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(a)A compassionate-use institutional review board
(CIRB) will be established to evaluate and approve proposed research
to study the medical use of low-THC cannabis, in accordance with Texas
Health and Safety Code §487.253.
(b)When seeking approval from a CIRB, the principal
investigator of a proposed research program must clearly identify
the medical condition for which a patient will be treated with low-THC
cannabis.
(c)A principal investigator shall only study the use
of low-THC cannabis in treating the medical condition identified in
the proposed research program application approved by a CIRB.
(d)The CIRB shall specify an end date to any study
it approves. A study may terminate earlier than the date specified
by the CIRB if the principal investigator chooses to end the study
early. However, a CIRB shall have authority to suspend or terminate
approval of research that is not being conducted in accordance with
the CIRB's requirements or that has been associated with unexpected
serious harm to subjects.
(e)Approval of a research program by a CIRB is not
transferable to another research program.
(f)A medical condition may be treated with low-THC
cannabis as part of an approved research program if:
(1)treatment is overseen by a CIRB;
(2)it is administered by a physician in accordance
with Texas Occupations Code §169.002 and certified by a CIRB
to participate in the program;
(3)the patient is a resident of Texas; and
(4)the patient or, if the patient is a minor or lacks
capacity to consent, a parent, guardian, or conservator signs a written
informed consent form provided by the approved research program.
(g)Reports.
(1)Not later than October 1 of each year, each CIRB
must submit a written report that describes and assesses the research
findings of each approved research program to the Texas Department
of State Health Services.
(2)Not later than October 1 of each even-numbered
year, each CIRB must submit a written report that describes and assesses
the research findings of each approved research program to the Legislature.
The agency certifies that legal counsel has
reviewed the proposal and found it to be within the state agency's
legal authority to adopt.
Filed with the Office
of the Secretary of State on August 9, 2021
TRD-202103085 Barbara L. Klein
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 19, 2021
For further information, please call: (512) 776-3829
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