LEGAL ASPECTS OF INFORMED CONSENT IN INDONESIABy : Anna Haroen AtmodironoMember of Bioetics Unit, Medical school, Airlangga UniversityLecturer on Medical LawHospital Legal Counsellor

INTRODUCTION The regulation on informed consent has been issued in Indonesia since 1989 under Regulation of Minister of Health No. 585

The contents of regulation are:General regulation.Consent.Information.The Person who are valid to consent.Responsibility.Legal sanctions.Other regulations.Closing regulation.

The implimentation of regulation was issued by General Director of Medical Service, Departement of Health, under the Letter of Decree on April, 21, 1999 and serves as guidelines

The content of the guide line are :Introduction.General regulation.The principle of regulation.The purpose of regulation.Definition of informed consent.

Informed consentThe rules of informed consent & refusal consent.The obligation of doctor to obtain consent.The validity of informed consent implementation.Content of information.Obligation to explain information.Methods of explaining information.The party who has right to consent.

The procedure to consent.Risky medical treatment.Extention of medical treatment.The implementation of certain medical treatment.Exception of informed consent.Closing regulation.

Regulation on informed consentis also mentioned in pargraph 2 article 45 of the law of Medical Practice for doctors & dentists that went into effect on October, 6, 2005.

DEFINITION OF INFORMED CONSENT According to both regulation and the law, informed consent is a consent that is given by the patient or his close relative or some body who has authority to act in his behalf after adequate information of the purpose procedures that has been explained.

The consent given may either be implied or express. Consent must be given by the patient freely, rationally and voluntary.

IMPLIED & EXPRESS CONSENTImplied consentMay be impliedby a patients conductVoluntaryExample : injection

Express ConsentOral ConsentFor the mayority of minor examinationThetapeutic procedureIn the presence of third party as witness from the part of institution

Written consentFor all risky & a major diagnostic procedure,general anaesthetics & surgical operationProvided by institutionConsent is legally valid if they put their signature or thumb print obn the formBut his thumb may not be held by onyone

INFORMATION FOR CONSENTThe consent given to a purposed procedure must be an informed consent with understanding.Make an informed decision.Relevation of risk, is always a compromise.

Acording to the law of Medical Practice(paragraph 2 article 45 ) The diagnose & the methods of treatment.The purpose of the treatment.The alternative of other treatment & risk involved.The risk & the complications that might occur.The prognoses of the treatment.

Addition ..The information included the advantages and disadvantages of the purpose treatment.The information is given to patient orally.

III.Extension Of Operation- Is legally valid if consent is obtain from patient, except to savethe patients live - The physician has a right to extend an operation beyond that authorizedby the patient (condition instuiting a thread to the patients life)- The right is limited to emergencies calling for immediate action.

Addition .When operation in over, the physician must explain to the patient or his close relative what he has done.

THE PERSON WHO ARE VALID TO CONSENTConsious, mentally sound adult (21 years old or married), give consent themselves.< 21 years old, unmarried Father / motherBrother / sister

< 21 years old, unmarried, has no parents / his parent is unable to present

Foster Father / foster motherBrother / sisterEmployer

The patient is under trusteeshipLegally appointed guardianLegally apointed trusteeThe order of adult Husband / wifeFather / motherChildrenBrother / sister

The patient is unsound mind and incompetent to understanding the nature Father / motherLegally appointed guardianBrother / sister

EXCEPTION OF THE RULES There are two kinds of incidents where informed consent is not necessary :

If a person is injured & unconscious , and requires prompt attention to safe his life & no one else present to consent for him.If the treatment is inline with the program of the government for welfare of the nation.

LEGAL SANCTION A physician who treats / operates upon a patient without obtaining consent from patient ( oral / written) commit an assault & battery for which he may be procecuted criminaly, held civilly & administratif sanction.