Okla. Stat. tit. 63, § 63-3091.2
This is the official text of Okla. Stat. tit. 63, § 63-3091.2, part of Oklahoma’s Stat. tit. 63, — part of the compiled statutory law of Oklahoma, published by the state as "Stat. tit. 63,." Browse the sections below, each linked to its official government source.
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Definitions
Official statutory text
For purposes of the Right to Try Act:
1. "Eligible patient" means a person who has:
a. a terminal illness, attested to by the patient's
treating physician,
b. considered all other treatment options currently
approved by the United States Food and Drug
Administration,
c. been unable to participate in a clinical trial for the
terminal illness within one hundred (100) miles of the
patient's home address, or not been accepted to the
clinical trial within one (1) week of completion of
the clinical trial application process,
d. received a recommendation from his or her physician
for the use of an investigational drug, biological
product or device,
e. given written, informed consent for the use of the
investigational drug, biological product or device or,
if the patient is a minor or lacks the mental capacity
to provide informed consent, a parent or legal
guardian has given written, informed consent on the
patient's behalf, and
f. documentation from his or her physician that he or she
meets the requirements of this paragraph.
"Eligible patient" does not include a person being treated as an
inpatient in a hospital licensed pursuant to the provisions of
Section 1-701 et seq. of Title 63 of the Oklahoma Statutes;
2. "Investigational drug, biological product or device" means a
drug, biological product or device that has successfully completed
phase one of a 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 clinical trial approved by the
United States Food and Drug Administration;
3. "Terminal illness" means a disease that, without life-
sustaining procedures, will soon result in death or a state of
permanent unconsciousness from which recovery is unlikely; and
Oklahoma Statutes - Title 63. Public Health and Safety Page 1456
4. "Written, informed consent" means a written document signed
by the patient and attested to by the patient's physician and a
witness that, at a minimum:
a. explains the currently approved products and
treatments for the disease or condition from which the
patient suffers,
b. attests to the fact that the patient concurs with his
or her physician in believing that all currently
approved and conventionally recognized treatments are
unlikely to prolong the patient's life,
c. clearly identifies the specific proposed
investigational drug, biological product or device
that the patient is seeking to use,
d. describes the best and worst potential outcomes of
using the investigational drug, biological product or
device with a realistic description of the most likely
outcome, including the possibility that new,
unanticipated, different or worse symptoms might
result, and that death could be hastened by the
proposed treatment, based on the physician's knowledge
of the proposed treatment in conjunction with an
awareness of the patient's condition,
e. makes clear that the patient's health insurer and
provider are not obligated to pay for any care or
treatments consequent to the use of the
investigational drug, biological product or device,
f. makes clear that the patient's eligibility for hospice
care may be withdrawn if the patient begins curative
treatment and care may be reinstated if the curative
treatment ends and the patient meets hospice
eligibility requirements,
g. makes clear that in-home health care may be denied if
treatment begins, and
h. states that the patient understands that he or she 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 drug, biological product or device
states otherwise.
1. "Eligible patient" means a person who has:
a. a terminal illness, attested to by the patient's
treating physician,
b. considered all other treatment options currently
approved by the United States Food and Drug
Administration,
c. been unable to participate in a clinical trial for the
terminal illness within one hundred (100) miles of the
patient's home address, or not been accepted to the
clinical trial within one (1) week of completion of
the clinical trial application process,
d. received a recommendation from his or her physician
for the use of an investigational drug, biological
product or device,
e. given written, informed consent for the use of the
investigational drug, biological product or device or,
if the patient is a minor or lacks the mental capacity
to provide informed consent, a parent or legal
guardian has given written, informed consent on the
patient's behalf, and
f. documentation from his or her physician that he or she
meets the requirements of this paragraph.
"Eligible patient" does not include a person being treated as an
inpatient in a hospital licensed pursuant to the provisions of
Section 1-701 et seq. of Title 63 of the Oklahoma Statutes;
2. "Investigational drug, biological product or device" means a
drug, biological product or device that has successfully completed
phase one of a 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 clinical trial approved by the
United States Food and Drug Administration;
3. "Terminal illness" means a disease that, without life-
sustaining procedures, will soon result in death or a state of
permanent unconsciousness from which recovery is unlikely; and
Oklahoma Statutes - Title 63. Public Health and Safety Page 1456
4. "Written, informed consent" means a written document signed
by the patient and attested to by the patient's physician and a
witness that, at a minimum:
a. explains the currently approved products and
treatments for the disease or condition from which the
patient suffers,
b. attests to the fact that the patient concurs with his
or her physician in believing that all currently
approved and conventionally recognized treatments are
unlikely to prolong the patient's life,
c. clearly identifies the specific proposed
investigational drug, biological product or device
that the patient is seeking to use,
d. describes the best and worst potential outcomes of
using the investigational drug, biological product or
device with a realistic description of the most likely
outcome, including the possibility that new,
unanticipated, different or worse symptoms might
result, and that death could be hastened by the
proposed treatment, based on the physician's knowledge
of the proposed treatment in conjunction with an
awareness of the patient's condition,
e. makes clear that the patient's health insurer and
provider are not obligated to pay for any care or
treatments consequent to the use of the
investigational drug, biological product or device,
f. makes clear that the patient's eligibility for hospice
care may be withdrawn if the patient begins curative
treatment and care may be reinstated if the curative
treatment ends and the patient meets hospice
eligibility requirements,
g. makes clear that in-home health care may be denied if
treatment begins, and
h. states that the patient understands that he or she 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 drug, biological product or device
states otherwise.
Status: in_force · Read it on the official government site
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