Texas Compassionate-Use Institutional Review Boards to Monitor Medical Marijuana Research – Newly Proposed Rule - Comment Period Open

Author: Andrea Steel

Date of publication: August 20, 2021

As mentioned in one of my recent articles, the last legislative session made slight expansions to the Texas Compassionate Use Program (“TCUP”), which serves as the State’s only pathway to legally access non-hemp cannabis (a/k/a marijuana or “marihuana”).?TCUP is an extremely restrictive medical marijuana program allowing registered patients with qualifying conditions to use a limited array of low-THC cannabis products (as of September 1, 2021, the THC cap will increase from 0.5% to 1%).??

One of the provisions of the new law provides for the Health & Human Services Commission (“HHSC”) to create compassionate use institutional review boards (“CIRBs”).[1] ?Generally, an institutional review board is an administrative body or formal committee, often within an academic setting, that reviews and oversees research on human subjects to ensure protection of their rights and welfare and compliance with ethical guidelines. ?HHSC has already established two institutional review boards, but they do not appear to be connected to the newly authorized CIRBs.?The new law allows these CIRBs to be created to research low-THC cannabis medical use for any condition designated by the HHSC Executive Commissioner (not just the nine named diagnoses).[2]

A proposed rule relating to CIRBs has been published in the August 20th edition of the Texas Register, but it is broad in nature and lacks details.?Though the stated purpose of the proposed rule is to provide guidelines for CIRBs, it essentially reiterates the recently passed legislation but fails to provide interested parties with any substantive details on how to participate.?

Background – What Does the New Law Say?

Before detailing what is in the proposed rule, it is helpful to understand the recently passed law concerning CIRBs.

Under the new law, which goes into effect September 1, 2021, one or more CIRBs may be established.?The proposed rule establishes one. This is reminiscent of the initial TCUP bill, which required at least three dispensaries be licensed under the program but subsequent rules and procedures resulted in only three licensees.

The CIRBs serve the purposes of not only evaluating medical use, but also overseeing patient treatment and, interestingly, certifications of treating physicians.?A physician treating a patient under an CIRB-authorized research program is required to be certified by that CIRB.

Under current law and regardless of CIRB status, in order for a physician to be able to prescribe[3] low-THC cannabis through TCUP, s/he must be properly licensed, board certified in a relevant medical specialty and essentially specialize in the patient’s particular medical condition. The physician must also register with the State’s Compassionate Use Registry as the patient’s prescriber (but the doctor’s name cannot be published unless s/he expressly consents). The physician is also required to maintain a patient treatment plan that includes dosage, means of administration, anticipated duration of treatment, and a plan to monitor symptoms and indications of tolerance or reactions to low-THC cannabis.

Patients in the TCUP program, whether part of a CIRB or not, must be permanent residents of Texas, and CIRB patients must also sign a written consent to receive the research treatment (or a parent/guardian/conservator must consent on behalf of a minor or incapacitated patient).

CIRBs must submit written reports on their findings by October 1, yearly to HHSC, and every other year to the legislature (even-numbered years).

CIRBs must be affiliated with one of the licensed TCUP dispensing organizations (recall there are currently only three in the state) and meet one of the following criteria:

1. be affiliated with a medical school as defined under Section 61.501, Texas Education Code;[4]
2. be affiliated with a hospital licensed under Chapter 241 that has at least 150 beds;
3. be accredited by the Association for the Accreditation of Human Research Protection Programs;
4. be registered by the United States Department of Health and Human Services, Office for Human Research Protections, in accordance with 21 C.F.R. Part 56; or
5. be accredited by a national accreditation organization acceptable to the Texas Medical Board.

What Does the Proposed Rule Say?

Under the law, HHSC was granted the authority to adopt all rules necessary to implement the CIRB program.?

The proposed rule implies a CIRB approval process whereby the principal investigator of a proposed research program must clearly identify the medical condition to be treated and shall study only that medical condition identified in the CIRB-approved application.?An end date of any CIRB-approved study must be established, but the actual end date may be earlier if either the principal investigator chooses, or if the CIRB suspends or terminates the program due to violations or the treatment is associated with unexpected serious harm to subjects.?Note that suspension/termination can be authorized for mere association and not necessarily causation.

The proposed rule also states that CIRB-approved research programs are non-transferable.

The rule includes a few other subsections that reiterate the law regarding patient and physician qualifications and written report deadlines but adds nothing else of substance.?

There are no other requirements or timelines and no details about applications.?In some respects, this broadness is preferable because the lack of details and restrictions allows for more flexibility and creativity, but on the other hand the lack of specificity provides minimal guidance for interested stakeholders.

What Should the Proposed Rule Include?

More details! Rules relating to research and institutional review boards for other programs in Texas exist and are more fleshed out.?It seems this rule is being proposed simply to have some progress before the September 1 effective date, but this attempt is not very informative.?Specifics with respect to timelines, reporting hierarchy, application guidelines, details as to applicability of other Department of State Health Services IRB policies at the very least are important factors that should be included.

While the State’s health agencies have much more important issues to deal with right now (ahem, COVID-19), it would be incredibly beneficial for a task force or advisory council to be established to focus specifically on the future of the state’s medical marijuana program.?The expansion of the TCUP program (and legality of cannabis generally) is inevitable and Houston is home to the world’s largest medical center. The best and the brightest are right here and can and should be utilized to provide another innovation pathway for Texas’s ascent as a medical breakthrough leader.

Written comments to the proposed rule are being accepted through September 20, 2021.?Contact us if you would like additional information.

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[1] Chapter 487, Texas Health and Safety Code, Subchapter F, as authorized by HB 1535.

[2] To otherwise qualify for TCUP, a patient must be diagnosed with epilepsy, a seizure disorder, MS, spasticity, ALS, autism, cancer, an incurable neurodegenerative disease, or PTSD.

[3] Because marijuana remains illegal under federal law, doctors cannot actually “prescribe” it, but a 2019 change to the TCUP law expressly states that any reference to a prescription for low-THC cannabis in any law means an entry in the TCUP registry.

[4] Medical schools meeting this definition are: The University of Texas Health Science Center at Houston, the medical school at The University of Texas Southwestern Medical Center, the medical school at The University of Texas Health Science Center at San Antonio, The University of Texas Medical Branch at Galveston, the medical school at The University of Texas at Austin, the medical school at The University of Texas Rio Grande Valley, the medical education program of The University of Texas Health Science Center at Tyler, the medical school at the Texas Tech University Health Sciences Center, the medical school at the Texas Tech University Health Sciences Center at El Paso, the Sam Houston State University College of Osteopathic Medicine, the University of Houston College of Medicine, the Baylor College of Medicine, the college of osteopathic medicine at the University of North Texas Health Science Center at Fort Worth, or the medical school at the Texas A&M University Health Science Center.