§ 144E.2 — Definitions

Iowa § 144E.2

• Jurisdiction: Iowa
• Title IV: PUBLIC HEALTH
• Ch. 144E: EXPERIMENTAL TREATMENTS FOR TERMINALLY ILL PERSONS

Text

As used in this chapter:
1. “Eligible facility” means an institution operating under a federalwide assurance for the
protection of human subjects pursuant to 42 U.S.C. §289(a) and 45 C.F.R. pt. 46, and subject
to the federalwide assurance laws, rules, policies, and guidelines including renewals and
updates.
2. “Eligible patient” means an individual who meets all of the conditions specified under
paragraph “a” or “b”:
a. (1) Has a terminal illness, attested to by the patient’s treating physician.
(2) Has considered and rejected or has tried and failed to respond to all other treatment
options approved by the United States food and drug administration.
(3) Has received a recommendation from the individual’s physician for an investigational
drug, biological product, or device.
(4) Has given written informed consent for the use of the investigational drug, biological
product, or device.
(5) Has documentation from the individual’s physician that the individual meets the
requirements of this paragraph “a”.
b. (1) Has a life-threatening or severely debilitating illness, attested to by the patient’s
treating physician.
(2) Has exhausted all other United States food and drug administration-approved
treatment options by contraindication, potential or previous treatment failure, or actual or
potential adverse reaction.
(3) Has received a recommendation from the individual’s physician for an individualized
investigational treatment, based on an analysis of the patient’s genomic sequence, human
chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as
enzymes and other types of proteins, or metabolites.
(4) Has given written informed consent for the use of the individualized investigational
treatment.
(5) Has documentation from the individual’s physician that the individual meets the
requirements of this paragraph “b”.
3. “Individualized investigational treatment” means a drug, biological product, or device
that is unique to, and produced exclusively for use by, an individual patient, based on the
individual patient’s own genetic profile, and is provided in a manner that is consistent
with a federalwide assurance for the protection of human subjects. “Individualized
investigational treatment” includes but is not limited to individualized gene therapy,
antisense oligonucleotides, and individualized neoantigen vaccines.
4. “Investigational drug, biological product, or device” means a drug, biological product,
or device that has successfully completed phase 1 of a United States food and drug
administration-approved clinical trial but has not yet been approved for general use by the
United States food and drug administration and remains under investigation in a United
States food and drug administration-approved clinical trial.
5. “Terminal illness” means a progressive disease or medical or surgical condition that
§144E.2, EXPERIMENTAL TREATMENTS FOR TERMINALLY ILL PERSONS 2
entails significant functional impairment, that is not considered by a treating physician to be
reversible even with administration of treatments approved by the United States food and
drug administration, and that, without life-sustaining procedures, will result in death.
6. “Written informed consent” means a written document that is signed by the patient, a
parent of a minor patient, or a legal guardian or other legal representative of the patient and
attested to by the patient’s treating physician and a witness and that includes, at a minimum,
all of the following:
a. If the patient is an eligible patient as specified in subsection 2, paragraph “a”:
(1) An explanation of the products and treatments approved by the United States food
and drug administration for the disease or condition from which the patient suffers.
(2) Anattestationthatthepatientconcurswiththepatient’streatingphysicianinbelieving
that all products and treatments approved by the United States food and drug administration
are unlikely to prolong the patient’s life.
(3) Clear identification of the specific proposed investigational drug, biological product,
or device that the patient is seeking to use.
(4) A description of the best and worst potential outcomes of using the investigational
drug, biological product, or device and a realistic description of the most likely outcome. The
descriptionshallincludethepossibilitythatnew,unanticipated,different,orworsesymptoms
might result and that death could be hastened by use of the proposed investigational drug,
biological product, or device. The description shall be based on the treating physician’s
knowledge of the proposed investigational drug, biological product, or device in conjunction
with an awareness of the patient’s condition.
(5) Astatementthatthepatient’shealthplanorthird-partyadministratorandproviderare
not obligated to pay for any care or treatments consequent to the use of the investigational
drug, biological product, or device, unless they are specifically required to do so by law or
contract.
(6) A statement that the patient’s eligibility for hospice care may be withdrawn if the
patient begins curative treatment with the investigational drug, biological product, or device
and that hospice care may be reinstated if this treatment ends and the patient meets hospice
eligibility requirements.
(7) A statement that the patient understands that the patient is liable for all expenses
consequent to the use of the investigational drug, biological product, or device and that
this liability extends to the patient’s estate unless a contract between the patient and the
manufacturer of the investigational drug, biological product, or device states otherwise.
b. If the patient is an eligible patient as specified in subsection 2, paragraph “b”:
(1) An explanation of the currently approved products and treatments for the disease or
condition from which the patient suffers.
(2) An attestation that the patient concurs with the patient’s treating physician in
believing that all currently approved and conventionally recognized products and treatments
are unlikely to prolong the patient’s life.
(3) Clear identification of the specific proposed individualized investigational treatment
that the patient is seeking to use.
(4) A description of the best and worst potential outcomes of using the individualized
investigational treatment and a realistic description of the most likely outcome. The
descriptionshallincludethepossibilitythatnew,unanticipated,different,orworsesymptoms
might result and that death could be hastened by use of the proposed individualized
investigational treatment. The description shall be based on the treating physician’s
knowledge of the proposed individualized investigational treatment in conjunction with an
awareness of the patient’s condition.
(5) Astatementthatthepatient’shealthplanorthird-partyadministratorandproviderare
not obligated to pay for any care or treatments consequent to the use of the individualized
investigational treatment, unless they are specifically required to do so by law or contract.
(6) A statement that the patient’s eligibility for hospice care may be withdrawn if the
patient begins curative treatment with the individualized investigational treatment and that
hospice care may be reinstated if this treatment ends and the patient meets hospice eligibility
requirements.
3 EXPERIMENTAL TREATMENTS FOR TERMINALLY ILL PERSONS, §144E.6
(7) A statement that the patient understands that the patient is liable for all expenses
consequent to the use of the individualized investigational treatment and that this liability
extends to the patient’s estate, unless a contract between the patient and the manufacturer
of the individualized investigational treatment states otherwise.