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144 Cards in this Set
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A legal document that specifies an individual's healthcare wishes in the event that he or she has a temporary or permanent loss of competence.
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Advance directive
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1. A patients acknowledgement that he or she understands a proposed intervention, including that interventions risks, benefits, and alternatives; 2. A patient's agreement that protected health information can be disclosed; the document that provides a record of the patients consent.
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Consent
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A specific type of advance directive in which an individual states that healthcare providers should not perform CPR if the individual experiences cardiac arrest or cessation of breathing.
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Do not resuscitate (DNR) order
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A power of attorney that remains in effect even after the principal is incapacitated; can be drafted to take effect only when the principal becomes incapacitated.
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Durable power of attorney (DPOA)
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A legal instrument through which a principal appoints an agent to make healthcare decisions on the principal's behalf in the event the principal become incapacitated.
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Durable power of attorney for healthcare decisions (DPOA-HCD)
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Consent that is communicated through words, regardless of whether those words are written or spoken.
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Express consent
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A form that covers routine diagnostic procedures and medical treatment by hospital staff, as well as other activities such as release of information for treatment purposes and disposal of human tissue and body fluids.
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General consent
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Federal legislation that prohibits discrimination by health insurers and employers based on genetic information.
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Genetic Information Nondiscrimination Act (GINA)
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State law or statute that protects healthcare providers from liability for not obtaining informed consent before rendering care to adults or minors at the scene of an emergency or accident.
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Good Samaritan statue
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A law enacted by Congress on August 21, 1996, governing various aspects of health information; federal legislation enacted to provide continuity of health coverage, control fraud and abuse in healthcare, reduce healthcare costs, and guarantee the security and privacy of health information.
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Health Insurance Portability Act (HIPAA)
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Consent for medical treatment that is communicated through a person's conduct or some other means besides words.
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Implied consent
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A type of consent in which the patient should have a basic understanding of which medical procedures or test may be performed as well as the risks, benefits, and alternatives for those tests or procedures.
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Informed consent
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A committee of at least five members with varying backgrounds that determines the acceptability of proposed human subjects research in accordance with institutional policies, applicable law, and standards of professional practice and conduct
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Institutional review board (IRB)
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A document executed by a competent adult that expresses that individuals wishes to limit treatment measures when specific health-related diagnoses or conditions exist.
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Living will
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A consent form that includes all of the informed consent requirements included in the Common Rule.
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Long form
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Not of sound mind.
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Non compos mentis
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A law that became effective in 1991 requiring healthcare institutions that bill Medicare or Medicaid for services to provide adult patients with information about the various types of advance directives.
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Patient Self-Determination Act (PSDA)
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A legal instrument used by a principal (person) to grant legal authority to one or more agents to make certain legal and financial decisions on behalf of the principal.
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Power of Attorney (POA)
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A written document stating that the elements of the informed consent required by the Common Rule have been orally presented to and understood by the subject's legally authorized representative.
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Short form
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A doctrine that has historically allowed physicians to withhold information from patients in limited circumstances.
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Therapeutic privilege
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An act that provides suggested standards for all aspects of organ donation, including who may make anatomical gifts and how intent to make anatomical should be expressed; designed to create uniformity in this area across all 50 states.
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Uniform Anatomical Gift Act (UAGA)
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A model law created in 1993 that provides that an individual may give an oral or written instruction to a healthcare provider that remains in force even after the individual loses capacity, and suggests decision-making priority for that individual surrogates.
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Uniform Health-Care Decisions Act (UHCDA)
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A physician who performs a surgical procedure on a patient without obtaining the patient’s consent may be liable for:
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Battery
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Consent that is conveyed through a person’s conduct is:
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Implied
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Consent that is conveyed through spoken or written words is:
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Express
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The Uniform Anatomical Gift Act:
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promotes consistency among state laws, suggests standards and includes an opt–in system.
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A do–not–resuscitate order:
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Is a type of advance directive used in emergency situations and may be revoked at any time.
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A living will:
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expresses an individual’s healthcare wishes when specific health conditions exist.
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Advance directives:
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provide a way for individuals to communicate their healthcare wishes before they become incapacitated.
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If it is not durable, a power of attorney (POA) is effective
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only when the principal has capacity
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Under HIPAA, compound authorizations:
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combine informed consent with authorization for use and disclosure of a research subject’s health information
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GINA applies to
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health insurers, group plans & employers with more than 15 employees
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Under the Common Rule, informed consent for human subjects in research studies may be waived if:
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the institutional review board approves a waiver
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If an individual is in an emergency condition and does not have capacity to communicate consent:
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consent is implied by law
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A patient signs a consent form, authorizing hospital staff to perform interventions necessary for overall medical care. This consent is:
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general
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Informed consent requires informing the patient of all of the following except:
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hospital charges versus amount covered by insurance
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If proposed medical intervention is related to a research study:
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institutional review board approval is required
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Laws that require drivers to consent to blood alcohol tests, with penalties for refusal, probably exist to:
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protect the public
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GINA
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prohibits discrimination based on genetic information.
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In In re Quinlan, the court held that:
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an incompetent individual has a right of privacy to terminate treatment.
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When a competent adult refuses to consent to lifesaving treatment, the two competing sets of interest that come into play are the individual’s privacy interest and:
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the government's interest in protecting and preserving human life.
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In the Cruzan case, the Missouri Supreme Court held that no one can make end–of–life choices on behalf of an incompetent person without:
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clear and convincing evidence
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The end–of–life controversy in the Terri Schiavo case included:
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a question about the authority of legislative bodies to intervene in judicial matters.
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The Uniform Health–Care Decisions Act (UHCDA)
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provides an additional option to creating advance directives.
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Emancipated minors are defined as those who have:
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been afforded legal status as an adult
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State laws most likely permit a minor to consent on their own behalf for which of the following conditions?
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alcohol addiction
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Frances has been experiencing abdominal pain. Removal of her gallbladder has been recommended. Who is responsible to obtain Frances’ informed consent?
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the physician who will be performing the surgery
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consent
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1. a patient's acknowledgement that he or she understands a proposed intervention, including that intervention's risks, benefits, and alternatives2. a patient's agreement that protected health information can be disclosed; the document that provides a record of the patient's consent.Individuals have the right to or refuse consent to medical treatment whether that treatment is minor or lifesaving.
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express consent
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refers to consent that is communicated through words, whether written or spoken. An individual may show express consent through written documentation or y orally agreeing to an intervention. Both are valid and written is more desirable than oral from an evidentiary standpoint. Also must provide the patient with enough information to make an informed decision regarding medical treatment for oral or written.
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implied consent
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refers to consent for medical treatment that is communicated through a persons conduct or some other means besides words. Example: most physicians do not directly ask the patient for express written or oral consent prior to conducting a basic physical examination or minor office procedure.
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informed consent
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means the patient should have a basic understanding of what medical procedures or tests may be performed as well as the risk, benefits, and alternatives for those tests or procedures also implies that the individual who is being asked to give his or her informed consent is competent to give such as consent and that the consent must be voluntary. A basic policy in both ethics and law that physicians must honor, unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent.
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general consent
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must be supplemented with informed consents for more invasive tests, operations, and other interventions that care may entail. Example: when patients are admitted to the hospital, they often sign a general consent for authorizing hospital staff to perform the underlying tests and interventions necessary for overall medial care.
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communication process
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involves answering any questions a patient may have about a proposed intervention or lack of intervention and patients may wish to consider the questions presented
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institutional review board (IRB)
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a committee of a least 5 members with varying backgrounds that determines the accept-ability of proposed research in accordance with institution policies, applicable law, and standards of professional practice and conduct. Under the law, any research on human subjects must be approved by.
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latter consent form
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to be included in the individual's health record. The basic elements of an informed consent for human subjects research included
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HIPAA Privacy Rule
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provides a framework for disclosures of medical information related to research. Medical information includes written documentation about an identifiable individual; also includes an individual's bodily materials such as blood and tissue samples.
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Good Samaritan statute
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protects various types of healthcare providers from liability for failing to obtain informed consent before rendering care to adults or minors at the scene of an emergency or accident and they are necessary in order to ensure that providers are not deterred from rending aid at accident or scene for fear of being sued for battery or negligence.
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Common Rule
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the informed consent requirement for human subjects research may be waived or altered if approved by an institutional review board. Imposed specific requirements designed to protect participants in that research.
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therapeutic privilege
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a doctrine that has historically allowed physicians to withhold information from patients in limited circumstances, stemming from the historical paternalistic nature of medicine whereby physicians had a duty to avoid things that would discourage a patient and depress his spirits.
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Genetic Information Nondiscrimination Act (GINA)
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a federal law that was passed in 2008 and prohibits health insurance and employment discrimination based on genetic information. Also generally requires that investigators included in their informed consent a description of reasonably foreseeable risks and a statement describing the degree to which the confidentiality of records identifying the subject will be maintained.
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Health Insurance Portability and Accountability (HIPAA)
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the privacy rule which went into effect in 2003, also addresses informed consent for research though its authorization requirements and a separate informed consent document for research is often preferable, HIPPA allows an organization's IRB or privacy board to permit compound authorizations that combine informed consent with an authorization for the use and disclosure of a research subject's health information.
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advance directives
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the law provides a means for individuals to communicate their healthcare wishes in advance should they become incapacitated and a legal document that specifies an individual's healthcare wishes in the event that he he or she has a temporary or permanent loss of competence.
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power of attorney (POA)
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a legal instrument used by a principal (person) to grant legal authority to one or more agents to make certain legal and financial decisions on behalf of the principal.The principal is the individual who signs the POA and the agent is is the person designated by the principal to make certain decisions or perform certain acts on the principal's behalf
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durable power of attorney (DPOA)
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is a POA that remains in effect even after principal is incapacitated and some are drafted so that they only take effect when the principal becomes incapacitated called springing POAs because they only spring into effect upon the principal's incapacitation.
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durable power of attorney for healthcare decisions (DPOA-HCD)
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a legal instrument thought which a principal appoints an agent to make healthcare decisions on the principal's behalf in the event the principal become incapacitated and important to note that not every state calls this type of instrument a DPOA-HCD. Sometime referred to as a medical power of attorney or healthcare proxy.
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living will
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a document executed by a competent adult that expresses that individual's wishes to limit treatment measures when specific health-related diagnoses or conditions exist and the individual cannot communicate on his or her own behalf.
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do not resuscitate (DNR) order
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a specific type of advance directive in which an individual states that healthcare providers should not perform CPR if the individual experiences cardiac arrest or cessation of breathing.
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Patient Self-Determination Act
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part of the Omnibus Budget Reconciliation Act of 1990, the law which became effective in December 1991, requires healthcare institutions that is hospitals, nursing facilities hospice programs and home health agencies that bill Medicare or Medicaid for services to provide adult patients with information about the various types of advance directives, to raise public awareness about the use of advance directives.
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Uniform Anatomical Gift Act (UAGA)
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promulgated by he National Conference of Commissioners of Uniform State Laws (NCCUSL) and provides suggested standards for all aspects of organ donation including who may make anatomical gifts and how intent to make anatomical gifts should be expressed and the first was created in 1968 and was adopted by all 50 states.
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competent adult
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an individual who is mentally capable and is at or above the age of majority.
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age of majority
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the legal recognition that an individual is considered responsible for, and has control over, his or her actions include consenting to or refusing medical treatment, voting, entering into biding contracts, enlisting in the armed forces, marrying, buying alcohol, and other action defined by state law.
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incompetent adult
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an individual who is no longer capable of controlling his or her actions due to illness, injury or disability and control over this individual is through an agent or guardian.
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2 important prerequisites for the right to refuse consent to medical care:
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1. adulthood 2. competence
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Adult, one must have reached the age of majority
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Competence can generally be described as an individual's overall ability to understand, process, and communication information adequately enough to meet essential life needs such as food ,clothing, shelter, safety, and health.
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2 competing sets of interests arise for adult refuses consent to lifesaving medical treatment:
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1. the individual's well-established interest in privacy, due process, and self-determination 2. the government's completing interest in protecting and preserving human life, which has also been established though years of case law.
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3 broad categories of cases involving incompetent adults
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1. Adults who were once competent and executed an advance directive2. Adults who were once competent but did not execute an advance directive3. Adults who never had competence
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Uniform Health-Care Decisions Act
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a model for state-adopted surrogate consent laws. Leaping over state DPOA_HCD and living will legislation, it provides an additional option to the creation of these documents and provides that an individual who is a adult with capacity or emancipated minor may give an oral or written instruction to a health-care provider which remains in force even after the individual loses capacity.
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Emancipated Minors
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those who have been afforded legal status as an adult, by a situation change such as marriage that provide that the minor and his or her patents agree to this and the minor is self-supporting and living independently.
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3 main types of consent forms
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1. general or blanket2. short3. long
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is used when individuals are admitted to a hospital or outpatient facility by signing this form, an individual consents to whatever procedures, interventions, or other routine services a provider may determine to be medically necessary.
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General form
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Short form
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a written document stating that the elements of informed consent required by the Common Rule have been orally presented to and understood by the subject or the subject's legally authorized representative.
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Long form
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a consent form that includes all of the informed consent requirements included in the Common Rule and should be used when a proposed medical intervention is particularly high risk, invasive or experimental.
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The failure to obtain the written consent of the patient before performing a surgical procedure may constitute: a. battery b. contempt c. libel d. malpractice |
battery
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Many states have recognized a minor's right to seek treatment without parental consent in all of the following situations EXCEPT a(n): a. minor seeking treatment for breast reduction b. minor seeking treatment for a sexually transmitted disease c. minor seeking treatment for alcohol and substance abuse d. emancipated minor seeking treatment for breast enlargement |
minor seeking treatment for breast reduction
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The ideal consent for medical treatment obtained by the physician is: a. expressed b. informed c. implied d. verbal |
informed
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Consent forms may be challenged on all the following grounds EXCEPT: a. wording was too technical b. the treating physician obtained the patient's signature c. it is written in a language that the patient could not understand d. the signature was not voluntary |
the treating physician obtained the patient's signature
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Informed consent
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The process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention. (AMA) is the willing acceptance of a medical intervention by a patient after adequate disclosure by the physician of the nature of the intervention with its risks and benefits and of the alternatives with their risks and benefits. |
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AMA's first Code of Ethics, 1847
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Consistent with Percival's Medical Ethics in that beneficent deception for the purpose of protecting the sense of hope of the patient was a prior duty to truth
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Summary of pivotal court cases
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Schloendorf vs. New York Hospital 1914- A person has fundamental right to control what is done to his/her body. (Consent) The Nuremberg Court 1946- Voluntary patient consent to invade that right of personal autonomy required. (Voluntary Consent) Salgo vs. Stanford 1957- Patient consent requires provision of information. (Informed consent) How much information? Natanson vs. Kline 1960- Doctor must present the amount of information a reasonable doctor would provide. Canterbury vs. Spence 1972- Must present the amount of information a reasonable patient would need. |
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"implied consent"
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Patient consent is not needed in an emergency
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November 5th, 1990, Congress passed the Patient Self-Determination Act (PSDA)
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Places requirements on Medicare and Medicaid providers (hospitals, nursing homes, hospice programs, home health agencies and HMO's), Applies to adult individuals, at the time of inpatient admission or enrollment. Patients have the right to: 1. participate in and direct their own health care decisions, 2. accept or refuse medical or surgical treatment, 3. prepare an advance directive, 4. Get clear information on the providers' policies that govern the implementation of these rights. |
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Elements of Informed Consent
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Preconditions: Competence, Voluntariness Information: Nature of intervention, Risks, Benefits, Alternatives Consent: Patient decision, Authorization |
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How much information is considered adequate?
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3 Approaches: Reasonable physician standard: What would a typical physician say about this intervention? Reasonable patient standard: What would the average patient need to know to make an informed decision? Subjective standard: What would this particular patient need to know in order to make an informed decision? |
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What sorts of interventions require informed consent?
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Most health care institutions have policies that state which interventions require a signed consent form (e.g. surgery, anesthesia, & other invasive procedures). Signed forms are the culmination of a required dialogue.
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When is it good to question a patient's ability to participate in decision making?
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Assess the patient's ability to: Understand his/ her situation. Understand the risks associated with the decision, and the alternatives available. Communicate a decision based on that understanding.
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What about the patient whose decision making capacity varies from day to day?
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Patients can move in and out of a coherent state as their medications and underlying diseases change. You should do what you can to catch a patient in a lucid state, even lightening up on medication, if necessary, in order to include him/her in the decision-making process.
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What should occur if the patient cannot give informed consent?
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If the patient is incapacitated/ incompetent to make health care decisions, a surrogate decision maker must speak for him/her. If no appropriate surrogate is available, physicians must act in the best interests of the patient until a surrogate is found or appointed.
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What is presumed or implied consent?
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The patient's consent should be "presumed," rather than obtained, in emergency situations when the patient is unconscious or incompetent, and when no surrogate decision maker is available. While the principle of respect for persons obliges you to include the patient in decisions that affect his/her life and body, the principle of beneficence requires that you act on his/her behalf when life is at stake.
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What about children?
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Doctrine of informed consent has limited direct application in pediatrics Parents and other surrogates can provide informed permission for diagnosis and interventions, Children and adolescents should be included in decision making whenever possible. Decisions should be made with child assent, whenever appropriate. Physicians have legal and ethical duties to provide competent care based on what the child needs. |
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A physician who performs a surgical procedure on a patient without obtaining the patient’s consent may be liable for: a. nonfeasance b. assault c. battery d. negligence |
battery
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Consent that is conveyed through spoken or written words is a. express b. implied c. informed d. unilateral |
express
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Consent that is conveyed through a person’s conduct is a. express b. implied c. informed d. unilateral |
implied
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If an individual is in an emergency condition and does not have capacity to communicate consent, a. there is no consent for treatment b. consent is express c. consent is implied by law d. none of the above |
consent is implied by law
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A patient signs a consent form, authorizing hospital staff to perform interventions necessary for overall medical care. This consent is a. oral b. implied c. general d. specific |
general
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Informed consent requires informing the patient of all of the following except a. nature and purpose of proposed treatment b. hospital charges versus amount covered by insurance c. risks and benefits of proposed treatment d. alternatives to proposed treatment |
hospital charges versus amount covered by insurance
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If proposed medical intervention is related to a research study a. institutional review board approval is required b. consent is not required c. consent is only required if the risk of death is significant d. none of the above |
institutional review board approval is required
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Laws that require drivers to consent to blood alcohol tests, with penalties for refusal, probably exist to a. protect the public b. harass citizens c. promote business for medical facilities d. none of the above |
protect the public
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Under the Common Rule, informed consent for human subjects in research studies may be waived if a. obtaining consent will take too much time b. obtaining consent will be too costly c. the institutional review board approves a waiver d. the human subjects agree to a waiver |
the institutional review board approves a waiver
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GINA applies to a. health insurers b. group health plans c. employers with 15 or more employees d. all of the above |
all of the above
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GINA: a. prohibits discrimination based on genetic information b. does not apply to genetic research c. has been adopted by about half of the states d. none of the above |
prohibits discrimination based on genetic information
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Under HIPAA, compound authorizations a. are prohibited b. combine informed consent with authorization for use and disclosure of a research subject’s health information c. apply to patients who will consent to two surgeries being performed during one admission d. none of the above |
combine informed consent with authorization for use and disclosure of a research subject’s health information
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Advance directives a. provide a way for physicians to ensure that life-saving treatment is given, regardless of an individual’s wishes b. provide a way for individuals to communicate their healthcare wishes before they become incapacitated c. are prohibited by federal law d. are not legal documents, so they can be disregarded by providers and judge |
provide a way for individuals to communicate their healthcare wishes before they become incapacitated
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If it is not durable, a power of attorney (POA) is effective a. only when the principal has capacity b. only when the principal is mentally incompetent c. both when the principal has capacity and when he or she is mentally incompetent d. none of the above |
only when the principal has capacity
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A living will a. enables another to make healthcare decisions for an individual b. expresses an individual’s healthcare wishes when specific health conditions exist c. is written when an individual is alive, but applies when the individual dies d. always takes precedence over a durable power of attorney for healthcare if both exist |
expresses an individual’s healthcare wishes when specific health conditions exist
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A do not resuscitate order a. is a type of advance directive b. is used only in emergency situations c. may be revoked at any time d. all of the above |
all of the above
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The Uniform Anatomical Gift Act a. promotes consistency among state laws b. provides suggested standards for all aspects of organ donation c. includes an opt-in system for organ donation d. all of the above |
all of the above
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When a competent adult refuses to consent to lifesaving treatment, the two competing sets of interest that come into play are the individual’s privacy interest and a. the physician’s interest in saving lives b. the government’s interest in protecting and preserving human life c. the government’s interest in collecting taxes from living individuals d. the physician’s interest in persuading a patient to seek and pay for treatment |
the government’s interest in protecting and preserving human life
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In In re Quinlan, the court held that a. an incompetent individual has a right of privacy to terminate treatment b. an incompetent individual has no right of privacy to terminate treatment c. an incompetent individual’s guardian cannot decide if that individual would refuse treatment d. none of the above |
an incompetent individual has a right of privacy to terminate treatment
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In the Cruzan case, the Missouri Supreme Court held that no one can make end-of-life choices on behalf of an incompetent person without a. preponderance of the evidence b. proof beyond a reasonable doubt c. clear and convincing evidence d. probable cause |
clear and convincing evidence
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The end-of-life controversy in the Terri Schiavo case included a. a dispute about how much evidence was required to determine Ms. Schiavo’s wishes b. a question about the authority of legislative bodies to intervene in judicial matters c. a dispute about removing a ventilator from a mentally incompetent patient d. none of the above |
a question about the authority of legislative bodies to intervene in judicial matters
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The Uniform Health-Care Decisions Act (UHCDA) a. provides an additional option to creating advance directives b. negates the effect of advance directives, even if they comply with the UHCDA c. does not allow a surrogate to be appointed in the absence of an advance directive d. provides no legal immunity to providers |
provides an additional option to creating advance directives
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Emancipated minors are defined as those who have a. reached age 17 b. gotten married c. disowned their parents d. been afforded legal status as an adult |
been afforded legal status as an adult
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State laws most likely permit a minor to consent on their own behalf for which of the following conditions? a. alcohol addiction b. carpal tunnel syndrome c. tonsillitis d. fractured femur |
alcohol addiction
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Frances has been experiencing abdominal pain. Removal of her gallbladder has been recommended. Who is responsible to obtain Frances’ informed consent? a. the anesthesiologist who will be administering general anesthesia b. the surgical nurse who will assist during surgery c. the physician who will be performing the surgery d. the administrator in the surgery department |
the physician who will be performing the surgery
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T/F A person must give permission to receive medical treatment through express consent. |
True
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T/F Informed consent should include alternatives to the proposed treatment or procedure. |
True
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T/F The law permits a presumption of consent during emergency situations. |
True
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T/F The Genetic Information Nondiscrimination Act (GINA) applies to any entity that has the potential to make a decision about a person based on that person’s genetic information. |
False
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T/F Compound authorizations combine informed consent with authorization for the use and disclosure of a research subject’s health information. |
True
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T/F Unless it is designated as durable, a power of attorney is only effective when the principal has capacity. |
True
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T/F A durable power of attorney for healthcare decisions expresses an individual’s wishes to limit treatment measures when specific health-related diagnoses or conditions exist and the individual cannot communicate on his own behalf. |
False
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T/F The Patient Self-Determination Act requires hospitals that are Medicare providers to document in the health record whether an individual has an advance directive. |
True
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T/F The Uniform Anatomical Gift Act permits an anatomical gift by any person designated to make decisions about a decedent’s remains. |
True
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T/F The technical process for executing a living will is standardized nationally. |
False
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T/F A competent adult’s right to refuse consent to medical treatment applies even when the treatment is lifesaving. |
True
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T/F In right-to-die cases, courts will balance an individual’s right to self-determination against the interest of the state. |
True
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T/F The Uniform Health-Care Decisions Act suggests that in the absence of a surrogate, a spouse be the first person to make healthcare decisions on behalf of an individual who has lost mental capacity. |
True
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T/F An emancipated minor is one who has not been afforded legal status as an adult. |
False
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T/F State laws generally allow minors to seek medical treatment for sexually transmitted diseases without parental consent. |
True
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T/F Battery is the usual basis of a claim for which an individual did not give consent for a procedure that was performed. |
True
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T/F The basis for a lack of informed consent claim is generally negligence. |
True
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T/F A treating provider should delegate the informed consent process to another person. |
False
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T/F General consent allows healthcare providers to provide routine noninvasive services. |
True
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T/FBoth written and oral consent should be documented in an individual’s health record.
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True
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