Informed consent and patient autonomy

1. Informedconsent and patientautonomy Jana Urbanová

2. Informedconsent • effectivemedicaltreatment - a mutual (bilateral) communication between a doctor and a patient • increases patient's legal and health awareness • represents a patient's consent to a medical treatment on the basis of previous instruction • is required in addition for the health care to be provided

3. Informedconsent • TheConvention on Human Rights and Biomedicine • „An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.“ (Article 5)

4. Informedconsent • 1957, in the case Salgo, the American court gave an interpretation of what is considered to be a duty of doctor • “...any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment.”

5. The Principle of Autonomy • one of the basic principles accepted worldwide • contains: 1) a protection of autonomous decisions 2) a protection of bodily integrity • Consistsof more partialrights: • theright of patient to know all the informationabout a treatment • theright to make decisions about treatment

6. The Principle of Autonomy • the right to not be treated withoutone's consent to it • the right to either consent or refuseproposed treatment • If a consent to a treatmentisgiven, a particulartreatment (intervention) canbe done. However, there is a possibility to withdraw such consent at any time.

7. Elements and Requirements of the Informed Consent • A validconsentiscomposedoutof3 segments, thatneed to bepresentallat a time: • given by a competent person; • a person has to be overly informed about the whole procedure or process to which he is giving his consent; • needs to be given voluntarily, not under any kind of pressure

8. Elements and Requirements of the Informed Consent • Theinformedconsentneeds to be: 1) INFORMED a) doctors b) patients 2) CONSENT

9. Elements and Requirements of the Informed Consent • „INFORMED“ - doctors • 2 approachesofwhatthe „informedconsent“ is: • Patientstandard- a patient has the right to know all the relevant information and details concerning his case • therapeutic privilege – rightof a doctor

10. Elements and Requirements of the Informed Consent • Professional standard - a doctor chooses the extent of facts, information and details that are necessary to divulged to the patient • still bound by all other principles and obligations that applied to them

11. Elements and Requirements of the Informed Consent • „INFORMED“ – patients • Patient understanding - the ability of a single human being to analyse and understand information given by a doctor • Researchers found out that a number of patients who are competent, in some cases do not fully understand to what procedure or act they have consented • Appreciation – referred to as a deep understanding – abilityofevaluationofthegiveninformation

12. Elements and Requirements of the Informed Consent • sometimes, patientunderstands a giveninformation about particular treatment, but fails to understand the exact affect on his life

13. Elements and Requirements of the Informed Consent • TIMING – notfulfilledifinformationisgiven immediately after a procedure or right before a procedure doctorisliablefornegligence • LANGUAGE OF GIVEN INFORMATION – a translationmaybeneeded • GIVEN BY A PROFESSIONAL – not by a stuffthatisnotwell-exprerienced and cannotanswerallpatient‘squestions

14. Form of Consent • Depends on legislationof a particular state • 1) Express consent to treatment a) written b) oral - “consent expressed “in form only” is no consent at all.” • 2) Impliedconsent to treatment - can be understood from patient's behaviour • Problemofsigning a consentwithoutreadingit

15. Refusal of Proposed Treatment • NOobligation for a patientto stay healthy and to accept all treatments • Adult and competent (fully or partially) patientcanrefuse a treatmentregardless of his reasons(evenifthere are none) • “It is well established in law and ethics that competent adults have the right to refuse any medical treatment, even if that refusal results in their death.” • maybe done partially or in its entiretyconcerningcertainprocedure

16. Refusal of Proposed Treatment • patient autonomypatientcan revoke his refusal at any time when he decides he wants to undergo a certain procedure or he accepts a proposed treatment • “Our present knowledge suggests that well-informed patients are less likely to refuse treatment than those who are poorly informed.”

17. Exceptions Concerning Informed Consent • In case of their appearance in a particular situation override the rightto self-determination, and a doctor's act is allowed even without obtaining consent to a treatment • 1) Emergency Exception • 2) Incompetence • 3) A Right to Not Know and Therapeutic Privilege of Doctor • 4) Compulsory Treatment

18. 1) Emergency Exception • To disclose information to a patient is very time-consuming process for a doctor • a lack of time to inform patient • a lack of time to obtain consent from a patient • a doctor may render treatment without a prior patient's consent it is seen as an implied consent to a medical treatment

19. 1) Emergency Exception • Problems: 1) Word “emergency” no certain definition of this term generally - the urgency of the need for medical care makes a clear ground to a situation to be sorted as an emergency situation how urgent a situation is - considerconsequences and results that may occur in case of waiting for consent to be made

20. 1) Emergency Exception different consequences depending on how serious a situation is - the nature, degree and duration of consequences • Each case needs to be solved ad hocconcerning above-mentioned issues • First aid to stabilize a patient may be done without a prior consent to it, butif it then becomes possible to receive consentfor subsequent treatment, it is needed to be done so

21. 1) Emergency Exception • Canbeused in case that a doctor can assume that the patient would normally consent to a treatment • In case„...there is strong evidence to the contrary, the physician may not override the patient's wishes.“

22. 1) Emergency Exception 2) Minimaldisclosure  contains a probability of success and if the results in case of failure of a procedure are to be grave or minimal  patient is capable to give a consent to treatment and there is a little time to ask for it and explain quickly a treatment  if possible a minimal disclosure should be made

23. 1) Emergency Exception 3) Case of an IncompetentPatient  general rule: if there is enough time to obtain consent from a proxy, it is required to obtain it  no-use of emergency exception in cases of possible surrogate consent to treatment

24. 2) Incompetence • definition of word “incompetence” • a legal point of view: “a determination that the patient does not have the requisite capacities to make a medical decision.” • general incompetence holds person unable to do decisions in all cases for any purposes • specific incompetence includes only one or more (but not all) certain areas in which a person is not competent to act on his own behalf • Incompetence to make medical decisions is a specific incompetence

25. 2) Incompetence • 2 approachesif a person isfullycapable to makedecisions: • status approach - one's capacity of making decisions depends on a status requirement (mostly age) regardless of a real capacity of each “child” • functionalapproach- composed of a one's real capability each case is judged individually • “The current position is to assume capacity unless there is strong evidence to the contrary.”

26. 2) Incompetence • “Individuals below the age of consent are presumed to lack capacity unless shown otherwise, and those above the age of consent are presumed to have capacity until shown otherwise.” • surrogate - a person “liable” for decision-making process in the areas that patient is not competent to decide by himself • “guardian” or “proxy” • guardian- a court-appointed surrogate • proxy - a surrogate chosen by the patient himself

27. 2) Incompetence • Surrogatemay be: 1) somebody who is close to a patient(usually a family member); or 2) a person who did not know a patient before - in this case, there is a liability for surrogate to get to know a patient more personally • choose an option that is either the best one possible for a patient, as well as the one that in case a patient would be fully competent he would choose for himself

28. 3) A Right to Not Know and Therapeutic Privilege of Doctor • therapeutic privilege– doctor‘srightto not divulge all the details to patient in case that there is a strong reason to think that a disclosure of such information may result in his psychologically or physically harm or endanger his health • usedmostly in caseofan incurable disease • Themainpurpose: to “free physicians from a legal requirement which would force them to violate “primary duty” to do what is beneficial for the patient.”

29. 3) A Right to Not Know and Therapeutic Privilege of Doctor • Problems:  a threat of taking advantage of this doctor's right - particular information cannotbe withhold just because of possible refusal of a treatment - in case of any disputes arisen, a burden of prooflays on a doctor(persuade that he had reasonable groundsforexecutingthisprivilege)

30. 3) A Right to Not Know and Therapeutic Privilege of Doctor • right of a patient to not knowaboutthetreatment • oneofpatient‘sright to beexecuted in casehewants to • patients may state they do not want to receive the information or they do not want to decide or possibly both • to protect a person who makes such a statement • canbepresentedin writing or givenorally

31. 3) A Right to Not Know and Therapeutic Privilege of Doctor • “The knowledge requirement raises the issue of capacity. A patient must be competent to waive a right as well as to exercise one.” • does not necessarily need to have such a capacity to waive a right to treatment as it is required in case of giving consent (becauseitiseasier to cometounderstandit) • has to be given freely out of person's own decision • reasonofsuchdecision: person's psychological state of mind

32. 3) A Right to Not Know and Therapeutic Privilege of Doctor • sexually transmitted diseases– thisrightcannot be executed by a patient even though he would like to do so • purpose: to protect other people

33. 4) Compulsory Treatment • By thisexceptionisprotected: 1) healthofanindividual; 2) society‘sinterestin protecting other people • may apply only upon a previous valid court order or statute authorizing such treatment • forexample: prisoners, alcohol or drug abusers or mentally ill people with dangerous infectious disease • sometimes to order a treatmentover patient's religiousobjections

34. 4) Compulsory Treatment • It“must be potentially beneficial for the patient but it may not be in patient's best interests as the patient defines them.”

35. SUMMARY • Validinformedconsentneeds to meetallthementionedrequirements (competentpatient, overlyinformedpatient, givenvoluntarily). • Consistsof more partialrights:  theright of patient to know all the informationabout a treatment  theright to make decisions about treatment  the right to not be treated without one's consent to it  the right to either consent or refuse proposed treatment

36. SUMMARY • Formof a consent:  Expressed (in writing or givenorally)  Implied • Consent, aswellas, refusal and withdrawalofconsent/refusalcanbedone atanytime • Exceptions are: • 1) Emergency Exception • 2) Incompetence • 3) A Right to Not Know and Therapeutic Privilege of Doctor • 4) Compulsory Treatment

37. THANK YOU FOR YOUR ATTENTION!