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who is responsible for Informed Consent
-physician is ultimately responsible for the informed consent process
-Radiation therapy/Imaging professionals may be required to witness the signing of a written informed consent form
Competence
the ability to do something successfully or efficiently
Surrogate
-a person who may be involved in the determination of competence and in the informed consent process
Possible Surrogates (3)
Parent
Individual named by the patient while competent
Person or persons appointed by the courts
Autonomy
-one human person precisely as a human person dares not have the authority and should not have power over another human person
Seven points that enable the imaging/radiation therapy professional to maintain a respect for autonomy (7)
1) Is the patient mentally capable and legally competent? Is there any evidence of incapacity that would affect the radiation therapy/imaging procedure?
2) If the radiation therapy/imaging patient is competent, has the patient expressed any preferences for the imaging procedure?
3) Does the RT/imaging patient understand the benefits and risks, and has he or she given consent?
4) If the patient is in need of a surrogate, is he or she using the appropriate standards for decision making?
5) Has the patient expressed prior preferences?
6) If the patient is unable or unwilling to cooperate with the imaging procedure, is there a specific reason?
7) Is the patient's right to choose being respected to the extent possible both ethically and legally?
Therapeutic Privilege
health care providers withhold information from a patient because they believe the information would have adverse effects on the patient's conditions or health
Emergency Exception
-situations in which informed consent may have to be abandoned to save the patient's life.
Emergency situations must meet the following criteria: (3)
1) The patient must be incapable of giving consent and no lawful surrogate is available.
2) Danger to life or risk of serious impairment to health is apparent.
3) Immediate treatment is necessary to avert these dangers
Obstacles to Autonomy and Informed Consent
Surrogates
Undue influences
Linguistic and cultural barriers
Lack of time
Lack of communication
Health care providers: may assume they know what is best for the patient
The Patient Care Partnership (document)
- document is to be given to patients whenever they are hospitalized.
-help patients understand the expectations, rights, and responsibilities regarding their health care
4 Rules to guide Provider in explaining information to patients:
1. Patient Preference rule
2. Professional custom rule
3. Prudent person rule
4. Subjective substantial disclosure rule
Patient Preference Rule
requires professionals to tell patients what they want to know
Professional Custom rule
Provides the information normally given to patients
Prudent person rule
measures the physician's disclosure to the patient based on the patient's need for information to make decisions regarding treatment.
Subjective Substantial disclosure rule
requires the physician to communicate meaningfully with the patient.
Possible outcomes of failing to obtain consent
allegations of assault, battery, false imprisonment, and negligence
intentional Tort
wrongs resulting from acts done with the intention of causing harm to another.
Unintentional tort
wrongs resulting from actions that were not intended to cause harm
Assault
deliberate act wherein one person threatens to harm another person without consent and the victim perceives that the other has the ability to carry out the threat
Battery
-touching to which the victim has not consented, even if the touching may benefit the patient.
Medical Immobilization
includes mechanisms usually and customarily applied during diagnostic and therapeutic procedures and is considered a regular and usual part of such procedures and based on standard practice.
False Imprisonment
when a person is unlawfully confined within a fixed area. The confined person must be aware of the confinement or must be harmed by the confinement
Items included on consent form (5)
1) Name of the procedure
2) Brief explanation of the procedure with benefits and risks
3) Spaces for patient's name and name of the physician
4) Signature lines for patient or surrogate, the physician explaining the procedure, and at least one witness
5) Date and time
Can a consent form be used in place of an oral explanation
NEVER
Advance Directives
A predetermined (usually written) choice made to inform others of the ways in which the patient wishes to be treated while incompetent. Also, a living will that contains written instructions for future health care.