PRINT DISCLAIMER: Official version of this document is accessible in the online policy library at https://policyoffice.ku.edu/. Printed copies may not reflect the most recent updates.
DOCUMENT TYPE:
Policy
PURPOSE:
To support and facilitate safe and responsible conduct of human research studies involving the administration of alcohol under the auspices of the University of Kansas Human Research Protection Program (HRPP).
APPLIES TO:
Researchers whose human research project involves administration of alcohol to human subjects.
CAMPUS:
Lawrence, Edwards, Leavenworth, Juniper Gardens, Parsons, Pittsburg, Salina, Topeka, Wichita, Yoder
POLICY STATEMENT:
The University of Kansas (KU) supports scientific inquiry involving administration of alcohol to human research participants. The Office of Research and the Office of the Provost in collaboration with Human Research Protection Program (HRPP) coordinate the campus-wide structure to support and facilitate safe conduct of human research involving administration of alcohol to human research participants. All researchers must receive approval of their proposed research study from HRPP. In addition, approval of purchase, storage, and space of alcohol used for administration to human research participants must be coordinated with the Office of Research Fiscal Affairs; Environment, Health & Safety; and the Office of the Provost, respectively, as appropriate. Further information regarding additional approvals that may be required is available by contacting HRPP. All researchers must abide by all applicable laws and university policies concerning the administration of alcohol in human research.
Minimum requirements for administration of alcohol to human research participants:
- The Principal Investigator (PI) or Faculty Supervisor of the research protocol must be a KU faculty member or have Regular Principal Investigator status.
- All research study team members who handle alcohol must be 21 or over.
- Research activities must occur in approved campus facilities. The Cofrin Logan Center for Addiction Research and Treatment (CLC) supports most social-behavioral research involving administration of alcohol. Other locations and conditions must be reviewed and approved through the Office of Research prior to HRPP approval of the study. Overnight stays are not currently supported.
- University of Kansas Center for Research (KUCR) or KU funds must be used to purchase alcohol for research use. Researchers must follow State of Kansas provisions for non-beverage use of alcohol for research purposes. State permits for purchase of alcohol for non-beverage research purposes, including HRPP projects, must be obtained through the Office of Research Business Services.
- The PI will need to complete a supplemental form to be submitted with the study materials to HRPP.
- Participants must be screened using the HRPP screening template or a more extensive screening tool appropriate for the study prior to a research session involving administration of alcohol.
- All participants must meet the following requirements to participate in human research involving alcohol:
- Be over the age of 21;
- Must not have medical/health issues or be using medications that may increase risk of complications due to consumption of alcohol (for more information see National Institute on Alcohol Abuse and Alcoholism);
- Must be a previous consumer of alcohol;
- Not have a history of or meet DSM-5 criteria of moderate or severe alcohol use disorder; and
- Not be currently participating in an alcohol or substance use disorder treatment program, seeking treatment, or planning on reducing use in the near future.
- Any participants that do not meet all of the minimum requirements to participate in human research involving alcohol requires scientific justification and, if approved, may require additional safety or security measures to secure approval.
- When screening identifies individuals who may be at risk for alcohol or substance use disorder, researchers must refer those individuals to appropriate resources for assistance (see List of Resources within the PI Handbook: Administration of Alcohol in Human Research).
- Target blood alcohol concentration (BAC) should not exceed a level that the subject has reached with self-administration on at least some occasions in the past year, as self-reported on the applicable screening tool.
- Study team members must be trained on an emergency preparedness plan, which must be described in the supplemental form submitted with the study materials to HRPP.
- Research study team members, as defined in the approved protocol, must stay and be available to the participants from intake to the study session until the individual is released, when blood alcohol concentration is 0.02% or less.
- Participants leaving the study session with a BAC more than 0.04% must be provided transportation to their home address.
CONSEQUENCES:
Research study team members who do not comply with the policy may be subject to employee and/or student disciplinary action. The Institutional Review Board has the authority to suspend or terminate a previously approved human subjects’ protocol.
CONTACT:
Research Integrity Director
(785) 864-4148
Researchintegrity@ku.edu
APPROVED BY:
Vice Chancellor for Research
APPROVAL DATE:
2025-06-25
EFFECTIVE DATE:
2025-06-25
REVIEW CYCLE:
Annual (As Needed)
RELATED RESOURCES:
National Institute on Alcohol Abuse and Alcoholism
NIAA guidance
PI Handbook: Administration of Alcohol in Human Research
CHANGE HISTORY:
06/26/2025: New policy published in Policy Library