Review Criteria

A significant change has been made to the TRDRP definition of “tobacco-relatedness”, which is an important, scorable review criterion for a research study to be deemed eligible for TRDRP funding. The change will largely impact the eligibility of biomedical science research applications, so please read carefully if your field of interest lies in this area.  Eligible studies include:

1. Basic and preclinical science studies of tobacco-related diseases that incorporate nicotine and/or other constituents of commercial tobacco products.
2. Clinical, translational, or implementation studies that involve human subjects with a history of commercial tobacco product use. Such studies should also produce outcomes that will inform the prevention of initiation of commercial tobacco product use and/or be informative or beneficial for current and prior commercial tobacco product users.
3. Health behavior and health policy research focused on tobacco use prevention, cessation strategies, or tobacco product regulation.
4. Studies of inhaled cannabis use policies and their potential to erode California’s smoke-free laws.
5. Observational or laboratory studies (biomedical or behavioral) of co-use of tobacco products with other substances including cannabis.

Please note that studies focused on tobacco-related diseases that do not incorporate nicotine and/or other constituents of commercial tobacco products are not responsive to this Call for Applications. Letters of Intent (LOIs) that are not responsive to this Call for Applications will not be invited to submit a Full Application. LOIs resubmitted from the 2024 Cycle will be exempt from this new requirement for eligibility; however, resubmitted Full Applications will be peer-reviewed and scored according to this revised definition of tobacco-relatedness.

Sex as a biological variable.

Consistent with the practices of the National Institutes of Health (NIH), TRDRP requires applicants proposing experiments with biological endpoints to determine whether the sex of an animal model or human subject should be considered a biological variable in designing their experiments. Applicants should review the following paper to make that determination: https://www.sciencedirect.com/science/article/pii/S0031938417302585

The following points are taken verbatim from the article:

1. First, before conducting research, find out whether there are known sex differences in the area of study by adding the terms sex, gender, male, and female to your literature search. In addition to PubMed, use the GenderMed database.
2. Second, randomize and balance the sexes in the study and control groups. If you are testing a pharmaceutical, consult the FDA snapshot page, which provides information about sex differences in drug metabolism and effects for recently approved drugs.
3. Third, if sex differences are suspected, e.g., from the literature search, conduct pilot studies to determine whether powering the study to detect sex differences is warranted.
4. Fourth, in the analyses of the data, regardless of whether the study was powered to detect sex differences, disaggregate the data to see if there are differences that are hidden when data from males and females are pooled. Analyze key relationships for males and females separately.

Applicants should clearly state the method that was used to determine whether sex should be used as a biological variable in their study.

Cannabis use and tobacco-related diseases.

The use of inhaled (combusted or aerosolized) cannabis and its influence on tobacco use behavior, including nicotine addiction, still requires additional research, especially among tobacco priority populations. Further, the health impacts of the combined use of inhaled cannabis and nicotine products are not well known. Research on the biological and population level impact of the use of inhaled cannabis is needed to inform effective public health policies. For this reason, TRDRP funds research that includes cannabis as it relates to tobacco use, tobacco policy, or tobacco-related disease. 

NOTE: To avoid conflicts with federal and state regulations, investigators are strongly encouraged to refer to their institutional policy on conducting cannabis research before designing studies involving cannabis. Applicable federal rules may include the federal Controlled Substances Act, applicable Drug Enforcement Agency (DEA), and Food and Drug Administration (FDA) policies and regulations. California state rules require researchers to obtain approval from the Research Advisory Panel of California before conducting research in California that involves use of Schedule I or Schedule II controlled substances (see guidance on the RAPC website). Also, if research using cannabis is proposed applicants are required to describe the status of their DEA registration for the use of a Schedule I drug.

Out-of-State Expenses.

Due to the mandate that Proposition 56 research dollars must be used within California, a close review of out-of-state budget justification requests will be made. Only a very limited number of projects with out-of-state expenses can be funded.

Letter of Intent (LOI) process.

TRDRP encourages applicants to contact TRDRP staff with questions regarding eligibility requirements before submitting an LOI or application. All LOIs for the 2025 TRDRP Call for Applications will be reviewed after the LOI deadline of Thursday, August 22, 2024 at 12:00 NOON Pacific Time (PT). Applicants will be notified whether they are eligible to submit a full application by Monday, September 9, 2024.

Please note that to improve the efficiency of our peer review and grantmaking practices, TRDRP reserves the right to limit the number of letters of intent (LOIs) that will be invited to full application. The LOI review will be performed by TRDRP Scientific Staff and studies that are deemed non-responsive to the refined definition of tobacco-relatedness described above will not be invited to full application. Although tobacco-relatedness will be the primary criteria, alignment with programmatic goals will also be considered in the decision to invite to full application, i.e. some eligible studies may not be invited to full application if the study goals do not strongly align with TRDRP goals. LOIs resubmitted from the 2024 Cycle will be exempt from this new requirement for eligibility; however, resubmitted Full Applications will be peer-reviewed and scored according to this revised definition of tobacco-relatedness.