chapter 6 consent for treatment

Why consent matters

Ethical obligation

Legal obligation

Protects patient autonomy

Reduces liability

Why consent matters

Legal obligation

Federal and state statues, case law and common rule

Why consent matters

Reduces liability

Treatment without consent or without proper consent can result in liability for negligence and/or battery

Foundations of consent

Consent defined

Voluntary agreement

Competent decision

Adequate information

Understanding

Historical development

Before modern law

Modern healthcare emphasizes

Historical development

Before modern law

Physicians often made decisions independently

Patients received limited information

Historical development

Modern healthcare emphasizes

Shared decision making

Patient rights

Transparency

Legal basis

Every competent adult has the right to determine

What treatments are accepted

What treatments are refused

Schloendorff v. Society of New York Hospital (1914)

Every human begin of adult years and sound mind has a right to determine what shall be done with his own body

Foundation for:

Informed consent

Right to refuse

Bodily autonomy

Types of consent

Express

Implied

Informed

Express consent

Verbal authorization

Signing surgical forms

Research participation

Does not necessarily result in informed consent

Implied consent

Communication through persons conduct or other mans besides words

Law presumes consent in incapacitated patients needing emergency treatment

Examples:

Extending arm for blood drawn

Sitting in exam chair

Opening mouth for oral exam

Informed consent

Part of standard of care required by CMS and JC

Is responsibility of treating provider

Can exclude particular provider from engaging in treatment

Procedure or treatment without consent constitutes battery

Required elements

Core elements that must be presented

Protects patient autonomy and supports shared decision making

Diagnosis

Nature/ purpose of proposed treatment

Risks/benefits of proposed treatment

Alternative treatments

Risks/benefits of alternative treatment

Risks/benefits of not receiving treatment

Name of individuals providing treatment

Comprehension

Providing information if not enough, patient must understand it or provider could be liable for negligence

Barriers include:

Language differences

Low health literacy

Hearing impairment

Cognitive limitations

Time pressures

Complex medical information

Emotional distress/ anxiety

Human subjects research

Consent to participate in research studies also include consent to disclose medical information related to research

Common law requirements protect research participants

IRB approval required for research on human subjects

Specific protections for vulnerable populations

Required elements for human subject research

A statement that the study involved research, an explanation of the purposed of the research and the expected duration of the subjects participation, a description of the procedures to be followed, and identification of any procedures which are experimental

A description of any reasonably foreseeable risks or discomforts to the subject

A description of any benefits to the subject or to others which may reasonably be expected from the research

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained

For research involving more than minimal risk, an explanation as

Exceptions to consent

Treatment may proceed without consent when

Immediate threat exists

Patient incapacitated

No surrogate available

Emergency exception must be documented in medical record

Exceptions to consent surgeries

Traditional rule states unless a true emergency exists, the original surgery should be completed, and newly discovered condition should be addressed at later time

However, when unanticipated conditions during surgery occur, additional emergency treatment may be necessary

Exceptions to consent

Public interest exception

Court orders

Infectious disease control

Forensic procedures

Capacity and competence

Patients must

Understand relevant information

Appreciate consequences of choices

Reason through options

Communicate choice

Shared decision making

CMS is empowered under ACA to condition payment if used

Involves using patient decision aid (PDA) certified by healthcare authority to help patients understand options and engage in thoughtful discussions regarding their preferences to make well informed decisions

Competent adults

Age of legal majority varies per state

Can consent, refuse, or withdraw consent

Decision to withdraw or forgo life sustaining medical treatment must be documented in medical record

Incompetent adults

Adult lacks decisional capacity, either permanently or temporarily

Decision makers include

Guardians

Surrogates

Court appointed representative

Consent: mentally incompetent

Judged by court to be insane, senile, mentally challenged or under influence of drugs/alcohol

Consent minors

Most state statues provide allowances for

Emancipated minors

Married persons, even if marriage is dissolved

Mature minors (some homelessness)

Active duty military

Court or other legal authority orders treatment

Refer to state law for consent requirements for minors of divorced or legally separated parents (normally, consent of either parent suffices)

Consent minors

State statutes grant rights for

STD treatment

Birth control

Drug or alcohol conditions

Prenatal care

Mental health

Advanced directives

Guide future care when capacity is lost

Legal documents that specify an individuals healthcare wishes in even of temporary or permanent loss of competence

Assigns power of attorney for decision making

Durable power of attorney (DPOA)

Durable power of attorney, healthcare decisions (DPOA-HCD)

Joint commission requires all accredited acute care facilities to have policies and procedures regarding advance directives (including DNR orders)

Powers of attorney

Durable power of attorney (DPOA)

Grants trusted person (agent) legal authority to handle affairs if one is not competent

Certain personal, legal, and financial actions are strictly excluded from agents authority to prevent fraud and protect persons fundamental rights

Powers of attorney: DPOA

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

Authorizes agent to make personal health care decisions if the authorizing individual (principal) becomes incapacitated

Principal must be competent when executing the instrument

May be revoked by principle or have an expiration clause

Copy should be kept in an easily accessible location as well as in the health record

Advanced directives: living will

Competent adult prepares document providing direction as to medical care in case of incapacitation or inability to make personal decisions

Limitations on care generally involve

Respirators

Artificially supplied nutrition and hydration

Cardiopulmonary resuscitation (CPR)

May be revoked, must be documented if so

A copy should be kept in an easily accessible location, as well as in the health record

Advanced directives: do not resuscitate (DNR)

No CPR/ code blue order

Patient or representative signs form, in addition to physician order

Preceded by informed consent procedure

Can be revoked

POLST or MOLST

Physicians order for life sustaining treatment (POLST) or medical order for life sustaining treatment (MOLST)

National POLST paradigm encourages patients and providers to discuss what the patient wants and does not want when seriously ill or frail

Informed decisions can then be made and documented on a form filled within the medical record

Standing order

Patient self determination act (PSDA)

Requires federally funded healthcare entities inform patients of rights to acccept/refuse treatment and right to formulate advance directives

Goal is ensure a patients rights to self determination in healthcare decisions to communicated and protected

Organ transplant legislation

Uniform anatomical gift act

Governs donation of organs, eyes, and tissues for transplantation, therapy, research, or education

Mandates hospitals have policies/procedures

Strict prohibitions on sale or purchase of human body parts

Cruzan v. Missouri dept of health (497 US 261, 1990)

Withdraw of care

No advanced directive on file

Family authority

Testifies to cruzans wishes

Evidentiary standards

January 11, 1983 driving alone, loses control of vechile and comes to rest face down in water filled ditch

After 2 weeks diagnosed with PVS

Could breathe without assistance

Had to receive nutrients and hydration through artificial means

Parents wanted to withdraw life support after 4 years, hospital refused requiring court order

MO law allowed that surrogates actions conform to wishes expressed by patient when was competent

Trail court required clear and convincing evidence of Nancy wishes before allowing withdraw

Had stated to roommate that she would not want to continue to live unless she lived halfway normal

Debate: preserving life, regardless of quality of life

Trail court: based on testimony given by Nancy’s friends stating she would not want to live on artificial life support, allowed to remove NG tube

State appealed and MO Supreme Court reversed rulings stating lower court did not meet clear and convincing evidence standards but upheld that competent persons are able to exercise right to refuse medical treatment under due process clause

Sent back to MO trail where 3 friends testified

Preponderance of evidence of clear and convincing standard

US Supreme Court by 5-4 majority, held that missouris requirement did not violate the constitution

NG tube removed

Nancy died 11 days later after a 3 year legal battle

SC03-1242 in re guardianship of Schwab o 780 so. 2d 176, 177 (fla dist ct app 2001)

Prolonged life support

Lack of living will

Family conflict

Politics

Ethics

Legal implications

Guardianship when no advanced directives is on file

Husband petitions court in 1998 to terminate life support

Parents object due to strong religious beliefs

Years of contentious litigation follow

14 appellate fl court decisions

5 federal decision