Hm300 week 4

© 2017 American Health Information Management Association© 2017 American Health Information Management Association
Chapter 8:
Consent to Treatment
Fundamentals of Law for Health
Informatics and Information
Management, Third Edition

© 2017 American Health Information Management Association
• The law recognizes the right to control
one’s own body, including medical
decision-making.
– Federal statutes
– State statutes
– Case law
– Common rule

• Rights regarding consent can be affected
by
– Age
– Competence
– Emergency circumstances

• Treatment without consent or without
proper consent can result in liability for
– Negligence
– Battery

Consent Defined
• A broad process that can be in written or
nonwritten form and vary in terms of how
much information is provided.
• In most cases, consent involves a patient’s
acknowledgement that he or she
understands a proposed intervention,
including that intervention’s risks, benefits,
and alternatives.

Type of Consent
• 3 types of consent:
– Express consent
– Implied consent
– Informed consent
• Exception to informed consent

Express Consent
• Consent that is communicated through
written or spoken word
– Written is more desirable than oral consent as
evidence
– Does not necessarily result in “informed
consent”

Implied Consent
• Consent for treatment communicated
through person’s conduct or other means
besides words
– Most appropriate for non-invasive, low-risk
interventions such as patient presents self for
appointment and submits to an exam
• Law presumes consent is given by
incapacitated individual (patient) needing
emergency treatment

Informed Consent—
Requirements
• Part of standard of care required by CMS and the Joint
Commission
• Patient’s consent should be informed:
– Demonstrates a competent patient’s understanding of the
treatment and voluntary consent to it
• Not just a form; it is a patient-provider process
• Is the responsibility of the treating provider
– Includes information material to the patient’s decision
– Shows that procedure consented to = procedure
performed
– Informed consent should be documented in the health
record and form placed in record

Informed Consent
• What shall be disclosed to the patient?
– Diagnosis/nature of illness or injury
– Nature and purpose of proposed treatment
– Risks/benefits and probable success of proposed treatment
– Alternatives (invasive and non-invasive), regardless of cost or
extent to which they are covered by insurance
– Risks and benefits of alternatives
– Risks and benefits of not receiving or undergoing a treatment
– Names of individuals who will provide the treatment
– Other information that would be material to the patient’s
decision-making process

Informed Consent for Human
Subjects Research
• Common law requirements protect
research participants
– IRB approval required for research on human
subjects
– Obtained consent (for the study) must be
obtained from study participants
• Usually separate from consent form for the
procedure

Subjects Research
• Prior misuse of human subjects resulted in
National Research Act of 1974 requiring
codifying policy for protecting human subjects
– Federal Policy for the Protection of Human
Subjects (Common Rule) implemented
– Common rule imposes protection for research
subjects, requires organizations have Institutional
Review Boards (IRBs) that must approve
research on subjects

Subjects Research
• Elements of informed consent for human subjects research
– A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the
subject’s 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

Subjects Research
• Elements of informed consent for human subjects research
(continued):
– For research involving more than minimal risk, an explanation as to
whether any compensation and an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they
consist of, or where further information may be obtained
– An explanation of whom to contact for answers to pertinent questions
about the research and research subjects’ rights, and whom to contact
in the event of a research-related injury to the subject
– A statement that participation is voluntary, that refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any time
without penalty or loss of benefits to which the subject is otherwise
entitled (45 CFR 46.116)

Subjects Research
• Consent to participate in research studies
also includes consent to disclose medical
information related to the research.
• IRB-approved informed consent may
restrict the rights of participants to access
their health information during a study.

Informed Consent and HIPAA
• HIPAA addresses informed consent through
its authorization requirements.
– Separate informed consent for research is
preferable.
– However, HIPAA allows an organization’s IRB or
privacy board to permit compound authorizations.
• Combine informed consent (for treatment) with
authorization for use and disclosure of a research
subject’s health information

Exceptions to Informed Consent
• Sometimes consent is not possible prior to
performing an intervention.
• The law provides exceptions to the
informed consent requirement.

• Emergency situations
– Patient cognizant, but time does not permit full
disclosure of risk related to intervention
– Patient incapacitated
– Emergencies must be documented in patient’s
record to prevent liability (emphasis on threat,
immediacy, and magnitude).
– Good Samaritan statutes protect against liability
for failing to obtain informed consent prior to
rendering emergency care.

• Governmental action (treatment required or
authorized by law in criminal or civil cases)
– Criminal cases:
• Often pertains to requests by law enforcement (for example,
test for alcohol in patient’s blood)
• Mandatory interventions for certain infectious diseases
– Civil cases:
• Mental or physical condition of a party is at issue; court
orders exam
– Cases involving mental competence:
• Emergency admissions of mental health patients
• Court-ordered examinations of criminal defendants

Exceptions To Informed
Consent
• Waiver
– Must be patient-initiated (patient didn’t want to be
informed)
• Not recommended
– Or waiver may be approved by IRB for research subjects if
• The research involves no more than minimal risk to the subjects
• The waiver or alteration will not adversely affect the rights and
welfare of the subjects
• The research could not practicably be carried out without the
waiver or alteration
• Whenever appropriate, the subjects will be provided with
additional pertinent information after participation

• Therapeutic privilege
– Disclosure may be of significant detriment to the
patient (risk of disclosure outweighs right to be fully
informed)
– Does not apply if the only fear is that information
would cause the patient to forgo treatment
– Highly discouraged
• Risk is too common to warrant special disclosure
or risk is remote and improbable (not material to
decision)
– May or may not be a valid defense in a legal case

Advance Directives
• Legal documents that specify an individual’s
healthcare wishes in event of temporary or
permanent loss of competence
• May appoint another person to make
decisions for oneself (legal and healthcare
through powers of attorney)
• May leave instructions on restricting use of
equipment or procedures to prolong life

Powers of Attorney
• Powers of Attorney (POA)
– 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.
Person must be mentally competent
– Power granted to agent must be defined in POA
instrument (as defined by state law)
– Types of powers of attorney
• Durable Power of Attorney (DPOA)
• Durable Power of Attorney—Healthcare Decisions (DPOA-
HCD)

Powers of Attorney
• Durable Power of Attorney (DPOA)
– POA must be durable otherwise only good if
person is competent or has capacity. If person
becomes incapacitated POA would be void.
– State law defines language to create a DPOA
vs. a POA
– DPOA may act for person (principal) in legal,
financial and real estate matters

Powers of Attorney
• Durable Power of Attorney for Healthcare Decisions (DPOA-HCD)
– May also be called a medical power of attorney or healthcare proxy,
may be revoked by principal
– Authorizes an individual (agent) to make personal health care decisions
if the authorizing individual (principal) becomes incapacitated
– Unlike power of attorney, it is in effect when principal is incapacitated
(thus, “durable”)
– Principal must be competent when executing the instrument.
– Agent must make decisions consistent with principal’s wishes or in
principal’s best interest
– May be revoked or have an expiration clause
– A copy should be kept in an easily accessible location as well as in the
health record.

Advance Directives
• Living will
– Competent adult prepares document providing direction as to
medical care in case of incapacitation or inability to make
personal decisions.
– May also be called a healthcare directive or advance care plan.
– State requirements include (for example) signature, date,
witness(es)
– Limitations on care generally involve
• Respirators
• Artificially supplied nutrition and hydration
• Cardiopulmonary resuscitation (CPR)
– May be revoked
– A copy should be kept in an easily accessible location, as well as
in the health record.

Advance Directives
• “Do not resuscitate” order (DNR)
– No CPR/no Code Blue order
• Exception to universal standing order to provide CPR
• Pertains to emergency situations only
• Patient or representative signs form, in addition to physician
order
• Preceded by informed consent procedure
• Can be revoked
• Joint Commission requires all accredited acute
care facilities to have policies and procedures
regarding advance directives (including DNR
orders).

Patient Self-Determination Act
(PSDA)
• Federal statute (effective 12-1-91) raised awareness of
advance directives
• Applies to providers receiving Medicare or Medicaid funds
• Must:
– Inform patients of legal right to make medical decisions,
including the right to create advance directives
– Document in the health record the existence of advance directive
– Educate staff and community about advance directives
– Not condition care on presence or absence of advance directives
– Ensure compliance with state law regarding advance directives

Uniform Anatomical Gift Act
• Suggest standards for all aspects of organ
donation
• Outlines the making of anatomical gift by
persons designated to make decisions
about the decedent’s remains
• States do not have to follow UAGA but
then must have requirements for obtaining
informed consent for organ donation

Parties to Consent —Who can
Consent?
• Competent adults
– Age of legal majority varies per state
– May refuse to consent or authorize withdrawal of
treatment (should be recorded via patient signature
and documentation in the health record)
• Religious beliefs
• Pursuant to advance directives
• Providers should be cautious in treating an non-consenting
adult without court order or other clear authority
• Medical record is primary or sole source
documenting decision to withdraw or forgo life-
sustaining medical treatment.

Uniform Health-Care Decisions
Act
• Uniform Health-Care Decisions Act
(UHCDA) is a model law that provides
another option to creating a durable power
of attorney for healthcare decisions or a
living will.
– Provides for a decision-making surrogate

Parties to Consent—Who Can
Consent?
• Incompetent adults
– Generally categorized as:
• Adults who were once competent and executed an
advance directives
• Adults who were once competent but did not
execute an advance directive
• Adults who never had competence

Who Can Give Consent
• Incompetent adults
– Decision is by guardian (court designee) or next of kin
– Known wishes of the patient are to be considered
– Incompetent adults have no right to refuse treatment if refusal was not
previously expressed
– Temporary incompetence: Treatment should be postponed until patient
is deemed competent (unless postponement = substantial risk; consent
= implied due to emergency)
• Major legal cases of incompetent adults who did not express their
wishes regarding treatment prior to becoming incompetent:
– Karen Ann Quinlan
– Nancy Cruzan
– Terri Schiavo

Who Can Give Consent
• Minors
– Legally classified as incompetent unless emancipated or
identified as mature
– Generally do not have the legal right to consent to or refuse
treatment unless emancipated or identified as mature
– Parental or guardian consent should be obtained prior to
treatment unless:
• Emergency treatment required (implied consent)
• State statute grants minors the right to consent (for example,
emancipated and mature minors)
• State statute grants minors the right to consent for treatment for STDs,
drug or alcohol conditions, prenatal care, abortion, etc.
• Court or other legal authority orders treatment
– Refer to state law for consent requirements for minors of
divorced or legally separated parents.

Challenges to Consents
• Patient did not give consent (battery)
• Patient was not (fully) informed of risks or other
factors that would have been material to the
patient’s decision (negligence claim based on lack
of informed consent)
• Patient was not competent at time of completion
• Form was too technical to be understood
• Signature was not voluntary (perhaps due to
physician misrepresentation)

Documenting Consent
• General consent given at time of
admission for treatment
• If more specific type of treatment is given
provider is required to obtain consent.
• Must be documented in record as required
by organization, CMS, Joint Commission,
and others

Types of Consent Forms
• General (blanket) consent form
– Signed upon admission
– For general medical treatment, general diagnostic procedures,
routine hospital care and nursing services (routine touching)
– Is not evidence of consent to major procedures
– May be valid for minor and noninvasive procedures with
insignificant risk
– Any better than implied consent?
• Short consent form
– Acknowledge of that explanation of risks benefits, and
alternatives have been explained
– Also applies to human subject research

Types of Consent Forms
• Long consent form
– Includes medical condition, proposed procedure,
consequences risks, alternatives, other factors
material to the patient’s decision
– In human subjects research, includes all consent
requirements in the Common Rule
– Much more difficult for patient to prove lack of
informed consent with this form
– Is not a substitute for verbal explanation and
dialog

Hm300 week 4

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Hm300 week 4