INFORMED

CONSENT

Prof. Moch. Istiadjid E.S.

Dr. dr. SpS. SpBS. Mhum.
 Definition
Informed Consent consist of words
informed, means already got information
and consent, means approval (permission).
So, Informed Consent in medical profession
is a declaration of approval (consent) or
permission from patient which given freely,
rationaly, without coercion (voluntary)
about medical procedures which will be
done to him/her after getting enough
information (well informed) about intended
medical procedures.
 INFORMED CONSENT
An approval given by someone
competent after receiving and
understanding doctor’s explanation
(in profession context), and make
decision without coercion or over
influenced, persuaded, or intimidated.
Written made and strengthen by at
least two witnesses.
 Informed consent
Informed consent is a legal condition whereby a
person can be said to have given consent based upon
an appreciation and understanding of the facts and
implications of an action. The individual needs to be in
possession of relevant facts and also of his or her
reasoning faculties, such as not being
mentally retarded or mentally ill and without an
impairment of judgment at the time of consenting.
Such impairments might include illness, intoxication,
insufficient sleep, and other health problems.
 BASIC OF INFORMED
CONSENT
1. Confidence relationship between
doctor and patient
2. Autonomics right or decide over
patient’s body themself
3. There is an agreement relationship
between doctor and patient.
• The Implementation of Informed Consent
considered TRUTHFULL if :
1. Approval or disapproval of medical act given for
specific medical procedures (the consent must be
for what will be actually performed)
2. Approval or disapproval of medical procedures
given without coercion (voluntary).
3. Approval or disapproval of medical procedures
given by someone (patient) who mentally healthy
and have the right to give it in the law term.
4. Approval or disapproval of medical procedures
given after informed and explained properly
(adequate).
• United Nations Declarations of Human Rights,
1948: “Every human being have a right to be
appreciated, recognized, and respected as a
human and being regarded humanly,
appropriate with their dignity as God’s Creature”
• B. Cardozo (1914): “Every human being of adult
years and sound mind has a right to determine
what shall be done with his own body; and a
surgeon who perform an operation without his
patient’s consent commits an assault, for wich
he is liable in damages”
 INFORMATION

1. Diagnosis
2. Medical procedure
3. Technical procedure
4. Risks and complications
5. Alternatives if available
6. Risks of such alternatives
7. Consequencies if the procedure is not performed

Who has to sign?

In the emergengy situation?
Contents of Information and
Explanation
Information and explanation considered enough if
at least six basic things below delivered in that
explanation, which are :
1. Information and explanation about the diagnosis of
disease suffered by the patient.
2. Information and explanation about purpose and
success prospect of medical procedures which will be
done. (purpose of medical procedures).
3. Information and explanation about the order of
medical procedures which will be done. (contemplated
medical prosedures).
4. Information and explanation about risk (risk inherent
in such medical prosedures) and possible
complication.
5. Information and explanation about another
alternative medical procedures and its own risks.
(alternative medical procedures and risks),
6 Information and explanation about disease prognosis
if that medical procedures done or not. (prognosis
with and without such medical procedure).
Person who have duty of giving
Information and Explanation
About Medical Procedures Approval said:
( 1 ) In surgery procedure (operation) or the other invasive
procedures, information must be given by by the doctor who will
do that surgery himself,
( 2 ) In a special condition where the doctor is not exist as said in
Subsection (1), information must be given by another doctor
with acknowledgement or instruction from the responsible
doctor.
(3) In the other non-surgery and non-invasive procedures,
information can be given by another doctor or nurse with
acknowledgement or instruction from the responsible doctor.
Note:
Invasive Procedure is a medical procedure which can influence
whole body’s tissue immediately.
 Methods in giving Information and
Explanation
In Section 4 and 5 Regulation from Indonesian Minister of
Health about Medical Procedures Approval said that :
Section 4:
(1) Information about medical procedures must be given to
the patient, whether it requested or not.
(2) Doctor must give the information completely, unless if
the doctor appraise that the information can harm the
patient healthiness or the patient refuse to be given the
information.
(3) In term concerned at Subsection (2), doctor with patient
approval can give information to closest family
accompanied by nurse as the witness.
Section 5:
(1) The given information include benefits and
disadvantages of the medical procedures which will be
done, in diagnostic or terapeutic.
(2) Information is given verbally.
(3) Information must be given honestly and truthfully unless
if the doctor appraise that the information can harm the
patient healthiness.
(4) In terms concerned at Subsection (3), doctor with
patient approval can give information to patient closest
family.
 THE WAY FOR INFORMED CONSENT
IS EASY TO UNDERSTOOD

1. Use clear and simple language

2. If necessary, use patient’s daily language
3. Use short sentences
4. Avoid the use of technical term
5. Don’t force or minimize risk
6. Don’t piled benefit
7. Answer all patient’s questions honestly
 Procedures of INFORMED CONSENT
1. Information must be given with good intention, honest, and not
frighten, give pressure or coercion. KUH-Perdata Ps.1321 : “An
approval doesn’t have Law value if given because of mistake,
violence threat, or trickery”.
2. Information must be given by the doctor himself, can’t be
represented to nurse because nurse doesn’t have authority, so if
that happen, it can endanger the doctor himself.
3. Information must be given to the patient, whether it requested
or not, unless the patient refuse to be given the explanation. In
that condition, information can be given to closest family.
4. Doctor can’t delay information to the patient, unless he has
opinion it will worsening the patient’s condition.
Person who have the right to give Medical
Approval
a. The patient himself, if the patient is 21 years old or have been
married.
b. For the patient under 21 years old, approval (Informed
Consent) or disapproval of Medical Procedures given by them
according to the rights as follows:
(1) Biological parents.
(2) Siblings.
c. For the patient under 21 yeas old and have no parents or their
parents can’t be present, Approval (Informed Consent) or
disapproval of Medical Procedures given by them according
to the rights as follows:
(1) Adopted Parents.
(2) Siblings.
(3) Close Family.
d. For an adult patient with mental disorder, Approval (Informed
Consent) or Disapproval of Medical Procedures given by
them according to the rights as follows :
( 1 ) Biological Parents.
( 2 ) Legal guardian.
( 3 ) Siblings.
e. For an adult patient whom under amnesty (curatelle),
Approval or Disapproval of Medical Procedures given by them
according to the rights as follows :
(1) Guardian.
(2) Curator.
f. For a married adult patient/parent, Approval or Disapproval of
Medical Procedures given by them according to the rights as
follows :
(1). Husband/Wife.
(2). Biological parents.
(3). Biological children.
(4). Siblings.
 Methods in giving Medical Procedures
Approval
Patient can give their approval through:
1. (express) or
2. (implied).
An express approval absolutely needed in high risk medical
procedures (for example, an operation with and/or with
anesthetic), while an implied approval needed in non high
risk medical procedures (for example, infus attachment),
with certainties as follows :
• Known and signed by two witnesses. nurse can be the
one, and another one from patient’s side;
• Meterai (stamp) is not required;
• Original form must be saved in patient medical record file
;
• Form must be filled and signed 24 hours before meducal
procedures done.
• Doctor must sign as a prove that information and
explanation had bee given properly.
• As the replacement of sign, patient or his/her family who
have illiteracy must put stamp of their right thumb.
 THE PURPOSE OF INFORMED
CONSENT
1. To protect patients toward every medical procedures
done without their knowledge.
For example, unnecessary and groundless medical
procedures, misapplication of sophisticated tools which
need a high cost. In other side, that procedure can give
protection to the doctor if appear an accusation. He/she
considered careless if not doing certain check, so causing
adverse outcome
2. To give law protection to the doctor towards an
expected and negative result.
For example, to “risk of treatment” which can’t be
avoided, although the doctor have tried as best as he can
and work carefully and accurately.
3. To protect the doctor from Error of
Judgement

- Doctor is a human being after all, who can’t avoid

mistakes. Standing diagnosis and given therapy can
be wrong, but in certain limits (as long as he works
according to lege artis), the doctor can’t be accused
wrong.

- It’s a different case, if the doctor done a big

mistake because of negligence which won’t be done
by the other doctors. That can be happen because of
ignorance to medical science which rapidly
developed, and already be a medical standard. If that
happen, he can be accused wrong.
Law Sanctions
1. Criminal Sanction (Kitab Undang-Undang Hukum
Pidana): according to Section 351 (standard
mistreatment), a doctor can be given sanction, as
Section 352 (light mistreatment), Section 353 (planned
mistreatment), Section 354 (serious mistreatment),
Section 355 (planned serious mistreatment), Section
360 (negligent that caused injury), Section 361
(negligent that caused death),
2. Civil Sanction: paying for the disadvantages according
to Section 1365, 1366, 1367, 1370 or Section 1371 of
Kitab Undang- Undang Hukum Perdata.
3. Administrative Sanction: as a warning until the
dispossession of practical permission.
 Competency

The ability to give informed consent will be governed by

a general requirement of competency. In common law
jurisdictions, adults are presumed competent to consent.
This presumption can be rebutted, for instance, in
circumstances of mental illness or other incompetence.
This may be prescribed in legislation or based on a
common-law standard of inability to understand the
nature of the procedure. In cases of incompetent adults,
informed consent--from the patients or from their
families--is not required. Rather, the medical practitioner
must simply act in the patient's best interests in order to
avoid negligence liability.
 Indonesian Doctor’s Competence
Standard
(Konsil Kedokteran Indonesia, 2007)

Competency areas:
1. Effective communication
2. Clinical Skill
3. Scientific based medical sciences
4. Health problem management
5. Information management
6. Self evaluation and development
7. Ethics, Moral, Medicolegal,
Proffesionalism and Patients safety
 A medical procedures is
compatible with the law, if:
1. The Physician is Competent
2. There is a medical indication to reach concrete
aim.

3. Done according to valid rule in Medical science.

( standard medical practice and standard
operating procedure)
4. Get patient’s approval first.
( Informed Consent )
 SERIOUS EMERGENCY
“An unconscious patient who doesn’t accompanied by
closest family, under serious emergency condition and
need medical procedure soon for his/her sake, doesn’t
need approval from anybody”
That, to saving the life or limb of the patient and there is
no time to wait or call his/her family, that doctor is given
authority to do operation soon and immediately
Even, if the patient doesn’t given a help and/or medical
procedures, that doctor can be accused because of
negligence or abandonment, if it caused death.
MEDICAL RECORD
 MEDICAL RECORDS

• Rapid development of science and technology give

impact to doctor and patient relationship, which was
paternalistic, and now impersonal (autonomy)
• Patients have the heart to accuse their doctor because
there is a presumption that that doctor have made
negligence
• Permenkes No. 749a/1989 : The Implementation of
Medical Records with making notes is a necessity,
already be law liability
 MEDICAL RECORD

• A medical record, health record, or medical chart is a

systematic documentation of a patient's medical history
and care. The term 'Medical record' is used both for the
physical folder for each individual patient and for the
body of information which comprises the total of each
patient's health history. Medical records are intensely
personal documents and there are many ethical and
legal issues surrounding them such as the degree of
third-party access and appropriate storage and disposal.
Although medical records are traditionally compiled and
stored by health care providers, personal health records
maintained by individual patients have become more
popular in recent years.
 THE BENEFITS OF MEDICAL
RECORDS
• Medical records is the only one note which can
give detail information about what happened and
done during the patient is hospitalized
• A good medical records will make doctor and
hospital possible to reconstruct the service given
to the patient and also give an image to be
appraised whether the treatment and therapy given
in that situation can be accepted or not
• Medical records must be filled immediately when
medical procedures done and the doctor gives
instruction, or by the nurse when observation
done, or the other medical staffs. If it doesn’t
obeyed, it can be accuse for negligence
 Purpose
• The information contained in the medical record allows
health care providers to provide continuity of care to
individual patients. The medical record also serves as a
basis for planning patient care, documenting communication
between the health care provider and any other health
professional contributing to the patient's care, assisting in
protecting the legal interest of the patient and the health
care providers responsible for the patient's care, and
documenting the care and services provided to the patient.
In addition, the medical record may serve as a document to
educate medical students/resident physicians, to provide
data for internal hospital auditing and quality assurance, and
to provide data for medical research.
Personal health records combine many of the above
features with portability, thus allowing a patient to share
medical records across providers and health care systems.
 Format

• Traditionally, medical records have been written

on paper and kept in folders. These folders are
typically divided into useful sections, with new
information added to each section
chronologically as the patient experiences new
medical issues. Active records are usually
housed at the clinical site, but older records
(e.g., those of the deceased) are often kept in
separate facilities.
• The advent of electronic medical records has not
only changed the format of medical records but
has increased accessibility of files.
 Contents
• Although the specific content of the medical record may
vary depending upon specialty and location, it usually
contains the patient's identification information, the
patient's health history (what the patient tells the health-
care providers about his or her past and present health
status), and the patient's medical examination findings
(what the health-care providers observe when the patient
is examined). Other information may include lab test
results; medications prescribed; referrals ordered to
health-care providers; educational materials provided;
and what plans there are for further care, including
patient instruction for self-care and return visits. In some
places, billing information is considered to be part of the
medical record.
 Demographics

• Demographics include patient information that is

not medical in nature. It is often information to
locate the patient, including identifying numbers,
addresses, and contact numbers. It may contain
information about race and religion as well as
workplace and type of occupational information.
It may also contain information regarding the
patient's health insurance. It is common to also
find emergency contacts located in this section
of the medical chart.
 Medical history
• The medical history is a longitudinal record
of what has happened to the patient since
birth. It chronicles diseases, major and
minor illnesses, as well as
growth landmarks. It gives the clinician a
feel for what has happened before to the
patient. As a result, it may often give clues
to current disease states. It includes
several subsets detailed below.
• Surgical history
The surgical history is a chronicle of surgery
performed for the patient. It may have dates of
operations, operative reports, and/or the detailed
narrative of what the surgeon did.
• Obstetric history
The obstetric history lists prior pregnancies and
their outcomes. It also includes any
complications of these pregnancies.
• Medications and medical allergies
The medical record may contain a summary of
the patient's current and previous medications
as well as any medical allergies.
• Family history
The family history lists the health status of
immediate family members as well as their
causes of death (if known). It may also list
diseases common in the family or found only in
one sex or the other. It may also include a
pedigree chart. It is a valuable asset in
predicting some outcomes for the patient.
• Social history
The social history is a chronicle of human
interactions. It tells of the relationships of the
patient, his/her careers and trainings, schooling
and religious training. It is helpful for the
physician to know what sorts of community
support the patient might expect during a major
illness. It may explain the behavior of the patient
in relation to illness or loss. It may also give clues
as to the cause of an illness (i.e., occupational
exposure to asbestos).
• Habits
Various habits which impact health, such as
tobacco use, alcohol intake, recreational drug
use, exercise, and diet are chronicled, often as
part of the social history. This section may also
include more intimate details such as sexual
habits and sexual preferences.
• Immunization history
The history of vaccination is included. Any blood
tests proving immunity will also be included in
this section.
• Growth chart and developmental history
For children and teenagers, charts documenting
growth as it compares to other children of the
same age is included, so that health-care
providers can follow the child's growth over time.
Many diseases and social stresses can affect
growth and longitudinal charting and can thus
provide a clue to underlying illness. Additionally,
a child's behavior (such as timing of talking,
walking, etc.) as it compares to other children of
the same age is documented within the medical
record for much the same reasons as growth.
• Medical encounters
Within the medical record, individual medical encounters
are marked by discrete summations of a patient's
medical history by a physician, nurse practitioner, or
physician assistant and can take several forms. Hospital
admission documentation (i.e., when a patient requires
hospitalization) or consultation by a specialist often take
an exhaustive form, detailing the entirety of prior health
and health care. Routine visits by a provider familiar to
the patient, however, may take a shorter form such as
the problem-oriented medical record (POMR), which
includes a problem list of diagnoses or a "SOAP" method
of documentation for each visit. Each encounter will
generally contain the aspects below:
• Chief complaint
This is the problem that has brought the
patient to see the doctor. Information on
the nature and duration of the problem will
be explored.
• History of the present illness
A detailed exploration of the symptoms the
patient is experiencing that have caused
the patient to seek medical attention.
• Physical examination
The physical examination is the recording of
observations of the patient. This includes the
vital signs and examination of the different organ
systems, especially ones that might directly be
responsible for the symptoms the patient is
experiencing.
• Assessment and plan
The assessment is a written summation of what
are the most likely causes of the patient's current
set of symptoms. The plan documents the
expected course of action to address the
symptoms (diagnosis, treatment, etc.).
 Orders

• Written orders by medical providers are

included in the medical record. These
detail the instructions given to other
members of the health care team by the
primary providers.
 Progress notes

• When a patient is hospitalized, daily updates are

entered into the medical record documenting
clinical changes, new information, etc. These
often take the form of a SOAP note and are
entered by all members of the health-care team
(doctors, nurses, dietitians, clinical pharmacists,
respiratory therapists, etc). They are kept in
chronological order and document the sequence
of events leading to the current state of health.
• Test results
The results of testing, such as blood tests
(e.g., complete blood count) radiology
examinations (e.g., X-rays), pathology
(e.g., biopsy results), or specialized testing
(e.g., pulmonary function testing) are
included. Often, as in the case of X-rays, a
written report of the findings is included in
lieu of the actual film.
• Other information
Many other items are variably kept within the
medical record. Digital images of the patient,
flowsheets from operations/intensive care units,
informed consent forms, EKG tracings, outputs
from medical devices (such as pacemakers),
chemotherapy protocols, and numerous other
important pieces of information form part of the
record depending on the patient and his or her
set of illnesses/treatments.
• Administrative issues
Medical records are legal documents and
are subject to the laws of the country/state
in which they are produced. As such, there
is great variability in rule governing
production, ownership, accessibility, and
destruction.
• Production
In the United States, written records must
be marked with the date and time and
scribed with indelible pens without use of
corrective paper. Errors in the record
should be struck out with a single line and
initialed by the author. Orders and notes
must be signed by the author. Electronic
versions require an electronic signature.
• Ownership
The data contained within the medical record
belongs to the patient, whereas the physical
form the data takes belongs to the entity
responsible for maintaining the record.
Therefore, patients have the right to ensure that
the information contained in their record is
accurate. Patients can petition their health care
provider to remedy factually incorrect information
in their records.
Accessibility

The most basic rules governing access to a medical record

dictate that only the patient and the health-care providers
directly involved in delivering care have the right to view
the record. The patient, however, may grant consent for
any person or entity to evaluate the record.
Capacity
When a patient does not have capacity (is not
legally able) to make decisions regarding his or
her own care, a legal guardian is designated
(either through next of kin or by action of a court
of law if no kin exists). Legal guardians have the
ability to access the medical record in order to
make medical decisions on the patient’s behalf.
Those without capacity include the comatose,
minors (unless emancipated), and patients with
incapacitating psychiatric illness or intoxication.
• Medical emergency
• In the event of a medical emergency involving a
non-communicative patient, consent to access
medical records is assumed unless written
documentation has been previously drafted
(such as an advance directive)
• Research, auditing, and evaluation
• Individuals involved in medical research,
financial or management audits, or program
evaluation have access to the medical record.
They are not allowed access to any identifying
information, however.
Risk of death or harm
• Information within the record can be shared with
authorities without permission when failure to do
so would result in death or harm, either to the
patient or to others. Information cannot be used,
however, to initiate or substantiate a charge
unless the previous criteria are met (i.e.,
information from illicit drug testing cannot be
used to bring charges of possession against a
patient).
 In some country include Indonesia, by their
regulations gave patients or their representatives
the right to a copy of their record, except where
information breaches confidentiality (e.g.,
information from another family member or where
a patient has asked for information not to be
disclosed to third parties) or would be harmful to
the patient's wellbeing (e.g., some psychiatric
assessments). Also, the legislation gives patients
the right to check for any errors in their record
and insist that amendments be made if required.
 Destruction

In general, entities in possession of medical

records are required to maintain those records
for a given period. Generally, any recorded
information should be kept legally for 7 years, but
for medical records additional time must be
allowed for any child to reach the age of
responsibility (20 years).
Medical records are required many years after a
patient’s death to investigate illnesses within a
community (e.g., industrial or environmental
disease or even deaths at the hands of doctors
committing murders).
 Abuses

• The outsourcing of medical record transcription

and storage has the potential to violate patient-
physician confidentiality by possibly allowing
unaccountable persons access to patient data.
• Falsification of a medical record by a medical
professional is a felony in most country
jurisdictions.
• Governments have often refused to disclose
medical records of military personnel who have
been used as experimental subjects.
THANKS FOR YOUR
ATTENTION