Chapter 7, Consent to Treatment

3 broad categories of cases involving incompetent adults page 153

1. Adults who were once competent and executed an advance directive 2. Adults who were once competent but did not execute an advance directive 3. Adults who never had competence

consent

1. a patient's acknowledgement that he or she understands a proposed intervention, including that intervention's risks, benefits, and alternatives 2. 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.

2 important prerequisites for the right to refuse consent to medical care: page 151

1. adulthood 2. competence Adult, one must have reached the age of majority 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.

3 main types of consent forms

1. general or blanket 2. short 3. long General forms 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.

2 competing sets of interests arise for adult refuses consent to lifesaving medical treatment: page 151

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.

institutional review board (IRB)

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.

Long form

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.

therapeutic privilege

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.

living will

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.

Genetic Information Nondiscrimination Act (GINA)

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.

durable power of attorney for healthcare decisions (DPOA-HCD)

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.

power of attorney (POA)

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

Uniform Health-Care Decisions Act

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.

do not resuscitate (DNR) order

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.

Short form

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.

competent adult page 151

an individual who is mentally capable and is at or above the age of majority.

incompetent adult page 151

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.

communication process page 139

involves answering any questions a patient may have about a proposed intervention or lac of intervention and patients may wish to consider the questions presented in figure 7.1 page 140

durable power of attorney (DPOA)

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.

informed consent

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.

general consent

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.

Patient Self-Determination Act

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.

Uniform Anatomical Gift Act (UAGA)

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.

Good Samaritan statute

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.

HIPPA Privacy Rule page 141

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.

implied consent

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.

express consent

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.

Common Rule page 140 & 143

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.

advance directives

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.

age of majority page 151

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.

Health Insurance Portability and Accountability (HIPPA)

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.

Emancipated Minors page 156

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.

latter consent form page 140

to be included in the individual's health record. The basic elements of an informed consent for human subjects research included: page 140-141