InformedConsentBernard W. Freedman, JD, MPHSanta Monica, CAbwfreedman@netscape.net
Maimonides: (1135 - 1204)The Duty of a Physician"It is the duty of the physician to regard thepatient not as a specimen to...
The American Medical AssociationSection 808 - Code of Medical EthicsPhysicians should sensitively and respectfully disclos...
Substantive Due Process and Fundamental Rights“In recognition of the dignity and privacy an adult has:Every person has a f...
The Captain of the Ship –California Probate Code 4631 "Primary physician" means a physician designatedby a patient or the...
California Probate Code 4609 4609. "Capacity" means a persons ability tounderstand the nature and consequences of adecisi...
California Probate Code 4732 4732. A primary physician who makes or isinformed of a determination that a patient lacks or...
California Probate Code 4658 Unless otherwise specified in a written advancehealth care directive,a determination that a ...
Right to Decline to TreatProbate Code 4735A health care provider or health care institution maydecline to comply with an i...
California Probate Code 4714 A surrogate, shall make a health care decision inaccordance with the patients individual hea...
Communication is lacking – CPR/DNRsIn a prospective cohort study in five tertiary medicalcenters found that:<23% physician...
Staying on theVentilator12% discussed preferences with their physicians20% said that they wanted it80% said that they did ...
Patient’s perspective…once pain rouses us, there is no one butourselves, alone with our disease, with the thousandthoughts...
Jose Ortega y GassetLaw is born from despair of human nature.
Bouvia v Superior Court “If the right exists, it matters not what motivates itsexercise. We find nothing in the law to su...
The California Supreme Court - Cobbs v. GrantThe patients right of self-decision is themeasure of the physicians duty to r...
The California Supreme Court - Cobbs v. Grant1. A mini-course in medical science is not required;2. There is no physicians...
The California Supreme Court - Cobbs v. GrantThe California Supreme Court held:A medical doctor, being the expert, appreci...
Disclosing the Magnitude of the RiskThe degree of disclosureTurns on the magnitude of the risk.The greater the risk,The gr...
Withholding Life Sustaining TreatmentTerminal Non TerminalPVSYes YesYes - ? Clear & ConvincingEvidence of ConsentMinimal(o...
State Interest in Preserving Life/ Fundamental Right of Privacy“We think the State’s interest weakens and theindividual’s ...
Withholding Information700 physicians were asked how often they withheld medicalinformation from their patient because of ...
Alternative Methods of Treatment Patients have a right to know about other respectedapproaches to treatment so that they ...
Preparing for Informed Consent Foster understanding at onset of disease. What are known (Statistics) what isn’t. Negotia...
The typical disease trajectories identified in patients with different diseases.Murtagh F E M et al. Nephrol. Dial. Transp...
Consent ProcessDoctor Patient Relationship is a FiduciaryRelationshipPatients goals of medical care are a product of their...
Capacity to UnderstandIn order to do so the patient must be able to: Understand Deliberate, and Communicate.Ask what pt...
I need to have a discussion with you about the risks…“Whatever you think, Doctor.”1. Find someone else (surrogate speaks f...
Surrogates and the Therapeutic Privilege Physicians may decide that telling a patient thetruth about their illness is not...
Risk of Refusing Treatment1. Equally important is a disclosure of the risks of notreceiving the treatment being recommende...
Excessive - Aggressive Care Physicians may tend to overuse technologicallyaggressive, life-prolonging treatments and, und...
Excessive - Aggressive CareIn a study of 164 patients with advanced dementia andmetastatic cancer admitted to a tertiary c...
What Must Disclosure Include ?1. Diagnosis, prognosis2. Burdens of Illness3. Effectiveness of Treatment v Acceptable Risk4...
The Gann Act - Blood Safety ActPaul Gann was a conservative political activist. Ganndied in 1989 due to complications of A...
Blood Safety Act1. 1645(b). Requires that the patients physician document onthe patients medical record that the patient w...
Blood Safety Act However, if a patient waives the right to allow adequatetime prior to the procedure for predonation to o...
Daisy Ashcraft v. John King, M.D.In 1983, plaintiff Daisy Ashcraft, age 16, was diagnosedas having scoliosis, which was pr...
Ashcraft v. KingDaisy’s mother and father and several other relativesgave blood before and during the operation.None of th...
Ashcraft v. King At the time of this surgery, in 1983, no test wasavailable to determine whether blood wascontaminated wi...
Ashcraft v. KingConditional Consent“A Patient Has the Right to Impose Express Limitationsor Conditions on a Doctors Author...
Do not hide behind the surrogateYou are not treating the surrogate.Dealing with a surrogate does not mean abandoning yourp...
Family Demands Surgery1. The patient, a 98 year old man suffering from a dissecting aorticaneurysm of 7.5 cm. He is unresp...
Refusal The hospital’s anesthesiologists refused to participatein the surgery, stating that such an operation hadnever be...
Decision to go Forward with out Consent1. The patient’s verbal instructions were to not do thesurgery.2. The patient clear...
The PatientThe patient was Dr. MichaelDeBakey, internationally renowned surgicalpioneer, who died on July 11, 2008, twomon...
Documentation and TransparencyUnambiguous documentation of the degree of details commensuratewith the degree of risk.1. Hi...
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    1. 1. InformedConsentBernard W. Freedman, JD, MPHSanta Monica, CAbwfreedman@netscape.net
    2. 2. Maimonides: (1135 - 1204)The Duty of a Physician"It is the duty of the physician to regard thepatient not as a specimen to be placed in aparticular class but as an individual, toconsider his constitution, his emotionalstate, habits, physical strength, theimmediate conditions, etc., and to avoidroutine treatment."
    3. 3. The American Medical AssociationSection 808 - Code of Medical EthicsPhysicians should sensitively and respectfully disclose allrelevant medical information to patients. The quantityand specificity of this information should be tailored tomeet the preferences and needs of individual patients.
    4. 4. Substantive Due Process and Fundamental Rights“In recognition of the dignity and privacy an adult has:Every person has a fundamental right to control their life, theirprivacy, including decisions relating to his or her own health care.This right cannot be effectuated without disclosure to the patientof all information in an intelligent, thoughtful and respectfulfashion.The rule to follow is:Disclosure, then Consent.
    5. 5. The Captain of the Ship –California Probate Code 4631 "Primary physician" means a physician designatedby a patient or the patients agent, conservator, orsurrogate, to have primary responsibility for thepatients health care or, in the absence ofdesignation or if the designated physician is notreasonably available or declines to act as primaryphysician, a physician who undertakes theresponsibility.
    6. 6. California Probate Code 4609 4609. "Capacity" means a persons ability tounderstand the nature and consequences of adecision and to make and communicate adecision, and includes in the case of proposedhealth care, the ability to understand its significantbenefits, risks, and alternatives.
    7. 7. California Probate Code 4732 4732. A primary physician who makes or isinformed of a determination that a patient lacks orhas recovered capacity, …, shall promptly record thedetermination in the patients health care recordand communicate the determination to thepatient, if possible, and to a person then authorizedto make healthcare decisions for the patient.
    8. 8. California Probate Code 4658 Unless otherwise specified in a written advancehealth care directive,a determination that a patientlacks or has recovered capacity, or that anothercondition exists that affects an individual healthcare instruction or the authority of an agent orsurrogate, shall be made by the primary physician.
    9. 9. Right to Decline to TreatProbate Code 4735A health care provider or health care institution maydecline to comply with an individual health careinstruction or health care decision that requiresmedically ineffective health care or health care contraryto generally accepted health care standards applicableto the health care provider or institution.
    10. 10. California Probate Code 4714 A surrogate, shall make a health care decision inaccordance with the patients individual health careinstructions, if any, and other wishes to the extentknown to the surrogate… In determining the patients best interest, thesurrogate shall consider the patients personal valuesto the extent known to the surrogate. Note: If the surrogate cannot do so, have themreplaced.
    11. 11. Communication is lacking – CPR/DNRsIn a prospective cohort study in five tertiary medicalcenters found that:<23% physicians discussed CPR preferences withseriously ill patients(n1589)Annals of Internal Medicine: (1997) 127:1; 1-12
    12. 12. Staying on theVentilator12% discussed preferences with their physicians20% said that they wanted it80% said that they did not want it. (n 1573)Annals of Internal Medicine 1 July 1997 | Volume 127 Issue 1
    13. 13. Patient’s perspective…once pain rouses us, there is no one butourselves, alone with our disease, with the thousandthoughts it provokes in us and against us.E. M. Cioran
    14. 14. Jose Ortega y GassetLaw is born from despair of human nature.
    15. 15. Bouvia v Superior Court “If the right exists, it matters not what motivates itsexercise. We find nothing in the law to suggest the right torefuse medical treatment may be exercised only if thepatient’s motives meet someone else’s approval.”
    16. 16. The California Supreme Court - Cobbs v. GrantThe patients right of self-decision is themeasure of the physicians duty to reveal.The scope of the physicians disclosure ismeasured by the patients need.
    17. 17. The California Supreme Court - Cobbs v. Grant1. A mini-course in medical science is not required;2. There is no physicians duty to discuss the relativelyminor risks inherent in common procedures
    18. 18. The California Supreme Court - Cobbs v. GrantThe California Supreme Court held:A medical doctor, being the expert, appreciates the risks inherent in theprocedure he is prescribing,But once this information has been disclosed, that aspect ofthe doctors expert function has been performed.The weighing of these risks against the individual subjective fears andhopes of the patient is not an expert skill.Such evaluation and decision is a nonmedical judgmentreserved to the patient alone.
    19. 19. Disclosing the Magnitude of the RiskThe degree of disclosureTurns on the magnitude of the risk.The greater the risk,The greater the required disclosure.
    20. 20. Withholding Life Sustaining TreatmentTerminal Non TerminalPVSYes YesYes - ? Clear & ConvincingEvidence of ConsentMinimal(or greater)ConsciousState
    21. 21. State Interest in Preserving Life/ Fundamental Right of Privacy“We think the State’s interest weakens and theindividual’s right of privacy grows as the degree ofbodily invasion increases and the prognosis dims.” The case of Karen Quinlan; Supreme Court of New Jersey (1976).
    22. 22. Withholding Information700 physicians were asked how often they withheld medicalinformation from their patient because of health plan rules.23% said sometimes;8% said often or very often.These physicians betrayed and abandoned their patient putting theinterest of the HMO or Health Plan as paramount.
    23. 23. Alternative Methods of Treatment Patients have a right to know about other respectedapproaches to treatment so that they have thenecessary information to base their decisions upon. When the evidence is lacking regarding theeffectiveness of a modality of treatment, it may beprudent to review what experimental protocols arebeing conducted.
    24. 24. Preparing for Informed Consent Foster understanding at onset of disease. What are known (Statistics) what isn’t. Negotiatethe content of the discussion. Pt wants to know; Does not want to know; Not sure.Everything does not have to be discussed at one sitting.Discuss positive and negative expectations
    25. 25. The typical disease trajectories identified in patients with different diseases.Murtagh F E M et al. Nephrol. Dial. Transplant.2008;23:3746-3748© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rightsreserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org
    26. 26. Consent ProcessDoctor Patient Relationship is a FiduciaryRelationshipPatients goals of medical care are a product of their:1. cultural background,2. religious views,3. personal experiences,4. prejudices,5. biases,6. feelings of responsibility or guilt, and7. socioeconomic realities.
    27. 27. Capacity to UnderstandIn order to do so the patient must be able to: Understand Deliberate, and Communicate.Ask what pt understands; what will he or shediscuss with family?Refer back to this conversation later, toremind, review, and ensure ongoing understanding.
    28. 28. I need to have a discussion with you about the risks…“Whatever you think, Doctor.”1. Find someone else (surrogate speaks for patient)2. If serious, take it to the Ethics CommitteePatient’s Refusal to Listen
    29. 29. Surrogates and the Therapeutic Privilege Physicians may decide that telling a patient thetruth about their illness is not in the patient’sbest interest. This does not, however, apply to a surrogatedecision maker. If a surrogate cannot fully and intelligentlyparticipate, then he or she cannot be thesurrogate. Then a second surrogate must beidentified, if possible. If not turn to a bestinterest standard.
    30. 30. Risk of Refusing Treatment1. Equally important is a disclosure of the risks of notreceiving the treatment being recommended.2. This is especially important in dealing with a patient whodemands to be discharged against medical advice.3. Please document that before the patient leaves the hospitalthe ramifications of non-treatment have been fullyexplained.4.
    31. 31. Excessive - Aggressive Care Physicians may tend to overuse technologicallyaggressive, life-prolonging treatments and, underusecommunication skills that can assist patients inmaking choices.Miettinen T, Tilvis RS. Medical futility as a cause of suffering of dying patients: the family members’perspective. J Palliat Care. 1999;15:26-29
    32. 32. Excessive - Aggressive CareIn a study of 164 patients with advanced dementia andmetastatic cancer admitted to a tertiary care teachinghospital, it was found that:47% received aggressive non-palliative treatments,24% received attempted cardiopulmonaryresuscitation.Ahronheim JC, Morrison RS, Baskin SA, et al. Treatment of the dying in the acutecare hospital. Arch Intern Med. 1996;156:2094-2100.
    33. 33. What Must Disclosure Include ?1. Diagnosis, prognosis2. Burdens of Illness3. Effectiveness of Treatment v Acceptable Risk4. Potential of rehabilitation,5. Diminished quality of life.6. Right to refuse treatment, and7. Right to request palliative care/comfort care
    34. 34. The Gann Act - Blood Safety ActPaul Gann was a conservative political activist. Ganndied in 1989 due to complications of AIDS which hehad contracted from a blood transfusion.Gann supported legislation which led to the BloodSafety Act, now set forth in Section 1645(b)) in theCalifornia Health and Safety Code, mandating thatphysicians discuss the risks of blood transfusion withtheir patients.
    35. 35. Blood Safety Act1. 1645(b). Requires that the patients physician document onthe patients medical record that the patient was informed ofhis/her transfusion options.2. When no life-threatening emergency and no other medicalcontraindications, the physician and surgeon or doctor ofpodiatric medicine shall allow adequate time forpredonation to occur.
    36. 36. Blood Safety Act However, if a patient waives the right to allow adequatetime prior to the procedure for predonation to occur, aphysician… shall not incur any liability for his or her failureto allow adequate time prior to the procedure forpredonation to occur.
    37. 37. Daisy Ashcraft v. John King, M.D.In 1983, plaintiff Daisy Ashcraft, age 16, was diagnosedas having scoliosis, which was predicted to becomedebilitating if not corrected. Ms. Ashcraft was referredto defendant John D. King, M.D., an orthopedicsurgeon.. Plaintiffs mother testified she insisted theoperation be performed using only family-donatedblood.
    38. 38. Ashcraft v. KingDaisy’s mother and father and several other relativesgave blood before and during the operation.None of this blood, however, ever went to DaisyAshcraft. Instead, all of the blood Daisy received duringthe operation came from the general supplies on hand atChildrens Hospital.
    39. 39. Ashcraft v. King At the time of this surgery, in 1983, no test wasavailable to determine whether blood wascontaminated with HIV. In 1987 the hospital discovered Daisy Ashcraft hadbeen transfused during surgery with blood from anHIV positive donor. Daisy was contacted to come into the hospital immediately for a blood test. The test was positive.
    40. 40. Ashcraft v. KingConditional Consent“A Patient Has the Right to Impose Express Limitationsor Conditions on a Doctors Authority to Perform anOperation.A Doctor Is Subject to Liability for Battery forExceeding the Conditions Imposed by the Patient.”Ashcraft v. King (1991) 228 Cal. App. 3d 604
    41. 41. Do not hide behind the surrogateYou are not treating the surrogate.Dealing with a surrogate does not mean abandoning yourpatient.
    42. 42. Family Demands Surgery1. The patient, a 98 year old man suffering from a dissecting aorticaneurysm of 7.5 cm. He is unresponsive and near death.2. He previously, and with unquestioned capacity, executed anadvance health directive indicating that he would refuse surgery.3. He also had told his physician that he would rather die than toface the probable mental and physical damage and quality of lifedeterioration that would accompany such damage.4. Yet, family is insistent on surgery.
    43. 43. Refusal The hospital’s anesthesiologists refused to participatein the surgery, stating that such an operation hadnever been performed on someone his age and in hiscondition, and also noted that patient had refusedthe surgery.
    44. 44. Decision to go Forward with out Consent1. The patient’s verbal instructions were to not do thesurgery.2. The patient clearly knew the risks of the surgery. Heknew of the high risk of respiratory failure, renal failureand brain damage.3. He declined to undertake these risks and refusedtreatment.
    45. 45. The PatientThe patient was Dr. MichaelDeBakey, internationally renowned surgicalpioneer, who died on July 11, 2008, twomonths shy of his 100th birthday.
    46. 46. Documentation and TransparencyUnambiguous documentation of the degree of details commensuratewith the degree of risk.1. History of discussion with patient or surrogate;2. Nursing Notes regarding information and discussions with Patient3. Document patient’s specific questions or concerns;4. State your ConclusionOnly by being forthright about these factors can real transparencyexist.
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