Information Matters:

Informed Consent,
Truth-telling, and Confidentiality
Nurtjahjo dr.,SpF.,SH
Bioethic Unit
Medical Forensic and Medicolegal
Medical Faculty
Airlangga University
clayton.thomason@ht.msu.edu
http://www.msu.edu/~thomaso5

1 3/30/17
 Informed Consent

2 3/30/17
 INFORMED CONSENT
PERTINDIK
PERSETUJUAN TINDAKAN MEDIK

3 3/30/17
 Why Informed Consent ?

4 3/30/17
 ETIKA PERTINDIK

5 3/30/17
 Pendahuluan
LANDASAN ATURAN
1.Menurut PerMenKes no 290/MenKes/Per/III/2008 dan 2.UU PK no 29 th 2004
Pasal 45 serta
3.Manual Persetujuan Tindakan Kedokteran KKI tahun 2008.

Informed Consent adalah persetujuan tindakan kedokteran yang diberikan oleh

pasien atau keluarga terdekatnya setelah mendapatkan penjelasan secara lengkap
mengenai tindakan kedokteran yang akan dilakukan terhadap pasien tersebut.

Menurut Lampiran SKB IDI No. 319/P/BA./88 dan Permenkes no

585/Men.Kes/Per/IX/1989 tentang Persetujuan Tindakan Medis Pasal 4 ayat 2
menyebutkan dalam memberikan informasi kepada pasien / keluarganya,
kehadiran seorang perawat / paramedik lainnya sebagai saksi adalah penting.

6 3/30/17
 Tujuan IC
A.. Memberikan perlindungan kepada pasien terhadap
tindakan dokter yang sebenarnya tidak diperlukan dan
secara medik tidak ada dasar pembenarannya yang
dilakukan tanpa sepengetahuan pasiennya.

B. Memberi perlindungan hukum kepada dokter terhadap

suatu kegagalan dan bersifat negatif, karena prosedur
medik modern bukan tanpa resiko, dan pada setiap
tindakan medik ada melekat suatu resiko ( Permenkes No.
290/Menkes/Per/III/2008 Pasal 3 )

7 3/30/17
 Hati-hati
Persetujuan yang ditanda tangani oleh pasien atau
keluarga terdekatnya tersebut, tidak membebaskan
dokter dari tuntutan jika dokter melakukan kelalaian.

Tindakan medis yang dilakukan tanpa persetujuan

pasien atau keluarga terdekatnya, dapat
digolongkan sebagai tindakan melakukan
penganiayaan berdasarkan KUHP Pasal 351.

8 3/30/17
 Hati-hati
Tindakan medis yang dilakukan tanpa izin pasien, dapat
digolongkan sebagai tindakan melakukan penganiayaan
berdasarkan KUHP Pasal 351 ( trespass, battery, bodily
assault ).
Menurut Pasal 5 Permenkes No 290 / Menkes / PER / III /
2008, persetujuan tindakan kedokteran dapat dibatalkan
atau ditarik kembali oleh yang memberi persetujuan,
sebelum dimulainya tindakan ( Ayat 1 ). Pembatalan
persetujuan tindakan kedokteran harus dilakukan secara
tertulis oleh yang memberi persetujuan ( Ayat 2 ).

9 3/30/17
 Isi informasi medik meliputi
Wajib diberikan sebelum suatu tindakan kedokteran
dilaksanakan adalah:
1. Diagnosa yang telah ditegakkan.
2. Sifat dan luasnya tindakan yang akan lakukan.
3. Manfaat dan urgensinya dilakukan tindakan.
4. Resiko resiko dan komplikasi yang mungkin terjadi
daripada tindakan kedokteran tersebut.
5. Konsekwensinya bila tidak dilakukan tindakan
tersebut dan adakah alternatif cara pengobatan yang
lain.
6. Kadangkala biaya yang menyangkut tindakan
kedokteran tersebut
10 3/30/17
 Resiko yang harus diinformasikan
a. Resiko yang melekat pada tindakan kedokteran tersebut.
b. Resiko yang tidak bisa diperkirakan sebelumnya.
(unforseeble risk)

Dalam hal terdapat indikasi kemungkinan perluasan

tindakan kedokteran, dokter yang akan melakukan tindakan
juga harus memberikan penjelasan ( Pasal 11 Ayat 1
Permenkes No 290 / Menkes / PER / III / 2008 ).
Penjelasan kemungkinan perluasan tindakan kedokteran
sebagaimana dimaksud dalam Ayat 1 merupakan dasar
daripada persetujuan ( Ayat 2 ).

11 3/30/17
 Perkecualian Pertindik
Pengecualian terhadap keharusan pemberian informasi
sebelum dimintakan persetujuan tindakan kedokteran
adalah:
1. Dalam keadaan gawat darurat ( emergensi ), dimana
dokter harus segera bertindak untuk menyelamatkan
jiwa.
2. Keadaan emosi pasien yang sangat labil sehingga ia
tidak bisa menghadapi situasi dirinya.
Ini tercantum dalam PerMenKes no
290/Menkes/Per/III/2008.

3)

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 HISTORY of INFORMED
CONSENT

13 3/30/17
 Research Done The Wrong Way I
The Tuskeegee Syphilis Study *

Longest non-therapeutic experiment on human beings in medical

history: The progress of untreated syphilis (1932-72).
399 poor African-American sharecroppers in rural Macon County,
Alabama, USA.
The men were told they were being treated for bad blood.
Even after penicillin was discovered and found to be a miracle cure, the
men were not treated or even told what they had.
US government officials went to extreme lengths to insure that they
received no therapy from any source.
Presidential apology, May 1997
* Tuskegee Syphilis Study Legacy Committee Final Report of May 20, 1996

14 3/30/17
Research Done The Wrong Way II
Nazi Prisoner Research During World War II

Objectives of various trials:

Effect of cold, heat, chemicals on men, women and children
Time to death testing in response to stressors in healthy

volunteers
Organ transplant experiments on healthy volunteers

Any information given (some?) is irrelevant because prisoners

were forced to participate
Outcome:
23 German scientists taken to court, 7 acquitted, 9 imprisoned, 7

given death sentence

Nuremberg Code of 1947

15 3/30/17
 Informed Consent in Human Research
The Origins

Before the 20th century, guidelines required

physicians need to adhere to acceptable medical
standards
Issue of patients agreement to the research never
discussed
Most requirements arose after the Nuremberg trials

16 3/30/17
 Exercise:
Examining Informed Consent Document

Reading the document before you:

Would you consent to this treatment, based
on the information documented here?
What else would you want to know?
What conversation might need to take place
before and after this documentation?

17 3/30/17
 Why Care about telling the truth,
informed consent, confidentiality?
Promote patient autonomy
Protect patients (and subjects)
Avoid fraud & duress
Encourage self-scrutiny by medical professionals
Promote rational decisions
Reduce risks to patients & physicians

cf., Capron A. Informed consent in catastrophic disease and treatment.

18 3/30/17 U Penn Law Review 123 (Dec. 1974):364-76.
 Elements of Informed Consent
Information
Disclosure of information
Comprehension of information
Consent
Voluntary consent
Competence to consent

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 Information to Disclose/Discuss
Medical condition, prognosis, and nature
of the test /laboratory or treatment
The proposed intervention
Benefits, risks, and consequences
Alternatives /second opinion
Benefits, risks, and consequences

20 3/30/17
 Legal Standards for Disclosure
Professionals are held to a standard of care,
judged by either:
Professional Standard: a reasonable & prudent
physician of ordinary skill (majority of states)
MI: minimum acceptable standard of care
Reasonable Patient Standard: what a reasonable
patient in similar situation would expect
Individual Patient Standard: what this patient expects
Usually determined by court (case law) relying
on expert testimony

21 3/30/17
 Barriers to Patient
Comprehension
Problems recalling information
Problems evaluating evidence,
probabilities
Failure to define jargon, technical
language
Reliance on Consent Forms alone

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 Voluntariness
Respects patient autonomy
Avoids
Fraud
Coercion
Manipulation
May still persuade patients
May enhance autonomy by promoting understanding
May dissuade from decisions against their best
interests

23 3/30/17
 Competence or Capacity?
Competence
Legal construct
Adjudicated by courts
Based on clinical assessment
Decision-Making Capacity
Clinical construct
Assessed by physicians

24 3/30/17
 Competent to do What?
Global Competence?
Overall ability to function in life
Medical diagnosis, general mental functioning,
appearance
Competence with regard to particular task
Competence to give informed consent
Consider prognosis, nature of Tx, alternatives,
risks and benefits, probable consequences

25 3/30/17
 Decision-Making Capacity
Capacity to make specific decisions about
Medical Care
Standard: Patient should have the ability to give
informed consent (or refusal) to the proposed
test or treatment
Balance Protecting patient from harm with
Respect for Autonomy
Sliding scale: depending on risk of harm

26 3/30/17
 Exceptions to Informed Consent
Lack of Decision-making Capacity
Emergencies: implied consent
UGD:unconsious Px,idiot.dumb
Therapeutic Privilege
When disclosure would severely harm patient
Waiver

27 3/30/17
 Summary - Informed consent:
Process?

28 3/30/17
 Summary - Informed consent:
Process?

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 Summary - Informed consent:
Process?
i.e., shared decision-making

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 Summary - Informed consent:

or Product?

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 Summary - Informed consent:

or Product?
i.e., signed consent form

32 3/30/17
 Summary - Informed consent:

or Product?
i.e., signed consent form

33 3/30/17
 Promoting a Shared Decision-
Making Process
Encourage patient to play active role in decision-
making
Elicit patients perspective about the illness
Interpret alternatives in light of patients goals
Ensure that patients are informed
Provide comprehensible information
Try to frame issues without bias
Check that patients have understood information
Protect the patients best interests
Make a recommendation
Try to persuade patients (avoiding coercion)

Lo B. Resolving Ethical Dilemmas: A Guide for Clinicians, 2d ed. 2000.

34 3/30/17 Baltimore: Lippincott Williams & Wilkins. 26.
 Truth-telling and
Nondisclosure of Errors

35 3/30/17
 Why tell the truth?
Reasons For
Disclosure
Lying is wrong
Px want to know Reasons Against
Px need information disclosure
More good than harm Prevent harm to Px
Deception requires Not culturally
further deception appropriate
Deception may be
impossible
When Px dont want to
be told

36 3/30/17
 Approaches to Disclosing Error in
Practice . . .
Report/Resolve conflicts as close to the bedside
as possible.
Keep accurate, contemporaneous records of all
clinical activities.
Notify insurer and seek assistance from others who
can help (e.g., risk manager).
Take the lead in disclosure; dont wait for patient to
ask.
Outline a plan of care to rectify the harm and prevent
recurrence.
Offer to get prompt second opinions where
appropriate.
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 Confidentiality

-----------------?

38 3/30/17
 The Duty to Maintain
Confidentiality
What I may see or hear in the course of the
treatment . . . which on no account one must spread
abroad, I will keep to myself, holding such things
shameful to be spoken about.
Hippocratic Oath
A physician may not reveal the confidences entrusted to
him in the course of medical attendance,or the
deficiencies he may observe in the character of his
patients, unless
he is required to do so by law
or unless it becomes necessary in order to protect the welfare of
the individual or the community.
American Medical Association, Code of Ethics, Section 9.

39 3/30/17
 Reasons for Maintaining
Confidentiality
Respects patient privacy
Encourages patients to seek medical care
Fosters trust in the doctor-patient
relationship
Prevents discrimination based on illness
Expected by patients

Lo B. Resolving Ethical Dilemmas: A Guide for Clinicians, 1995.

40 3/30/17 Baltimore: Williams & Wilkins. 45.
 Records, Confidentiality, &
Privilege
Records & Record Keeping
Duty of Confidentiality
Consent for release of information
Written
Valid
Specific
Time-limited
Right to revoke

41 3/30/17
 Records, Confidentiality, &
Privilege II
Patient access to medical records
Privileged Communication
Only in legal proceedings
Dr./Pt. communications in course of treatment
Privilege belongs to Patient
If not asserted by pt. = waived
Health Insurance Portability and Accountability
Act
Consent v. Authorization

42 3/30/17
 Confidentiality Exceptions
Disclosure mandated by statute /act
e.g., adult or child abuse
Disclosures necessary to prevent harm
to self
to others
duty to inform victims/other reasonable steps to
avert foreseeable harm if pt. threatens to harm or
kill (Tarasoff)

43 3/30/17
 Situations in which Overriding
Confidentiality is Warranted
The potential harm to 3rd parties is serious
The likelihood of harm is high
No less-invasive alternative means exist
to warn or protect those at risk
Third party can take steps to prevent harm
Harms resulting from the breach of
confidentiality are minimized and
acceptable
Lo B. Resolving Ethical Dilemmas: A Guide for
44 3/30/17 Clinicians, 1995. Baltimore: Williams & Wilkins. 48.
 Focus is on Informed Consent:

Three major elements:

1.The type of information needed by the
participant
Amount and type of information
About the study (nature, duration purpose,
methods, how data collected will be used, etc)
Potential risks and benefits
Any compensation
Follow up
other
45 3/30/17
 Continued informed consent

2. The degree of understanding required

of the subject in order to give consent:
Informed in own language
Level of reading and understanding
Common vocabulary; lay terminology
Cultural considerations
Balanced explanation without bias for consent
No coercion

46 3/30/17
 Continued Informed Consent
3. Participant has a free choice in giving
consent:
No coercion
Compensation should be mentioned after the fact
(subject not compelled to consent for reward)
Subject told he/she can withdraw at any time before or
during the study without jeopardy
Write out want you want the subject to know as an
information sheet give this to subject
Proxy consent with children or mentally challenged
warrants additional attention
Without full and clear informed consent, research is
subject to criticism
47 3/30/17
 Summary
You can respect patients & build trust by:
Treating Shared Decision-making as a
process
Disclosing information appropriately and
thoughtfully
Has more beneficial than harmful consequences
Avoiding defensive practice

Maintaining confidences and protecting

privacy to the greatest extent possible

48 3/30/17
 Case study
Mrs Y 93 years old, widow, get status asthmaticus ,pre
operation mamary cancer 3 rd stage have been
diagnosed three month ago , came to Hospital
Emergency room. She came with the only one child Mr
X 35 years .He need hospitalized his mother to
day,and also prepare mamary operation after.General
condition woman:thinny ,difficult breathing ,thinny
breathing,thinny,weakness. T 130/80 P 84/m R 50/m
dyspnoe .Consious,can talk by herself Tumor in left
mamary 5 cm,mobile ,no spontan pain , negative
spreading area.
How the doctor make decision to the family with no
harm. Please , as a good doctor give information to the
family and the patient.
49 3/30/17
 ETIKA PERTINDIK

50 3/30/17
 Pendahuluan
LANDASAN ATURAN
1.Menurut PerMenKes no 290/MenKes/Per/III/2008 dan 2.UU no 29 th 2004 Pasal
45 serta
3.Manual Persetujuan Tindakan Kedokteran KKI tahun 2008.

Informed Consent adalah persetujuan tindakan kedokteran yang diberikan oleh

pasien atau keluarga terdekatnya setelah mendapatkan penjelasan secara lengkap
mengenai tindakan kedokteran yang akan dilakukan terhadap pasien tersebut.

Menurut Lampiran SKB IDI No. 319/P/BA./88 dan Permenkes no

585/Men.Kes/Per/IX/1989 tentang Persetujuan Tindakan Medis Pasal 4 ayat 2
menyebutkan dalam memberikan informasi kepada pasien / keluarganya,
kehadiran seorang perawat / paramedik lainnya sebagai saksi adalah penting.

51 3/30/17
 Tujuan IC
A.. Memberikan perlindungan kepada pasien terhadap
tindakan dokter yang sebenarnya tidak diperlukan dan
secara medik tidak ada dasar pembenarannya yang
dilakukan tanpa sepengetahuan pasiennya.

B. Memberi perlindungan hukum kepada dokter terhadap

suatu kegagalan dan bersifat negatif, karena prosedur
medik modern bukan tanpa resiko, dan pada setiap
tindakan medik ada melekat suatu resiko ( Permenkes No.
290/Menkes/Per/III/2008 Pasal 3 )

52 3/30/17
 Hati-hati
Persetujuan yang ditanda tangani oleh pasien atau
keluarga terdekatnya tersebut, tidak membebaskan
dokter dari tuntutan jika dokter melakukan kelalaian.

Tindakan medis yang dilakukan tanpa persetujuan

pasien atau keluarga terdekatnya, dapat
digolongkan sebagai tindakan melakukan
penganiayaan berdasarkan KUHP Pasal 351.

53 3/30/17
 Hati-hati
Tindakan medis yang dilakukan tanpa izin pasien, dapat
digolongkan sebagai tindakan melakukan penganiayaan
berdasarkan KUHP Pasal 351 ( trespass, battery, bodily
assault ).
Menurut Pasal 5 Permenkes No 290 / Menkes / PER / III /
2008, persetujuan tindakan kedokteran dapat dibatalkan
atau ditarik kembali oleh yang memberi persetujuan,
sebelum dimulainya tindakan ( Ayat 1 ). Pembatalan
persetujuan tindakan kedokteran harus dilakukan secara
tertulis oleh yang memberi persetujuan ( Ayat 2 ).

54 3/30/17
 Isi informasi medik meliputi
Wajib diberikan sebelum suatu tindakan kedokteran
dilaksanakan adalah:
1. Diagnosa yang telah ditegakkan.
2. Sifat dan luasnya tindakan yang akan lakukan.
3. Manfaat dan urgensinya dilakukan tindakan.
4. Resiko resiko dan komplikasi yang mungkin terjadi
daripada tindakan kedokteran tersebut.
5. Konsekwensinya bila tidak dilakukan tindakan
tersebut dan adakah alternatif cara pengobatan yang
lain.
6. Kadangkala biaya yang menyangkut tindakan
kedokteran tersebut
55 3/30/17
 Resiko yang harus diinformasikan
a. Resiko yang melekat pada tindakan kedokteran tersebut.
b. Resiko yang tidak bisa diperkirakan sebelumnya.
(unforseeble risk)

Dalam hal terdapat indikasi kemungkinan perluasan

tindakan kedokteran, dokter yang akan melakukan tindakan
juga harus memberikan penjelasan ( Pasal 11 Ayat 1
Permenkes No 290 / Menkes / PER / III / 2008 ).
Penjelasan kemungkinan perluasan tindakan kedokteran
sebagaimana dimaksud dalam Ayat 1 merupakan dasar
daripada persetujuan ( Ayat 2 ).

56 3/30/17
 Perkecualian Pertindik
Pengecualian terhadap keharusan pemberian informasi sebelum dimintakan
persetujuan tindakan kedokteran adalah:
1. Dalam keadaan gawat darurat ( emergensi ), dimana dokter harus segera
bertindak untuk menyelamatkan jiwa.
2. Keadaan emosi pasien yang sangat labil sehingga ia tidak bisa menghadapi
situasi dirinya.
Ini tercantum dalam PerMenKes no 290/Menkes/Per/III/2008.

Tujuan Informed Consent:

a. Memberikan perlindungan kepada pasien terhadap tindakan dokter yang
sebenarnya tidak diperlukan dan secara medik tidak ada dasar pembenarannya
yang dilakukan tanpa sepengetahuan pasiennya.
b. Memberi perlindungan hukum kepada dokter terhadap suatu kegagalan dan
bersifat negatif, karena prosedur medik modern bukan tanpa resiko, dan pada setiap
tindakan medik ada melekat suatu resiko ( Permenkes No. 290/Menkes/Per/III/2008
Pasal 3 )

57 3/30/17
 Thank you
4U
attention
58 3/30/17