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Patient Consent

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In this presentation it has been tried to give a glimpse of different type of consent, how it should be taken, how the patient to be explained, when consent is must and conditions where consent is not …

In this presentation it has been tried to give a glimpse of different type of consent, how it should be taken, how the patient to be explained, when consent is must and conditions where consent is not required, so as to guide you in your every day practice.

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  • 1. CONSENT DR. N. C. DAS
  • 2. CONSENTConsent refers to the provision of approval oragreement, particularly and especially afterthoughtful consideration and understandingAs per jurisprudence prior provision of consentsignifies a possible defense (justification) againstcivil or criminal liability by the doctor.Practitioners who use this defense claim thatthey should not be held liable for a tort or a crime,as the consequence in question occurred with theprior consent and permission of the patient withoutrealising whether it is a commission or an omissionand the extent of negligence.
  • 3. MEDICAL CONSENTConsent is one of the critical issues in the area ofmedical treatment.The earliest expression of this fundamental principle,based on autonomy, is found in the Nuremberg Codeof 1947.The Nuremberg Code was adopted immediatelyafter World War II in response to medical andexperimental atrocities committed by the GermanNazi regime .The code makes it mandatory to obtain voluntaryand informed consent of human subjects.
  • 4. Similarly, the Declaration of Helsinki adopted bythe World Medical Association in 1964 emphasizesthe importance of obtaining freely given informedconsent for medical research.Medical Council of India (MCI) has laid downguidelines that are issued as regulations in whichconsent is required to be taken in writing beforeperforming an operation.The MCI guidelines are applicable to operationsand not cover to the extent other treatments orproceduresThese are covered under Implied and expressedconsent
  • 5. MEDICAL CONSENTConsent is perhaps the only principle that runsthrough all aspects of health care provisions today.It also represents the legal and ethical expressionof the basic right to have ones autonomy and self-determination.If a medical practitioner attempts to treat a personwithout valid consent, then he will be liable underboth tort and criminal law.Patient must give valid consent to medicaltreatment; and it is his prerogative to refuse treatmenteven if the said treatment will save his or her life.
  • 6. LAW AND MEDICAL CONSENTThe rights (autonomy) of the patient have deeplyeroded the old model of doctor-patient relationship.“Doctors are no more Gods”.There have been significant changes in thedoctor patient relationship with the advancement oftechnology in day-to-day practice.More and more patients are becoming aware oftheir rights and are keen to make free choice anddecision on their treatment.This helps them to choose the treatment of theirchoice from the options available and to select aphysician of their choice
  • 7. Informed consent was practically non-existent tillthe time COPRA (Consumer Protection Act) cameinto existence.This is seen as more of a legal requirement thanan ethical moral obligation on part of the doctortowards his patient.The patient has now the ability to select or dismisstheir doctors and to choose the treatment of theirchoice from the options available.Important aspect of several Medical Consumerlitigations is improper consent .
  • 8. CONSENT AND MEDICAL PRACTICEThere exists a duty to obtain prior consent (withrespect to living patients) for the purpose ofdiagnosis, treatment, organ transplant, researchpurposes, disclosure of medical records, andteaching and medico-legal purposes.With respect to the dead with regard topathological autopsy, organ transplant (for legalheirs), and for disclosure of medical record, it isimportant that prior informed consent of the patient,or relative is obtained after death.
  • 9. CONSENT AND MEDICAL ETHICSThe Hippocratic Oath prevalent for centuries hasgranted doctors the right to decide in the best interestof the Patient. But the same has been conflicted with the trend oftwentieth century right of “freedom to control health aswell as avoiding non-consensual medical treatment.”Clinical ethics teaches physicians, a wide range ofspecific ethical issues. •Informed consent, truth telling, •End-of-life decisions, •Advance directives (substitute decision making for incompetent patients) •Emergency consent
  • 10. TYPES OF CONSENT INFORMED CONSENTADVANCE EXPRESSEDCONSENT CONSENT SURRGATE IMPLIED CONSENT CONSENT
  • 11. 1.INFORMED CONSENT:It is defined as voluntary acceptance after full understanding,by a competent patient , of a plan for medical care afterphysician adequately discloses the proposed plan, its risksand benefits, and alternative approaches.The decision-making capacity is free from coercion ormanipulation by the patient/doctorCOMPONENTS :Informed consent must contain four vital components:-Mental capacity of the patient to enter into a contract (Thisalso includes his ability to understand information given)Complete Information to be provided by doctorVoluntary acceptance of the procedure by the patientShould be person and the procedure specific
  • 12. CONTENTS OF THE CONSENT:Condition (Disease) of the patientPurpose and Nature of interventionConsequences of such interventionAny alternatives availableRisks involvedPrognosis in the absence of interventionThe immediate and future costThe knowledge regarding the intervention should bein an understandable language and format so thatdecision in the form of authorization by patient canbe made.
  • 13. ELIGIBILITY FOR CONSENT: Age, Soundness of mind, Ability to understand Remember the information given, Ability to deliberate and decide the treatment choices, Believes that the information applies to the said patient and specific purpose.
  • 14. 2. EXPRESSED CONSENT:• It may be oral or in writing.•Though both these categories of consents are of equal value, writtenconsent can be considered as superior because of its evidential value.Oral:•Oral consent should be taken in the presence of uninterested third party•Mainly in cases where intimate examination of female is required.•Tests necessitating removal of body fluids, radiological examination canbe done after securing oral consent.Written:• It is advisable to take written consent in the presence of disinterestedthird party (this third party is only to attest the signature of the patient).•Consent should be taken in the patients own language.• Written consent is mandatory in every invasive diagnostic/ therapeuticprocedures or any medico legal examination.
  • 15. 3. IMPLIED CONSENT:Implied consent may be implied by patients conduct.So it is basically the conduct of the patient when he comes tothe doctor for examination / treatment.Doctor should remember that this is only for routineexamination as well as treatment.This does not extend to the performance of intimateexamination or diagnostic procedures.If there is slightest chance of any complication expressconsent should be taken.4. TACIT CONSENT:Tacit consent means implied consent understood without beingstated.Usually the way a patient present him self for treatment implyconsent.
  • 16. 5.SURROGATE CONSENT:This consent is given by family members for minors or dead.Generally, courts have held that consent of family memberswith the written approval of 2 physicians sufficiently protects apatients interest.6. ADVANCE CONSENT :It is the consent given by patient in advance before death7. PROXY CONSENT :It indicates consent given by an authorized person before orafter death.If an unconscious patient brought by police from road andoperation essential to save life 2 or 3 doctors to give consentby signing on consent form, preferably along with police.Informed consent obtained after explaining all possible risks and sideeffects is superior to all other forms of consent and legally defensive.
  • 17. CONSENT PROFORMAI _____S/D/W of ______ aged __ address ______under the treatment of Dr______do hereby give consent to the performance of _____(procedure/treatment) and to the administration of _____(anaesthesia) uponmyself/upon ____ aged __who is related to me as _____.The nature and purpose has been explained to me by Dr _______.I declare that I am more than 18 years of age.I have been informed that there are inherent risks involved in the treatment.No assurance has been given to me regarding the success of the treatment.I have given this consent voluntarily out of my free will without any pressure.Place:Date & Time:SIGNATUREI hereby declare that I have explained in detail regarding the case to the patientand answered all his queries to his satisfaction in a language that he couldunderstand.Place:Date & Time:Signature of the Doctor
  • 18. WHO CAN GIVE CONSENTSimple medical examination the minimum ageof consent is 12 years.For consenting to have any major diagnosticor therapeutic procedure or surgery the age isabove 18 years (I.P.C. Sections 87-93).The patient should be mentally sound andhe/she should not be under any fear or threat orany false conception.The patient should not be intoxicated orsedated.Incomplete information about the patient’sdiagnosis, therapeutic plan etc. is acommission than misconception of omission.
  • 19. CONSENT REQUIREDi) Some body else other than the “patient” wantshim to be medically examined and a medical certificateto be issued (employers,),ii) Consent of the concerned person must be obtainedotherwise the doctor runs the risk of liability to pay damages.Such as:-a. Issuing certificate involving complicated process ofexamination or infertility in women.b. When the process is likely to affect the physical ormental well being of the patient e.g financial loss,c. damage to reputation, social status (STD, HIV etc.).d. Procedures violating rights of spouse is in cases such asSterilisation, artificial insemination.Even after the consent is taken the examination should be done inpresence of third person (nurse ,Female attendant) while examininga female patient.
  • 20. EXCEPTIONS TO THE INFORMED CONSENTa. Doctrine of Therapeutic Procedure:• Certain procedural details (especially invasive tests orcomplicated surgery) may be difficult to explain tothe patient.•Often patients themselves do not want to know about it.•It is better to explain to the family members.b. Doctrine of Emergency:•Under section 92 of Indian Penal Code (IPC) treating without consent ofpatient is permissible if patient is unconscious, mentally illor gravely sick and no attendant with the patient.•It is implied that the procedure /surgery is done to save thelife or limb of the patient.•If possible, surrogate/proxy consent should be taken.c. Doctrine of Loco Parents:•In children in an emergency, when parents / guardians are not available,consent can be obtained from the person bringing the child (school teacher,)
  • 21. EXCEPTIONS TO THE INFORMED CONSENTd)Incompetence: Incompetent patients such as delirious,unconscious, senile, psychotic nature etc are unable to makerational decision. In these cases they can be treated withoutinformed consent involving the “Emergency” doctrine.e)Therapeutic privilege: If doctor suspects that passing fullinformation could have detrimental effect on the health of thepatient than he need not follow “Doctrine of Full Disclosure”•And can be excused of obtaining consent from the patient.•However, to take the privilege of the doctrine, he shoulddisclose full information to the competent relative of the patient.
  • 22. DOCTRINE OF FULL DISCLOSUREThe Doctor is legally bound to pass on everydetail regarding the disease condition, nature of theproposed treatment, any alternative treatment, andprognosis with possible risks and benefits of theprocedure to the patient.Mental capacity, physical condition as well as ageof the patient should be considered while deliveringthis information and likely after effect or else thesame information can be passed on to any otherauthorized person.This therapeutic privilege of a doctor is anexception to professional secrecy.
  • 23. CONSENT NOT REQUIREDi. Medico-legal cases bought by police consent is implied under sec 53 of criminal procedure code. Hence can be examinedii. Consent is not required in medical examination andissue of certificate for insurance policies .iii. Cases where it is issued in the interest of the communityiv) A person suffering from disease under “notified” category( to notify theauthorities only)v)Prisoners ( new entrants)vi)Examination under Court Ordervii)Request by a police officer under Cr.P.C. Section 53(1)-To avoid insufficient legal interpretations, Informed Consent (IC )should be understood in terms of autonomy .-A continuous interaction between the patient and the givenphysician is considered as an essential pre requisite forthe realisation of the standards of IC
  • 24. DIFFICULTY IN OBTAINING CONSENT The difficulties in getting informed consent include: a. Incompetence and mental incapacity of the patient, b. Unusual (socio, religious) beliefs of patient. c.. Extent of truthful disclosure, d. Incompleteness of information disclosed e. Advance directives by terminally ill patients or those who anticipate grave illness. f. Durability of power of attorney for health care, when holder gives the consent and decisions in advance
  • 25. INDIAN LEGAL PROVISIONSection 53(1) Cr PC: In criminal cases when examination of anarrested person can lead to vital evidence related with thecommission of crime, he can be examined by the doctor without hisconsent and even using force, if the application for examination isfrom a person not below the rank of sub Inspector.Section 54 Cr PC: An arrested person can also request to beexamined by a doctor to detect any evidence which he feels is goodfor him.Section 87 IPC: A person above 18 yrs of age can give consent tosuffer any harm if the act is not intended and not known to causedeath or grievous hurt.Section 89 IPC: A child under 12 yrs of age or a person of unsoundmind cannot give consent to suffer any harm for an act which maycause grievous hurt or death even if done in good faith , but theconsent has to be obtained from the guardian of the child or insaneperson.
  • 26. Section 90 IPC: Consent given by an insane person orgiven under fear of injury, death etc. or due tomisconception of a fact is invalid.Section 92 IPC: Any harm caused to a person in goodfaith even without the person’s consent is not an offenceif the circumstances were such that it was impossible toobtain consent of the person or his lawful guardian atthat material time for that thing to be done for thebenefit of the person.However the act should not extend to intentionallycausing hurt other than for preventing death, grievoushurt or curing of disease or infirmity.Consent of both spouse required in case ofsterilisation and Artificial insemination
  • 27. hospiad Hospital Administration Made Easy http//hospiad.blogspot.com An effort solely to help students and aspirants in their attempt to become a successful Hospital Administrator. DR. N. C. DAS