Research with Prohibited Materials

PURPOSE / SCOPE:

• This policy applies to all ICOM-affiliated research activities. If more than one institution/entity is collaborating with ICOM, the guidelines, laws and regulations for both entities must be followed when planning a research project. 
• The purpose of this policy is to protect individuals, facilities, and the environment, and to comply with legal and regulatory requirements.
• Adherence to this policy ensures the safety and well-being of individual researchers and the public, provides guidance for the protection of sensitive materials from misuse or unauthorized access and enforces the “culture of safety” for ICOM Research.

DEFINITIONS:

• Controlled Substance: A drug or other substance that is tightly controlled by the government because it may be abused or cause addiction. The control applies to the way the substance is made, used, handled, stored, and distributed. Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Controlled substances with known medical use, such as morphine, Valium, and Ritalin, are available only by prescription from a licensed medical professional. Other controlled substances, such as heroin and LSD, have no known medical use and are illegal in the United States. Source: Cancer.gov
• Drug Enforcement Administration (DEA): The Drug Enforcement Administration is a United States federal law enforcement agency under the U.S. Department of Justice tasked with combating illicit drug trafficking and distribution within the U.S.
• Dual Use Research of Concern (DURC): life sciences research products or methods that could be misapplied to pose a threat to public health or national security. Institutional Biosafety Committees are obligated to review research that could be classified as DURC. For example, DURC would be reviewed for an experiment involving the genetic modification of a flu virus to be more virulent or contagious. Recent Guidance: Dual Research of Concern and Pathogens with Enhanced Pandemic Potential.
• Select Agent and Toxins: biological substances deemed to pose a severe threat to public, animal, or plant health by the U.S. Department of Health and Human Services (HHS) or the U.S. Department of Agriculture (USDA). The Federal Select Agent Program (FSAP) regulates their possession, use, and transfer to ensure safety and security. These substances can include bacteria, viruses, fungi, and their toxins.

POLICY:

Any persons affiliated with ICOM (faculty, staff, student physicians, visitors) planning to or working with prohibited/restricted materials are required to follow all policies and procedures for security, notification, training, compliance,  reporting, obtaining permits and federal and local laws, guidelines, and regulations. All persons at ICOM, including ICOM Administration, the Research Department, and research study teams bear responsibility for creating and maintaining a safe, ethical and legal environment for research to take place. A detailed list of prohibited and restricted materials and the specific procedures for their handling are outlined in the Research with Prohibited Materials Procedure. Failure to comply with federal and state rules and regulations can result in significant fines and/or jail time in addition to disciplinary action by ICOM.

PRIMARY POLICY OWNER:

Assistant Dean of Research

APPROVAL:

Effective: 9/23/25

Last Reviewed: 9/23/25

Review Requirement: 3 Years

CROSS REFERENCE AND SUPPORTING DOCUMENTS:

Information and links to other policies or supporting documents referenced within this policy.