Guidance on Hemp and Cannabis Research and Funding

Guidance on Industrial Hemp and Cannabis Research and Funding

This guidance is intended to provide information to Southern Illinois University (SIU) researchers, research administrators, faculty, staff and students regarding the legal and policy issues related to research and funding involving industrial hemp and cannabis. Failure to comply with federal regulations could put federal funding at risk.

The term "hemp" means the plant species Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration (THC) of not more than 0.3 percent on a dry weight basis.

Important things to consider:

Industrial hemp can only be grown in licensed plots. Investigators are responsible for ensuring planting, harvesting, and disposal reports are correctly filed with the appropriate state or federal office(s). Hemp grown for research purposes must be disposed of at the conclusion of the research period. Contact the Office of Research Compliance for additional information.
While many states are legalizing the use of cannabis for medical or recreational purposes, cannabis is still illegal under federal law.
Universities (like SIU) receiving federal funds are obligated to comply with the Safe and Drug-Free Schools and Communities Act and the Drug-Free Workplace Act.
Federal laws require SIU to implement policies that prohibit the unlawful manufacture, distribution, dispensing, possession, or use of any controlled substances at SIU.

Federal and State Regulations

United States Department of Agriculture (USDA)

United States Department of Agriculture (USDA)

Section 7606 of the 2014 Farm Bill legitimized industrial hemp research, hemp-related research and associated outreach. The following information about the USDA Hemp Production Program and USDA NIFA funded hemp research and extension is being provided since the 2018 Farm Bill was signed into law and implementation of 2018 Farm Bill provisions by USDA.

This Bill created the Domestic Hemp Production Program, which allowed for hemp to be grown outside of a research setting. Under the 2018 Farm Bill, states are required to either submit their hemp plans for approval to USDA or allow USDA to directly regulate hemp in that state.

The Farm Bill of December 2018 amended the Federal Controlled Substances Act to specifically exclude hemp and hemp derivatives from the definition of marijuana, so hemp plants (often labeled "industrial hemp") are legal and can be used for research so long as the Delta-9 Tetrahydrocannabinol (THC) concentration does not exceed 0.3% by dry weight.

Funding

Any activity supported by the National Institute of Food and Agriculture (NIFA) funds must comply with federal law. NIFA funds can be used for industrial hemp research. NIFA funds cannot be used for research with cannabis. Rresearch activity with cannabis could subject parties to criminal liability under the federal Controlled Substances Act. This includes programs and activities where mixed funding models include federal funds.

U.S. Food and Drug Administration (FDA)

U.S. Food and Drug Administration (FDA)

The FDA also regulates research involving cannabis. The FDA considers cannabis containing more than 0.3% THC to be a regulated drug, and thus requires an individual or an organization wishing to conduct research on cannabis to submit a New Drug Application (NDA) proposing an Investigational New Drug (IND) to the FDA's Center for Drug Evaluation and Research (CDER), just as any other potential drug research would require.

Illinois Department of Agriculture (IDOA)

Illinois Department of Agriculture

In 2015, the Industrial Hemp Pilot Program became effective in Illinois Law. This statute allowed for researchers and institutions of higher education to grow hemp for educational and research purposes.

In August 2018, the Industrial Hemp Act became effective in Illinois. This Act expanded the growing and processing of hemp outside of higher education and researchers, and allowed for farmers and others to plant and process hemp in Illinois.

On January 1, 2020, the Cannabis Regulation and Tax Act became effective in Illinois. The Act changed state law to allow adults aged 21 years or older to possess and use cannabis and those who are registered qualifying patients under the Compassionate Use of Medical Cannabis Pilot Program Act to cultivate a limit of no more than 5 cannabis plants, both of which have certain restrictions.

In November 2020, Illinois, through the Illinois Department of Agriculture (IDOA), submitted a Hemp Plan to the United States Department of Agriculture (USDA), which was approved. In March of 2021, a new set of rules was published by the federal government, which required revision of Illinois's hemp plan. IDOA has submitted a new Hemp Plan, which USDA has approved.

Drug Enforcement Agency (DEA)

Drug Enforcement Agency (DEA)

The Drug Enforcement Agency (DEA) maintains a Schedule I classification for cannabis, classifying it as a drug with "no currently accepted medical use" in the United States, along with drugs like heroin and ecstasy. As a Schedule I Controlled Substance, the use, possession, distribution, and cultivation of cannabis is illegal under the federal Controlled Substances Act, with limited exceptions (including exceptions that allow certain research that complies with strict federal controls). The Department of Justice (DOJ)/DEA has authority to enforce the Controlled Substances Act, including through civil and criminal penalties.

The August 21, 2020 DEA Interim Final Rule allows for research without a Schedule I license if the end product of the plant being researched has less than 0.3 % THC.

Research That Does Not Involve the Possession and Use of Cannabis

The following types of research and other activities are acceptable (as long as the funding is not from a prohibited source), with normal approvals for research:

Surveys of individuals already using cannabis for recreational or medical purposes.
Environmental impact studies on the impact of cannabis cultivation on the environment.
Research on the socioeconomic effects of cannabis cultivation, sale, or use.
Research on policy and legislative issues concerning cannabis.
Establishing websites or publishing newsletters through which results of the above referenced research or other information on cannabis may be disseminated.
Conducting conferences, seminars, or informal meetings intended to provide objective information to SIU staff and the public on various cannabis-related issues.

Links

USDA 2018 Farm Bill
USDA Final Rule
USDA Hemp Production

FDA New Drug Application Guidance
FDA Regulation of Cannabis

IDOA Hemp Plan
IDOA Industrial Hemp

DEA Website
DEA Diversion Control Division

NIDA's Role in Providing Cannabis for Research

Risks in Accepting Funding from the Cannabis Industry

The cannabis industry includes cultivators, manufacturers, distributors, and retailers. It can also include trade association groups and those organizations that provide ancillary products and services to support federally illegal cannabis-related activities (e.g., lighting or hydroponic equipment companies whose main clientele is the marijuana industry).

There are concerns about accepting funding from or conducting transactions with members of this industry, either directly or indirectly. Possible legal risks of accepting funding from cannabis entities include:

• Federal criminal charges of money laundering or aiding and abetting and violations of the Controlled Substances Act;

• Risk of federal forfeiture (i.e., funds that are determined to be the proceeds of criminal activities, which could apply if funds donated to a university were derived from the donor's sale or distribution of cannabis, and can be seized by the federal government);

• Allegations that the university has violated the Drug Free Schools Act and/or the Drug Free Workplace Act, which could put its federal funding at risk;

• Reputational risks of working with an individuals or entities engaged in illegal activities.

Due to the risks involved, SIU campuses may not accept donations, grants or other funding from entities or individuals known to directly derive most or all of their funding from conducting cannabis-related activities that are illegal under federal law (e.g., sale, cultivation, distribution).

This includes grants that are earmarked specifically for the study of the impact of cannabis directly from companies that distribute or manufacture cannabis products or foundations that are created by such companies.

Cannabis Research

Research involving the possession and use of cannabis in humans and animals is allowable if the researcher has obtained a Schedule I registration with the DEA and approval for their research protocol through scientific review by the U.S. Food and Drug Administration's Investigational New Drug process.

Must obtain DEA Schedule I registration for research project

Must obtain cannabis from National Institute on Drug Abuse (NIDA), procured at University of Mississippi (or other sources approved by the DEA). At present, only the University of Mississippi is authorized to produce marijuana plant-based products for use by researchers in the U.S.

Must obtain approval from the FDA for clinical and non-clinical research

Must obtain other standard research approvals from the appropriate institutional review board(s) (IRBs) and Institutional Animal Care and Use Committee(s) (IACUCs) if research involves humans or animals.

Cannot accept research funding from individuals or entities that directly obtain most of their revenue from the cannabis industry in violation of federal law.

May conduct cannabis research that does not involve the direct use, possession, distribution, or cultivation of cannabis (e.g. surveying individuals who use cannabis, analyzing public records, and data)

Guidance on Hemp and Cannabis Research and Funding | Office of Research Compliance | SIU

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