informed consent icu - iitd pan wrocław · 2010-04-07 · informed consent was obtained from all...
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The formal and the actual validity of informed consent
in emergency medical studies
Piotr Zaborowski
Medical University of Warsaw
VII International Bioethical Conference, Warsaw, June 2, 2006
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1.
Informed consent
has different connotations, when is applied in different medical situations
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2.
Informed consent
applies to two related, but nevertheless different, settings:
• biomedical research and
• medical practice
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researchexperimental clinical
• clinical studies
• clinical trials
animals
humans
therapeutical non-therapeutical
basic
• cost-effectiveness studies
• epidemiological studies
• genetical studies
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The main goal of
biomedical research is
the acquisition and application of new knowledge for the benefit of individual patient and society as a whole
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Achieving this goal requires:
• excellence in scientfic methodology
• honesty in data collection
• honesty in data interpretation
• realistic assesment of the implications of the findings or results
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researchexperimental clinical
• clinical studies
• clinical trials
animals
humans
therapeutical non-therapeutical
basic
• cost-effectiveness studies
• epidemiological studies
• genetical studies
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freedom of research right to selfdetermination
researcher person, patient, subject
Bauer 1987
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Have the terms
• „person”
• „patient” and
• „(research) subject”
the same meaning?
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PATIENTS’ RIGHTS
• protection of personal autonomy • to be informed• access to health care• appropriate quality of health care• free choice of caregiver
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Principle based ethics
• beneficence, • non maleficence, • respect for autonomy, and • justice
("Georgetown mantra")
[Beauchamp RL,Childress JF: Encyclopedia of Bioethics,1995:215-20]
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Principle based ethics
• beneficence [balance between potential benefits and harms of participation] • non maleficence and justice [vulnerable people are not to be exploited and eligible candidates who may benefit from participation are not to be excluded without reasonable cause], • respect for patient's/subject’s autonomy [real informed consent],
and traditional military values• loyalty and respect, • courtesy and chivalry Pearn, 2000
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Translational ethics
• autonomy of the patient and • informed consent
Kagarise MJ, Sheldon G: Arch Surg. 2000;135:39 45.
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Autonomy• self determination and • independence
(autonomous choices [informed consent, informed refusal, informed choice] – patient is expert about his own life and psychosocial-spiritual circumstances; he contributes decision making by expressing his personal preferences, beliefs and values i.e. “personal freedom” and “freedom of choice”)
• right to privacy and confidentiality (regarding all health problems)
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Human beeingPerson
consumer
patient
I.Kant: Autonomy is governedby rational choices (rationality)
J.S.Mill:Autonomy means the right to self determination as long as is not harmful to others (preferences, desires)
also in [Davis MP, et al. J.Clin.Oncol. 2001: 19(17), 3787-3789]
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„Captive subjects”
• service members (e.g. soldiers)
• prisoners
• students
• children
• intellectually disabled(eg. frightened patient in ER; patient with trauma in ICU or OR; but also drug user or alcohol abused
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principle of necessity
LARcourt decision
permanentlymentally retarded psychiatric disordersunconsciousness (eg. due to TBI)
Incompetent
next of kin (or LAR)
inf.consenttemporarilydrunk, dizzyconfusionunconsciousness
Patient
inf.consentinf.consent Competent
emergency*elective Procedure
*) - time (risk of loosing competence)- prognosis (risk of fatal complications, death)
LAR - Legal Authorised Representative
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Legal validity of informed consent
1. patients’ ability to give consent
2. sufficient information
3. appropriate form of consent
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EVERYDAY LIFEvs
EMERGENCY SETTINGS
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1. patients’ ability to give consent
- able to legal functions (age, not incapacitated) - able to give and understand the meaning of consent (able to read, speak and understand [mentally competent and educated]; free of mental deficiency or certain psychiatric disorders).
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1. patients’ ability to give consent
- able to legal functions (age, not incapacitated) - able to give and understand the meaning of consent (able to read, speak and understand [mentally competent and educated]; free of mental deficiency or certain psychiatric disorders).
What about above mentioned patients with:• traumatic brain injury (TBI) or stroke?• trauma?• alcohol or drug abuse?• phase I/II hepatic encephalopathy?
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2. sufficient information
• what does it mean “sufficient”?
• is “sufficient” equal to “understandable”?
• is the meaning of the term “risk” the same to the physician and the patient? for physician – unexpected, unfovarourable events or circumstances concerned with equipment failure or unexpected patients’ reactions or adverse events
for patient – fear of additional pain or suffering, health deterioration, missed diagnosis and further consequences with various complications (...”all the worst always happens to me...”) including fatal events (..”is it a risk, that I may die?”)
If you don’t agree …… you will probably die!
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Providing information for informed consent:• orally
(discussion and asking questions improves understanding, confidence and doctor-patient relationship –if given by physician)
• written (information leaflets, sheets, booklets improve understanding if readable; ensure the same information; convenient for the patients and the staff; may be used any time)
• video-tapes (eliminate the problems of written documents’ readability; ensure reproducibility of information)
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3. the form of consent
eg. in cases of emergency, trauma (incl. TBI) – • informed consent by patient when feasible (preferably written - „short form”). • If patient is unable to give consent - family or LAR (written, preferably abbreviated form). - consent exception by second physician.• Repeated consent to continue when available or when prior consent has been „utilised” (consent for additonal procedures etc. - always in written form [patient, next of kin, LAR])
Narayan R.K.: J.Neurotrauma 2002:19(5); 503-557
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“Valid” vs “informed” consent
Richards, Schwartz 2002; Ramcharan, Cutliffe 2001; Syse 2000;
Personal competence?
Procedural competence?
Material competence?
Validconsent?
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INFORMED, VALID
OR
„INSTITUTIONALLY TRANSFERED” CONSENT
some cases from real life
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Case 1: Is informed consent necessary?
Therapeutical activity prevents functional decline and reduces mortality. Little is known about typical levels of activity among ICU patients.
Aim: to determine the benefits of measuring or implementing therapeutic activity (direct observation, actigraphy and turning the patient)
Patients: chronically, critically ill adults in ICU
Winkelman C., Higgins PA., Chen Y-JK.: Dimens. Crit.Care Nurs. 2005; 24(6): 281-290
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Decision of the hospital Human Subject Review Board?
Informed consent
If beeing able - by themselves
if not - by families or LAR
Winkelman C., Higgins PA., Chen Y-JK.: Dimens. Crit.Care Nurs. 2005; 24(6): 281-290
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The provision of nutritional support for patients in ICUs varies widely.
Hypothesis: Evidence based algorithms would improve patients outcome
Intervention: ACCEPT (algorithms for critical care enteral and parenteral therapy) in 14 hospitals; observation; enteral or parenteral nutrition
Martin CM., Doig GS., Heyland DK. et el. CMAJ 2004; 170(2): 197-204
Case 2: Is informed consent necessary?
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Decision of the University Ethics Review Board?
Informed consent waived on the basis that intervention was a quality-improvement initiative.
Martin CM., Doig GS., Heyland DK. et el. CMAJ 2004; 170(2): 197-204
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Hypothesis: Patients’ recollections of experiences in the ICU may affect their quality of life.
Intervention: 10 Portugese ICUs; prospective study on experiences of 1433 adult patients 6 months after their ICU discharge; original HR-QoL and EQ-5D questionnaires send by mail with a letter containing detailed information on the aims ot the study; patients completed their questionnaires at home, and returned them by mail (5 ICUs) or directly during follow-up consultation (5 ICUs).
Granja C., Lopes A., Moreira S. et el. Critical Care 2005; 9: R96-R109
Case 3: Is informed consent necessary?
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Decision of the hospital Ethics Committee?
Informed consent was obtained from all patients at the time of the follow-up visit, where applicable.
Because consent was implicit in answering the questionnaire, the need for additional informed consent was waived.
Martin CM., Doig GS., Heyland DK. et el. CMAJ 2004; 170(2): 197-204
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Obtaining valid informed consent for procedures or
studies in emergency settings
is one of the most difficult tasks for the staff
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Always try to keep the balance