ethics focuses on the morality of the
act rather than the consequences of the action.
 The theory of teleological ethics concerned with results of an
action.
 The theory of utilitarian ethics focuses on utility of services.
 Virtue ethics: focuses on what a virtuous person would do in the
particular circumstance.
 Puritan ethics: Is a set of beliefs and attitudes that holds that god
rewards people for their honest toil in this life as well in the next, and
that individual wealth or poverty is justified and largely controlled by
own efforts.
02-01-17 8
02-01-17 9
Other theories
 Descriptive theories are those that seek to define the meaning of good
either in terms of non-moral characteristics or in terms of moral
notions considered as having a peculiar character of their own, that is,
there is a special sense by which moral situations are apprehended.
 Prescriptive theories define ethical terms as carrying mandatory force
enjoined by some kind of authority. Eg: ‘Ethical rules for Dentists’.
02-01-17 10
Other theories
 The principles of research ethics have been influenced by the
Nuremberg code. The Nuremberg code of ethics for medical research
grew out of the deliberation of the Nuremberg war crimes tribunal.
Later the principles established were reinforced by the declaration of
Helsinki which was adopted by the World Medical Association in
1964.
02-01-17 11
Philosophy of Ethics
 It was originally based upon the concept of mysticism, which
speculates on the unknown.
 Gradually when man began to accumulate and record knowledge, he
based his concepts on facts.
 The Egyptian “Book of the Dead” dated 3,500 BC describes
immortality of the soul and lists behavior conducive to a desirable
destiny.
02-01-17 12
Philosophy of Ethics
 Ethics have been mentioned even in the Vedas and Upanishads prior to
1,000 BC.
 By 470 BC Greek philosophy evolved. According to philosophers like
Aristotle, Plato, Socrates, one’s action was either right or wrong, based
entirely on the philosophy of the individual’s group.
 During the middle ages, philosophy and religion, united by a common
ethical interest, transferred old theories to a new setting.
02-01-17 13
Philosophy of Ethics
 The early modern period was more naturalistic and less religious. It
was a compromise between the classical period and the middle ages.
 The 20th century brought a great variety of moral beliefs, allowing a
freedom in which each man could select his own values.
 Only by accepting parts of philosophic theories and harmonizing them
can man form realistic functional ethical principles.
WHYCODE OF MEDICALAND
DENTALETHICS?
 Professions adopt ethical standards because that is part of the
professional charge.
 A patient’s trust in a professional comes in part from the expectation
that the professional’s behaviour is governed by norms prescribed by
the group.
 It is also a public expectation that ethical standards be developed
and enforced by any profession, a requirement that comes with the
privilege of self-regulation.
 A systematic body of rules is needed “in order that dignity and honour
of the dental profession may be upheld, its standard exalted, its sphere
of usefulness extended and the advancement of dental sciences
promoted and that the members of the dental association may
understand clearly their duties and obligations to the dental
profession, to their patients, and to the community at large” (Indian
Dental Association-Constitution, bylaws and code of ethics, 1988).
DUTIESAND OBLIGATIONS OF
THE DENTIST
TOWARDS THE
PATIENT/
POPULATION.
THE PROFESSION /
PROFESSIONAL
COLLEAGUES.
SOCIETY.
161/2/2017 Ethics
DUTIESAND OBLIGATIONS OF THE
DENTIST TOWARDS PATIENT/POPULATION:
 The first principle of medicine enunciated in the Hippocratic Oath is
that the doctor's first duty is to his or her patient.
 Major ethical principles that can guide in the performance of these
duties are
171/2/2017
Ethics
 PRINCIPLES OF ETHICS
1. NON-MALEFICENCE
2. BENEFICENCE
3. AUTONOMY
4. JUSTICE
5. TRUTHFULNESS
6. CONFIDENTIALITY
To do no Harm (Non- maleficence):
1/2/2017 Ethics 19
 Hippocrates, pioneer in Greek medicine has laid an emphasis on non-
maleficence or to do no harm.
 As per this, the first and foremost duty of the health care professional
is to ensure that his actions do not harm the patient in any way.
1/2/2017 Ethics 20
 Use of unsterilized instruments, under filling or overfilling,
carelessness in handling hard and soft tissues of the mouth are
some of the instances, which can harm the patients.
 Such circumstances are to be avoided in the best interest of the
patient by carefully thought and implemented health care.
1/2/2017 Ethics 21
 The dentist, in cases where pain cannot be avoided, can make attempts
to minimize the pain. If feasible, the alternative of minimal or no
treatment can be presented to the patient.
 In a population-based research, the investigator has a dual
responsibility; to individual subject and to the population of which
they are a part.
 One of the problems in screening of the population is that persons who
regard themselves as healthy are found not to be so. This may have
several consequences, e. g. such persons may assume a ‘sick role’ –
lose time from work and become excessively worried about their
health.
1/2/2017 22Ethics
To Do Good (Beneficence)
1/2/2017 Ethics 23
 The health care professional, before instituting any
action or care should question himself whether such
actions will help the patient to recover or to perform
his functions better or not.
 He has to place the interest of the patient above his
own interest.
 He has to plan a treatment or order an investigation
only if it is necessary.
 In the process of treating a patient –weigh the consequences of
treatment Vs no treatment.
E.g. in questionable dental caries - the attempts should be to
maximize the benefits and minimize the harm.
 At a community level, one has to balance harms and benefits of
programmes and select the one, which provides the greatest balance of
good over evil. Secondly make use of cost-benefit analysis to
determine appropriate programme for the community.
1/2/2017 24Ethics
 If the communities do not receive benefits, they will have difficulties
in seeing the relevance of the study.
 In epidemiological studies it is unethical to carry out screening when
no treatment is possible or treatment is beyond the financial reach of
the people who offered the screening program.
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Respect for persons
1/2/2017 Ethics 26
Incorporates two other ethical principles :
 1. Autonomy
 2. Informed consent
1.Autonomy –
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 This principle is in line with interactive model of health care
wherein patient is the prominent member in the process of
decision making.
 This principle emphasizes the patient's right to make decisions
and is free to determine what will happen on his/her body.
 A patient is diagnosed with dental caries in relation to 46 and 36. The
treatment of choice which could be given here are silver amalgam ,
GIC, composites. But the dentist attending the case insists on
composite restoration.
1/2/2017 Ethics 29
 This term first appeared in American common law in the late 1950s,
and subsequently has been reflected in international codes and in the
legislations and regulations of many countries.
Four attributes of a consent –
 Consent must be “voluntary”, “legally competent”, “informed” and
“comprehending”.
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 The health care professional has to ensure that consent is obtained
before any care is instituted.
 Patients are provided with relevant information such as different
modes of treatment, their risks and benefits consequences of not
availing the treatment etc.
 Information given should be easily understood facilitating the patient
to make a voluntary consent.
 In case of minors, parents or legal guardians can grant the consent for
the care.
Informed consent – has a two step process.
 First, information is presented to subject by the investigator
 Secondly, the subject satisfies himself/herself that he/she understands,
and based upon this understanding either agrees or refuses to
participate in the research project.
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1) Description of the procedures
to be carried out.
2) Description of any reasonably
risks.
3) Description of any benefits to
the subjects.
4) Disclosure of appropriate
alternative procedures
5) Statement that the patient has
understood the procedure
6) Signature of the patient
1
2
3
4
5
6
CONSENT
 When two or more persons agree up on the same thing in the same
sense they are said to consent - section 13 of Indian Contract
Act , 1872
 Implied consent
 Express consent
 Informed consent
 Proxy consent
Justice
1/2/2017 Ethics 33
 This principle directs health care professional to provide equal
treatment to all, giving to each patient what he/she needs.
 Dental practitioners are often found to be reluctant to treat the poor
because they cannot afford; treat the children or mentally retarded
because it takes longer time.
1/2/2017 Ethics 34
 Dentists also have responsibilities for such group of patients and
cannot shy away from the responsibilities bestowed on them by the
society.
 Dentists probably can provide care at a concessional rate or designate
certain time for the care of such patients or support programmes for
such patients conducted by local, regional or state bodies.
1/2/2017 Ethics 35
 On the other hand, when the resources are limited, especially at a
community level, one has to choose a group of patients eligible for
treatment as well as type of care. Also whether it is possible to give
same or equal treatment for all or equitable treatment for the group
concerned is to be considered.
Truthfulness (Veracity) –
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 Patient-doctor relationship is based on mutual trust.
 Patients expect the dentist to be truthful about the information given,
treatment rendered, and the prognosis.
 Even if the dentist believes lying or concealing or manipulation of the
information is required in the best interest of the patient, the
relationship is bound to, suffer.
 In certain epidemiological studies, it may be said that the use of
placeboes transgresses their principle of veracity.
 The dentist may feel that it would be better if the patient took certain
course of action and therefore manipulates the information that is
given to the patient. Whatever the reason, the relationship will suffer
and the dentist will be guilty of transgressing a major ethical
principle.
1/2/2017 37Ethics
 Mr. Y comes to the dental clinic complaining of pain in lower right
back tooth (46). The dentist tells the patient that an RCT has to be
done. And the patient agrees for the same. While doing the RCT the
dentist happens to breaks a file in the canal which he is not able to
retrieve. But he does not tell the patient about it. After the treatment,
the patient returns with pain in the teeth after 6 months. The dentist
says there is infection in the canal and that the tooth cannot be saved
and that it has to be extracted.
Confidentiality –
 Patients have the right to expect that all communications and records
pertaining to their care will be treated as confidential.
 Gossiping/discussing about patient (some famous patient/neighbor)
would break a bond of trust between dental professional and patient.
 Now, patients permission has to be sought to disclose the
confidentiality, even if it is beneficial to the patient.
1/2/2017 39Ethics
 In no instance other than the court of law or the patient changes the
dentist, should the confidentiality be breached.
In epidemiological studies –
 The information about the subjects is either unlinked/linked
information.
 Clear rules are needed when disclosures can ethically occur in absence
of consent when report of studies have to be submitted to the sponsors
of the study.
1/2/2017 40Ethics
 A patient named X comes to the dental clinic for getting his teeth
restored. The dentist suspects him of HIV. He tells him to get various
confirmatory tests done. The patient comes back after a week with the
reports. It shows he is HIV positive. The dentist does the treatment, but
tells his attender that the patient is HIV positive. The attender who
stays near the patients house tells about it to his neighbours.
DUTIESAND OBLIGATIONS TOWARDS
PROFESSION/PROFESSIONAL
COLLEAGUES
 Every dentist has to remember that the treatment and cure of the
disease depends on the skill and prompt attention showed to the
patient.
 The dentist has to be sober, courteous, sympathetic, helpful, modest
and punctual.
 He should enroll in societies and update his knowledge and skill.
 It is the professional courtesy to treat the family of his fellow-
professionals without charge.
1/2/2017 42Ethics
Following practices are unethical –
 To ‘put down’ another dentist to the patient.
 Paying or accepting commissions.
 Undercutting of charges in order to solicit patients.
 Not referring the patient to the consultant if the planned treatment is
beyond the skills of the dentist.
 In absence of other dentist, temporary service is provided to the patient
and the patient is not sent back.
 If consulted, the dentist accepts charge of the case without request of
the referring dentist.
1/2/2017 43Ethics
3. DUTIESAND OBLIGATIONS
TOWARDS THE SOCIETY.
 The dentist has to assume leadership in the community on matters
pertaining to dental health.
 People should be urged to seek care without influencing the choice of
dentist.
1/2/2017 44Ethics
Ethical Rules for Dentists :
Prescribed by DCI
1/2/2017 45Ethics
Duties and obligations of dentist towards the
patient
1.Every dentist should be courteous, sympathetic, friendly and helpful.
2.He should observe punctuality in fulfilling his appointments.
3.He should establish a well merited reputation for professional ability
and fidelity.
4. The welfare of patient should be conserved to the utmost of the
practitioner’s ability.
5. A dentist should not permit considerations of religion, nationality,
race, party politics or social standing to intervene between his duties
and his patients.
1/2/2017 46Ethics
6. Information of personal nature which may be learned about or directly
from a patient in the course of dental practice should be kept in utmost
confidence. It is also obligation of the dentist to see that his auxiliary
staff observed this rule.
1/2/2017 47Ethics
Duties and Obligations towards Professional
Colleagues:
1. Every dentist should cherish a proper pride in his/her colleagues and
should not disparage them either by act or word.
2. Mutual arrangements should be made regarding remuneration, when
other dentist’s patient is taken care in his sickness/absence.
3. If a dentist is called for providing emergencies, he should retire after it
is over (in favor of the regular dentist), but is entitled to charge the
patient for his services.
4. If a dentist is consulted by the patient of another dentist and the former
finds that the patient is suffering from previous faulty treatment it is
his duty to institute correct treatment at once with as little comments as
possible and in such a manner as to avoid reflection on his
predecessor.
DUTIESAND OBLIGATIONS TOWARDS THE
PUBLIC : POLICEAND LAW COURTS:
 A dentist is not bound to disclose professional secrets unless
called upon by the Magistrate or judge to do so.
 Knowledge of patient gained in the course of examination and
treatment is privileged and should not be disclosed without the
consent of the patient or an order from presiding judge in the
Court of Law.
1/2/2017 50Ethics
Some unethical acts are-
 1.Unregistered persons
 2. Publicity and Signage
 3. Advertising
 4. Use of bogus diploma
 5. Rebates and Commission
 6. Secret Remedies
 7. Undercutting the charges
 8. Unethical practices
 9. Naming and styling of dental establishments
 9. Doctor- Patient sexual misconduct
 10. Abiding by all laws of the land
 15. Relationship with pharmaceutical companies and medical and
dental industry
ETHICS IN RESEARCH
 Researchers bear the responsibility for identifying and propagating truth
in matters of science. Much research involves studies with humans
and human tissues, as well as with animals, and there are strict rules
governing research with both.
 As with patient care, the first detailed research codes were developed in
the shadow of World War II. The revulsion that followed the disclosure
of Nazi experiments brought serious public scrutiny to patients’ rights in
research studies and resulted in the 1947 Nuremberg Code.
THE NUREMBERG CODE:
 The U.S Government believes it has an ethical and legal
responsibility to protect the right of citizens who agree to
participate in research studies.
 The principles underlying the protection of human subjects have
their seeds in events following World War II.
 In 1947, the Nuremberg Military Tribunal developed a code of
standards to use in judging physicians accused of conducting
research atrocities in Nazi concentration camps.
 Nazi physicians committed human atrocities in the name of
medical research.
 Received a great deal of attention in trials for World War II
criminals.
 Resulted from prosecution of 23 German physicians and
administration for allowing and performing experience like
injecting prisoners with gasoline.
 First internationally recognized code
 Focus, ethical treatment of humans even in non therapeutic
research.
 It has become the corner stone for all the guidance, regulations
required in human research.
Ten Points of Nuremberg Code:
1) Consent must be voluntary
 Legal capacity to give consent.
 Without element of force.
 Sufficient knowledge of nature, duration and purpose.
2) Experiments should yield fruitful results for the good of the
society.
3) Design should be based on results of animal experiments
and knowledge of natural history of the disease.
4) Avoid all unnecessary physical and mental suffering and
injury.
5) No experiment should be conducted where there is prior
reason to believe that death or disabling injury will occur.
6) The degree of risk should not exceed as determined by
humanitarian principles.
7) Proper preparations should be made and adequate facilities
provided to protect the experimental subjects against even
remote possibilities of injury, disability or death.
8) The experiment should be conducted only by scientifically
qualified persons with the highest degree of skill and care.
9) During the course of the experience the human subject should
be given liberty to bring the experiment to an end.
10) During the course of the experiment, the scientist in charge
must be prepared to terminate the experiment at any stage, if
he has probable cause to believe, that a continuation of the
experiment is likely to result in injury, disability or death to the
experimental subject.
Declaration of Helsinki
 In addition to drafting the Declaration of Geneva, which was aimed at
patient care, the World Medical Association further refined the subject
of the rights of human participants in research through the Declaration
of Helsinki in 1964 and its subsequent amendments.
 The World Medical Association developed the Declaration of Helsinki
as a statement of ethical principles to provide guidance to physicians
and other participants in medical research involving human subjects.
 Adopted by the 18th World Medical Association General
Assembly, Helsinki, Finland, June 1964, and amended by the
 29th WMA General Assembly, Tokyo, Japan, October 1975
 35th WMA General Assembly, Venice, Italy, October 1983
 41st WMA General Assembly, Hong Kong, September 1989
 48th WMA General Assembly, Somerset West, Republic of South
Africa, October 1996
 and the 52nd WMA General Assembly, Edinburgh, Scotland, October
2000
 Note of Clarification on Paragraph 29 added by the WMA General
Assembly, Washington 2002
 Note of Clarification on Paragraph 30 added by the WMA General
Assembly, Tokyo 2004.
 In year 2000, the Central Ethics Committee on Human Research
(CECHR) of the Indian Council of Medical Research (under the
chairmanship of Honourable Justice Shri M.N. Venkatachaliah) put
together a set of “Ethical Guidelines for Biomedical Research on
Human Subjects”.
General statement
 Medical and related research using human beings as subjects must
necessarily ensure that-
 The PURPOSE, of such research is that it should be directed towards
the increase of knowledge about the human condition in relation to its
social and natural environment, and that such research is for the
betterment of all, especially the least advantaged.
 Such research is CONDUCTED under conditions that no person or
persons become a mere means for the betterment of others and that
human beings who are subject to any medical research or scientific
experimentation are dealt with in a manner conducive to and consistent
with their dignity and well being, under conditions of professional fair
treatment and transparency; and after ensuring that the subject is
placed at no greater risk other than such risk commensurate with the
well being of the subject in question in the light of the object to the
achieved.
 Such research must be subjected to a regime of EVALUATION at
all stages of the proposal.
ETHICS VIOLATION IN RESEARCH
 Vipeholm Dental Caries Study (1954):
The most significant human study does at Vipeholm Hospital, in
Sweden reported in 1954 by Gustafsson et al.
 436 adult mental patients were placed on controlled diet and
observed for 5 years. The subjects were divided into 1 control and 6
experimental groups. Some ate complex and simple carbohydrates
at mealtimes' only, while others supplemented meal time food
with meal snacks, sweetened with sucrose, chocolate, caramel or
toffee.
 Among the conclusions drawn from the study, was that sucrose
consumption could increase caries activity. The risk increased if
the sucrose was consumed in a sticky form that adhered to the
tooth's surface. The greatest damage was inflicted by foods
between meals.
Ethical Issue:
 Mentally retarded children
 Coercion -No informed consent
 Hazards not informed
Ethical review procedures
 It is mandatory that all proposals on biomedical research involving
human subjects should be cleared by an appropriately constituted
Institutional Ethics Committee (IEC), also referred to as Institutional
Review Board (IRB) in many countries, to safeguard the welfare and
the rights of the participants.
 The Ethics Committees are entrusted not only with the initial review
of the proposed research protocols prior to initiation of the projects
but also have a continuing responsibility of regular monitoring for
the compliance of the ethics of the approved programmes till the
same are completed.
 Such an ongoing review is in accordance with the Declaration of
Helsinki and all the international guidelines for biomedical research.
Submission of application
 The researcher should submit an appropriate application in a
prescribed format along with the study protocol at least three weeks
in advance. The protocol should include the following : -
 Clear research objectives and rationale for undertaking the
investigation in human subjects in the light of existing
knowledge.
 Recent curriculum vitae of the Investigators indicating
qualification and experience.
 Subject recruitment procedures.
 Inclusion and exclusion criteria for entry of subjects in the study.
 Precise description of methodology of the proposed research,
including intended dosages of drugs, planned duration of
treatment and details of invasive procedures if any.
 A description of plans to withdraw or withhold standard therapies
in the course of research.
 The plans for statistical analysis of the study.
 Procedure for seeking and obtaining informed consent with sample
of patient information sheet and informed consent forms in
English and vernacular languages.
 Safety of proposed intervention and any drug or vaccine to be
tested, including results of relevant laboratory and animal
research.
 For research carrying more than minimal risk, an account of
plans to provide medical therapy for such risk or injury or toxicity
due to overdosage should be included.
 Proposed compensation and reimbursement of incidental expenses.
 Storage and maintenance of all data collected during the trial.
 Plans for publication of results – positive or negative – while
maintaining the privacy and confidentiality of the study
participants.
 A statement on probable ethical issues and steps taken to tackle the
same.
 All other relevant documents related to the study protocol including
regulatory clearances.
 Agreement to comply with national and international GCP
protocols for clinical trials.
 Details of Funding agency / Sponsors and fund allocation for the
proposed work.
The Consumer ProtectionAct
 The Consumer Protection Act (CPA) of 1986 was enacted for better
protection of the interests of consumers and to provide simple and
quick access to redress consumer grievances. This is done through
quasi-judicial mechanisms set up at the District, State, and National
levels. Consumers can file their complaints which will be entertained
by the quasi-judicial bodies - referred to as Consumer Forums or
Commissions.
 These Consumer Commissions have been empowered to award
compensation to aggrieved consumers for the hardships she/he has
endured. A nominal court fee (INR 200) is required to be paid to these
Forums and there is no obligation to engage a lawyer to argue the case
(the consumer can, her/himself, present the case)
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When the doctor -patient relationship begins:
1/2/2017 Ethics 81
 The legal foundation of the doctor - patient relationship is contract law.
At the moment a dentist expresses a professional opinion to an
individual who has reason to rely on the opinion, the doctor - patient
relationship begins, and the doctor is burdened with implied warranties
(duties).
1/2/2017 Ethics 82
 Dentist may refuse to treat a patient for any reason except race, creed,
colour, or national origin. With the Disabilities Act of 1990, (USA)
refusal to accept a patient based upon a person's disability may be in
violation of the law.
1/2/2017 Ethics 83
 Patients suffering from acquired immunodeficiency syndrome, or who
test positive for HIV, fall into the category of disabled persons and
may not be refused care, if the refusal is based solely on the presence
of AIDS or their HIV +ve status.
 The law declares that all health providers' offices are "places of public
accommodation" and therefore subject to antidiscrimination laws.
1/2/2017 Ethics 84
 As long as the person is not a patient of record, dentist may even
refuse to provide emergency care. It may be unethical, but it is not
illegal and cannot form the basis of a civil suit.
 However just as soon as the dentist expresses a professional
judgement, or performs a professional act, the doctor- patient
relationship begins, and duties begin to attach.
When the doctor- patient relationship ends
 Both parties agree to end it
 Either the patient or dentist dies
 The patient ends it by act or statement
 The patient is cured
 The dentist unilaterally decides to terminate the care.
The major causes that contribute to a decision to
terminate treatment before it is complete are
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 The patient has not fulfilled the payment agreement.
 The patient has not co-operated in keeping appointments
 The patient has not complied with home care instructions.
 There has been a breakdown in interpersonal relationships.
 Any of these is ample justification for the dentist to terminate
treatment. The dentist should not discontinue treatment at a time when
the patients health may be compromised.
Express terms
1/2/2017 Ethics 87
 An 'express term' is one in which both parties are in agreement. Putting
the term in writing is not required to make it enforceable, although to
prevent misunderstandings a written agreement is always preferred.
Usually, the express terms define items such as fee, the treatment, and
the manner in with payments are to be made.
1/2/2017 Ethics 88
 Express terms may be written in separate form, because the treatment
record should contain only treatment notes and patient reactions to
treatment. Guarantees made by the dentist constitute an express term in
the agreement. "Never guarantee a result". If the patient is not
satisfied, the dentist has breached the contract despite the excellent
quality of the service.
IMPLIED WARRANTIES OWED BYTHE
DOCTOR
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In accepting a patient for care the dentist warrants that he or she will do
the following:
 Use reasonable care in the provision of services as measured against
acceptable standards set by other practitioners with similar training in
a similar community.
 Be properly licensed and registered and meet all other legal
requirements to engage in the practice of dentistry.
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 Obtain informed consent from the patient before instituting an
examination or treatment.
 Not abandon the patient.
 Ensure that care is available in emergency situations.
 Charge a reasonable fee for services based on community standards.
 Not exceed the scope of practice authorized by the license or permit
any person acting under his or her direction to engage in unlawful acts.
 Keep the patient informed of her or his progress.
 Not undertake any procedure for which the practitioner is not
qualified.
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 Complete the care in a timely manner.
 Keep accurate records of the treatment rendered to the patient.
 Maintain confidentiality of information.
 Inform the patient of any untoward occurrences in the course of
treatment.
 Make appropriate referrals and request necessary consultations.
 Comply with all laws regulating the practice of dentistry.
 Practice in a manner consistent with the code of ethics of the
profession.
Implied duties owed by the patient:
1/2/2017 Ethics 93
In accepting care, the patient warrants the following:
1. Home care instructions will be followed. 
2. Appointments will be kept
3. Bills for services will be paid in a reasonable time.
4. That the patient will co-operate in the care.
5. That the patient will notify the dentist of a change in health status.
6. If the patient breaches any of these duties, notes to that effect should
be made in the patients record.
 Torts
1/2/2017 Ethics 94
A tort is a civil wrong or injury, independent of a contract, that results
from a breach of a duty.
It is of two type:
1. An un-intentional tort is one in which harm was not intended as in
the case in tort of negligence
2. An intentional tort contains the element of intended harm.
 If the negligence involves an act that is performed in a professional
capacity; it is termed professional negligence or malpractice.
1/2/2017 Ethics 95
Professional Negligence
 It is defined as a failure to exercise reasonable care in one's
professional capacity.
Criminal Negligence
 For criminal proceedings to be started the negligent action must be
very serious and have some accentuating factors
 e.g. dentist was drunk or drugged or disregarded well known safety
principles.
1/2/2017 Ethics 96
Contributory Negligence
 When the actions of a patient have been partially or completely to
blame for the damage that occurred
 e.g. failure to follow post operative instruction.
Vicarious Liability
 An employer can be held responsible for any negligence by an
employee. A dentist is responsible for the actions or omissions of his
staff. A charge of negligence can be brought against both employee
and employer.
Breach of Confidentiality
1/2/2017 Ethics 97
 Information obtained from the patients in thecourse of diagnosis (or)
treatment must remain confidential.
 The patients dental record is a legal document. It serves many
purposes in the judicial process.
 It contains information about the patient complaint, health history, and
basis for the diagnosis, and it reports all treatment rendered, the
patients reaction to treatment, and the result of the treatment. Case law
requires that the health practitioners keep accurate records of the
diagnosis and treatment of their patients.
1/2/2017 Ethics 98
 At one time, doctors had the exclusive right to the possession of the
record and its contents.
 Today, the doctor is considered the custodian of the record and the
patient has a property right in its contents. If the patient demands in
writing to be sent a copy to the treatment record or demands that a
copy be sent to another practitioner or to any other person or agency.
Legal Remedy
1/2/2017 Ethics 99
There are many avenues of legal remedy when negligence occurs.
 (i) Criminal liability: IPC section 304A: Grossly rash or grossly
negligent act, which is proximate, direct or substantive cause of
patient's death.
 (ii) Civil liability: Indian Contract Act section 73 & 74.
 (iii) Indian Medical/Dental Council Act - 1948.
 (iv) Consumer Protection Act 1986.
CONCLUSION
 The special status that society confers on the dental professionals
requires them to behave in an ethical manner.
 Principles of beneficence, non-maleficence, respect for autonomy
and justice should guide the conduct of the professionals in
patient care and research.
 Adherence to a code of ethics is important for the continued trust
of the society in dental professionals.
REFERENCES
 Soben Peter: Essentials Of Preventive And Community
Dentistry:3rd Edition,2003
 George M. Gluck And Warren M. Morganstein:jong’s Community
Dental Health:5th Edition,2002.
 Acharya A B, Savitha Jk , Nadagouda Sv. Professional Negligence
In Dental Practice:potential For Civil And Criminal Liability In
India:journal Of Forensic Dental Sciences . January-june 2009 ;Vol
1 (1)
 Nuremberg Code- Wikipedia, The Free Encyclopedia.
En.Wikipedia.Org/Wiki/Nuremberg_code
 Ethical Guidelines For Biomedical Research On Human Subjects.
Www.Icmr.Nic.In/Ethical.Pdf
THANK YOU

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ETHICS

  • 3. CONTENTS  INTRODUCTION  HISTORY  PHILOSOPHY OF ETHICS  DUTIES AND OBLIGATION OF A DENTIST  PRINCIPLES OF ETHICS
  • 4.  ETHICS IN RESEARCH  IRB  ETHICAL RULES PRESCRIBED BY THE DCI  LEGAL VULNERABILITY IN DENTAL PRACTICE  COPRA  DOCTOR PATIENT CONTRACT  CONCLUSION  REFERENCES
  • 5. 02-01-17 5 What is Ethics?  It’s a branch of philosophy concerned with the study of those concepts that are used to evaluate human activities, in particular the concepts of goodness and obligation.
  • 6. 02-01-17 6 Definition of Ethics  Is defined as "the science of the ideal human character and behaviour in situations where distinction must be made between right and wrong, duty must be followed and good interpersonal relations maintained". Professional Ethics:  It is the code by which it regulates actions and sets standards for its members.
  • 7. 02-01-17 7 History of Ethics  The "Hippocratic oath" has been regarded as a summing up of a standard professional ethics.  Over years various theories have been put forward regarding ethics.  The theory of deontological ethics focuses on the morality of the act rather than the consequences of the action.  The theory of teleological ethics concerned with results of an action.  The theory of utilitarian ethics focuses on utility of services.
  • 8.  Virtue ethics: focuses on what a virtuous person would do in the particular circumstance.  Puritan ethics: Is a set of beliefs and attitudes that holds that god rewards people for their honest toil in this life as well in the next, and that individual wealth or poverty is justified and largely controlled by own efforts. 02-01-17 8
  • 9. 02-01-17 9 Other theories  Descriptive theories are those that seek to define the meaning of good either in terms of non-moral characteristics or in terms of moral notions considered as having a peculiar character of their own, that is, there is a special sense by which moral situations are apprehended.  Prescriptive theories define ethical terms as carrying mandatory force enjoined by some kind of authority. Eg: ‘Ethical rules for Dentists’.
  • 10. 02-01-17 10 Other theories  The principles of research ethics have been influenced by the Nuremberg code. The Nuremberg code of ethics for medical research grew out of the deliberation of the Nuremberg war crimes tribunal. Later the principles established were reinforced by the declaration of Helsinki which was adopted by the World Medical Association in 1964.
  • 11. 02-01-17 11 Philosophy of Ethics  It was originally based upon the concept of mysticism, which speculates on the unknown.  Gradually when man began to accumulate and record knowledge, he based his concepts on facts.  The Egyptian “Book of the Dead” dated 3,500 BC describes immortality of the soul and lists behavior conducive to a desirable destiny.
  • 12. 02-01-17 12 Philosophy of Ethics  Ethics have been mentioned even in the Vedas and Upanishads prior to 1,000 BC.  By 470 BC Greek philosophy evolved. According to philosophers like Aristotle, Plato, Socrates, one’s action was either right or wrong, based entirely on the philosophy of the individual’s group.  During the middle ages, philosophy and religion, united by a common ethical interest, transferred old theories to a new setting.
  • 13. 02-01-17 13 Philosophy of Ethics  The early modern period was more naturalistic and less religious. It was a compromise between the classical period and the middle ages.  The 20th century brought a great variety of moral beliefs, allowing a freedom in which each man could select his own values.  Only by accepting parts of philosophic theories and harmonizing them can man form realistic functional ethical principles.
  • 14. WHYCODE OF MEDICALAND DENTALETHICS?  Professions adopt ethical standards because that is part of the professional charge.  A patient’s trust in a professional comes in part from the expectation that the professional’s behaviour is governed by norms prescribed by the group.  It is also a public expectation that ethical standards be developed and enforced by any profession, a requirement that comes with the privilege of self-regulation.
  • 15.  A systematic body of rules is needed “in order that dignity and honour of the dental profession may be upheld, its standard exalted, its sphere of usefulness extended and the advancement of dental sciences promoted and that the members of the dental association may understand clearly their duties and obligations to the dental profession, to their patients, and to the community at large” (Indian Dental Association-Constitution, bylaws and code of ethics, 1988).
  • 16. DUTIESAND OBLIGATIONS OF THE DENTIST TOWARDS THE PATIENT/ POPULATION. THE PROFESSION / PROFESSIONAL COLLEAGUES. SOCIETY. 161/2/2017 Ethics
  • 17. DUTIESAND OBLIGATIONS OF THE DENTIST TOWARDS PATIENT/POPULATION:  The first principle of medicine enunciated in the Hippocratic Oath is that the doctor's first duty is to his or her patient.  Major ethical principles that can guide in the performance of these duties are 171/2/2017 Ethics
  • 18.  PRINCIPLES OF ETHICS 1. NON-MALEFICENCE 2. BENEFICENCE 3. AUTONOMY 4. JUSTICE 5. TRUTHFULNESS 6. CONFIDENTIALITY
  • 19. To do no Harm (Non- maleficence): 1/2/2017 Ethics 19  Hippocrates, pioneer in Greek medicine has laid an emphasis on non- maleficence or to do no harm.  As per this, the first and foremost duty of the health care professional is to ensure that his actions do not harm the patient in any way.
  • 20. 1/2/2017 Ethics 20  Use of unsterilized instruments, under filling or overfilling, carelessness in handling hard and soft tissues of the mouth are some of the instances, which can harm the patients.  Such circumstances are to be avoided in the best interest of the patient by carefully thought and implemented health care.
  • 21. 1/2/2017 Ethics 21  The dentist, in cases where pain cannot be avoided, can make attempts to minimize the pain. If feasible, the alternative of minimal or no treatment can be presented to the patient.
  • 22.  In a population-based research, the investigator has a dual responsibility; to individual subject and to the population of which they are a part.  One of the problems in screening of the population is that persons who regard themselves as healthy are found not to be so. This may have several consequences, e. g. such persons may assume a ‘sick role’ – lose time from work and become excessively worried about their health. 1/2/2017 22Ethics
  • 23. To Do Good (Beneficence) 1/2/2017 Ethics 23  The health care professional, before instituting any action or care should question himself whether such actions will help the patient to recover or to perform his functions better or not.  He has to place the interest of the patient above his own interest.  He has to plan a treatment or order an investigation only if it is necessary.
  • 24.  In the process of treating a patient –weigh the consequences of treatment Vs no treatment. E.g. in questionable dental caries - the attempts should be to maximize the benefits and minimize the harm.  At a community level, one has to balance harms and benefits of programmes and select the one, which provides the greatest balance of good over evil. Secondly make use of cost-benefit analysis to determine appropriate programme for the community. 1/2/2017 24Ethics
  • 25.  If the communities do not receive benefits, they will have difficulties in seeing the relevance of the study.  In epidemiological studies it is unethical to carry out screening when no treatment is possible or treatment is beyond the financial reach of the people who offered the screening program. 1/2/2017 25Ethics
  • 26. Respect for persons 1/2/2017 Ethics 26 Incorporates two other ethical principles :  1. Autonomy  2. Informed consent
  • 27. 1.Autonomy – 1/2/2017 Ethics 27  This principle is in line with interactive model of health care wherein patient is the prominent member in the process of decision making.  This principle emphasizes the patient's right to make decisions and is free to determine what will happen on his/her body.
  • 28.  A patient is diagnosed with dental caries in relation to 46 and 36. The treatment of choice which could be given here are silver amalgam , GIC, composites. But the dentist attending the case insists on composite restoration.
  • 29. 1/2/2017 Ethics 29  This term first appeared in American common law in the late 1950s, and subsequently has been reflected in international codes and in the legislations and regulations of many countries. Four attributes of a consent –  Consent must be “voluntary”, “legally competent”, “informed” and “comprehending”.
  • 30. 1/2/2017 Ethics 30  The health care professional has to ensure that consent is obtained before any care is instituted.  Patients are provided with relevant information such as different modes of treatment, their risks and benefits consequences of not availing the treatment etc.  Information given should be easily understood facilitating the patient to make a voluntary consent.  In case of minors, parents or legal guardians can grant the consent for the care.
  • 31. Informed consent – has a two step process.  First, information is presented to subject by the investigator  Secondly, the subject satisfies himself/herself that he/she understands, and based upon this understanding either agrees or refuses to participate in the research project. 1/2/2017 31Ethics 1) Description of the procedures to be carried out. 2) Description of any reasonably risks. 3) Description of any benefits to the subjects. 4) Disclosure of appropriate alternative procedures 5) Statement that the patient has understood the procedure 6) Signature of the patient 1 2 3 4 5 6
  • 32. CONSENT  When two or more persons agree up on the same thing in the same sense they are said to consent - section 13 of Indian Contract Act , 1872  Implied consent  Express consent  Informed consent  Proxy consent
  • 33. Justice 1/2/2017 Ethics 33  This principle directs health care professional to provide equal treatment to all, giving to each patient what he/she needs.  Dental practitioners are often found to be reluctant to treat the poor because they cannot afford; treat the children or mentally retarded because it takes longer time.
  • 34. 1/2/2017 Ethics 34  Dentists also have responsibilities for such group of patients and cannot shy away from the responsibilities bestowed on them by the society.  Dentists probably can provide care at a concessional rate or designate certain time for the care of such patients or support programmes for such patients conducted by local, regional or state bodies.
  • 35. 1/2/2017 Ethics 35  On the other hand, when the resources are limited, especially at a community level, one has to choose a group of patients eligible for treatment as well as type of care. Also whether it is possible to give same or equal treatment for all or equitable treatment for the group concerned is to be considered.
  • 36. Truthfulness (Veracity) – 1/2/2017 Ethics 36  Patient-doctor relationship is based on mutual trust.  Patients expect the dentist to be truthful about the information given, treatment rendered, and the prognosis.  Even if the dentist believes lying or concealing or manipulation of the information is required in the best interest of the patient, the relationship is bound to, suffer.
  • 37.  In certain epidemiological studies, it may be said that the use of placeboes transgresses their principle of veracity.  The dentist may feel that it would be better if the patient took certain course of action and therefore manipulates the information that is given to the patient. Whatever the reason, the relationship will suffer and the dentist will be guilty of transgressing a major ethical principle. 1/2/2017 37Ethics
  • 38.  Mr. Y comes to the dental clinic complaining of pain in lower right back tooth (46). The dentist tells the patient that an RCT has to be done. And the patient agrees for the same. While doing the RCT the dentist happens to breaks a file in the canal which he is not able to retrieve. But he does not tell the patient about it. After the treatment, the patient returns with pain in the teeth after 6 months. The dentist says there is infection in the canal and that the tooth cannot be saved and that it has to be extracted.
  • 39. Confidentiality –  Patients have the right to expect that all communications and records pertaining to their care will be treated as confidential.  Gossiping/discussing about patient (some famous patient/neighbor) would break a bond of trust between dental professional and patient.  Now, patients permission has to be sought to disclose the confidentiality, even if it is beneficial to the patient. 1/2/2017 39Ethics
  • 40.  In no instance other than the court of law or the patient changes the dentist, should the confidentiality be breached. In epidemiological studies –  The information about the subjects is either unlinked/linked information.  Clear rules are needed when disclosures can ethically occur in absence of consent when report of studies have to be submitted to the sponsors of the study. 1/2/2017 40Ethics
  • 41.  A patient named X comes to the dental clinic for getting his teeth restored. The dentist suspects him of HIV. He tells him to get various confirmatory tests done. The patient comes back after a week with the reports. It shows he is HIV positive. The dentist does the treatment, but tells his attender that the patient is HIV positive. The attender who stays near the patients house tells about it to his neighbours.
  • 42. DUTIESAND OBLIGATIONS TOWARDS PROFESSION/PROFESSIONAL COLLEAGUES  Every dentist has to remember that the treatment and cure of the disease depends on the skill and prompt attention showed to the patient.  The dentist has to be sober, courteous, sympathetic, helpful, modest and punctual.  He should enroll in societies and update his knowledge and skill.  It is the professional courtesy to treat the family of his fellow- professionals without charge. 1/2/2017 42Ethics
  • 43. Following practices are unethical –  To ‘put down’ another dentist to the patient.  Paying or accepting commissions.  Undercutting of charges in order to solicit patients.  Not referring the patient to the consultant if the planned treatment is beyond the skills of the dentist.  In absence of other dentist, temporary service is provided to the patient and the patient is not sent back.  If consulted, the dentist accepts charge of the case without request of the referring dentist. 1/2/2017 43Ethics
  • 44. 3. DUTIESAND OBLIGATIONS TOWARDS THE SOCIETY.  The dentist has to assume leadership in the community on matters pertaining to dental health.  People should be urged to seek care without influencing the choice of dentist. 1/2/2017 44Ethics
  • 45. Ethical Rules for Dentists : Prescribed by DCI 1/2/2017 45Ethics
  • 46. Duties and obligations of dentist towards the patient 1.Every dentist should be courteous, sympathetic, friendly and helpful. 2.He should observe punctuality in fulfilling his appointments. 3.He should establish a well merited reputation for professional ability and fidelity. 4. The welfare of patient should be conserved to the utmost of the practitioner’s ability. 5. A dentist should not permit considerations of religion, nationality, race, party politics or social standing to intervene between his duties and his patients. 1/2/2017 46Ethics
  • 47. 6. Information of personal nature which may be learned about or directly from a patient in the course of dental practice should be kept in utmost confidence. It is also obligation of the dentist to see that his auxiliary staff observed this rule. 1/2/2017 47Ethics
  • 48. Duties and Obligations towards Professional Colleagues: 1. Every dentist should cherish a proper pride in his/her colleagues and should not disparage them either by act or word. 2. Mutual arrangements should be made regarding remuneration, when other dentist’s patient is taken care in his sickness/absence.
  • 49. 3. If a dentist is called for providing emergencies, he should retire after it is over (in favor of the regular dentist), but is entitled to charge the patient for his services. 4. If a dentist is consulted by the patient of another dentist and the former finds that the patient is suffering from previous faulty treatment it is his duty to institute correct treatment at once with as little comments as possible and in such a manner as to avoid reflection on his predecessor.
  • 50. DUTIESAND OBLIGATIONS TOWARDS THE PUBLIC : POLICEAND LAW COURTS:  A dentist is not bound to disclose professional secrets unless called upon by the Magistrate or judge to do so.  Knowledge of patient gained in the course of examination and treatment is privileged and should not be disclosed without the consent of the patient or an order from presiding judge in the Court of Law. 1/2/2017 50Ethics
  • 51. Some unethical acts are-  1.Unregistered persons  2. Publicity and Signage  3. Advertising  4. Use of bogus diploma  5. Rebates and Commission  6. Secret Remedies  7. Undercutting the charges
  • 52.  8. Unethical practices  9. Naming and styling of dental establishments  9. Doctor- Patient sexual misconduct  10. Abiding by all laws of the land  15. Relationship with pharmaceutical companies and medical and dental industry
  • 53. ETHICS IN RESEARCH  Researchers bear the responsibility for identifying and propagating truth in matters of science. Much research involves studies with humans and human tissues, as well as with animals, and there are strict rules governing research with both.  As with patient care, the first detailed research codes were developed in the shadow of World War II. The revulsion that followed the disclosure of Nazi experiments brought serious public scrutiny to patients’ rights in research studies and resulted in the 1947 Nuremberg Code.
  • 54.
  • 55. THE NUREMBERG CODE:  The U.S Government believes it has an ethical and legal responsibility to protect the right of citizens who agree to participate in research studies.  The principles underlying the protection of human subjects have their seeds in events following World War II.
  • 56.  In 1947, the Nuremberg Military Tribunal developed a code of standards to use in judging physicians accused of conducting research atrocities in Nazi concentration camps.  Nazi physicians committed human atrocities in the name of medical research.  Received a great deal of attention in trials for World War II criminals.  Resulted from prosecution of 23 German physicians and administration for allowing and performing experience like injecting prisoners with gasoline.
  • 57.  First internationally recognized code  Focus, ethical treatment of humans even in non therapeutic research.  It has become the corner stone for all the guidance, regulations required in human research.
  • 58. Ten Points of Nuremberg Code: 1) Consent must be voluntary  Legal capacity to give consent.  Without element of force.  Sufficient knowledge of nature, duration and purpose.
  • 59. 2) Experiments should yield fruitful results for the good of the society. 3) Design should be based on results of animal experiments and knowledge of natural history of the disease. 4) Avoid all unnecessary physical and mental suffering and injury.
  • 60. 5) No experiment should be conducted where there is prior reason to believe that death or disabling injury will occur. 6) The degree of risk should not exceed as determined by humanitarian principles. 7) Proper preparations should be made and adequate facilities provided to protect the experimental subjects against even remote possibilities of injury, disability or death.
  • 61. 8) The experiment should be conducted only by scientifically qualified persons with the highest degree of skill and care. 9) During the course of the experience the human subject should be given liberty to bring the experiment to an end.
  • 62. 10) During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, that a continuation of the experiment is likely to result in injury, disability or death to the experimental subject.
  • 63. Declaration of Helsinki  In addition to drafting the Declaration of Geneva, which was aimed at patient care, the World Medical Association further refined the subject of the rights of human participants in research through the Declaration of Helsinki in 1964 and its subsequent amendments.  The World Medical Association developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
  • 64.  Adopted by the 18th World Medical Association General Assembly, Helsinki, Finland, June 1964, and amended by the  29th WMA General Assembly, Tokyo, Japan, October 1975  35th WMA General Assembly, Venice, Italy, October 1983  41st WMA General Assembly, Hong Kong, September 1989  48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
  • 65.  and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000  Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002  Note of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004.
  • 66.  In year 2000, the Central Ethics Committee on Human Research (CECHR) of the Indian Council of Medical Research (under the chairmanship of Honourable Justice Shri M.N. Venkatachaliah) put together a set of “Ethical Guidelines for Biomedical Research on Human Subjects”.
  • 67. General statement  Medical and related research using human beings as subjects must necessarily ensure that-  The PURPOSE, of such research is that it should be directed towards the increase of knowledge about the human condition in relation to its social and natural environment, and that such research is for the betterment of all, especially the least advantaged.
  • 68.  Such research is CONDUCTED under conditions that no person or persons become a mere means for the betterment of others and that human beings who are subject to any medical research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well being, under conditions of professional fair treatment and transparency; and after ensuring that the subject is placed at no greater risk other than such risk commensurate with the well being of the subject in question in the light of the object to the achieved.
  • 69.  Such research must be subjected to a regime of EVALUATION at all stages of the proposal.
  • 70. ETHICS VIOLATION IN RESEARCH  Vipeholm Dental Caries Study (1954): The most significant human study does at Vipeholm Hospital, in Sweden reported in 1954 by Gustafsson et al.  436 adult mental patients were placed on controlled diet and observed for 5 years. The subjects were divided into 1 control and 6 experimental groups. Some ate complex and simple carbohydrates at mealtimes' only, while others supplemented meal time food with meal snacks, sweetened with sucrose, chocolate, caramel or toffee.
  • 71.  Among the conclusions drawn from the study, was that sucrose consumption could increase caries activity. The risk increased if the sucrose was consumed in a sticky form that adhered to the tooth's surface. The greatest damage was inflicted by foods between meals. Ethical Issue:  Mentally retarded children  Coercion -No informed consent  Hazards not informed
  • 72. Ethical review procedures  It is mandatory that all proposals on biomedical research involving human subjects should be cleared by an appropriately constituted Institutional Ethics Committee (IEC), also referred to as Institutional Review Board (IRB) in many countries, to safeguard the welfare and the rights of the participants.  The Ethics Committees are entrusted not only with the initial review of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring for the compliance of the ethics of the approved programmes till the same are completed.
  • 73.  Such an ongoing review is in accordance with the Declaration of Helsinki and all the international guidelines for biomedical research. Submission of application  The researcher should submit an appropriate application in a prescribed format along with the study protocol at least three weeks in advance. The protocol should include the following : -
  • 74.  Clear research objectives and rationale for undertaking the investigation in human subjects in the light of existing knowledge.  Recent curriculum vitae of the Investigators indicating qualification and experience.  Subject recruitment procedures.  Inclusion and exclusion criteria for entry of subjects in the study.  Precise description of methodology of the proposed research, including intended dosages of drugs, planned duration of treatment and details of invasive procedures if any.
  • 75.  A description of plans to withdraw or withhold standard therapies in the course of research.  The plans for statistical analysis of the study.  Procedure for seeking and obtaining informed consent with sample of patient information sheet and informed consent forms in English and vernacular languages.  Safety of proposed intervention and any drug or vaccine to be tested, including results of relevant laboratory and animal research.
  • 76.  For research carrying more than minimal risk, an account of plans to provide medical therapy for such risk or injury or toxicity due to overdosage should be included.  Proposed compensation and reimbursement of incidental expenses.  Storage and maintenance of all data collected during the trial.  Plans for publication of results – positive or negative – while maintaining the privacy and confidentiality of the study participants.  A statement on probable ethical issues and steps taken to tackle the same.
  • 77.  All other relevant documents related to the study protocol including regulatory clearances.  Agreement to comply with national and international GCP protocols for clinical trials.  Details of Funding agency / Sponsors and fund allocation for the proposed work.
  • 78. The Consumer ProtectionAct  The Consumer Protection Act (CPA) of 1986 was enacted for better protection of the interests of consumers and to provide simple and quick access to redress consumer grievances. This is done through quasi-judicial mechanisms set up at the District, State, and National levels. Consumers can file their complaints which will be entertained by the quasi-judicial bodies - referred to as Consumer Forums or Commissions.
  • 79.  These Consumer Commissions have been empowered to award compensation to aggrieved consumers for the hardships she/he has endured. A nominal court fee (INR 200) is required to be paid to these Forums and there is no obligation to engage a lawyer to argue the case (the consumer can, her/himself, present the case)
  • 81. When the doctor -patient relationship begins: 1/2/2017 Ethics 81  The legal foundation of the doctor - patient relationship is contract law. At the moment a dentist expresses a professional opinion to an individual who has reason to rely on the opinion, the doctor - patient relationship begins, and the doctor is burdened with implied warranties (duties).
  • 82. 1/2/2017 Ethics 82  Dentist may refuse to treat a patient for any reason except race, creed, colour, or national origin. With the Disabilities Act of 1990, (USA) refusal to accept a patient based upon a person's disability may be in violation of the law.
  • 83. 1/2/2017 Ethics 83  Patients suffering from acquired immunodeficiency syndrome, or who test positive for HIV, fall into the category of disabled persons and may not be refused care, if the refusal is based solely on the presence of AIDS or their HIV +ve status.  The law declares that all health providers' offices are "places of public accommodation" and therefore subject to antidiscrimination laws.
  • 84. 1/2/2017 Ethics 84  As long as the person is not a patient of record, dentist may even refuse to provide emergency care. It may be unethical, but it is not illegal and cannot form the basis of a civil suit.  However just as soon as the dentist expresses a professional judgement, or performs a professional act, the doctor- patient relationship begins, and duties begin to attach.
  • 85. When the doctor- patient relationship ends  Both parties agree to end it  Either the patient or dentist dies  The patient ends it by act or statement  The patient is cured  The dentist unilaterally decides to terminate the care.
  • 86. The major causes that contribute to a decision to terminate treatment before it is complete are 1/2/2017 Ethics 86  The patient has not fulfilled the payment agreement.  The patient has not co-operated in keeping appointments  The patient has not complied with home care instructions.  There has been a breakdown in interpersonal relationships.  Any of these is ample justification for the dentist to terminate treatment. The dentist should not discontinue treatment at a time when the patients health may be compromised.
  • 87. Express terms 1/2/2017 Ethics 87  An 'express term' is one in which both parties are in agreement. Putting the term in writing is not required to make it enforceable, although to prevent misunderstandings a written agreement is always preferred. Usually, the express terms define items such as fee, the treatment, and the manner in with payments are to be made.
  • 88. 1/2/2017 Ethics 88  Express terms may be written in separate form, because the treatment record should contain only treatment notes and patient reactions to treatment. Guarantees made by the dentist constitute an express term in the agreement. "Never guarantee a result". If the patient is not satisfied, the dentist has breached the contract despite the excellent quality of the service.
  • 89. IMPLIED WARRANTIES OWED BYTHE DOCTOR 1/2/2017 Ethics 89 In accepting a patient for care the dentist warrants that he or she will do the following:  Use reasonable care in the provision of services as measured against acceptable standards set by other practitioners with similar training in a similar community.  Be properly licensed and registered and meet all other legal requirements to engage in the practice of dentistry.
  • 90. 1/2/2017 Ethics 90  Obtain informed consent from the patient before instituting an examination or treatment.  Not abandon the patient.  Ensure that care is available in emergency situations.  Charge a reasonable fee for services based on community standards.
  • 91.  Not exceed the scope of practice authorized by the license or permit any person acting under his or her direction to engage in unlawful acts.  Keep the patient informed of her or his progress.  Not undertake any procedure for which the practitioner is not qualified.
  • 92. 1/2/2017 Ethics 92  Complete the care in a timely manner.  Keep accurate records of the treatment rendered to the patient.  Maintain confidentiality of information.  Inform the patient of any untoward occurrences in the course of treatment.  Make appropriate referrals and request necessary consultations.  Comply with all laws regulating the practice of dentistry.  Practice in a manner consistent with the code of ethics of the profession.
  • 93. Implied duties owed by the patient: 1/2/2017 Ethics 93 In accepting care, the patient warrants the following: 1. Home care instructions will be followed.  2. Appointments will be kept 3. Bills for services will be paid in a reasonable time. 4. That the patient will co-operate in the care. 5. That the patient will notify the dentist of a change in health status. 6. If the patient breaches any of these duties, notes to that effect should be made in the patients record.
  • 94.  Torts 1/2/2017 Ethics 94 A tort is a civil wrong or injury, independent of a contract, that results from a breach of a duty. It is of two type: 1. An un-intentional tort is one in which harm was not intended as in the case in tort of negligence 2. An intentional tort contains the element of intended harm.  If the negligence involves an act that is performed in a professional capacity; it is termed professional negligence or malpractice.
  • 95. 1/2/2017 Ethics 95 Professional Negligence  It is defined as a failure to exercise reasonable care in one's professional capacity. Criminal Negligence  For criminal proceedings to be started the negligent action must be very serious and have some accentuating factors  e.g. dentist was drunk or drugged or disregarded well known safety principles.
  • 96. 1/2/2017 Ethics 96 Contributory Negligence  When the actions of a patient have been partially or completely to blame for the damage that occurred  e.g. failure to follow post operative instruction. Vicarious Liability  An employer can be held responsible for any negligence by an employee. A dentist is responsible for the actions or omissions of his staff. A charge of negligence can be brought against both employee and employer.
  • 97. Breach of Confidentiality 1/2/2017 Ethics 97  Information obtained from the patients in thecourse of diagnosis (or) treatment must remain confidential.  The patients dental record is a legal document. It serves many purposes in the judicial process.  It contains information about the patient complaint, health history, and basis for the diagnosis, and it reports all treatment rendered, the patients reaction to treatment, and the result of the treatment. Case law requires that the health practitioners keep accurate records of the diagnosis and treatment of their patients.
  • 98. 1/2/2017 Ethics 98  At one time, doctors had the exclusive right to the possession of the record and its contents.  Today, the doctor is considered the custodian of the record and the patient has a property right in its contents. If the patient demands in writing to be sent a copy to the treatment record or demands that a copy be sent to another practitioner or to any other person or agency.
  • 99. Legal Remedy 1/2/2017 Ethics 99 There are many avenues of legal remedy when negligence occurs.  (i) Criminal liability: IPC section 304A: Grossly rash or grossly negligent act, which is proximate, direct or substantive cause of patient's death.  (ii) Civil liability: Indian Contract Act section 73 & 74.  (iii) Indian Medical/Dental Council Act - 1948.  (iv) Consumer Protection Act 1986.
  • 100. CONCLUSION  The special status that society confers on the dental professionals requires them to behave in an ethical manner.  Principles of beneficence, non-maleficence, respect for autonomy and justice should guide the conduct of the professionals in patient care and research.  Adherence to a code of ethics is important for the continued trust of the society in dental professionals.
  • 101. REFERENCES  Soben Peter: Essentials Of Preventive And Community Dentistry:3rd Edition,2003  George M. Gluck And Warren M. Morganstein:jong’s Community Dental Health:5th Edition,2002.
  • 102.  Acharya A B, Savitha Jk , Nadagouda Sv. Professional Negligence In Dental Practice:potential For Civil And Criminal Liability In India:journal Of Forensic Dental Sciences . January-june 2009 ;Vol 1 (1)  Nuremberg Code- Wikipedia, The Free Encyclopedia. En.Wikipedia.Org/Wiki/Nuremberg_code  Ethical Guidelines For Biomedical Research On Human Subjects. Www.Icmr.Nic.In/Ethical.Pdf