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21 Cards in this Set
- Front
- Back
What does informed consent legally require
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1. Discussion of pertinent information
2. Patient's agreement to the plan of care 3. Freedom from coercian Pts must understand the risks, benefits, and alternatives including no intervention |
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Exceptions to informed consent
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1. Pt lacks decision making capacity or is legally incompetent
2. Implied consent in an emergency 3. Therapeutic privilege - witholding information when disclosure would harm the patient or undermine informed decision making capacity 4. Waiver - patient waives the right of informed consent |
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Consnt for minors
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Parental consent must be obtained unless minor is emancipated (married, self supporting, has children or is in the military)
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You are preparing a clinical trial of different doses of Drug X. Drug X has already been proven to be clinically effective and is approved by the FDA for clinical use. You are only studying whether a higher dose of Drug X will lead to enhanced benefit. Is informed consent required?
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Yes, always
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A infectious disease specialist is asked to be a clinician member of a local pharmaceutical company’s IRB. What would be her primary role?
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Ensure humane tx of participants
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Discuss the prohibitions of the Genetic Information Nondiscrimination Act.
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Health insurers cannot use genetic information to determine eligibility or premiums.
Employers or prospective employers cannot use genetic information for hiring, job assignment, promotion or firing decisions. Health insurers and employers cannot require or request genetic testing. |
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Requirements for appropriate testing:
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reliable and accurate test;
predictive of presence or absence of disease or condition, i.e. high positive and negative predictive values; identifying relative and absolute risk of disease; leading to better outcome for patient. |
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Genetic Screening tests:
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only if intervention will prevent disease or treatment is more effective when started early in disease. (Personal utility by patient may occur without clinical utility – family planning for example)
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Assisted Suicide
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Pt swallows or administers to themselves the lethal dose of drug
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Active Voluntary Euthanasia
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Physician a lethal dose of medication; both supplies the lethal agent and is the final human agent in events leading to the pts death
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Passive Euthanasia
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Witholding or discontinuing tx to all pt to die
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A 23 yo man was caught up in a mob and crushed 3 weeks ago. He currently is nonresponsive to oral commands but sleeps and wakes (having his eyes open and blinking) and occasionally grunts. What is his LOC status
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Vegetative State
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Vegetative Functions
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Breathing, circulation; wake/sleep cycles
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Minimally Conscious State
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some awareness, potentially responsive
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Persistent Vegetative State
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unresponsive but wakeful, at least 1 month duration
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coma
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unresponsive, not wakeful
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brain dead
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neither cortical nor brainstem function
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vegetative state
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unresponsive but wakeful
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Determination of death
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Cessation of breathing and circulation
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A 47 yo woman suffered hypoxia during a swimming accident. She is nonresponsive, requires artificial ventilation. She has spinal reflexes and maintains a heart beat without artificial means.
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Brain dead
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Durable power of attorney
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Pt designated surrogate to make medical decisions in the event that he/she loses decision making capacity. Pt may also specify decision sin clinical situations. Surrogate retains power unless revoked by patient. More flexible than a living will.
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