Texas Register

RULE §1.65Compassionate-use Research and Reporting
ISSUE 11/12/2021
ACTION Final/Adopted
Preamble Texas Admin Code Rule

(a)One or more compassionate-use institutional review boards (CIRBs) may 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)treatment is administered by a physician in accordance with Texas Occupations Code §169.002 and the physician is 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.


  (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 adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on October 28, 2021


Scott A. Merchant

Interim General Counsel

Department of State Health Services

Effective date: November 17, 2021

Proposal publication date: August 20, 2021

For further information, please call: (512) 776-3829

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