MEDICAL ETHICS AND MEDICAL ETHICS AND LEGAL ISSUESLEGAL ISSUES

Mochamad AnwarMochamad AnwarKomite Etik dan HukumKomite Etik dan Hukum

RS Dr.SarjitoRS Dr.SarjitoYogyakarta.Yogyakarta.

Medical Ethical Medical Ethical ValuesValues

AutonomyAutonomyBeneficenceBeneficenceNon-MaleficenceNon-MaleficenceJusticeJustice

SocialSocialDistributiveDistributive

GENERAL PRINCIPLEGENERAL PRINCIPLE

AutonomyAutonomy : Clinicians are obligated to respect : Clinicians are obligated to respect patients as individuals and to honor their patients as individuals and to honor their preferences in medical care. The patient has the preferences in medical care. The patient has the right to refuse or choose their treatment right to refuse or choose their treatment (Voluntas aegroti suprema lex)(Voluntas aegroti suprema lex)

BeneficenceBeneficence: Physicians have a responsibility to : Physicians have a responsibility to act in the patient’s best interest (“the physician act in the patient’s best interest (“the physician is a fiduciary/is a fiduciary/pengabdi pengabdi ). ).

Patient autonomy may conflict with beneficence.Patient autonomy may conflict with beneficence. A practitioner should act in the best interest of A practitioner should act in the best interest of

the patient the patient (Salus aegroti suprema lex.)(Salus aegroti suprema lex.)

GENERAL PRINCIPLEGENERAL PRINCIPLE

Non-maleficenceNon-maleficence : ”Do no harm”. If the : ”Do no harm”. If the benefits of an intervention outweigh the benefits of an intervention outweigh the risk, however, a patient may make an risk, however, a patient may make an informed decision to consent and proceed. informed decision to consent and proceed. (Primum non nocere)(Primum non nocere)

Paternalism Paternalism (pengayom)(pengayom):: Physicians at Physicians at times make decisions for their patients, or times make decisions for their patients, or act to prevent a patient from carrying out act to prevent a patient from carrying out a decision, on the premise a decision, on the premise (dasar)(dasar) that it is that it is for the patient’s benefit. for the patient’s benefit.

Cont…………Cont…………

JusticeJustice : Concern the distribution of scarce : Concern the distribution of scarce (jarang)(jarang) health resources, and the decision of health resources, and the decision of who gets what treatment (fairness and who gets what treatment (fairness and equality).equality).

DignityDignity (martabat):(martabat): the patient (and the the patient (and the person treating the patient) have the right to person treating the patient) have the right to dignity.dignity.

Truthfulness Truthfulness (sesuai kenyataan)(sesuai kenyataan) and and honestyhonesty (kejujuran):(kejujuran): the concept of informed the concept of informed consent has increased in importance since the consent has increased in importance since the historical events of the Doctor’s Trial of historical events of the Doctor’s Trial of Nuremberg trials and Tuskegee Syphilis Study.Nuremberg trials and Tuskegee Syphilis Study.

EuthanasiaEuthanasia Some American physicians interpret the non-Some American physicians interpret the non-

maleficence principle (do no harm) to maleficence principle (do no harm) to exclude the practice of euthanasia, though exclude the practice of euthanasia, though not all concur not all concur (setuju).(setuju).

In some countries, euthanasia is accepted as In some countries, euthanasia is accepted as standard medical practice. Legal regulations standard medical practice. Legal regulations assign this to the medical profession.assign this to the medical profession.

In such nations, the aim is to alleviate In such nations, the aim is to alleviate (mengurangi)(mengurangi) the suffering of patients from the suffering of patients from diseases known to be incurable by the diseases known to be incurable by the methods known in that culture.methods known in that culture.

In that sense, the In that sense, the “Primum non nocere”“Primum non nocere” is is based on the realization based on the realization

Several medical ethics and Several medical ethics and legal issues :legal issues :

1.1. Informed consentInformed consent

2.2. MinorsMinors

3.3. CompetenceCompetence

4.4. Decision making capasityDecision making capasity

5.5. DisclosureDisclosure

6.6. ConfidentialityConfidentiality

7.7. Conflict of interestConflict of interest

8.8. Development of ethical morals and Development of ethical morals and value. value.

1. INFORMED CONCENT1. INFORMED CONCENT

Defined as willing acceptance Defined as willing acceptance (without coercion) of a medical (without coercion) of a medical intervention by a patient after intervention by a patient after adequate discussion with a physician adequate discussion with a physician about, about, benefitsbenefits, , risksrisks, , potential potential alternativesalternatives (including no treatment), (including no treatment), indicationsindications,, and and the naturethe nature of the of the intervention intervention ( B-R-A-I-N)( B-R-A-I-N)

Patients may change their minds at Patients may change their minds at any time. any time.

Informed consentInformed consent Refers to the idea that a person must be fully-Refers to the idea that a person must be fully-

informed about and understand the potential informed about and understand the potential benefits and risks of their choice of treatment.benefits and risks of their choice of treatment.

An uninformed person is at risk of mistakenly making An uninformed person is at risk of mistakenly making a choice not reflective of his or her values or wishes.a choice not reflective of his or her values or wishes.

Patients can elect to make their own medical Patients can elect to make their own medical decisions, or can delegate decision-making authority decisions, or can delegate decision-making authority to another party.to another party.

If the patient is incapacitated, laws around the world If the patient is incapacitated, laws around the world designate different processes for obtaining informed designate different processes for obtaining informed consent, typically by having a person appointed by consent, typically by having a person appointed by the patient or their next of kin (famili) make decision the patient or their next of kin (famili) make decision for them.for them.

The value of informed consent is closely related to The value of informed consent is closely related to the values of autonomy and truth tellingthe values of autonomy and truth telling

EXCEPTIONEXCEPTION

““Exceptions” to informed consentExceptions” to informed consentEmergenciesEmergencies – if there is no time to get a – if there is no time to get a

person’s consent, but emergency person’s consent, but emergency treatment is required (consent is treatment is required (consent is implied/tidak langsungimplied/tidak langsung). It is unlikely that ). It is unlikely that they would have consented.they would have consented.

Incompetent PatientsIncompetent Patients – since the patient – since the patient cannot consent, one must find out who is cannot consent, one must find out who is authorized to consent on their behalf. For authorized to consent on their behalf. For example patients lack decision-making example patients lack decision-making capacity, consent can be obtained from a capacity, consent can be obtained from a surrogate (wali) decision maker. surrogate (wali) decision maker.

Informed ConsentInformed Consent

A process involving A process involving discussiondiscussion between a between a provider and a patient provider and a patient (BRAIN).(BRAIN).

It is not only the “signing of a consent form.”It is not only the “signing of a consent form.”

Alternatives to the proposed Alternatives to the proposed treatmenttreatmentFore each alternative, discuss its risks Fore each alternative, discuss its risks

and benefitsand benefitsConsequences of “no treatment” should Consequences of “no treatment” should

always be discussedalways be discussed

Informed ConsentInformed Consent

Not just a piece of paperNot just a piece of paper Informed consent is a means of Informed consent is a means of

engaging a patient in important engaging a patient in important health care decisionshealth care decisions

There is therapeutic value to true There is therapeutic value to true informed consentinformed consent

Elements of Informed Elements of Informed Consent Consent

DiagnosisDiagnosisNature Nature (dasar)(dasar) of the proposed of the proposed

treatmenttreatmentPurpose Purpose (tujuan)(tujuan) of the proposed of the proposed

treatmenttreatmentRisks and side effects of the proposed Risks and side effects of the proposed

treatmenttreatmentProbability that the proposed Probability that the proposed

treatment will succeedtreatment will succeed

Diagnosis kerja/Problem aktip/ diagnosa banding

Isi informasi Paraf penerima informasi

1. Dasar diagnosis

2. Tindakan kedokteran

3. Alat kesehatan yang dipasang

4. Insdikasi tindakan

5. Tujuan

6. Tata cara

7. Resiko tindakan

8. Komplikasi tindakan

9. Prognosis

10. Resiko bila tidak dilakukan tindakan

11. Lain-lain

Pemberian informasi Pemberian informasi tindakan kedokterantindakan kedokteran

Nama :Nama : Unit:Unit:

Umur: Ruang: Kelas Umur: Ruang: Kelas ::

Dokter pelaksanan tindakan : 1. 2.

Pemberi informasi : Penerima informasi:

Informed consentInformed consent

Tanda Tanda tangan tangan

(Dokter)(Dokter)

Tanda Tanda tangan tangan (pasien)(pasien)

Lembar 1 (putih) untuk Rumah Lembar 1 (putih) untuk Rumah sakitsakit

Lembar 2 (kuning) untuk pasienLembar 2 (kuning) untuk pasien

Dengan ini menyatakan bahwa saya telah menerima informasi sebagaimana diatas yang memberi paraf di kolom sebelah kanannya dan telah memahami

Dengan ini menyatakan bahwa saya teah menerangkan hal hal diatas secara benar dan jujur dan memberikan kesempatan untuk bertanya dan/atau berdiskusi

2. MINORS2. MINORS In law, a minor is a person under a certain age - the age of In law, a minor is a person under a certain age - the age of

majority- which legally demarcates childhood from majority- which legally demarcates childhood from adulthood; the age depends upon jurisdiction and adulthood; the age depends upon jurisdiction and application, but it is typically 18.application, but it is typically 18.

Refusal treatment :A parent has the right to refuse treatment Refusal treatment :A parent has the right to refuse treatment for his/her child as long as those decisions do not pose for his/her child as long as those decisions do not pose (merupakan(merupakan) a serious threat to the child’s well-being (e.g. ) a serious threat to the child’s well-being (e.g. refusing immunizations is not considered a serious threat).refusing immunizations is not considered a serious threat).

If a decision is not in the best interest of the child, a If a decision is not in the best interest of the child, a physician may seek a court order physician may seek a court order (pertimbangan hukum)(pertimbangan hukum) to to provide treatment against parent wishes. provide treatment against parent wishes.

In emergent situations, if withholding treatment jeopardizes In emergent situations, if withholding treatment jeopardizes (membahayakan)(membahayakan) the child’s safety, treatment can be the child’s safety, treatment can be initiated on the basis of legal precedent initiated on the basis of legal precedent (yang pernah (yang pernah dilakukan).dilakukan).

3. Competence3. Competence CompetenceCompetence : Refer to a person’s legal : Refer to a person’s legal

capacity to make decisions and be held capacity to make decisions and be held accountable in a court of law. accountable in a court of law.

Competent is assessed by the courts and Competent is assessed by the courts and may be used interchangeably may be used interchangeably (tak dapat (tak dapat diganti)diganti) with the term with the term decision-making decision-making capacity.capacity.

Incompetent patients, as assessed by the courts, Incompetent patients, as assessed by the courts, or temporarily incapacitated patients (e.g., or temporarily incapacitated patients (e.g., intoxicated patients with altered mental status) intoxicated patients with altered mental status) cannot decide to accept or refuse treatment.cannot decide to accept or refuse treatment.

4. Decision-making capacity4. Decision-making capacity

Decision-making capacity : Decision-making capacity : a a medical term that refers to the ability medical term that refers to the ability of a patient to understand relevant of a patient to understand relevant information, appreciate information, appreciate (menyadari)(menyadari) the severity of the medical situation the severity of the medical situation and its consequences. and its consequences.

Patients who have decision-making capacity Patients who have decision-making capacity have the right to refuse or discontinue have the right to refuse or discontinue treatment (e.g. Jehovah’s Witnesses can treatment (e.g. Jehovah’s Witnesses can refuse blood products).refuse blood products).

5. Disclosure 5. Disclosure (keterbukaan)(keterbukaan) Patient have a right to know about their Patient have a right to know about their

medical status, prognosis, and treatment medical status, prognosis, and treatment option (full disclosure)option (full disclosure)

A doctor may withhold (tidak memberikan) A doctor may withhold (tidak memberikan) information only if the patient request not to information only if the patient request not to be told or in the rare case when a physician be told or in the rare case when a physician determines (menentukan/berpendapat) that determines (menentukan/berpendapat) that disclosure would severely harm the patient or disclosure would severely harm the patient or undermine (merugikan/ mengurangi manfaat) undermine (merugikan/ mengurangi manfaat) their informed decision-making capacity their informed decision-making capacity (therapeutic privilege)(therapeutic privilege)

Disclosure in Disclosure in Medical errorsMedical errors

Physicians are obligated to inform Physicians are obligated to inform patients of mistakes made in their patients of mistakes made in their medical treatmentmedical treatment

In events where the specific error or In events where the specific error or series is not known, the physician series is not known, the physician should communicate this with the should communicate this with the family promptly and maintain contact family promptly and maintain contact with the patient as investigations with the patient as investigations further reveal facts of the casefurther reveal facts of the case

Disclosure in Clinical researchDisclosure in Clinical research Physicians are obligated to inform patients Physicians are obligated to inform patients

considering involvement in a clinical research considering involvement in a clinical research protocol about the purpose of the research protocol about the purpose of the research study and the entire study design as it will study and the entire study design as it will affect the patient’s treatment. This includes the affect the patient’s treatment. This includes the possible risks, benefits, and alternatives to the possible risks, benefits, and alternatives to the research protocolresearch protocol

An informed consent form approved by the An informed consent form approved by the overseeing research institutional review board overseeing research institutional review board (IRB) should be completed for participation in (IRB) should be completed for participation in any clinical research protocol, describing the any clinical research protocol, describing the possible risks and benefits of involvement in the possible risks and benefits of involvement in the research study research study

The Evolution of Research EthicsThe Evolution of Research Ethics

Ethical review and bio-medical ethics Ethical review and bio-medical ethics evolved evolved (berkembang)(berkembang) in response to a in response to a history of medical abuses history of medical abuses (penyalah (penyalah gunakan)gunakan) Medical abuses by Nazi doctors Medical abuses by Nazi doctors

(Nuremburg Trial and code of 1947)(Nuremburg Trial and code of 1947)Publication of article on medical abuses Publication of article on medical abuses

in the New England Journal of Medicine in the New England Journal of Medicine Public revelation Public revelation (pengungkapan)(pengungkapan) of the of the

Tuskegee syphilis study in 1974Tuskegee syphilis study in 1974

The Evolution of Research GuidelinesThe Evolution of Research Guidelines

The various abuses of the dignity and The various abuses of the dignity and rights of human beings led to the set-rights of human beings led to the set-

up of different commissions to set up of different commissions to set international standards in Research international standards in Research

involving human beingsinvolving human beings

The World Medical Association created The World Medical Association created the Declaration of Helsinki, to guide the Declaration of Helsinki, to guide physicians who become involved in physicians who become involved in

medical research.medical research.

The Nuremberg Code – outlines permissible medical experimentation on

human beings. The first provision (ketetapan) of the code requires that

“the voluntary informed consent of the human subject is absolutely essential.”

The Code also requires that:1. the risks to patients be minimized2. research be conducted by qualified

investigators using appropriate designs3. participants always be free to withdraw

from participation at any time; and4. Any research pursued, have a

favorable risk/benefit ratio

Identification must be made of whom to contact Identification must be made of whom to contact for answers regarding the conduct of the research for answers regarding the conduct of the research and the subject’s rights as well as whom to and the subject’s rights as well as whom to contact in the event of an injurycontact in the event of an injury

An explanation must be given of the subject’s An explanation must be given of the subject’s rights to refuse participation and to withdraw rights to refuse participation and to withdraw from the studyfrom the study

Information for research Information for research protocols when obtaining protocols when obtaining

informed consentsinformed consents

A description must be given of the A description must be given of the confidentiality of research records and data confidentiality of research records and data

An explanation must be given of the An explanation must be given of the availability or unavailability of compensation availability or unavailability of compensation or treatment for injury or treatment for injury

Information regarding currently unforeseeable Information regarding currently unforeseeable (tak (tak terduga)terduga) risks risks

Reasons why an investigator might expel Reasons why an investigator might expel (mengeluarkan)(mengeluarkan) a subject from a study a subject from a study

Identification of additional costs to the subject Identification of additional costs to the subject incurred incurred (yang terjadi)(yang terjadi) as a result of participation in as a result of participation in the study the study

Consequences of the subject’s withdrawal from the Consequences of the subject’s withdrawal from the studystudy

Information about pertinent findingsInformation about pertinent findings Information about the number of subjects Information about the number of subjects

participating in the research participating in the research

6. Confidentiality 6. Confidentiality

Patient’s medical condition are Patient’s medical condition are confidential and cannot be divulged confidential and cannot be divulged (membuka rahasia)(membuka rahasia) without without expressed patient consentexpressed patient consent

A patient may waive A patient may waive (melepaskan (melepaskan hak)hak) the right to confidentiality for a the right to confidentiality for a certain reason (e.g., with insurance certain reason (e.g., with insurance companies)companies)

ConfidentialityConfidentiality It is ethically and legally necessary to It is ethically and legally necessary to

override override (mengesampingkan)(mengesampingkan) confidentiality in the following situations:confidentiality in the following situations:Patient intent to commit a violent crime, Patient intent to commit a violent crime,

physicians have a dutyphysicians have a duty to protect the to protect the intended victim intended victim (korban)(korban) through through reasonable means (e.g., warn the reasonable means (e.g., warn the victim, notify police)victim, notify police)

Suicidal patientsSuicidal patientsChild and elder abuseChild and elder abuse

Infectious diseases (duty to warn public Infectious diseases (duty to warn public officials and identifiable people at risk)officials and identifiable people at risk)

Gunshot and knife wounds (duty to Gunshot and knife wounds (duty to notify the police)notify the police)

Impaired automobile drivers (e.g., the Impaired automobile drivers (e.g., the department of motor vehicles requires department of motor vehicles requires that licensed drivers be seizure free for that licensed drivers be seizure free for at least six months)at least six months)

ConfidentialityConfidentiality

The importance of the patient being able The importance of the patient being able to trust their health care provider to not to trust their health care provider to not reveal reveal (membuka)(membuka) personnel and private personnel and private information without the person’s information without the person’s permissionpermission

Goal: Accurate diagnosis depend on a Goal: Accurate diagnosis depend on a complete historycomplete history

Goal: Society benefits, such as with Goal: Society benefits, such as with reported diseases, by protecting othersreported diseases, by protecting others

Justification of confidentiality Justification of confidentiality breach breach (pelanggaran)(pelanggaran)

A threat A threat (ancaman)(ancaman) to the patient to the patientA threat to other unidentified personsA threat to other unidentified personsA threat to some other specific A threat to some other specific

individualindividualEX: Child abuse and specified EX: Child abuse and specified

contagious diseasescontagious diseasesWhen benefits from the breach When benefits from the breach

outweigh the “wrong” to the patientoutweigh the “wrong” to the patient

7. Conflict of interest7. Conflict of interest

1.1. Referal :Referal : Doctors who receive income from Doctors who receive income from refering patients for medical test have been refering patients for medical test have been shown to refer more patients for medical test.shown to refer more patients for medical test.

2.2. Vendor relationshipsVendor relationships : Doctors can be influenced : Doctors can be influenced by drug company, including gift and food.by drug company, including gift and food.

3.3. Treatment of family membersTreatment of family members : Doctors who do : Doctors who do so must be vigilant (waspada) not to create so must be vigilant (waspada) not to create conflicts of interest or treating in appropriately.conflicts of interest or treating in appropriately.

4.4. Sexual relationshipsSexual relationships : Sexual relationships : Sexual relationships between doctors and patients can create ethical between doctors and patients can create ethical conflicts.conflicts.

Conflicts of interestConflicts of interest

Physicians should not allow a conflict of Physicians should not allow a conflict of interest to influence medical judgment.interest to influence medical judgment.

In some cases, conflicts are hard to avoid, In some cases, conflicts are hard to avoid, and doctors have a responsibility to avoid and doctors have a responsibility to avoid entering such situation.entering such situation.

Unfortunately, research has shown that Unfortunately, research has shown that conflicts of interests are very common conflicts of interests are very common among both academic physicians and among both academic physicians and physicians in practice physicians in practice

Conflicts of interest among Conflicts of interest among pharmacistspharmacists

Most pharmacists who work in retail Most pharmacists who work in retail pharmacies have a serious potential conflict pharmacies have a serious potential conflict of interest. On the one hand, they are of interest. On the one hand, they are professionals, expected to be knowledgeable professionals, expected to be knowledgeable about drugs and to dispense them in a about drugs and to dispense them in a responsible and ethical manner. On the other responsible and ethical manner. On the other hand, their income depends on the sale of hand, their income depends on the sale of products. products.

A physician may own stock (saham) in a A physician may own stock (saham) in a pharmaceutical company (financial interest) pharmaceutical company (financial interest) that produces a drug he is prescribing to his that produces a drug he is prescribing to his patient (patient care interest)patient (patient care interest)

Sexual relationshipsSexual relationships

Sexual relationships between doctors and Sexual relationships between doctors and patients can create ethical conflicts , since sexual patients can create ethical conflicts , since sexual consent may conflict with the fiduciary consent may conflict with the fiduciary (pengabdian) responsibility of the physician.(pengabdian) responsibility of the physician.

Doctors who enter into sexual relationships with Doctors who enter into sexual relationships with patients face the threats of deregistration and patients face the threats of deregistration and prosecution (penuntutan) prosecution (penuntutan)

In the early 1990s, it was estimated that 2-9% of In the early 1990s, it was estimated that 2-9% of doctors have violated this rule.doctors have violated this rule.

Sexual relationships between physician and Sexual relationships between physician and patient’s relatives may also be prohibited in some patient’s relatives may also be prohibited in some jurisdiction, although this prohibition is highly jurisdiction, although this prohibition is highly controversial.controversial.

Issues related to research at Issues related to research at universitiesuniversities

Universities being driven by research Universities being driven by research dollars rather than teaching dollars rather than teaching evaluationsevaluations

Relentless (terburu-buru) time and Relentless (terburu-buru) time and financial constraints to produce data financial constraints to produce data for funding sourcefor funding source

Teaching hospitals often represent a Teaching hospitals often represent a place where vulnerable populations place where vulnerable populations with specific medical conditions are with specific medical conditions are brought together in one locationbrought together in one location

What can we do to improve the What can we do to improve the value system in institutions?value system in institutions?

More effort must be made to integrate More effort must be made to integrate values into the social fabric (struktur) of the values into the social fabric (struktur) of the institution: supportive, compassionate institution: supportive, compassionate (rasa kasihan), thoughtful (tenggang rasa)(rasa kasihan), thoughtful (tenggang rasa)

Greater emphasis on learning and less on Greater emphasis on learning and less on evaluation to decrease cheating and evaluation to decrease cheating and dishonesty.dishonesty.

Engage faculty and students in a series of Engage faculty and students in a series of discussion regarding the ethical foundations discussion regarding the ethical foundations and core values of the professionalismand core values of the professionalism

8. DEVELOPMENT OF ETHICAL 8. DEVELOPMENT OF ETHICAL MORALS AND VALUESMORALS AND VALUES

Good ethics begin with good factsGood ethics begin with good facts Ideally, discussing case studies results in: Ideally, discussing case studies results in:

Some narrowing of disagreements and Some narrowing of disagreements and differencesdifferences

Some knowledge gainedSome knowledge gained It is not always easy to discern It is not always easy to discern

(mendapatkan) the right answer to an (mendapatkan) the right answer to an ethical problem, but it is often easy to ethical problem, but it is often easy to identify a wrong answeridentify a wrong answer Bad facts, failure to consider alternatives, or Bad facts, failure to consider alternatives, or

inconsistent reasoninginconsistent reasoning

ConclusionConclusion

Public health cannot compromise on value Public health cannot compromise on value systemssystems

““Teaching values is particularly difficult Teaching values is particularly difficult when education has become a trade with when education has become a trade with lots of money involved” lots of money involved” (Sheriff and (Sheriff and Manopriya, 2000).Manopriya, 2000).

Students learn a professional value system Students learn a professional value system as it is portrayed by the institution they as it is portrayed by the institution they attend and by the faculty attitudes towards attend and by the faculty attitudes towards each other and towards their profession.each other and towards their profession.

Thank youThank you

Any comments?Any comments?

Medical EthicsMedical Ethics Medical ethicsMedical ethics is the discipline of is the discipline of

evaluating the merits evaluating the merits (kebaikan),(kebaikan), risks, and risks, and social concerns of activities in the field of social concerns of activities in the field of

medicine. medicine. Many methods have been suggested to help Many methods have been suggested to help

evaluate the ethics of a situation. These evaluate the ethics of a situation. These methods tend to introduce methods tend to introduce principlesprinciples that that should be thought about in the process of should be thought about in the process of

making a decision. making a decision.

http://www.wordiq.com/definition/Medical_ethicshttp://www.wordiq.com/definition/Medical_ethics